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    Q&A WITH MORGAN GREGORY GOOGLE CLOUD OFFICE OF THE CTO: STRATEGY & PROGRAMS AT GOOGLE

    Apr 30, 2020

    Morgan Gregory, Google Cloud Office of the CTO: Strategy & Programs at Google runs strategy and programs for Google Cloud's CTO Office, working closely with their senior leaders and technical CXOs of strategic customers on co-innovation and thought leadership initiatives. Morgan has a passio...

    DECK 7
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    TSCAN AND NOVARTIS PARTNER TO DEVELOP CANCER THERAPIES

    Apr 16, 2020

    Biopharmaceutical firm TScan Therapeutics has signed an agreement with Novartis to discover and develop therapies for the treatment of cancer. The companies aim to work on TCR-engineered T-cell therapies for solid tumours. TScan’s platform will identify cancer antigens that could be targeted b...

    PHARMACEUTICAL TECHNOLOGY
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    BEIGENE REPORTS POSITIVE PHASE III INTERIM ANALYSIS FOR LUNG CANCER DRUG

    Apr 14, 2020

    Interim results from a Phase III clinical trial have shown that patients receiving a cancer immunotherapy drug for a form of lung cancer on top of chemotherapy were more likely than those receiving chemotherapy alone to survive without their disease worsening, the company developing the drug said Mo...

    MEDCITY NEWS
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    WOULD-BE CORONAVIRUS DRUGS ARE CHEAP TO MAKE

    Apr 10, 2020

    With a vaccine for the novel coronavirus still likely a year or more away, the first weapon against the virus could be one of the drugs now in clinical trials with COVID-19 patients. A new analysis out today shows that many of these drugs, which are currently manufactured or in development to treat ...

    SCIENCE
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    ANTI-PARASITIC DRUG SAID TO 'KILL' COVID-19 CELLS

    Apr 09, 2020

    Scientists in Australia have found that an anti-parasitic drug available on the market “can kill” the growing cell culture of the deadly coronavirus within 48 hours. However, researchers say the drug cannot be used in humans for COVID-19 until further testing and clinical trials prove it...

    ALCOHOLICS ANONYMOUS
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    MEDICAL MORPHINE MARKET MAY SEE A BIG MOVE PFIZER, PURDUE PHARMA, HIKMA PHARMACEUTICALS

    Apr 08, 2020

    Advance Market Analytics released the research report of Global Medical Morphine Market, offers a detailed overview of the factors influencing the global business scope. Medical Morphine Market research report shows the latest market insights with upcoming trends and breakdown of the products and se...

    OPENPR
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    ASHP DEMANDS MORE MANUFACTURING OF VENTILATOR DRUGS FOR COVID-19

    Apr 07, 2020

    ASHP recently urged the Trump administration to take action to address shortages of supportive ventilator drugs as the number of confirmed COVID-19 cases continues to rise. The American Society of Health-System Pharmacists (ASHP) recently called on the Trump Administration to address shortages of su...

    PHARMANEWSINTELLIGENCE
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    ELI LILLY, SITRYX SIGN POTENTIAL $880M DEAL TO DEVELOP IMMUNOMETABOLIC MEDICINES

    Apr 01, 2020

    Eli Lilly has entered into a potential $880m research deal with Sitryx to discover and develop new immunometabolic medicines. Under an exclusive global licensing and research collaboration, the companies will involve in the assessment of up to four novel preclinical targets detected by Sitryx. The n...


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    ASTELLAS, CYTOMX FORM T-CELL ENGAGING CANCER ANTIBODIES PARTNERSHIP

    Mar 26, 2020

    Astellas has entered into a new partnership with CytomX Therapeutics, in order to develop T-cell engaging bispecific antibodies targeting CD3 and tumour cell surface antigens for the treatment of cancer. The companies have revealed that the deal, which is potentially worth more than $1.6 billion, wi...


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    INTENT DATA IN THE AGE OF DATA REGULATION

    Mar 23, 2020

    Since the implementation of Data Protection Act in 2018, the approach behind the use of data has changed dramatically. Our clients and customers don’t just want a great experience, they also want to make sure they can trust us. Tweet This! And it makes perfect sense in the present time and spa...

    DECK 7
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    VALERITAS RECEIVES COURT APPROVAL OF SALE OF BUSINESS TO ZEALAND PHARMA

    Mar 20, 2020

    Valeritas Holdings, Inc.("Valeritas" or the "Company"), a medical technology company and maker of the V-Go® Wearable Insulin Delivery device, today announced that the U.S. Bankruptcy Court for the District of Delaware (the "Court") approved the sale of substantially...


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    CORRECTING AND REPLACING CIRCLE PHARMA RAISES $45 MILLION IN SERIES B FINANCING

    Mar 17, 2020

    Circle Pharma, Inc., a macrocycle drug discovery and development company focused on intractable cancer targets, today announced that it has raised $45 million in a Series B financing. The financing was led by The Column Group, with participation by Nextech Invest. All investors from the prior round ...


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    HOW EHR-INTEGRATED PDMPS INCREASE INTEROPERABILITY, DECREASE BURDEN

    Mar 11, 2020

    A prescription drug monitoring program (PDMP) that is implemented into the EHR can decrease the strenuous process of checking the PDMP, thus reducing the cognitive workload and burden for the clinician. However, only one-in-three hospitals can access PDMP data within its EHR system. PDMPs are state-...


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    UROGEN PHARMA ANNOUNCES INDUCEMENT GRANT UNDER NASDAQ LISTING RULE 5635(C)(4)

    Mar 06, 2020

    UroGen Pharma Ltd. a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced the grants of inducement restricted stock units (“RSUs”) to seventy-six new employees in connec...


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    CHINA TURNS ROCHE ARTHRITIS DRUG ACTEMRA AGAINST COVID-19 IN NEW TREATMENT GUIDELINES

    Mar 04, 2020

    Some patients infected with the novel coronavirus can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. After seeing promising results in clinical practice, Chinese authorities now recommend a Roche arthritis drug to tackle that rampage. Roche&rsquo...


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    GILEAD TO ACQUIRE IMMUNO-ONCOLOGY COMPANY FORTY SEVEN FOR $4.9 BILLION

    Mar 02, 2020

    Gilead Sciences is buying Forty Seven for $95.50 per share, or a deal value of $4.9 billion. The deal was unanimously approved by both companies’ boards. Gilead picks up Forty Seven’s lead product candidate, magrolimab, a monoclonal antibody in the clinic for several cancers, including m...


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    TETRA BIO-PHARMA ENTERS INTO CO-DEVELOPMENT AGREEMENT WITH MAKSCIENTIFIC

    Feb 27, 2020

    Tetra Bio-Pharma Inc. a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has signed a co-development definite agreement with MAKScientific. This agreement provides Tetra with access to novel patented new molecules with CB1 and CB2 agonist or antagonist pro...


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    OXYCONTIN MAKER PURDUE PHARMA STARTS AD CAMPAIGN FOR CLAIMS

    Feb 25, 2020

    OxyContin maker Purdue Pharma launched an ad campaign Monday to tell people harmed by their powerful prescription opioid where they can file claims against the company. The $23.8 million campaign is part of Purdue's bankruptcy proceedings as it tries to resolve close to 3,000 lawsuits over its r...


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    POWERFUL ANTIBIOTIC DISCOVERED USING MACHINE LEARNING FOR FIRST TIME

    Feb 21, 2020

    A powerful antibiotic that kills some of the most dangerous drug-resistant bacteria in the world has been discovered using artificial intelligence. The Guardian reports To find new antibiotics, the researchers first trained a "deep learning" algorithm to identify the sorts of molecules tha...


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    VIFOR PHARMA ACQUIRES PRIORITY REVIEW VOUCHER

    Feb 17, 2020

    Vifor Pharma today announced that it has agreed to purchase a US Food and Drug Administration (FDA) priority review voucher (PRV). Vifor Pharma Group is a global speciality pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The com...


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    ACERUS ANNOUNCES PRIVATE PLACEMENT AND REFINANCING TRANSACTIONS

    Feb 13, 2020

    Acerus Pharmaceuticals Corporation Today announced that it has entered into agreements with First Generation Capital, Inc. (“First Generation”) in respect of an equity financing and debt-to-equity conversion by First Generation and with SWK Funding LLC (“SWK”) in respect of a...


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    HUATENG PHARMA DEVELOPS SPRAY AGAINST NEW CORONAVIRUS INFECTION

    Feb 11, 2020

    This year is an unusual year due to the infection of the Novel Coronavirus Pneumonia (NCP) epidemic. Hunan Huateng Pharmaceutical Co., Ltd. (hereinafter referred to as Huateng)， as a drug research and development company with rich experience in developing antiviral drugs, has attached close attentio...


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    AS ADCETRIS SLOWS, SEATTLE GENETICS TOUTS EARLY LAUNCH FIGURES FOR BLADDER CANCER MED PADCEV

    Feb 07, 2020

    It wasn’t long ago when Seattle Genetics shareholders moved past earlier letdowns and cheered strong performance from key cancer drug Adcetris. But now, they might be disappointed again. During the fourth quarter, Adcetris pulled in sales of $166.2 million in the U.S. and Canada, a 26% increas...


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    MERCK TO SPIN OFF WOMEN’S HEALTH AND BIOSIMILAR DRUG BUSINESSES

    Feb 05, 2020

    Merck & Co Inc said on Wednesday it will spin off its women’s health, biosimilar drugs and older products into a separate publicly traded company as it tightens its focus on growth drivers like cancer drug Keytruda and vaccines. The new company’s assets currently make up around 15 pe...


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    GILEAD CLIMBS AS CORONAVIRUS DRUG SHOWS EFFICACY, STARTS TRIAL

    Feb 03, 2020

    Gilead has made progress in its effort to reposition failed Ebola drug remdesivir as a treatment for the coronavirus sweeping across China. In quick succession, it emerged that the nucleotide analogue prodrug appeared to help the first U.S. case of the virus and is set to undergo clinical testing in...


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    J&J LAUNCHES ‘MULTI-PRONGED’ CORONAVIRUS RESPONSE

    Jan 30, 2020

    The company has initiated efforts to broadly collaborate with others in order to screen a library of antiviral therapies, hoping to identify compounds with antiviral activity against the virus – which is also known as 2019-nCoV or Wuhan coronavirus. Using its AdVac and PER.C6 technologies - th...


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    PFIZER LAYS OUT GENE THERAPY ASPIRATIONS

    Jan 28, 2020

    Pfizer aims to be the third big pharma with a significant presence in gene therapy. Its plans to initiate this year three Phase 3 trials targeting mutation-driven blood and muscular diseases would make it a large player in this cutting-edge area of medicine. The difference between Pfizer and its Swi...


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    OCUPHIRE PHARMA ANNOUNCES IN-LICENSE OF PHASE 2 ORAL SMALL MOLECULE DRUG CANDIDATE FOR DIABETIC RETINOPATHY

    Jan 22, 2020

    Ocuphire Pharma, Inc., a clinical-stage pharmaceutical company focused on the development and commercialization of therapies to treat patients with a variety of ophthalmic disorders, today announced that it has entered into an agreement with Apexian Pharmaceuticals, Inc., granting Ocuphire an exclus...


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    CIVICA RX PARTNERS WITH THERMO FISHER SCIENTIFIC TO DEVELOP AND MANUFACTURE DRUGS WITH A HISTORY OF DRUG SHORTAGES

    Jan 16, 2020

    Today announced it has signed a long-term agreement with Thermo Fisher Scientific to develop and manufacture medications with Civica as the owner of the regulatory pathway. By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufac...


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    GROUND-BREAKING COLLABORATION TO OFFER NEW HEART DISEASE DRUG TO NHS PATIENTS

    Jan 14, 2020

    The government on Monday announced a collaboration with Novartis to launch a clinical trial for ‘yet to be approved’ drug inclisiran. The drug could benefit thousands of patients at risk of heart disease in coming years. The ground-breaking collaboration includes Novartis, NHS England an...


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    FIVE WAYS PHARMA IS LEVERAGING DIGITAL THERAPEUTICS TO DEMONSTRATE VALUE TO HEALTH PLANS

    Jan 10, 2020

    Some estimates now put the cost of developing a new drug at nearly $2.9 billion. Adding to this financial pressure, pharmaceutical companies have little control over what CMS, health plans and PBMs will agree to pay for approved drugs, or if their new drugs will be listed on formularies—often ...


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    GALEN TAKES OVER POA PHARMA, EXPANDS REACH

    Jan 08, 2020

    Irish pharma firm Galen has announced the completion of its POA Pharma (POA) acquisition. The company has stated that the multi-million pound takeover will help to “significantly expand” its global reach and product portfolio in exciting new therapy areas, such as rare metabolic disease....


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    BENZER PHARMACY GROUP AND QUALITYCARE PHARMACIES INK DEAL

    Jan 06, 2020

    Tonya Shackelford, Benzer Pharmacy, President, “We are thrilled that QualityCare Pharmacies has joined our GPO Model. QualityCare members will benefit from the comprehensive healthcare program and preferred pricing and pharmacy management model driven through Benzer. Not to mention, Benzer off...


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    MACHINE LEARNING PLATFORMS GENERATES MORE ALERTS FOR DRUG ERRORS

    Jan 02, 2020

    A new machine learning platform can generate clinically valid alerts for medication errors that might be missed with existing clinical decision support (CDS) systems, according to a study published in the January issue of The Joint Commission Journal on Quality and Patient Safety. Dr Ronen Rozenblum...


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    NORTH AMERICA TRADE PACT DEALS RARE SETBACK TO BIG PHARMA

    Dec 20, 2019

    A revamped North American trade deal nearing passage in Congress gives both the White House and Democrats a chance to claim victory and offers farmers and businesses clearer rules governing the vast flow of goods among the United States, Canada and Mexico. But the pact leaves at least one surprising...


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    OBALON ENTERS INTO A DISTRIBUTION AGREEMENT FOR QATAR

    Dec 18, 2019

    Obalon Therapeutics, Inc. a vertically integrated weight loss solutions company with the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity, announces that it has entered into a one-year agreement with Al Danah Medical Company (“Al Dana...


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    ANTIBE ENGAGES GLOBAL CMO TO SUPPORT PLANNED PAIN DRUG PARTNERSHIP LIKE

    Dec 16, 2019

    Toronto, Canada-based Antibe Therapeutics is running a Phase IIb clinical trial of ATB-346, a hydrogen sulfide-releasing derivative of naproxen, to generate more efficacy and metabolism data. Antibe designed ATB-346 to deliver the positive effects on pain and inflammation that make naproxen a widely...


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    KROGER AND WALGREENS TO BUY PRODUCTS TOGETHER TO CUT COSTS

    Dec 12, 2019

    Grocery store Kroger and drug store Walgreens are teaming up. In an effort to cut supplier costs, the two companies want to start buying merchandise together, CNBC reported. The chain retailers will call this partnership the Retail Procurement Alliance, and will have them identifying overlap in prod...


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    RESEARCH SHOWS THE PHARMA INDUSTRY BELIEVES AI WILL LIKELY OPTIMISE R&D

    Dec 10, 2019

    A survey has shown that the pharmaceutical industry believes R&D will see a lot of benefit from digital transformation and that AI will be at the forefront of this. New research has shown that the global pharmaceutical industry spends a significant amount of revenue on research and development (...


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    PELOSI PRICING PLAN WILL YIELD 100 FEWER NEW DRUGS WHITE HOUSE PREDICTS

    Dec 04, 2019

    As debate over drug pricing proposals rolls on in Washington, White House advisers have concluded House Speaker Nancy Pelosi's aggressive pricing plan would result in 100 fewer new drugs over a decade, lowering Americans' expected lifespan along the way. Unveiled this fall, Pelosi's plan...


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    ROCHE TRUMPETS DATA FOR SOLIRIS RIVAL IN NMOSD AFTER US, EU FILINGS

    Dec 02, 2019

    Roche has continued to build the case for satralizumab, its experimental therapy for rare disease neuromyelitis optica spectrum disorder (NMOSD), which is heading for approval decision in the US and Europe next year. The results of the pivotal SAkuraSky trial have now been published in the New Engla...


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    OREXO ACQUIRES US RIGHTS TO COMMERCIALISE VORVIDA

    Nov 28, 2019

    Swedish company Orexo has purchased the exclusive US rights to vorvida, a digital therapy to treat alcohol use disorder (AUD), from GAIA, for an undisclosed sum. In August, Orexo signed an agreement with GAIA to secure exclusive secure global commercial rights to OXD01, a digital therapy being devel...


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    AZ AND NOVOHEART COLLABORATE ON ‘HEART IN A JAR’, TO DEVELOP NEW HF DRUGS

    Nov 27, 2019

    Stem cell biotech Novoheart is to collaborate with AstraZeneca to develop a “heart in a jar” that will be used to help develop new heart failure drugs. The companies will work on the world’s first human-specific in vitro functional model of heart failure with preserved ejection fra...


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    NHS HAS ‘BIG TECH’ PATIENT DATA ANALYSIS FEARS

    Nov 26, 2019

    A new survey has revealed that the mass majority of NHS staff are not comfortable with the idea of “big tech” companies such as Facebook and Apple analysing their patient data. The YouGov poll discovered that just 12% of healthcare professionals felt comfortable with the companies analys...


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    DISCOVERY OF MECHANISM BEHIND ALEXANDER DISEASE MAY LEAD TO ENHANCED DRUG DEVELOPMENT

    Nov 25, 2019

    Researchers have long known that the cause behind Alexander disease is a genetic culprit—mainly a mutation leading to the production of a defective protein called GFAP. Alexander disease (AxD) is a rare neurological condition involving myelin destruction and is present during many stages of li...


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    ABBVIE EXERCISES LICENSING OPTION FOR A DRUG FROM HARPOON COLLABORATION

    Nov 22, 2019

    AbbVie and Harpoon Therapeutics have announced that the former will has licensed the B cell maturation antigen (BCMA)-targeting drug HPN217 for multiple myeloma from the pair’s drug discovery collaboration. AbbVie and Harpoon entered into a drug discovery collaboration in October 2017 to lever...


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    LILLY TO INVEST $400M TO BOOST MANUFACTURING CAPACITY IN US

    Nov 21, 2019

    Eli Lilly is set to invest $400m to boost the capacity of its manufacturing facilities at its technology centre campus in Indianapolis, Indiana, US. The move is intended to meet the increasing demand for the company’s existing medicines and to support the production of future drugs in its pipe...


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    BIG DATA TURNS OLD DRUGS INTO NEW ONES

    Nov 20, 2019

    Big Data, biology and genomics have led to understanding how to create a new drug from an old one. An algorithm has been used to analyse the molecular properties of an existing drug used for treat some tumors and found that it also works against metabolic syndrome. The research study, published by N...


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    PRIMARY ENDPOINT MET IN DRUG STUDY FOR WORSENING CHRONIC HEART FAILURE

    Nov 19, 2019

    Merck has announced that the Phase III VICTORIA study evaluating the efficacy and safety of vericiguat, a soluble guanylate cyclase (sGC) stimulator being developed to treat patients with worsening chronic heart failure, has met the primary efficacy endpoint. Vericiguat reduced the risk of the compo...


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    EMA ANNOUNCES MEDICINE APPROVAL RECOMMENDATIONS FROM NOVEMBER MEETING

    Nov 18, 2019

    The European Medicines Agency’s (EMA) human medicines committee (CHMP) has announced the results of its November 2019 meeting, recommending seven medicines for approval. The committee suggested granting a marketing authorisation for Isturisa (osilodrostat), a treatment for Cushing’s synd...


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    BEIGENE RECEIVES ITS FIRST FDA APPROVAL FOR A MCL DRUG

    Nov 15, 2019

    The accelerated approval was based upon overall response rate (ORR) results from two single-arm trial; ORR data was assessed by an independent review committee. Continued approval of Brukinsa is contingent on a confirmatory trial. In a Phase II trial, 84% of patients receiving Brukinsa achieved ORR,...


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    CORK COUNTY ON THE RISE: BIG PHARMA FEELS AT HOME IN CORK

    Nov 14, 2019

    In 1969, when global biopharmaceutical company Pfizer located in Ringaskiddy, Cork was a very different place. Verolme, the Dutch-owned shipyard in Rushbrooke, was busy making ships, some of them patrol and fisheries vessels for the State. For generations, workers at the Sunbeam factory in Blackpool...


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    THE SIDE-EFFECTS TO A COMMON BLOOD CANCER DRUG

    Nov 13, 2019

    A popular cancer drug, known as ruxolitnib, was found to cause an increased weight gain as well as an increase in liver enzymes and systolic blood pressure. “Weight gain with ruxolitinib has previously been reported in clinical trials, but our study provides real-world experience regarding the...


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    SEE WHAT PEOPLE ARE SAYING ABOUT THE POLY STUDIO USB VIDEO BAR

    Nov 13, 2019

    “The Polycom Studio is fantastic because it gives organisations access to the flexible huddle room environments they need, without asking them to deal with complicated tools and technology. The Polycom Studio is a powerful piece of equipment, but it’s not complicated or daunting. Unlike ...

    SOURCE
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    FOR LOGISTICS FIRM ANTARES, WORKING IN PHARMA PRESENTS CHALLENGES — AND OPPORTUNITIES

    Nov 12, 2019

    The pharmaceutical industry is New Jersey’s perennial list topper when it comes to measuring what drives the state’s economy, but logistics is never far behind. And, just as often in the Garden State, the two go hand-in-hand. Besides the state’s higher-than-average concentration of...


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    CCA SHOWS SUCCESS IN MANAGING MEMBERS’ PAIN AND OPIOID USE

    Nov 11, 2019

    The United States is battling an opioid crisis, and it is critically important that healthcare organizations do what they can to identify patients at high risk of suffering from the negative effects of this form of pain management. One organization addressing this issue is Commonwealth Care Alliance...


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    NEWPHARMA COLLABORATES WITH INGENICO FOR E-PAYMENTS

    Nov 08, 2019

    Belgian online pharmacy firm Newpharma has partnered with UK-based payments company Ingenico Group to enable secure payments for pharmaceutical customers. Newpharma will be able to provide various payment options for buyers in certain European markets. The company expects the alliance to support its...


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    REGENERON AND VYRIAD TO DEVELOP ONCOLYTIC VIRUS THERAPIES

    Nov 07, 2019

    Regeneron Pharmaceuticals has formed a five-year alliance with Vyriad for the development of oncolytic virus-based treatments for cancer. Under the research collaboration and option licensing agreement, a clinical trial is set to be initiated next year to assess Regeneron’s Libtayo (cemiplimab...


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    FDA GRANTS SANDOZ APPROVAL FOR ZIEXTENZO IN ONCOLOGY CARE

    Nov 06, 2019

    The US Food and Drug Administration (FDA) has approved Sandoz’ biosimilar Ziextenzo (pegfilgrastim-bmez). The biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018, and now Sandoz intends to launch Ziextenzo in the US as soon as possible this...


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    BAYER FOCUSES ON DIGITAL TRANSFORMATION OF HEALTHCARE AT DIGITRANS 2019

    Nov 05, 2019

    Bayer, a leading life sciences company, focused on digitally transforming the healthcare sectrtor at the Digital Transformation forum, Digitrans 2019, in Dubai. With a focus on emerging technologies such as AI, 3D technology and IoT, this two-day forum brought together regional leaders from across a...


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    POLY ANNOUNCES SECOND QUARTER FISCAL YEAR 2020 FINANCIAL RESULTS

    Nov 05, 2019

    Plantronics, Inc. (NYSE: PLT) ("Poly" or the "Company") today announced second quarter fiscal year 2020 results for the period ending September 30, 2019. Highlights of the second quarter include the following: “During the second quarter, we made further progress reducing ou...

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    POLY INTRODUCES POLY STUDIO X SERIES FOR MICROSOFT TEAMS AT MICROSOFT IGNITE 2019

    Nov 04, 2019

    Plantronics, Inc. (“Poly” – formerly Plantronics and Polycom) (NYSE: PLT), a global communications company that powers meaningful human connection and collaboration, will introduce video conferencing devices with a built-in Microsoft Teams experience at Microsoft Ignite 2019. The P...

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    TELSTAR PROMOTES ASEPTIC TECHNOLOGY DEVELOPMENTS FOR PHARMA PRODUCTION

    Nov 04, 2019

    The Telstar portfolio also includes integrated turnkey engineering & construction services for process facilities, manufacturing plants, critical installations and laboratories, as well as GMP consultancy for regulatory compliance and IT solutions for regulated processes & logistics manageme...


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    DICERNA ENTERS ALLIANCE TO DEVELOP HEPATITIS B DRUGS

    Nov 01, 2019

    Dicerna Pharmaceuticals has signed a research collaboration and licensing agreement with Roche to create treatments for chronic hepatitis B virus (HBV) infection. The partnership will leverage Dicerna’s GalXC RNAi platform, designed to develop RNAi-based therapies that silence genes, which cau...


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    TAKING A CLOSER LOOK AT DRUG DELIVERY

    Oct 31, 2019

    Nanocapsules and other containers can transport drugs through a patient's body directly to the origin of the disease and release them there in a controlled manner. Such sophisticated systems are occasionally used in cancer therapy. Because they work very specifically, they have fewer side effect...


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    VACCINE FOR LASSA FEVER SET TO BE TRIALED

    Oct 25, 2019

    There is currently no vaccine for the Lassa arenavirus, which causes Lassa fever. This hemorrhagic fever, endemic in West Africa, infects up to 300,000 people each year. Given the urgency of the situation, scientists in the Biology of Viral Emerging Infections Unit and the Viral Genomics and Vaccina...


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    NHS ENGLAND AND VERTEX BREAK STALEMATE OVER PRICE OF CF DRUGS

    Oct 24, 2019

    Four years after Orkambi was approved in the European Union, this life-saving drug will now be available to Cystic Fibrosis (CF) patients in England through the NHS. The reason for the delay was continued failing pricing negotiations between Orkambi's manufacturer, Vertex, and NHS England, leadi...


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    BLOOD PRESSURE DRUGS WORK BEST AT BEDTIME

    Oct 23, 2019

    People with high blood pressure who take all their anti-hypertensive medication in one go at bedtime have better controlled blood pressure and a significantly lower risk of death or illness caused by heart or blood vessel problems, compared to those who take their medication in the morning, accordin...


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    VERSEAU THERAPEUTICS LAUNCHES WITH FOCUS ON IMMUNOTHERAPIES

    Oct 22, 2019

    Verseau Therapeutics has launched to develop immunotherapies that act as checkpoint modulators of macrophages, inducing an immune response against cancer. The company received a $50m investment from 3SBio, 20 / 20 HealthCare Partners, Yonghua Capital, The Mark Foundation for Cancer Research, InHarv ...


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    PURDUE PHARMA SETTLEMENTS A WINDOW INTO U.S. OPIOID CRISIS

    Oct 21, 2019

    After more than 2,600 lawsuits nationwide involving their role in the opioid epidemic sweeping through the country, Purdue Pharma — the manufacturer of prescription painkiller OxyContin — filed for bankruptcy Sept. 16. In 2017, opioids were responsible for 47,600 of the 70,237 U.S. drug ...


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    IS THE US OPIOID LITIGATION NEARING AN END GAME?

    Oct 18, 2019

    Drugmakers, wholesalers and lawmakers in the US are said to be thrashing out the details of a big settlement – maybe as much as $50 billion – to settle thousands of lawsuits related to the US opioid crisis. The frenzied negotiations are taking place ahead of the start of the first federa...


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    THE BIOAVAILABILITY CHALLENGES FACING CBD MEDICINES

    Oct 17, 2019

    Cannabidiol, or CBD, is one of more than 100 different derivatives of Cannabis. CBD is produced from both synthetic and natural sources. It is non-psychotropic and is being increasingly promoted for its potential therapeutic benefits in pharmaceutical, nutraceutical, cosmetic, food and beverage appl...


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    ACQUISITION IN THE PHARMA WORLD NOW A TREND?

    Oct 16, 2019

    The pharmaceutical companies have been acquiring new assets and subsidiaries in order to take over their research and intellectual property this has become a growing trend in the pharmaceutical world. Here’s a look at some new acquisitions in pharma. Alkem Laboratories Limited informed the mar...


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    /news-article.aspx?ID=34983498

    IMAGINAB JOINS WITH AZ, PFIZER AND TAKEDA TO DEVELOP TUMOUR IMAGING TECH

    Oct 14, 2019

    LA-based biotech ImaginAb has signed a multi-party agreement with pharma giants AstraZeneca, Pfizer, and Takeda, for technology that allows scientists to see inside tumours, and monitor whether immunotherapies are taking effect. ImaginAb’s imaging technology targets and visualises CD8+ T cells...


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    MEDICAL MARIJUANA ALLOWED IN CALIFORNIA K-12 SCHOOLS

    Oct 11, 2019

    Gavin Newson, the governor of California and the leading 2016 proponent of the recreational pot legalization initiative Proposition 64, signed a bill on Wednesday that will allow parents of students in some California school districts to bring cannabis to their children at K-12 campuses. The bill st...


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    BAYER CHOOSES UK FOR ITS AI-FOCUSED R&D HUB

    Oct 10, 2019

    Bayer has continued its policy of setting up R&D hubs to get closer to innovative companies with a UK site that will focus on applying artificial intelligence to drug discovery and disease diagnosis. The cluster – based at Reading’s Green Park – is the seventh in the German com...


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    /news-article.aspx?ID=34863486

    CQC APPROVES UK CLINIC TO PRESCRIBE MEDICAL CANNABIS

    Oct 09, 2019

    The CQC decision marks the first time the agency has given its approval for a clinic to prescribe patients with medical cannabis in the UK. he Care Quality Commission (CQC) has granted its approval to Sapphire Medical Clinic to offer medical cannabis in the UK. The clinic is the first in the UK to r...


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    THE STATE OF PERSONALISED MEDICINE IN 2019

    Oct 07, 2019

    When researchers completed mapping the human genome in 2003, it broke new ground for what was medically possible. This work specifically involved determining the order of the four chemical building blocks that make up a DNA molecule, called “bases,” and every person has approximately 3 b...


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    /news-article.aspx?ID=34803480

    GOLDFINCH ACQUIRES GLOBAL RIGHTS TO TAKEDA’S MONOCLONAL ANTIBODY

    Oct 04, 2019

    US-based clinical-stage biotechnology company Goldfinch Bio has entered an agreement with Japanese firm Takeda Pharmaceutical for global rights to a preclinical, peripherally restricted cannabinoid receptor 1 (CB1) monoclonal antibody. Under the agreement, the company will assume the development and...


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    /news-article.aspx?ID=34773477

    FDA RECOMMENDS LC-HRMS TO TEST FOR NDMA IN RANITIDINE PRODUCTS

    Oct 03, 2019

    The US Food and Drug Administration (FDA) has announced an update on its method recommendation of testing for NDMA in ranitidine medication products. The ingredient is a probable human carcinogen. A previous method published by the FDA for testing angiotensin II receptor blockers (ARBs) for nitrosam...


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    FDA’S RESEARCH GUIDANCE WILL HELP TAKE GUESSWORK OUT OF DRUG DOSING IN NEWBORNS

    Oct 01, 2019

    When we need to give medicine to newborns in our hospital, we often have to guess at the correct dose to give them. That’s a problem: give too little and the medicine might not work; give too much and it might cause harm. Dosing newborn babies with greater precision has been a challenge becaus...


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    LIPID NANOPARTICLES USED TO DELIVER RNA IN VACCINES

    Sep 30, 2019

    Researchers have developed a series of lipid nanoparticles, which encapsulate RNA, for effective and improved vaccine delivery. Researchers have developed a series of lipid nanoparticles to deliver RNA vaccines accurately, to ensure the therapy reaches the correct immune cells and produces sufficien...


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    /news-article.aspx?ID=34673467

    AUDIT BODY WARNS OF RISKS TO MEDICINE SUPPLIES IN NO-DEAL BREXIT, DESPITE PREPARATIONS

    Sep 27, 2019

    Amid the political chaos and bitter recriminations in Westminster in the build-up to Brexit, there is still a risk of delays to health and social care supplies if the UK leaves the EU without a deal, the UK’s National Audit Office (NAO) has warned. An independent Parliamentary body, the NAO au...


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    /news-article.aspx?ID=34653465

    GSK TO INVEST $120M TO EXPAND MANUFACTURING FACILITY IN US

    Sep 26, 2019

    GlaxoSmithKline (GSK) has committed $120m to expand its biopharmaceutical manufacturing facility in Upper Merion, Pennsylvania, US. The investment is intended to fit the manufacturing facility with technologies that will offer the flexibility and speed required to produce complex speciality medicine...


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    SHORT SELLERS GROW MORE SELECTIVE IN BIG PHARMA

    Sep 25, 2019

    Pharmaceutical companies usually are involved in a lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, should a study come back negative or a candidate not be approved. Conversely, if a drug gains FDA approval or passes a clini...


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    /news-article.aspx?ID=34593459

    OMEGA THERAPEUTICS LAUNCHES WITH FOCUS ON EPIGENETIC DRUGS

    Sep 24, 2019

    US-based Flagship Pioneering has launched a genomics medicine company, Omega Therapeutics, to develop drugs that will leverage the human genome to cure or treat various diseases. The epigenetic drugs regulate genomic expression without impacting nucleic acid sequences. Omega Therapeutics was origina...


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    /news-article.aspx?ID=34563456

    PHARMA COMPANIES ADMIT TO SHARING 'SENSITIVE' INFO TO KEEP PRICES HIGH

    Sep 23, 2019

    As U.S. officials press a massive case for alleged generic drug price fixing, authorities in the U.K. have unearthed an example of rivals working a little too closely with each other. King Pharmaceuticals and Alissa Healthcare Research, which both sold the antidepressant drug nortriptyline, admitted...


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    /news-article.aspx?ID=34533453

    TAKEDA AND LUNDBECK’S TRINTELLIX APPROVED IN JAPAN FOR DEPRESSION

    Sep 20, 2019

    Takeda has announced that its drug Trintellix (vortioxetine) has been approved by the Japanese Ministry of Health, Labour and Welfare for the treatment of depression and depressed state. Danish company Lundbeck discovered Trintellix, but since 2017 Lundbeck and Takeda have been collaborating on the ...


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    /news-article.aspx?ID=34503450

    ASTRAZENECA REVISES LINZESS DEAL WITH IRONWOOD PHARMACEUTICALS

    Sep 19, 2019

    AstraZeneca has revised its agreement with Ironwood Pharmaceuticals for irritable bowel syndrome with constipation (IBS-C) drug Linzess (linaclotide). Linzess is a guanylate cyclase-C (GC-C) agonist, which activates the GC-C receptor, leading to improved secretion of intestinal fluid and transit and...


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    /news-article.aspx?ID=34473447

    J&J FINDS COMPETITIVE EDGE WITH LATEST ERLEADA APPROVAL

    Sep 18, 2019

    Generic competition is eating away at J&J's prostate cancer empire. Sales of Zytiga (abiraterone acetate) totaled $698 million in the second quarter, reflecting a 23% decline year over year. According to Iqvia data cited by SVB Leerink, J&J held 56% of the abiraterone acetate market for ...


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    /news-article.aspx?ID=34443444

    POLY INTRODUCES THE NEXT GENERATION OF SAVI WIRELESS HEADSETS

    Sep 18, 2019

    Plantronics, Inc. (“Poly” – formerly Plantronics and Polycom) (NYSE: PLT), a global communications company that powers meaningful human connection and collaboration, today announced the next generation of the company’s lineup of popular Savi wireless headsets. The enhanced Sa...

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    MYMEDS&ME LAUNCH MOBILE DRUG SAFETY SITE

    Sep 17, 2019

    In time for World Patient Safety Day, MyMeds&Me has announced the launch of an “enhanced, intuitive, mobile-web version” of its safety reporting solution Reportum Public. The solution enables patients and healthcare professionals to report adverse events directly to marketing authori...


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    /news-article.aspx?ID=34373437

    PURVEYORS OF BLACK-MARKET PHARMACEUTICALS TARGET IMMIGRANTS

    Sep 16, 2019

    The bootleg medications were smuggled across the border and sold to mostly Latino immigrants in public spaces throughout Los Angeles at swap meets, parks, beauty salons and makeshift stands outside mom-and-pop grocery stores. The drugs were cheap, and the customers mostly from Mexico and Central Ame...


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    /news-article.aspx?ID=34343434

    TEVA SUBSIDIARY INKS DISTRIBUTION DEAL WITH ISRAELI MEDICAL MARIJUANA PRODUCT MAKER

    Sep 13, 2019

    As drugmakers dip their toes into the water of cannabis-based drugs, major companies have so far mostly shied away from diving in. Now, a Teva subsidiary is looking for the on-ramp with a distribution deal with an Israeli medical cannabis company. Israeli subsidiary Salomon, Levin, Elstein (SLE) ink...


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    WHO JOINS PURDUE ON PHARMA'S TOP 10 SETTLEMENTS LIST? MERCK, GSK AND PFIZER, FOR STARTERS

    Sep 12, 2019

    Purdue’s pending opioid settlement with thousands of cities and counties, worth between $10 billion and $12 billion, could rank as the largest deal ever inked by a pharma if it passes a Cleveland federal judge’s muster. But where do pharma’s other major settlements fall on that lis...


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    /news-article.aspx?ID=34283428

    INSULIN: A CASE STUDY FOR WHY WE NEED A PUBLIC OPTION IN THE PHARMACEUTICAL INDUSTRY

    Sep 10, 2019

    When Frederick Banting, Charles Best, and James Collip filed for a U.S. patent on insulin in 1923 and sold it to the University of Toronto for $1 each, they did it because, as Best once said, “insulin belongs to the world.” They also believed that securing the patent was a form of public...


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    SPECTRUM PHARMACY PRODUCTS INTRODUCES NEW LINE OF PHARMACEUTICAL BASES

    Sep 09, 2019

    Spectrum Pharmacy Products, a division of Spectrum Chemical Manufacturing Corporation and a leading North American distributor of pharmaceutical compounding chemicals, equipment and supplies, has announced the introduction of a new line of pharmaceutical bases to meet the needs of compounders in pro...


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    /news-article.aspx?ID=34183418

    BENEVOLENTAI AND NOVARTIS SIGN AI R&D DEAL

    Sep 06, 2019

    The Artificial Intelligence (AI)-based drug development firm BenevolentAI has signed an agreement with Novartis to find potential new uses for oncology drugs already in its pipeline. UK-based BenevolentAI said the collaboration programme will be led by Novartis’ Precision Medicine Team, within...


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    /news-article.aspx?ID=34153415

    NEW MEDICINE MAY ENHANCE THE EFFECT OF CHEMOTHERAPY ON PANCREATIC CANCER

    Sep 05, 2019

    One of the major obstacles in the treatment of pancreatic cancer is the defense wall that is formed around the tumor. This "desmoplastic stroma" prevents chemotherapy from reaching the tumor. Scientists of the University of Twente now found out which part of the stroma can best be attacked...


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    /news-article.aspx?ID=34113411

    BIGTINCAN TAKES AIM AT REVENUE ENABLEMENT WITH ASDEQLABS ACQUISITION

    Sep 05, 2019

    Bigtincan (ASX:BTH), the leader in mobile, AI-powered sales enablement automation, today announced the acquisition of AsdeqLabs, whose platform provides support for field-based employees and mobile service capabilities, helping to usher in the next evolution of service enablement and customer engage...

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    TEVA UNDERGOES REBRANDING

    Sep 04, 2019

    Teva has launched a new patient-centric brand in the UK, marked by a “refreshed visual identity” and a new digital platform entitled ‘Life Effects’. The rebrand will be launched at the 2019 NHS Health and Care Innovation Expo in Manchester, after being drawn from insights fro...


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    /news-article.aspx?ID=34083408

    TUBERCULOSIS VACCINE SHOWS EFFICACY IN PRE-CLINICAL TRIALS

    Sep 02, 2019

    Researchers have successfully developed and pre-clinically tested a new vaccine for tuberculosis (TB). The research was conducted by the Centenary Institute and the University of Sydney, both Australia. Using mouse models, the team have demonstrated the efficacy of the treatment. Two peptides normal...


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    /news-article.aspx?ID=34053405

    GREEK PROSECUTORS DROP ANOTHER INQUIRY IN NOVARTIS BRIBERY CASE, BUT 3 REMAIN OPEN

    Aug 30, 2019

    Allegations that Novartis bribed top Greek officials may look even flimsier now that prosecutors have decided to toss out yet another line of inquiry. But the case isn’t dead yet. Greece’s corruption prosecutor Eleni Touloupaki found no reason to continue investigating the country’...


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    WORST DEAL EVER? BAYER’S MARKET CAP NOW CLOSE TO THE TOTAL COST IT PAID FOR MONSANTO

    Aug 29, 2019

    What does one of the worst corporate deals in modern history look like? In Bayer’s Monsanto takeover, it means the value of an entire company has gone poof. Bayer acquired Monsanto for $63 billion in 2018 after a tough buyout battle and intense antitrust scrutiny. The German conglomerate&rsquo...


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    /news-article.aspx?ID=33963396

    GSK TAKES OPTION TO LICENSE HEPATITIS B RNA DRUGS FROM IONIS

    Aug 28, 2019

    GlaxoSmithKline has taken an option to license Ionis’ antisense medicines for people with chronic hepatitis B virus infection after supportive phase 2 trial results. Ionis could receive up to $262 million, including a $25 million up front license fee, and tiered royalties in the low double dig...


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    /news-article.aspx?ID=33933393

    PHARMA CASH ROLLS INTO CONGRESS TO DEFEND AN EMBATTLED INDUSTRY

    Aug 27, 2019

    In the heat of the most ferocious battle over drug prices in years, pharmaceutical companies are showering U.S. senators with campaign cash as sweeping legislation heads toward the floor. A new Kaiser Health News database tracks campaign donations from drugmakers over the past 10 years. In the first...


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    /news-article.aspx?ID=33893389

    BIGTINCAN NAMED IN GARTNER’S MARKET GUIDE FOR SALES ENGAGEMENT PLATFORMS, MEETING ALL IDENTIFIED CAPABILITIES

    Aug 27, 2019

    Bigtincan (ASX:BTH), the leader in mobile, AI-powered sales enablement automation, today announced it has been recognized as a Representative Vendor of Sales Engagement Platforms in all of the capabilities defined by Gartner as part of the August 2019 Market Guide for Sales Enablement Platforms* for...

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    CAN LILLY JAK OLUMIANT, PLAGUED BY SIDE EFFECTS, REALLY CHALLENGE DUPIXENT IN DERMATITIS?

    Aug 26, 2019

    Eli Lilly and Incytes Olumiant has run up against safety hurdles in the past. But can those hurdles stop the drugmakers from adding another feather to the drugs cap, this time in the booming and increasingly competitive atopic dermatitis AD market? Adding Olumiant to standard-of-care corticosteroids...


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    /news-article.aspx?ID=33873387

    MULTIPLE ANTIBIOTIC COURSES LINKED TO PEDIATRIC TREATMENT FAILURE

    Aug 23, 2019

    A new report in the British Journal of General Practice has revealed that children prescribed more than two courses of antibiotics within a year for coughs, sore throat and earache are less likely to respond to a subsequent course. The cohort study, compiled of statistics from the Clinical Practice ...


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    /news-article.aspx?ID=33833383

    NEW CANNABIS-BASED DRUG SHOWS PROMISE FOR PANCREATIC CANCER

    Aug 22, 2019

    Cancer of the pancreas is a particularly deadly cancer, claiming over 90 Precent of its victims within 5 years from diagnosis. It resists most standard therapies, including surgery, chemotherapy, radiation therapy, immunotherapy and targeted therapy, and metastasizes early, often before being diagno...


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    /news-article.aspx?ID=33803380

    AZ IMFINZI COMBO FAILS LUNG CANCER STUDY

    Aug 21, 2019

    AstraZeneca has announced that its combination of Imfinzi durvalumab and tremelimumab has failed to hit its key target in a late-stage trial assessing its potential in patients with late-stage lung cancer. The drug giant reported that in the primary analysis population - patients with stage IV non-s...


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    /news-article.aspx?ID=33763376

    UNHAPPY PUPILS MORE LIKELY TO BE SMOKERS AND DRINKERS

    Aug 20, 2019

    New figures from NHS Digital have revealed that pupils who have recently smoked, drunk alcohol and taken drugs are more likely to be unhappy. Specifically, 51 Percent of young people aged 11 to 15 who had recently drunk alcohol, smoked cigarettes and taken drugs reported experiencing low levels of h...


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    MARKETERS SHOULDN’T HAVE TO BE DATA SCIENTISTS

    Aug 20, 2019

    Over the past decade, the rise of Data-Driven Marketing and Account-Based Marketing (ABM) have both followed steep trajectories, and that’s no coincidence. After all, the best ABM programs are the ones built on rich data and insights. However, the meteoric rise of data-fueled ABM has had an un...

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    RINVOQ BAGS FDA GREEN LIGHT

    Aug 19, 2019

    AbbVie has announced the US Food and Drug Administration FDA approval of Rinvoq upadacitinib for moderate to severe active rheumatoid arthritis RA. In the SELECT programme, the oral JAK inhibitor met all primary and ranked secondary endpoints across a variety of patients with moderately to severely ...


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    AZ CALQUENCE GRANTED US BREAKTHROUGH THERAPY DESIGNATION

    Aug 14, 2019

    AstraZeneca has announced that Calquence acalabrutinib has been granted US Breakthrough Therapy Designation BTD for chronic lymphocytic leukaemia. The US Food and Drug Administration FDA granted the designation as a monotherapy treatment for adult patients with the disease, based on positive results...


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    RCGP HIGHLIGHTS DANGERS OF ANTIBIOTICS FOR CHILDREN WHEN NOT ABSOLUTELY NECESSARY

    Aug 13, 2019

    A new study published in the British Journal of General Practice has reported that childhood antibiotic exposure has important clinically relevant implications, including disruption to the microbiome, antibiotic resistance, and clinical workload manifesting as treatment failure. The cohort study, wh...


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    /news-article.aspx?ID=33553355

    BIGTINCAN RECOGNIZED BY KEY INDUSTRY ORGANIZATIONS AS LEADER IN SALES ENABLEMENT

    Aug 13, 2019

    Bigtincan (ASX:BTH), the leader in mobile, AI-powered sales enablement automation, was presented with the MarTech Breakthrough Award for “Best Sales Enablement Software for SMBs” for the second year in a row. Additionally Bigtincan was recently named a “Sales Automation Solution&rd...

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    TREMFYA TOPS COSENTYX IN LATE-STAGE STUDY

    Aug 12, 2019

    Johnson and Johnsons Janssen has announced results from the Phase III ECLIPSE study, which show superior long-term efficacy of Tremfya guselkumab compared with Cosentyx secukinumab in adults with moderate to severe plaque psoriasis. According to the data, published in The Lancet, a statistically sig...


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    PURE CBD WON'T MAKE YOU FAIL A DRUG TEST, BUT...

    Aug 09, 2019

    As the CBD craze sweeps the nation, some users may wonder whether the cannabis extract can make them fail a drug test. A preliminary study suggests the answer is no-at least if the CBD is pure. Researchers found that CBD, or cannabidiol, did not react with either of two commercially available tests ...


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    /news-article.aspx?ID=33503350

    FIVE-YEAR FRAMEWORK FOR COMMUNITY PHARMACY FUNDING ANNOUNCED

    Aug 08, 2019

    The Pharmaceutical Services Negotiating Committee PSNC, Department of Health and Social Care DHSC and NHS England have announced a five-year funding framework for community pharmacy. The framework agreement for community pharmacies announced funding of almost 13 billion pounds over the five years to...


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    /news-article.aspx?ID=33473347

    FIRST PATIENT DOSED IN ASTELLAS LATE-STAGE MENOPAUSE TRIAL

    Aug 07, 2019

    Astellas Pharma has announced the initiation and dosing of the first patient in its SKYLIGHT1 Phase III pivotal trial for fezolinetant. The investigational oral, non-hormonal compound is being studied for the treatment of moderate-to-severe menopause related vasomotor symptoms VMS, such as hot flash...


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    /news-article.aspx?ID=33443344

    MADISON LOGIC ANNOUNCES ORACLE ELOQUA INTEGRATION

    Aug 07, 2019

    Madison Logic, the leading global account-based marketing (ABM) platform, today announced bi-directional integration with market-leading marketing automation platform Oracle Eloqua. This cutting-edge integration allows B2B marketers to combine best-in-class campaign management tools with Madison Log...

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    REGENERONS SANOFI DEAL FINALLY TURNS A PROFIT, THANKS TO DUPIXENT

    Aug 06, 2019

    More than 10 years after Sanofi and Regeneron joined forces in a high-profile antibody drug partnership, the tie-up has recorded its first-ever profits no thanks to the PCSK9 laggard Praluent, but with big bouquets for hard-driving Dupixent. Fueled by Dupixents 557 million dollars in second-quarter ...


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    /news-article.aspx?ID=33413341

    NUCALA RECEIVES SELF-ADMINISTRATION EU APPROVAL

    Aug 02, 2019

    GlaxoSmithKline has announced that the European Commission has granted marketing authorisation for two new methods of administering the companys Nucala mepolizumab - a pre-filled pen and a pre-filled safety syringe. It is the only monthly anti-IL5 biologic approved in Europe that people with severe ...


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    /news-article.aspx?ID=33393339

    GSK COMPLETES TRANSACTION WITH PFIZER

    Aug 01, 2019

    GlaxoSmithKline GSK has announced the completion of its transaction with Pfizer to combine their consumer healthcare businesses into a world-leading joint venture. Under the terms GSK has a controlling equity interest of 68 Percent and Pfizer has an equity interest of 32 Percent in the venture, whic...


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    NEURAXPHARM LAUNCHES FIRST PRODUCTS IN UK

    Jul 31, 2019

    Neuraxpharm Group has announced the launch of its first products in the United Kingdom, as well as the appointment of the companys new general manager Craig Bowen, who will run Neuraxpharm UK, based in Reading. The specialty pharmaceutical company focused on the treatment of central nervous system C...


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    /news-article.aspx?ID=33353335

    O, CANADA LIKE HIS ACROSS-THE-AISLE RIVALS, TRUMP LOOKS TO IMPORTS TO CUT DRUG COSTS

    Jul 30, 2019

    President Donald Trump and his 2020 challengers are in a heated skirmish to prove to voters who is the toughest candidate on Big Pharma. Now, Trump has found even more common ground with Democrats on lowering the cost of drugs. The Trump administration is drafting a plan to allow the Department of H...


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    SKIN CANCER RATES ROCKET 45% IN 10 YEARS

    Jul 29, 2019

    Cancer Research UK has announced that incidences of melanoma have increased by 45% since 2004. Latest figures show that rates have increased by more than a third 35% for women and by almost three-fifths 55% for men, and that rates for 25-49 year-olds have increased by as much as 70% since the 1990s....


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    KEY EUROPEAN COMMITTEE BACKS GWS EPIDYOLEX, BAYERS VITRAKVI AND MORE

    Jul 26, 2019

    In a busy meeting this week, experts with the European Medicines Agencys Committee for Medicinal Products for Human Use endorsed four new drugs, a Mylan generic, and numerous new indications for already-marketed meds. All the recommendations will go to the European Commission for final approval. Asi...


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    /news-article.aspx?ID=33283328

    LIQTEQS BI RESTRUCTURING DATA-DRIVEN DECISION MAKING IN THE PHARMA INDUSTRY

    Jul 25, 2019

    Todays pharmaceutical companies are large and complex with a critical need for information and data. How does Business Intelligence BI support pharmaceutical enterprises? The answer is simple. Liquid Technologies business intelligence solutions go beyond simple enterprise reporting. Our solutions pr...


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    /news-article.aspx?ID=33273327

    BIGTINCAN EXPANDS TECH MARKET PRESENCES WITH ACQUISITION OF VEELO INC.

    Jul 25, 2019

    Bigtincan (ASX:BTH), the leader in mobile, AI-powered sales enablement automation, today announced the acquisition of Veelo Inc., a pioneer in sales enablement, to expand Bigtincan’s presence and offerings in the technology market vertical. The combination of Bigtincan’s solution, design...

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    PROMISING EARLY DATA FOR MSDS INVESTIGATIONAL HIV DRUG

    Jul 24, 2019

    MSD has announced results from a Phase I study evaluating the pharmacokinetics and safety of a prototype subdermal drug-eluting implant for islatravir, an antiretroviral therapeutic for the prevention and treatment of HIV. The investigational drug is a nucleoside reverse transcriptase translocation ...


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    /news-article.aspx?ID=33253325

    2019 CONTENT MARKETING AWARD WINNERS & TOP FINALISTS REVEALED

    Jul 24, 2019

    The Content Marketing Institute (CMI) just announced the 85 category winners as well as the finalists for the top seven prizes in the prestigious 2019 Content Marketing Awards. The Content Marketing Awards, produced by the Content Marketing Institute, is the largest and longest-running international...

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    A 100B DOLLARS SETTLEMENT? OR MUCH LESS? OPIOID PAYOUTS A MYSTERY UNTIL J AND J JUDGE RULES

    Jul 23, 2019

    After Johnson and Johnson failed in its latest bid to toss out the opioid suit playing out in an Oklahoma courtroom, the possibility of a settlement continues to grow. For analysts watching the case as a bellwether for other opioid suits, the question is how big the payout could get. Short answer: W...


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    /news-article.aspx?ID=33233323

    MALLINCKRODT, SILENCE THERAPUTICS TO COMMERCIALISE RNAI THERAPEUTICS

    Jul 22, 2019

    Silence Theraputics and Mallinckrodt have announced a collaboration that will allow the companies to develop and commercialise RNAi drug targets designed to inhibit or silence the complement cascade, a group of proteins that are involved in the immune system and that play a role in the development o...


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    MHRA GIVES BAVENCIO, INLYTA COMBO EARLY ACCESS TO MEDICINES STATUS

    Jul 22, 2019

    Merck and Pfizer have announced that the UK Medicines and Healthcare Products Regulatory Agency MHRA has issued an Early Access to Medicines Scheme EAMS positive scientific opinion for Bavencio avelumab used in combination with Inlyta axitinib. The opinion is for the combination as first-line treatm...


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    NOVARTIS SICKLE CELL DRUG WINS FDA PRIORITY REVIEW

    Jul 18, 2019

    The US Food and Drug Administration (FDA) has given Novartis investigational sickle cell medicine, crizanlizumab SEG101, Priority Review. The governing body accepted the company's Biologics License Application (BLA) which was submitted for the prevention of vaso-occlusive crises (VOCs) in patien...


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    /news-article.aspx?ID=33143314

    GENDER IMBALANCE EXPECTED IN SENIOR PHARMA ROLES UNTIL 2090

    Jul 18, 2019

    This years definitive Women Count has reported that there has been no progress on gender diversity in senior roles in the FTSE 350, and that only 3.7% of FTSE350 companies have female CEOs down from 4.6% two years ago. Funded by The Pipeline, the UKs leading gender diversity business, this research ...


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    /news-article.aspx?ID=33153315

    PURETECH ACQUIRES LYT-100 TO TREAT LYMPHEDEMA

    Jul 17, 2019

    PureTech Health has announced that it has acquired and plans to develop a clinical-stage product candidate for the potential treatment of lymphatic and immunofibrotic diseases, including lymphedema.The candidate, LYT-100, demonstrated anti-fibrotic and anti-inflammatory mechanisms in pre-clinical st...


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    BOEHRINGER ENRICHES CANCER IMMUNOLOGY PORTFOLIO WITH AMAL THERAPEUTICS ACQUISITION

    Jul 17, 2019

    Boehringer Ingelheim has announced its acquisition of all shares of AMAL Therapeutics, a private Swiss biotechnology company focused on cancer immunotherapy. AMAL’s lead vaccine ATP128 is currently developed for stage IV colorectal cancer and is slated to begin first-in-human trials later this...


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    /news-article.aspx?ID=33103310

    ROCHES GENENTECH INKS DEAL WITH SOSEI HEPTARES

    Jul 17, 2019

    Sosei Heptares has announced a multi-target research collaboration and license agreement with Genentech, a member of the Roche Group, to discover and develop novel medicines that modulate G protein-coupled receptor (GPCR) targets of interest to Genentech. Under the terms of the agreement, Sosei Hept...


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    NOVARTIS CRIZANLIZUMAB WINS SPEEDY FDA REVIEW, PUTTING IT CLOSER TO BLOCKBUSTER SICKLE CELL LAUNCH

    Jul 16, 2019

    Novartis plan to launch over 10 potential blockbuster drugs or new indications by 2021 is quickly unfolding. The FDA has accepted a biologics application for the pharma giant's sickle cell disease candidate crizanlizumab (SEG101) and put the drug under priority review, which slashes four months ...


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    /news-article.aspx?ID=32993299

    J AND J EXECS HAVE PLENTY TO BRAG ABOUT IN PHARMA. WHY DOWNPLAY XARELTO, ZYTIGA WOES.

    Jul 16, 2019

    Johnson and Johnsons pharma unit is still churning out growth, partly because of out performing new launches like cancer med Darzalex. But execs had to explain away some disappointing results for two of its older blockbusters. Prostate cancer med Zytiga, which executives last year predicted wouldnt ...


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    /news-article.aspx?ID=33003300

    WHOS TOUGHEST ON DRUG PRICES. WATCH TRUMP AND HIS 2020 CHALLENGERS WRESTLE FOR THE TITLE

    Jul 16, 2019

    One year away from the next presidential election, the rising cost of prescription drugs is once again at the forefront of American politics, with action plans from two Democratic candidates in two days. And brace yourselves, drugmakers: Analysts figure the target on your backs will only get bigger....


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    /news-article.aspx?ID=33013301

    ASTRAZENECAS FARXIGA FOLLOWS RIVAL ZYNQUISTA TO FDA REJECTION IN TYPE 1 DIABETES.

    Jul 15, 2019

    Turns out, the FDAs March rejection of Sanofi and Lexicon Pharmaceuticals Zynquista was just a preview of what would come for the SGLT class in Type 1 diabetes. The agency shot down a second drug from the group, AstraZeneca’s Farxiga, the British drugmaker said Monday. Regulators issued a comp...


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    /news-article.aspx?ID=32943294

    ABBVIES RISING IMMUNOLOGY STAR SKYRIZI SCORES NOD FROM ENGLANDS COST WATCHDOG.

    Jul 15, 2019

    With long time immunology blockbuster Humira on the decline, AbbVie is looking to next-gen competitor Skyrizi to chip in. A nod from England's cost watchdog could help. The National Institute for Health and Care Excellence (NICE) recommended (PDF) Skyrizi as a second-line treatment for severe pl...


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    /news-article.aspx?ID=32953295

    RECORD NUMBER OF CHILDREN HOSPITALISED FOR EATING DISORDERS.

    Jul 15, 2019

    Public Health England has reported that hospital admissions for eating disorders in girls aged just 10 years old have increased by 146% since 2013/14, with a total of 2,196 hospital admissions for eating disorder of children and young people aged 10 to 24 years in 2017/18. The report also states tha...


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    /news-article.aspx?ID=32963296

    TRUE INNOVATION OR JUST LATER TO MARKET? GERMAN AGENCY QUESTIONS BENEFITS OF NEW DRUGS

    Jul 12, 2019

    When a new drug is approved, the developer usually trumpets its ability to fill an unmet medical need. But a German agency that evaluates the quality of medical treatments disagrees is calling for an international reform of drug development and approval. In a recent analysis published in The BMJ, th...


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    /news-article.aspx?ID=32873287

    EMGALITY MAKER LILLY COURTS PAYERS WITH NEW MIGRAINE ER DATA

    Jul 12, 2019

    Sales of Eli Lilly’s migraine and cluster headache med Emgality have lagged behind competitors from Amgen and Novartis and Teva Pharmaceutical. And in its push to bring payers on board, Lilly is deploying a full-court press with some new patient data. Just 5% of frequent migraine sufferers who...


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    /news-article.aspx?ID=32883288

    ICER DEEMS UNAPPROVED AIMMUNE, DBV PEANUT ALLERGY DRUGS UNAFFORDABLE, SPARKING BACKLASH

    Jul 12, 2019

    Two small companies, Aimmune Therapeutics and DBV Technologies, are racing to break into what analysts expect will be a billion-dollar market for drugs to treat peanut allergies. But neither of their experimental treatments, Aimmune’s AR101 and DBV’s Viaskin, has been approved by the FDA...


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    /news-article.aspx?ID=32893289

    BMJ DATA SUGGESTS LINK BETWEEN SUGARY DRINKS AND CANCER

    Jul 11, 2019

    A study published by The BMJ has reported a possible association between higher consumption of sugary drinks and and an increased risk of cancer. The data comes from a team of researchers based in France, who set out to assess the associations between the consumption of sugary drinks (sugar sweetene...


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    /news-article.aspx?ID=32823282

    FDA SET TO REVIEW SANOFI’S ISATUXIMAB FOR MULTIPLE MYELOMA

    Jul 11, 2019

    The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for isatuximab for a review, for the indication of relapsed/refractory multiple myeloma (RRMM). The drug’s maker Sanofi has announced that the target action date for the FDA decision is April 30, 2020....


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    /news-article.aspx?ID=32833283

    HPV VACCINE TO BE OFFERED TO SCHOOL-AGE BOYS

    Jul 11, 2019

    From September 2019, boys in school year eight will be offered the free Human Papilloma Virus (HPV) vaccine for the first time. Modelling produced by the University of Warwick estimate that the HPV vaccine programme could prevent over 64,000 cervical cancers and nearly 50,000 non-cervical cancers by...


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    /news-article.aspx?ID=32843284

    NOVARTIS AMPS UP SYMJEPI LAUNCH TO FILL PFIZERS EPIPEN SUPPLY GAP

    Jul 10, 2019

    Mylan and its EpiPen manufacturing partner Pfizer have had trouble keeping up with demand. That's not good news as the key back-to-school season nears. Except, perhaps, for Novartis' Sandoz unit and its stepped-up rollout of rival epinephrine injector Symjepi. Amid a long-running EpiPen shor...


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    /news-article.aspx?ID=32783278

    BAYER MAY MERGE ANIMAL HEALTH UNIT WITH ELANCO

    Jul 10, 2019

    Bayer has delayed a planned sale of its animal health unit to private equity interests in order to explore a merger with US firm Elanco, claims Reuters. Citing three separate anonymous sources, the news agency says the two companies are already working with banks to ensure any merger would secure re...


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    /news-article.aspx?ID=32793279

    FEDERAL COURT PUTS KIBOSH ON TRUMP PLAN FOR DRUG PRICES IN TV ADS

    Jul 10, 2019

    A federal judge has blown a hole in an attempt by the Trump administration to force drugmakers to put the list prices of their medicines in TV advertising. The measure – which had been due to come into effect just a few hours after the verdict – would have required the wholesale acquisit...


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    /news-article.aspx?ID=32803280

    LIONBRIDGE WINS EMPLOYEE ENGAGEMENT AWARD FROM THE CONFERENCE BOARD

    Jul 10, 2019

    Lionbridge, the world's most trusted global communications platform, is pleased to announce that it has won the Technology division award for Employee Engagement in the Conference Board's Excellence in Marketing & Communications Awards Program. This prestigious program honors organizatio...

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    /news-article.aspx?ID=33733373

    ROCHE, MERCK, NOVARTIS AND OTHERS HIKE PRICES ON 83 MEDS STARTING IN JULY

    Jul 09, 2019

    Its not uncommon for drugmakers to raise prices on big-selling meds to start each year and at each years halfway point. So as the calendar turned to July, many companies marked the occasion with price increases in an indication that political pressure against pharma's price hikes may be waning. ...


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    /news-article.aspx?ID=32683268

    IN WIN FOR PHARMA, TRUMP TV DRUG PRICE RULE STRUCK DOWN

    Jul 09, 2019

    The proposal seeks to shame biopharma companies into lowering their prices through public pressure. HHS published the rule in May, arguing that price disclosure would allow Medicare and Medicaid beneficiaries to make informed decisions about their own out-of-pocket costs. It was due to go into effec...


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    /news-article.aspx?ID=32693269

    OKLAHOMA TO CONTINUE PURSUING LEGAL ACTION AGAINST NOTORIOUS OPIOID MANUFACTURER

    Jul 09, 2019

    An Oklahoman judge has just denied notorious drug manufacturer Johnson & Johnson and Janssen Pharmaceuticals’ motion to end Oklahoma’s public-nuisance lawsuit, meaning that Oklahoma is set to become the first successful state to bring a pharmaceutical company to trial. This denial co...


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    /news-article.aspx?ID=32703270

    NICE SHUTS DOWN AZS TAGRISSO AND BACKS PFIZER RIVAL VIZIMPRO INSTEAD

    Jul 08, 2019

    Englands cost watchdogs wont get behind AstraZeneca blockbuster Tagrisso in previously untreated patients with EGFR-mutated lung cancer. But in a change of events, they’re instead backing a Pfizer challenger. Friday, the National Institute for Health and Care Excellence (NICE) deemed Tagrisso ...


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    /news-article.aspx?ID=32633263

    REVIEW OF IMPACT OF DRUG HOLIDAYS ON BONE HEALTH

    Jul 08, 2019

    The impact of interruption of anti-osteoporosis treatment in patients on therapy with bisphosphonates or denosumab is reviewed in a new International Osteoporosis Foundation (IOF) working group paper 'Fracture risk following intermission of osteoporosis therapy' published in the journal Oste...


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    /news-article.aspx?ID=32643264

    RESEARCHERS IDENTIFY EFFECTIVE DRUG COMBINATION AGAINST UVEAL MELANOMA

    Jul 08, 2019

    Uveal melanoma is a very aggressive type of melanoma that affects the eye. It is a rare disorder, affecting an estimated 2,500 people in the United States each year. However, nearly half of uveal melanoma patients will develop metastatic disease that migrates to other part of the body, primarily the...


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    /news-article.aspx?ID=32653265

    NICE CLEARS FRONT-LINE NHS USE FOR PFIZERS LUNG CANCER DRUG VIZIMPRO

    Jul 05, 2019

    Pfizer has stolen a march on rival AstraZeneca in the first-line non-small cell lung cancer category, after NICE backed the use of its EGFR inhibitor Vizimpro for NHS use. The once-daily pill will now be routinely available for adults with locally advanced or metastatic non-small cell lung cancer (N...


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    /news-article.aspx?ID=32583258

    AZ APPEALS AGAINST NICE REJECTION OF TAGRISSO IN UNTREATED LUNG CANCER

    Jul 05, 2019

    AstraZeneca is appealing against NICEs decision not to recommend funding for its lung cancer drug Tagrisso (osimertinib) in untreated patients with epidermal growth factor receptor (EGFR) mutations. In final draft guidance, NICE said it had rejected regular NHS funding for Tagrisso, because the surv...


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    /news-article.aspx?ID=32593259

    EMA RESOLVES DISPUTE OVER PRICEY CANARY WHARF TENANCY

    Jul 05, 2019

    After months of wrangling, the EMA finally has a solution to the £500 million financial liability it has faced over the tenancy to its former home in Canary Wharf. The EU regulator – now based in temporary accommodation in Amsterdam – has sub-let the entire 284,704 square feet (26,...


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    /news-article.aspx?ID=32603260

    JANSSEN HANDS BACK RIGHTS TO HANMI'S DIABETES/OBESITY DRUG

    Jul 04, 2019

    Shares in Hanmi Pharmaceutical have taken a hit after Johnson & Johnson's Janssen handed back rights to HM12525A, a novel biologic GLP-1/Glucagon dual receptor agonist being developed for weight loss and blood glucose control in certain patients with diabetes. According to the Korean drugmak...


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    /news-article.aspx?ID=32543254

    GSK LAUNCHES PHIII PROGRAMME FOR OTILIMAB IN RA

    Jul 04, 2019

    GSK has kicked off a Phase III clinical development programme testing otilimab in patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to disease modifying antirheumatic drugs (DMARD) or targeted therapies. The move follows a successful Phase II study with t...


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    /news-article.aspx?ID=32553255

    VIIVS DOVATO HIV PILL APPROVED IN EU

    Jul 03, 2019

    The new regimen, dubbed Dovato, is approved in adults and adolescents above 12 years of age with HIV-1, and is based on a combination of dolutegravir and lamivudine given as a single pill once daily. Patients must weigh at least 40 kg and have no known suspected resistance to integrase inhibitors or...


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    /news-article.aspx?ID=32473247

    LEO PHARMA COMPLETES BAYER PRESCRIPTION DERMATOLOGY BUSINESS ACQUISITION

    Jul 03, 2019

    LEO Pharma has completed the acquisition of Bayer’s prescription dermatology business. The companies announced the proposal in July 2018, and completed the first step of the acquisition with the closing in the United States on September 4, 2018. Today’s second and final closing covers al...


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    /news-article.aspx?ID=32483248

    OBESITY NOW LEADING CAUSE OF FOUR CANCERS

    Jul 03, 2019

    New analysis from Cancer Research UK has found that excess weight causes more cases of certain cancers than smoking, as the number of people who are obese now outnumbers those who smoke two to one in the UK. According to the charity, almost one third of UK adults are obese, and being overweight or o...


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    /news-article.aspx?ID=32493249

    SANOFI, REGENERON'S LIBTAYO HITS HOT STREAK WITH EU GREEN LIGHT, NICE BACKING

    Jul 02, 2019

    Sanofi and Regeneron’s Libtayo is two for two in the last two days-with European officials, that is. One day after the European Commission cleared the PD-1 drug to treat cutaneous squamous cell carcinoma, England’s cost watchdog signed off on an access agreement for the product in adults...

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    /news-article.aspx?ID=32443244

    UNDER THREAT FROM NOVARTIS, BIOGEN HAILS NEW DATA FROM SMA DRUG SPINRAZA

    Jul 02, 2019

    Under threat from a gene therapy from Novartis, Biogen is making the case for its drug Spinraza for the muscle wasting disease spinal muscular atrophy, with new data that it hopes persuades doctors to prescribe it. Despite its steep list price of around £450,000 for the first year of treatment...

    PHARMAPHORUM
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    /news-article.aspx?ID=32453245

    ROCHE CLOSES ON EU APPROVAL FOR TECENTRIQ IN BREAST CANCER

    Jul 01, 2019

    Roche is heading for EU approval of Tecentriq as first-line therapy for triple-negative breast cancer (TNBC), ahead of its checkpoint inhibitor rivals. The Committee for Medicinal Products for Human Use (CHMP) backed the use of the PD-L1 inhibitor in patients with locally-advanced or metastatic TNBC...


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    /news-article.aspx?ID=32393239

    AZS ASTHMA AND DIABETES DRUGS GET LABEL BOOSTS IN EU

    Jul 01, 2019

    Two of AstraZenecas most important drugs have received a boost, after European regulators backed a pen allowing people to inject themselves with respiratory drug Fasenra, and agreed that cardiovascular benefits data could be added to the label of diabetes drug Forxiga. The European Medicines Agency&...


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    /news-article.aspx?ID=32403240

    CHARITY BACKS R&D INTO PARKINSON’S DRUGS TARGETING MITOCHONDRIA

    Jul 01, 2019

    The charity Parkinson’s UK has struck a £1 million partnership with NRG Therapeutics to develop drugs targeted at mitochondria that could protect cells producing dopamine, which have been damaged by the condition. The research will build on recent discoveries showing a direct link betwee...


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    /news-article.aspx?ID=32413241

    PHARMA RANKED A HIGHEST CONTRIBUTOR TO SOCIETY, DESPITE PUBLIC PERCEPTION

    Jun 28, 2019

    The pharmaceutical industry has been ranked as one of the highest contributors to UK society, but public perception still falls far below other sectors, claims a new study by Portland. The dissonance means that the industry ranks among the least successful sectors in demonstrating its value to socie...


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    /news-article.aspx?ID=32343234

    ALEXIONS SOLIRIS GETS NEW, AND LUCRATIVE, RARE DISEASE INDICATION.

    Jun 28, 2019

    Alexion’s rare disease drug Soliris has a new indication after the FDA approved it for a disease that attacks the optic nerves.Approval of Soliris (eculizumab) for neuromyelitis optica spectrum disorder (NMOSD) in adults who have the anti-aquaporin-4 antibody opens up further revenues for Alex...


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    /news-article.aspx?ID=32353235

    IS BAYER FINALLY HEADING FOR A ROUNDUP DEAL? ITS NEW LEGAL TEAM SUGGESTS SO

    Jun 28, 2019

    Bayer has said it intends to defend itself vigorously in thousands of lawsuits that claim its Roundup weedkiller causes cancer. But that harsh tone has softened, increasing the possibility that a settlement could be near. The German company has hired an independent lawyer to advise its supervisory b...


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    /news-article.aspx?ID=32363236

    NEW PROSTATE CANCER TEST COULD DIAGNOSE FIVE YEARS EARLIER

    Jun 27, 2019

    Researchers at the University of East Anglia and the Norfolk and Norwich University Hospital have developed a urine test, dubbed PUR (Prostate Urine Risk), to diagnose aggressive prostate cancer and predict whether patients will require treatment up to five years earlier than standard clinical metho...


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    /news-article.aspx?ID=32293229

    U.S. REPS TO GILEAD: DID YOUR DONATION OF FREE HIV PREVENTION DRUG TRUVADA HAVE STRINGS ATTACHED?

    Jun 27, 2019

    In May, Gilead pledged to donate 2.4 million bottles of its HIV drug Truvada to the U.S. governments effort to eradicate the disease, partly by preventing new infections. Gilead even promised it would donate its newer drug, Descovy, if the FDA approves it for prevention as it did for Truvada. But no...


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    /news-article.aspx?ID=32303230

    MERCK, PFIZER KEEP HIGH-FLYING VACCINE SALES INTACT WITH KEY CDC BACKING

    Jun 27, 2019

    Merck and Pfizer faced uncertainty on big-selling vaccines going into this week meeting of the Advisory Committee on Immunization Practices, a CDC panel that sets U.S. vaccination policy. But in votes on Wednesday, the panel either maintained favourable recommendations for the vaccines, or in Merck&...


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    /news-article.aspx?ID=32313231

    SANOFI AND REGENERON'S DUPIXENT SCORES 3RD FDA APPROVAL IN SINUSITIS WITH NASAL POLYPS

    Jun 26, 2019

    Sanofi and Regeneron’s Dupixent has been charging ahead since its initial approval in moderate-to-severe atopic dermatitis, later picking up a follow-up nod in moderate-to-severe asthma. Wednesday, the drug scored FDA approval for its third use: to treat adults with chronic rhinosinusitis with...


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    /news-article.aspx?ID=32243224

    AFTER ROCHE, BMS SURPRISES, WHAT DOES ABBVIE NEED TO DO TO WIN FTC CLEARANCE FOR ALLERGAN BUY?

    Jun 26, 2019

    With mergers and acquisitions come antitrust reviews. And with the U.S. Federal Trade Commission (FTC) cracking down on pharma deals these days, it’s only natural to ask whether AbbVie’s proposed $63 billion acquisition of Allergan could face anti-competition scrutiny, despite across-boa...


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    /news-article.aspx?ID=32253225

    BMS’ OPDIVO DISAPPOINTS IN LATE-STAGE TRIAL

    Jun 26, 2019

    Bristol-Myers Squibb has announced topline results from its CheckMate -459 trial evaluating Opdivo (nivolumab) in patients with unresectable hepatocellular carcinoma (HCC). The results show that the cancer drug failed to show superiority to Nexavar (sorafenib), and did not achieve statistical signif...


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    /news-article.aspx?ID=32263226

    ALMIRALL TAKES OPTION ON DERMIRA’S ECZEMA DRUG LEBRIKIZUMAB

    Jun 25, 2019

    Spain’s Almirall has taken an option granting rights to develop and market Dermira’s eczema drug lebrikizumab in Europe, in a bid to take on Sanofi/Regeneron’s recently approved Dupixent. The companies had struck an option and license agreement in February which granted Almirall Eu...


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    /news-article.aspx?ID=32193219

    FDA PRIORITY REVIEW GRANTED FOR GSKS ZEJULA

    Jun 25, 2019

    The US Food and Drug Administration (FDA) has accepted Glaxo Smith Klines application for Zejula (niraparib) in late stage ovarian cancer with priority review. The company announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental New Drug Application (sNDA) to the...


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    /news-article.aspx?ID=32203220

    NHS TO OPEN YOUNG PEOPLES GAMBLING ADDICTION SERVICE

    Jun 25, 2019

    NHS England has announced the opening of a new gambling clinic for children and young people, as part of the Long Term Plan. The news comes after a recent Gambling Comission report found that the number of children classed as having a gambling problem is 55,000, and that 450,000 are gambling regular...


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    /news-article.aspx?ID=32213221

    GSK WINS SPEEDY FDA ZEJULA REVIEW IN OVARIAN CANCER NICHE

    Jun 24, 2019

    GlaxoSmithKline has been working to restrengthen in cancer, particularly through a multibillion-dollar purchase of Tesaro. The main drug from the buyout, Zejula, is now up for a priority review in late-stage ovarian cancer, where it's working to pick up a niche nod its rivals don't have. The...


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    /news-article.aspx?ID=32103210

    BRISTOL-MYERS SQUIBB’S OPDIVO MISSES ITS SHOT AT EARLIER USE IN LIVER CANCER

    Jun 24, 2019

    Bristol-Myers Squibb’s Opdivo already boasts an FDA approval in liver cancer patients who have been treated with Bayer’s Nexavar. But its quest to jump into the front line just hit a snag. The BMS PD-1 drug failed to beat Nexavar at extending patients’ lives in a phase 3 study, the...


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    /news-article.aspx?ID=32113211

    CELGENE, SAY GOODBYE TO OTEZLA: BMS AGREES TO SELL PSORIASIS DRUG TO CLEAR $74B MERGER

    Jun 24, 2019

    With the Federal Trade Commission (FTC) sweating the details of Bristol-Myers Squibb and Celgene’s proposed $74 billion merger, all eyes were on the companies’ combined psoriasis portfolio, which regulators feared would corner the market. The feds found a solution: You can have your merg...


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    /news-article.aspx?ID=32123212

    COST-EFFECTIVENESS WATCHDOGS SKEWER NOVARTIS' MS DRUG MAYZENT AND J&J'S DEPRESSION SPRAY SPRAVATO

    Jun 21, 2019

    The Institute for Clinical and Economic Review (ICER) had a busy day Thursday, issuing final cost assessments on two highly anticipated neurology drugs: Spravato, the inhalable depression treatment from Johnson & Johnson’s Janssen, and Novartis’ Mayzent to treat secondary progressive...


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    /news-article.aspx?ID=32053205

    £8M DRUG-RESISTANCE GRANT FOR OXFORD DRUG DESIGN

    Jun 21, 2019

    Oxford Drug Design has received over 8 million pounds in grant and equity investment from CARB-X, the UK Department of Health and Social Care (DHSC) and o2h Ventures. The funding will help to develop new antibiotics effective against drug-resistant superbugs, and to expand Oxford Drug Design’s...


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    /news-article.aspx?ID=32063206

    J&J’S SPRAVATO FOR DEPRESSION ‘SHOULD BE MUCH CHEAPER’

    Jun 21, 2019

    Johnson & Johnson has priced its new Spravato nasal spray for treatment-resistant depression (TRD) too high to offer value for money, says a US cost-effectiveness body. The Institute for Clinical and Economic Review (ICER) has published its final report on Spravato (esketamine) and says the drug...


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    /news-article.aspx?ID=32073207

    DAIICHI WAITS ON FDA AS AML DRUG QUIZARTINIB APPROVED IN JAPAN

    Jun 20, 2019

    The Japanese regulator has approved Daiichi Sankyo’s quizartinib for certain patients with acute myeloid leukaemia (AML), amid doubts over the outcome of a regulatory review in the US. Japan’s Ministry of Health, Labor and Welfare (MHLW) approved quizartinib, newly branded as Vanflyta, f...


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    /news-article.aspx?ID=31983198

    BAYER’S REGORAFENIB KICKS OFF BRAIN CANCER PLATFORM TRIAL

    Jun 20, 2019

    Bayer has become the first pharma company to take part in a new platform trial designed to find new treatments for brain cancer. GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is an international trial testing several therapies for patients with newly diagnosed and recurren...


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    /news-article.aspx?ID=31993199

    PHARMACY TAKES FDA TO TASK IN CITIZEN PETITION OVER TAINTED VALSARTAN

    Jun 20, 2019

    The FDA has tied the contamination of blood pressure drugs by probable carcinogens to an approved switch in manufacturing to a process that uses certain solvents. Now an online pharmacy says it has discovered the solvents are as bad as the impurities they have been creating and has criticized the FD...


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    /news-article.aspx?ID=32023202

    COGNIZANT JOINS FORCES WITH ZENITH TO DIGITISE PHARMA MANUFACTURING

    Jun 19, 2019

    Professional services firm Cognizant has struck a deal to buy Zenith Technologies, a privately-held life sciences manufacturing technology company specialising in digital technologies to manage, control and optimise drug and medical device production. Cognizant, which said it already works with the ...


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    /news-article.aspx?ID=31953195

    VACCINES MISTRUST A “GLOBAL CRISIS” SAYS WELCOME REPORT

    Jun 19, 2019

    A wide-ranging survey involving 140,000 people in 140 countries has revealed a worryingly high level of concern about the safety of vaccines, with scepticism highest in the developed world. While the report by the Wellcome Trust suggests that more than three-quarters of the world’s population ...

    PHARMAPHORUM
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    /news-article.aspx?ID=31963196

    MERCK SCOUTS REPLACEMENTS FOR CEO FRAZIER LESS THAN A YEAR AFTER SCRAPPING RETIREMENT RULE: REPORT

    Jun 19, 2019

    It was less than a year ago that Mercks board scrapped a policy that CEOs must retire at the age of 65 in a move designed to keep Ken Frazier around longer. Now, the company is scouting replacements for the long-tenured helmsman, Bloomberg reports. Merck is preparing for Frazier’s exit and has...


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    /news-article.aspx?ID=31973197

    AGENCIES SEE GROWTH IN CONTENT MARKETING BUSINESS

    Jun 19, 2019

    Agencies are banking on content marketing. That’s the key finding in the newly released Content Marketing Institute 2019 Agency Survey. This inaugural research looks at how full-scope agencies, as well as specialized agencies, are doing content marketing for clients, how well it’s workin...

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    /news-article.aspx?ID=33583358

    NOVO NORDISK’S VICTOZA GETS FDA OKAY FOR PAEDIATRIC USE

    Jun 18, 2019

    Novo Nordisk’s GLP-1 agonist Victoza has become the first non-insulin drug to be approved in the US as a treatment for type 2 diabetes in children for almost two decades. The FDA says the okay to use Victoza (liraglutide) in paediatric patients aged 10 or over comes “at a time when an in...


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    JAPAN APPROVES ROCHE’S TUMOUR AGNOSTIC CANCER DRUG ROZLYTREK

    Jun 18, 2019

    Japan has become the first country to approve Roche’s personalised cancer drug Rozlytrek (entrectinib). Roche added entrectinib to its pipeline through its $1.7 billion buyout of Ignyta at the end of 2017 in a move that brought it into competition with Bayer and its newly acquired targeted the...


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    MERCK'S KEYTRUDA GIVES BMS' OPDIVO SOME COMPANY WITH SMALL CELL LUNG CANCER NOD

    Jun 18, 2019

    Bristol-Myers Squibb's FDA approval for Opdivo in patients with previously treated small cell lung cancer (SCLC) already has looked shaky since the drug failed to extend patients' lives in a phase 3 trial. Now, Opdivo will have to make some room for its archrival, Merck & Co.’s Key...


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    GREATER MANCHESTER JOINS CITIES CHANGING DIABETES INITIATIVE

    Jun 17, 2019

    Novo Nordisk has named Greater Manchester as the 22nd city, and second in the UK, to join Cities Changing Diabetes, a scheme designed to address the dramatic rise of type II diabetes in urban areas. Launched in 2014 by Novo, University College London and the Steno Diabetes Center Copenhagen, the pro...


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    ASTRAZENECA'S CALQUENCE SETS IMBRUVICA IN ITS SIGHTS WITH BIG CLL SURVIVAL NUMBERS

    Jun 17, 2019

    When AstraZeneca ended a late-stage trial for Calquence early after seeing promising results, the news boded well for the drug’s chances in previously treated chronic lymphocytic leukemia (CLL). Now, the drugmaker has unveiled the detailed data it plans to take before regulators later this yea...


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    LAWYERS PITCH MASSIVE OPIOID NEGOTIATION PLAN TO BRING 'GLOBAL PEACE' TO LEGAL BATTLE

    Jun 17, 2019

    Thousands of cities and counties have sued opioid drugmakers and distributors for an alleged role in a nationwide epidemic, and now lawyers for the plaintiffs have pitched a novel process to aid settlement talks. It's an idea that could simplify the legal process and offer drugmakers "globa...


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    LILLY'S TALTZ SCRAPES WIN AGAINST HUMIRA IN PSORIATIC ARTHRITIS

    Jun 14, 2019

    Eli Lilly’s Taltz has beaten AbbVie’s blockbuster Humira in a psoriatic arthritis study involving patients who hadn’t been treated before with a disease-modifying drug, but only just. Lilly reported last year that the SPIRIT-H2H trial had shown Taltz (ixekizumab) met its primary en...


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    TEVA EXPANDS BLOOD PRESSURE DRUG RECALL IN THE US AMID CANCER FEARS

    Jun 14, 2019

    Teva has expanded a recall of losartan potassium tablets after tests revealed a potential human carcinogen in the blood pressure drug. The Israeli pharma earlier this week recalled six lots of the drug containing unacceptable levels of a nitrosamine impurity. This builds on a decision in April when ...


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    PFIZER'S XELJANZ MATCHES IMMUNOSUPPRESSANT COMBO IN RHEUMATOID ARTHRITIS STUDY

    Jun 13, 2019

    Pfizer’s troubled JAK inhibitor Xeljanz has had its share of hiccups after pulmonary embolism fears derailed the drug’s higher dose in rheumatoid arthritis. Now, Pfizer is hoping for better results using Xeljanz to treat RA patients who wean off immunosuppressants. Patients treated with ...


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    ASTRAZENECA ADMITS ITS DELAY-RIDDEN HQ PROJECT WILL NOW COST ALMOST $1B

    Jun 13, 2019

    AstraZeneca has taken a lot of heat for its massive new headquarters and R&D facility in Cambridge, U.K., which has been beset by everything from cost overruns to a four-year completion delay. So it’s no wonder the drugmaker buried the latest details about the project on page 27 of its 244...


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    BOEHRINGER, LILLY PRESENT POSITIVE TRAJENTA RESULTS AT ADA

    Jun 12, 2019

    Boehringer Ingelheim and Eli Lilly have announced full data from the CAROLINAtrial, in which Trajenta (linagliptin) demonstrated no increased cardiovascular risk compared to glimepiride in adults with type II diabetes and cardiovascular risk. The study is the only active-comparator cardiovascular ou...


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    COSENTYX SHOWS EFFICACY IN KEY MANIFESTATIONS OF PSORIATIC ARTHRITIS

    Jun 12, 2019

    Novartis has announced that its drug Cosentyx (secukinumab) has been found to show efficacy and safety of a biologic in the management of axial manifestations of psoriatic arthritis, in first-of-its kind data. The company announced that the ongoing 52-week Phase IIIb trial met both its primary and k...


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    KEYTRUDA WINS FDA APPROVAL IN HEAD AND NECK CANCER

    Jun 12, 2019

    MSD’s blockbuster cancer drug Keytruda (pembrolizumab) has won approval from the US Food and Drug Administration (FDA) to treat a type of head and neck cancer. It was approved in the Indication of first-line treatment of patients with metastatic or with unresectable, recurrent head and neck sq...


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    HOW TO CORRECT OPIOID MISINFORMATION? SPEND $285M ON COUNTER-MARKETING, EXPERT SAYS IN J&J TRIAL

    Jun 11, 2019

    Countless lawsuits have sought to estimate the costs of fixing the U.S. opioid and addiction epidemic. Now, thanks to an expert in Oklahoma's ongoing trial against Johnson & Johnson, we have one dollar figure. Oklahoma would have to spend nearly $285 million to mount a counter-marketing camp...


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    ADA: J&J'S STRUGGLING INVOKANA SLASHES HEART, KIDNEY RISKS IN LATEST TRIAL WIN

    Jun 11, 2019

    Johnson & Johnson and its fellow SGLT2 drugmakers are all working to show benefits for patients with kidney disease. But in that group, J&J can tout data its rivals don’t have. Tuesday at the American Diabetes Association annual meeting, J&J’s Janssen unit rolled out a new an...


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    ROCHE LAUNCHES FIRST IN VITRO LUNG CANCER DIAGNOSTIC TEST

    Jun 10, 2019

    Roche Diagnostics has launched its first in vitro diagnostic test to target ROS1 positive lung cancers, VENTANA ROS1 (SP384) Antibody. The biomarker is the first and only in vitro diagnostic ROS1 immunohistochemistry assay on the market and looks promising to provide a cost-effective and efficient m...


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    POSITIVE RESULTS FOR NOVO’S XULTOPHY

    Jun 10, 2019

    Novo Nordisk’s Xultophy (degludec/liraglutide) has been found to significantly delay time-to-treatment intensification when compared to insulin glargine U100 in adults with type II diabetes inadequately controlled on oral treatments. The DUAL VIII trial results were presented at the 79th Scien...


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    SOSEI HEPTARES TO GET $3M PFIZER MILESTONE PAYMENT

    Jun 10, 2019

    Sosei Heptares has announced that it is to receive a new $3 million milestone payment from its strategic alliance partner Pfizer, as it advances a second candidate from the GPCR collaboration for clinical development. The first clinical candidate under this collaboration was nominated by Pfizer in M...


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    GLAXOSMITHKLINE'S NUCALA SCORES CONVENIENCE BOOST WITH AT-HOME DOSING OPTIONS

    Jun 07, 2019

    GlaxoSmithKline’s Nucala has suffered against a more convenient AstraZeneca rival, but the company finally has an answer. Thursday, the FDA greenlighted two new delivery options for Nucala: an autoinjector and a prefilled syringe, both of which severe eosinophilic asthma patients can self-admi...


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    DIGITAL TOOL AIMS TO CUT COSTS AND RISKS OF UNDERPERFORMING TRIALS

    Jun 07, 2019

    ArcheMedx, which provides tech solutions for life sciences and healthcare, has launched a new digital service that aims to cut risks and costs associated with under-performing clinical trials. The company will unveil the tool called Ready at this year’s Drug Information Association (DIA) annua...


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    COELIAC UK, INNOVATE UK ANNOUNCE £180K RESEARCH FUNDING AVAILABLE

    Jun 06, 2019

    Coeliac UK and Innovate UK have announced that the companies have £180k available for research and are inviting applications from UK businesses and researchers. The collaboration is launching a second research call to industry and researchers to make improvements for people living with the aut...


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    INFLARX FLATLINES AFTER SKIN DISEASE DRUG FLOPS IN MIDSTAGE TRIAL

    Jun 06, 2019

    The phase 2b SHINE study of the anti-human complement factor C5a antibody was conducted in hidradenitis suppurativa (HS), a chronic inflammatory skin disease with limited treatment options that causes symptoms including inflamed nodules or boils in the armpits, groin and genital area. Unfortunately ...


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    GLOBAL PHARMA GIANT DEVELOPS DLT-BASED CARE NETWORK FOR DIABETES PATIENTS

    Jun 06, 2019

    А leading pharmaceutical firm Boehringer Ingelheim has teamed up with blockchain-based healthcare platform Solve.Care, according to a press release shared with Cointelegraph on June 6. Germany-based Boehringer, one of the world’s 20 largest pharma companies, and Solve.Care are planning to buil...


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    LEADING EUROPEAN ANALYST FIRM OVUM NAMES MADISON LOGIC A “LEADER” IN THEIR REPORT ON ACCOUNT BASED MARKETING

    Jun 05, 2019

    Madison Logic, the leading global account-based marketing (ABM) platform, today announced that Ovum, a market-leading data, research and consulting business headquartered in the U.K., named Madison Logic a “Leader” in the Ovum Market Radar: Account-Based Marketing report. Ovum recognized...

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    ASTRAZENECA SCOUTS REPLACEMENTS FOR LONGTIME CHAIRMAN JOHANSSON

    Jun 04, 2019

    During his seven-year stint as AstraZeneca chairman, Leif Johansson weathered some ups and downs and helped fend off one major hostile takeover attempt. Now, the drugmaker is getting ready to scout for successors, Sky News reports. The company hasn't set a timetable for a transition, but its nom...


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    MACROGENICS LOOKS TO FUTURE WITH BREAST CANCER DRUG MARGETUXIMAB

    Jun 03, 2019

    A small biotech, MacroGenics, took the market by surprise earlier this year with some surprising data from its margetuximab essentially a tweaked version of Roche’s Herceptin (trastuzumab) where a few amino acid mutations are enough to produce a stronger cellular response to cancer.CEO Scott K...


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    SANOFI, REGENERON DIVE DEEP ON ASTHMA IN DEBUT DIGITAL AWARENESS CAMPAIGN

    Jun 03, 2019

    Most people know what asthma is, but even asthma patients can underestimate it. Sanofi and Regeneron’s new online disease awareness campaign highlights the problems of uncontrolled asthma. “The Next Breath” campaign, launched on World Asthma Day in May, aims to make patients, careg...


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    PFIZER, ASTELLAS' XTANDI RACKS UP MORE DATA FOR NEW PROSTATE CANCER APPROVAL

    Jun 02, 2019

    Pfizer and Astellas’ Xtandi is gunning for a new indication in prostate cancer, and they say Sunday's new data complement the supporting evidence they’ve already generated. Sunday at the American Society of Clinical Oncology annual meeting, researchers trumpeted datafrom an investiga...


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    BIG PHARMA'S CHINA GROWTH; PFIZER'S NEW UPJOHN HQ; HANSOH'S $1B HONG KONG IPO

    May 31, 2019

    As the Chinese government pilots a bulk procurement program for generic drugs, Big Pharma's older medicines are under increasing pricing pressure. Pfizer is planning a push into China's rural areas in response to the headwinds, and it has moved the headquarters of its Upjohn established medi...


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    PROSECUTORS STRIKE YET ANOTHER PHARMA KICKBACK SETTLEMENT, THIS TIME WITH ALMIRALL

    May 30, 2019

    One by one, drugmakers have been handing over millions of dollars to the U.S. government to settle kickback allegations. And Almirall is the latest.The Spain-based drugmaker agreed to pay $3.5 million to the Department of Justice (DOJ) and $3.1 million to the California Department of Insurance to wr...


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    JOIN THE DOTS OR LOSE OUT, SYNEOS HEALTH ADVISES BIG PHARMA

    May 30, 2019

    Pharma companies need to rethink how they communicate and share information and insights within their own organisations, according to Syneos Health’s principal for real world and late phase development, Erwin De Cock. We spoke to him at the eyeforpharma conference in Barcelona to learn about t...


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    PHS HEALTH SOLUTIONS ANNOUNCES REBRANDING ON AMPLITY HEALTH

    May 29, 2019

    New Brand Identity Paves the Way for New Pure Play Marketing Partner for the Pharmaceutical Industry PHS Health Solutions (PHS), a premier contract merchant organization that has been a trusted partner to its pharmaceutical industry customers for 35 years, announced today that the company is operati...


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    27-YEAR-OLD SEARCH MARKETING CEO LANDS 13-STOP U.S. SPEAKING TOUR

    May 29, 2019

    Garrett Mehrguth, the CEO and co-founder of the B2B and enterprise search marketing agency, Directive, recently was selected to speak at 13 stops of the Digital Summit tour. Digital Summit, the largest conference series in the digital marketing industry, has invited Mehrguth to share his unique pres...

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    ZOLGENSMA WINS FDA GREEN LIGHT IN CHILD SMA

    May 28, 2019

    The U.S. Food and Drug Administration (FDA) has approved Novartis’ Zolgensma (onasemnogene abeparvovec-xioi) at a cost of $2.1 milllion per treatment. The drug is the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), which is the most ...


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    NEWRON PHARMA DELAYS SCHIZOPHRENIA TRIALS OVER SAFETY CONCERNS

    May 28, 2019

    Switzerland-based Newron Pharmaceuticals announced that it is delaying its Phase II/III clinical trials of evenamide for schizophrenia based on concerns raised by the U.S. Food and Drug Administration (FDA).The agency expressed concern over the results of recently finished studies in rats and dogs t...


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    CHINA'S DRIVING SALES GROWTH AHEAD OF THE U.S. FOR BIG PHARMA. BUT CAN IT LAST?

    May 28, 2019

    If you follow Big Pharma companies’ investor updates, you’ll notice China popping up frequently these days. The world’s second-largest pharmaceutical market has been turning up sales increases that continuously surpass those in the U.S. and other developed regions. In the first qua...


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    EMCURE INJECTED SCHIZOPHRENIA DRUG RECALLED AFTER CONTAMINATION DETECTED

    May 28, 2019

    Two injected drugs manufactured by an Indian company with a history of sterility problems are being recalled because of microbial contamination. The drugs were both manufactured by Emcure Pharmaceuticals but are distributed in the U.S. by Heritage Pharmaceuticals.East Brunswick, New Jersey-based Her...


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    NHS TO UNDERGO ‘AMBITIOUS’ TECH OVERHAUL

    May 24, 2019

    Matt Hancock, health secretary, has announced major improvements to general practice IT and more support for NHS Trusts to improve cyber security, as part of a new “ambitious tech overhaul”.Under the new plans top technology companies will be challenged to develop new, innovative GP IT s...

    PHARMATIMES
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    CMA ACCUSES FOUR PHARMAS OF ANTICOMPETITIVE BEHAVIOUR

    May 23, 2019

    Four pharma companies stand accused in the UK of colluding to artificially inflate the price of prescription-only, anti-nausea and dizziness drug prochlorperazine, costing the NHS millions of pounds and breaking competition law.In a statement of objections, the UK's the Competition and Markets A...

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    H1 2019 REPORT FEATURING DAEWOONG PHARMACEUTICAL, RAQUALIA PHARMA

    May 23, 2019

    Functional (Non Ulcer) Dyspepsia - Pipeline Review, H1 2019, provides comprehensive information on the therapeutics under development for Functional (Non Ulcer) Dyspepsia (Gastrointestinal), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administrati...

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    700% PRICE SPIKE SPURS UK TO ALLEGE FOUR PHARMA COMPANIES AGREED TO RESTRICT COMPETITION

    May 23, 2019

    The UK’s Competition and Markets Authority (CMA) on Thursday alleged that Focus Pharmaceuticals, Medreich, Alliance Pharmaceuticals and Lexon have breached UK and EU law by entering into anti-competitive agreements that restricted the supply of the nausea and dizziness drug prochlorperazine.Un...

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    6SENSE LAUNCHES ACCOUNT-BASED EXTERNAL MEDIA CAMPAIGNS ANALYTICS

    May 23, 2019

    Today 6sense, a leading Account Based Orchestration Platform, powered by AI, announced its External Media Campaigns feature. This capability extends 6sense's ability to track digital media campaigns launched on non-6sense platforms for use in account segmentation within the 6sense platform, and ...

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    ‘RECORD’ NUMBER OF PATIENTS TAKING PART IN CLINICAL TRIALS

    May 20, 2019

    The National Institute for Health Research (NIHR) has announced that a record number of patients are now taking part in clinical trials. The report states that over 870,250 participants were involved in health and social care studies supported by the organisation over the last twelve months, marking...


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    NEW SCREENING TO HELP DETECT GROUP B STREP IN PREGNANT WOMEN

    May 20, 2019

    The National Institute for Health Research (NIHR) has announced a clinical trial to improve the diagnosis and treatment of a potentially life-threatening infection in newborn babies. The trial will test the effectiveness of two types of screening compared to no screening in 80 hospitals in England a...


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    EMA’S PRAC TO REVIEW XELJANZ AND RECOMMENDS FENSPIRIDE WITHDRAWL

    May 20, 2019

    The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has announced its latest meeting highlights, including a restriction of the use of Xeljanz (tofacitinib), and a call for withdrawal of marketing authorisations for fenspiride medicines. The Xeljanz restric...


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    REVLIMID, IMNOVID COMBOS RECEIVE EU APPROVAL

    May 17, 2019

    The European Commission has approved two of Celgene’s combination regimens involving Revlimid (lenalidomide) and Imnovid (pomalidomide). The first, Revlimid in combination with bortezomib and dexamethasone (RVd) is for the indication of adult patients with previously untreated multiple myeloma...


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    FRAGMIN APPROVED BY FDA AS FIRST ANTICOAGULANT FOR CHILDREN

    May 17, 2019

    The US Food and Drug Administration has approved Pfizer’s Fragmin (dalteparin sodium) injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in paediatric patients one month of age and older. The drug was initially approved by the FDA in 1994 for adults and is a type of...


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    WINNERS ANNOUNCED - 2019 INTERNATIONAL CLINICAL RESEARCHER OF THE YEAR!

    May 17, 2019

    The winners of the PharmaTimes International Clinical Researcher of the Year have been announced, find out who emerged victorious in the 2019 competition. Celebrating its 20th anniversary, the International Clinical Researcher of the Year awards ceremony took place last night at the Chelsea Harbour ...


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    BOEHRINGER SETTLES HUMIRA LAWSUIT, JOINS BIOSIMILAR QUEUE IN US

    May 15, 2019

    Boehringer Ingelheim was the last man standing among challengers to AbbVie’s patents on immunology blockbuster Humira but has joined the pack and settled its litigation. The German company has agreed to delay the introduction of its Humira (adalimumab) biosimilar Cyltezo until 2023, following ...


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    NOT-FOR-PROFIT GENERIC DRUG COMPANY CIVICA RX INKS 1ST SUPPLIER DEAL WITH XELLIA PHARMA

    May 15, 2019

    In January 2018, Civica Rx was launched by five healthcare systems as a not-for-profit generic drug company. The systems were the U.S. Department of Veterans Affairs (VA), Intermountain Healthcare, Ascension, SSM Health and Trinity Health. It almost immediately expanded to seven health systems and t...


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    R&D SMES AT RISK DUE TO TAX CREDIT SCHEME CHANGE

    May 14, 2019

    The BioIndustry Association (BIA) has announced that changes to small and medium enterprises (SME) research and development (R&D) tax credit schemes could harm a thriving sector. This is because the Government is proposing to introduce a cap on the value of cash payments loss-making SMEs can rec...


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    SMC APPROVES NEW CANCER DRUGS, AMONG OTHERS

    May 14, 2019

    The latest round of Scottish Medicines Consortium (SMC) decisions have brought medicines for breast cancer, skin cancer and schizophrenia into the spotlight and recommended them for use on the NHS in Scotland.The governing body has firstly accepted Eli Lilly's Verzenios (abemaciclib) for the tre...


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    UK SHOULD BE "PROUD" OF SERVICE AND SUPPLY SECTOR

    May 14, 2019

    A new report by the Medicines Discovery Catapult and the BioIndustry Association has unveiled a thriving service and supply sector for the UK's medicines discovery. The 2019 ‘State of the Discovery Nation’ report specifically highlights two breakthrough technologies set to influence ...


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    ‘GROUNDBREAKING’ NEW BRAIN CANCER TREATMENT AVAILABLE

    May 13, 2019

    A new treatment hailed as ‘groundbreaking’ has been rolled out across the country as part of the NHS' Long Term Plan, and could see as many as 2,000 patients benefit as a result. 5-ALA (5-AminoLevulinic Acid), dubbed ‘the pink drink’, uses fluorescent dye and ultraviolet ...


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    QUIETER INTENSIVE CARE UNITS MAY TRANSLATE TO BETTER OUTCOMES FOR INFANTS IN NEW STUDY

    May 13, 2019

    Excessive noise is widely known to have negative effects on health, and children in neonatal intensive care units are among the most vulnerable. To help preterm infants make a smooth transition to life outside of the womb, some NICUs have instituted set quiet times to limit children's exposure t...


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    GPS NEED TRAINING TO TACKLE CHRONIC OPIOID USE

    May 13, 2019

    GPs must be better-equipped to support patients to manage the psychological challenge of reducing their opioid use—according to new research from the University of East Anglia. The recommendation is part of a toolkit being launched today to help GPs reduce the amount of opioids they prescribe....


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    ASTRAZENECA SHOWS CARDIOVASCULAR SAFETY FOR ROXADUSTAT

    May 10, 2019

    AstraZeneca has announced that pooled analyses of the phase III trials for its kidney disease drug roxadustat confirm the drug’s cardiovascular safety – a good sign for the potential blockbuster that hopes to compete with well-established treatments. Roxadustat, co-developed with FibroGe...


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    POTENTIAL FIRST EVER TARGETED THERAPY DESIGNED FOR ‘UNTREATABLE’ CHILDHOOD BRAIN CANCER

    May 10, 2019

    Scientists at The Institute of Cancer Research, London have discovered a new type of drug that targets a genetic weakness in ‘diffuse intrinsic pontine glioma’ (DIPG), an untreatable childhood brain cancer, which could become the first ever treatment designed to target the disease. The i...


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    TAKEDA DIVESTS EYE DRUG TO NOVARTIS FOR $5.3 BILLION

    May 09, 2019

    In January, Takeda Pharmaceutical announced plans to sell about $10 billion worth of assets to offset some of the debt the company garnered in its $62 billion acquisition of Shire. On Wednesday, the Osaka, Japan company announced divestitures worth about $5.7 billion. Takeda entered into agreements ...


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    BRISTOL-MYERS SQUIBB’S OPDIVO FAILS IN BRAIN CANCER TRIAL

    May 09, 2019

    It feels sometimes as if Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) is a miraculous cancer drug, given the number of indications it has been approved for. And in many ways it is. However, it apparently can’t do everything, and the company announced today that the drug...


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    MERCK TO INVEST $1 BILLION IN VIRGINIA FACILITY, ADD 100 JOBS

    May 09, 2019

    Merck & Company is planning a $1 billion expansion to its manufacturing facility in Elkton, Va. over the course of the next three years that will include the addition of approximately 100 new jobs, the office of the governor of Virginia announced Wednesday. Merck will add 120,000 square feet to ...


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    PFIZER ACQUIRES THERACHON AND ITS DWARFISM DRUG

    May 08, 2019

    Pfizer has announced it will pay $340 million upfront to snap up rare disease biotech Therachon, which is developing treatments for a form of dwarfism and short bowel syndrome (SBS). There’s also an additional $470 million worth of payments on the table contingent on Therachon achieving certai...


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    PFIZER AGREES ON $340M UPFRONT TO BUY THERACHON FOR DWARFISM DRUG

    May 08, 2019

    Pfizer is set to pay $340 million (€304 million) upfront to buy Therachon for its treatment for a form of short-limbed dwarfism. The deal commits Pfizer to up to $470 million in additional milestones tied to the advance of the early-phase rare disease drug. Therachon has emerged as one of the b...


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    AMARIN DEFENDS VASCEPA'S CV-PREVENTION DATA AGAINST SUPPLEMENT MAKERS EAGER TO CASH IN

    May 08, 2019

    Amarin spent years, millions of dollars and a lot of willpower proving its fish oil-based drug Vascepa really could cut the risk of heart attacks, strokes and other cardiovascular problems. To make that effort pay off, it needs to keep that proof to itself. That's just what the drugmaker did in ...


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    TEA LEAF PARTICLES COULD DESTROY LUNG CANCER CELLS – SCIENTISTS

    May 07, 2019

    British scientists in a breakthrough study, have found a natural replacement for chemotherapy in lung cancer patients, as they have demonstrated how tiny particles derived from tea leaves can restrain the growth of lung cancer cells, destroying up to 80 percent of them. The researchers from Swansea ...


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    INTENSIVE HYPERTENSION TREATMENT MAY LOWER DEATH RISK

    May 07, 2019

    A new research published in the American Heart Association’s (AHA) journal Hypertension,has shown that people with type 2 diabetes who received intensive treatment to keep blood pressure levels at or below 130/80 mmHg may reduce the risk of death from any cause. Diabetes is one of the most com...


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    PROSTATE CANCER MUTATION FOUND TO TRIPLE RISK OF DEATH

    May 07, 2019

    The largest ever study of advanced prostate cancer genomics has revealed that men with mutations in the retinoblastoma gene in their tumours were more than three times as likely to die and nearly seven times as likely to relapse on standard treatments as those without the gene. Scientists identified...


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    STUDY PRESENTS DRUG CANDIDATE FOR REVERSING MUCOSAL BARRIER DAMAGE BY HIV

    May 06, 2019

    A vaginal microbicide that could prevent sexual transmission of HIV-1 in women has tremendous potential for saving lives and helping staunch an epidemic. But the delicate milieu of microbes that naturally colonize the vagina and maintain a healthy mucosal barrier have made the search for such a micr...


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    RHEUMATOID ARTHRITIS DRUG DIMINISHES ZIKA BIRTH DEFECTS IN MICE

    May 06, 2019

    In experiments with pregnant mice infected with the Zika virus, Johns Hopkins Medicine researchers report they have successfully used a long-standing immunosuppressive drug to diminish the rate of fetal deaths and birth defects in the mice's offspring. The U.S. Food and Drug Administration-appro...


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    AWAITING FDA NOD, NOVARTIS TOUTS LATEST DATA ON GENE THERAPY ZOLGENSMA

    May 06, 2019

    As Novartis waits for FDA action on its gene therapy Zolgensma, expected this month, the company has rolled out yet another round of data on the spinal muscular atrophy treatment. Novartis’ AveXis, which developed the gene therapy, touted interim data through March 8 from a phase 1 study in Ty...


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    MADISON LOGIC UNVEILS NEW DATA CLOUD TO ACCELERATE ABM FOR B2B ORGANIZATIONS GLOBALLY

    May 06, 2019

    Madison Logic, the leading global account-based marketing (ABM) platform, today announces the launch of the ML Data Cloud, powering cutting-edge ABM to accelerate your pipeline and convert your best accounts faster. With state-of-the-art architecture, rich data, and a robust data gateway, the ML Dat...

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    NICE RECOMMENDS ROCHE’S TECENTRIQ COMBO FOR CERTAIN LUNG CANCER PATIENTS

    May 03, 2019

    Certain patients with untreated lung cancer in England have a new treatment option after cost-effectiveness body NICE made a draft recommendation that the NHS should fund Roche’s cocktail involving its immunotherapy Tecentriq. The combination of Tecentriq (atezolizumab), Avastin (bevacizumab),...


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    TRIAL COULD UNLOCK ASTHMA USE FOR GSK’S TRELEGY

    May 03, 2019

    GlaxoSmithKline CEO Emma Walmsley has been predicting big things for respiratory triple therapy Trelegy in the next couple of years and has new data that could open up a new market.Top-line results from the CAPTAIN study have shown that Trelegy (fluticasone furoate/umeclidinium/vilanterol) works bet...


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    /news-article.aspx?ID=30483048

    AVOIDING EXCIPIENT VARIABILITY

    May 02, 2019

    Excipients are essential components in drug products. Although sometimes defined as “functional” or “inert,” each has a specific role within the formulation that is necessary for the overall function of the medicine. Variability in the properties and performance of excipients...


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    EMA UPDATES PRESCRIBING INFORMATION OF BREAST CANCER MEDICINE WHILE DATA ARE RE-ANALYZED

    May 01, 2019

    The European Medicines Agency (EMA) has revealed in an April 30, 2019 press release that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results. In a study, which involved postmenopausal women who had HR+/HER2+ breast cancer and whose...


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    INTERTEK EXPANDS PHARMA SERVICES FACILITY

    May 01, 2019

    Intertek, a provider of total quality assurance, has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, United Kingdom, through the acquisition of a new 20,000 sq. ft facility. The new facility doubles the current footprint of the company’s laborator...


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    NHS, MSD COLLABORATE TO HELP ELIMINATE HEP C

    Apr 30, 2019

    The NHS has announced plans to collaborate with American Pharma giant MSD in a deal that could help England become the first country in the world to eliminate hepatitis C. MSD has already announced a commitment to help see hepatitis C eliminated in the UK by 2025, and over 30,000 people have already...


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    AZ TO ACCELERATE DRUG DISCOVERY WITH BENEVOLENTAI PARTNERSHIP

    Apr 30, 2019

    AstraZeneca has announced a collaboration with Benevolent AI in order to use machine learning and artificial intelligence (AI) to discover potential new drugs for chronic kidney disease and idiopathic pulmonary fibrosis.The two companies will create a team of scientists that will work side-by-side t...


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    GLAXOSMITHKLINE WINS BENLYSTA US LABEL EXPANSION FOR CHILDREN

    Apr 30, 2019

    GlaxoSmithKline has announced the US Food and Drug Administration expansion of its intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age. The approval, which marks the first medicine in the...


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    ASEMBIA LAUNCHES A NETWORK OF RETAIL PHARMACIES FOR SPECIALTY DRUG SERVICES

    Apr 29, 2019

    As it kicks off its annual Specialty Pharmacy Summit (Las Vegas, Apr. 29-May 2), Asembia has announced a new offering that provides a level of patient support to drugs that typically are not budgeted for the high-touch, high-cost services of hub providers. The Asembia Managed Retail Network combines...


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    CHP SET TO BRIDGE ADVOCACY GAP WITH US

    Apr 29, 2019

    At a time when world's largest market for pharmaceuticals, the US is sparing no words to accuse India as a source of counterfeit medicines, and complaining about India's intellectual property protection policies and drugs and medical device pricing regulatory systems, an industry veteran - G...


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    /news-article.aspx?ID=30243024

    PHARMACEUTICAL COMPANY RECALLS BLOOD PRESSURE DRUG OVER CANCER CONCERNS

    Apr 29, 2019

    A popular blood pressure medicine is under recall for possible carcinogens. Teva Pharmaceuticals is recalling 35 lots of bulk Losartan Potassium US tablets in 25 and 100 milligram strengths. The company says the pills may have been contaminated with an impurity that may cause cancer


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    HEMOGENYX PHARMACEUTICALS PLC ANNOUNCES FINAL RESULTS FOR THE YEAR ENDED 31 DECEMBER 2018 - 29/04/2019

    Apr 29, 2019

    Hemogenyx Pharmaceuticals plc ("Hemogenyx" or the "Company")(HEMO.L), the biopharmaceutical group developing new therapies and treatments designed to transform bone marrow transplantation for the treatment of blood diseases, announces its Final Results for the year ended 31 Decem...


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    MEAG MUNICH ERGO KAPITALANLAGEGESELLSCHAFT MBH PURCHASES SHARES OF 97,965 TAKEDA PHARMACEUTICAL CO LTD (TAK)

    Apr 29, 2019

    Meag Munich Ergo Kapitalanlagegesellschaft MBH purchased a new position in shares of Takeda Pharmaceutical Co Ltd (NYSE:TAK) during the 1st quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The institutional investor purchased 97,965 shares ...


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    /news-article.aspx?ID=30273027

    POLICE MAKE ARREST IN FATAL DRUG OVERDOSES ON WEST SIDE

    Apr 26, 2019

    Chicago police have arrested a man in connection with a batch of drugs laced with the potent painkiller fentanyl that was distributed on the West Side this week, resulting in at least 17 overdoses, four of them fatal. The man was taken into custody Friday morning, but no charges have been announced....


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    /news-article.aspx?ID=30173017

    COPS BUST SYNTHETIC DRUG OPERATION IN PORTER COUNTY, SEIZE CHEMICALS, GUNS, CASH, POLICE SAY

    Apr 26, 2019

    Officers found inside of Portage residence 64 pounds of synthetic drugs; 940 grams of synthetic chemical compound used to manufacture the substance commonly referred to as Spice; evidence of several gallons of acetone, which also is used to manufacture the substance; $2,955 from the illicit sales of...


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    /news-article.aspx?ID=30183018

    POLL TAKERS PLACE OPIOID CRISIS BLAME AT THE FEET OF THE PHARMACEUTICAL INDUSTRY

    Apr 26, 2019

    It is estimated that more than 130 people in the United States die every day from an opioid-related overdose and the general public vastly lays the blame for these deaths at the feet of the pharmaceutical industry. A poll conducted by the Associated Press-NORC Center for Public Affairs Research reve...


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    PFIZER TAKES TOP SPOT IN PHARMA MARKET CAP FOR 2018, ANALYSIS SHOWS

    Apr 26, 2019

    In the battle of titans, Pfizer has emerged on top as the most valuable pharma company by market cap for 2018. According to an analysis conducted by GlobalData, Pfizer replaced Swiss-based pharma giant Roche at the top of the mountain with a market cap of $253.2 billion. Roche, which came in at numb...


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    /news-article.aspx?ID=30203020

    LONDON DRUGS AUGMENTS LOCAL RECYCLING OPTIONS WITH SATURDAY SPECIAL

    Apr 26, 2019

    London Drugs hosts a recycling day for Victoria residents on April 27. The event encourages residents to responsibly recycle old household goods at the end of their usable life, including electronics and packaging to assist with reducing the amount of waste going to the landfill. “It is a grea...


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    /news-article.aspx?ID=30213021

    RAPID, AI-POWERED GENETIC DISEASE DIAGNOSIS FOR CRITICALLY ILL INFANTS

    Apr 25, 2019

    The researchers at Rady Children’s Institute for Genomic Medicine (RCIGM) are known for working quickly. In February of last year, they broke the Guinness World Record for the fastest diagnosis through whole genome sequencing, with an average of 19 hours. Continuing that work, they have built ...


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    /news-article.aspx?ID=30063006

    DRUGS FOR TREATMENT OF STROKE, VASCULAR DEMENTIA SHOW PROMISING RESULTS IN EARLY TRIAL

    Apr 25, 2019

    Treatments that prevent recurrence of types of stroke and dementia caused by damage to small blood vessels in the brain have moved a step closer, following a small study. The drugs - called cilostazol and isosorbide mononitrate - are already used to treat other conditions, such as heart disease and ...


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    /news-article.aspx?ID=30073007

    OBESITY AND DIABETES RISK LINKED TO COMMON FOOD INGREDIENT

    Apr 25, 2019

    The combined results from a small-scale randomized human trial and studies in mice suggest that consuming propionate, a common food ingredient that is used widely to prevent mold, increases levels of hormones that are linked with diabetes and obesity. The research, headed by a team at the Harvard T....


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    /news-article.aspx?ID=30083008

    SIX FACTORS ASSOCIATED WITH INVASIVE BREAST CANCER RECURRENCE AFTER DCIS DIAGNOSIS

    Apr 25, 2019

    Current guidelines recommend surgical excision of DCIS, often followed by radiotherapy and sometimes endocrine therapy, yet most cases will likely not progress or become life-threatening. As a result, many women are overtreated. "There is a large unmet need to distinguish harmless from potentia...


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    /news-article.aspx?ID=30093009

    PREDICTING WHETHER A PATIENT WILL BENEFIT FROM CHEMOTHERAPY

    Apr 25, 2019

    Case Western Reserve University researchers and partners, including a collaborator at Cleveland Clinic, are pushing the boundaries of how "smart" diagnostic-imaging machines identify cancers--and uncovering clues outside the tumor to tell whether a patient will respond well to chemotherapy...


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    /news-article.aspx?ID=30103010

    6SENSE EXPANDS INTEGRATION WITH HUBSPOT FOR HEIGHTENED ACCOUNT BASED ORCHESTRATION

    Apr 25, 2019

    6sense, a leading Account Based Orchestration Platform, powered by AI, announced $27 million in funding. The round was led by Industry Ventures and included participation from existing investors Bain Capital Ventures, Battery Ventures, Costanoa Ventures, Salesforce Ventures, and Venrock. “We b...

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    PSORIASIS AND CARDIO DRUGS DRIVE NOVARTIS’ Q1 SALES

    Apr 24, 2019

    Novartis has begun 2019 at a sprint, upgrading its sales forecasts for the year after strong performances from psoriasis drug Cosentyx and cardiology medicine Entresto. The company’s revolutionary CAR-T cancer cell therapy Kymriah has also begun to gain traction after a slow launch, according ...


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    FULCRUM REPURPOSES FAILED GSK DRUG FOR RARE DISEASE

    Apr 24, 2019

    GSK’s failed cardiovascular drug losmapimod looks like it might get a new lease of life after being picked up by biotech Fulcrum Therapeutics, who want to repurpose the drug to treat the rare genetic disease facioscapulohumeral muscular dystrophy (FSHD). Fulcrum had identified inhibitors of p3...


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    STUDY REVEALS HOW GENERAL ANESTHETICS AFFECT THE BRAIN

    Apr 24, 2019

    New research reveals for the first time that diverse drugs that induce general anesthesia activate a brain circuit that brings on sleep. The scientists at Duke University in Durham, NC who carried out the study, suggest that the findings will help to develop better drugs that can induce sleep with f...


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    HOW KETAMINE CAN CHANGE THE BRAIN TO FIGHT DEPRESSION

    Apr 24, 2019

    New research in mice, which the National Institutes of Health supported, shows how ketamine can alter brain circuits, quickly redressing depression-like symptoms. Previous studies have shown that ketamine — an anesthetic — can rapidly reduce severe symptoms of major depressive disorder, ...


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    /news-article.aspx?ID=29982998

    USING SMALL MOLECULES TO REGENERATE HEART TISSUE

    Apr 24, 2019

    New research, which appears in the journal Nature Communications, shows that delivering two small molecules to mice helps their hearts regenerate after a heart attack. Heart disease is the leading cause of death in the United States and responsible for almost 1 in 4 deaths in the country. An adverse...


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    /news-article.aspx?ID=29992999

    CAN A BLOOD PRESSURE DRUG PROTECT THE BRAIN FROM PARKINSON'S?

    Apr 23, 2019

    A prescription drug already in use for the treatment of high blood pressure could be effective against conditions such as Parkinson's, Alzheimer's, and Huntington's, in which toxic proteins build up in brain cells. Scientists at the University of Cambridge in the United Kingdom and the G...


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    /news-article.aspx?ID=30003000

    USING STEM CELLS TO COMBAT OSTEOARTHRITIS

    Apr 23, 2019

    In a recent preliminary study, scientists used stem cells to ease osteoarthritis. Although the trial was small-scale, the results are promising and will pave the way for larger studies. Osteoarthritis of the knee (KOA) occurs when the cartilage — the joint's natural cushioning system &mdas...


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    /news-article.aspx?ID=29952995

    STUDY IDENTIFIES A HORMONE THAT MAY HINDER WEIGHT LOSS

    Apr 23, 2019

    A series of experiments in mice demonstrates that a well-known hormone might have a previously unidentified role in the metabolic response to energy restriction during weight loss. Scientists have known about growth hormone (GH) for several decades. It plays a role in bone growth and is particularly...


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    /news-article.aspx?ID=29962996

    HEALTH INDUSTRY LOBBYISTS PUMP MORE MONEY INTO DEMOCRATS’ CONGRESSIONAL CAMPAIGN ARM

    Apr 23, 2019

    Corporate lobbyists collected almost $1 million for the Democratic Congressional Campaign Committee (DCCC) during the first quarter of 2019, according to an analysis by MapLight and Sludge. The amounts have been rising gradually since the first of the year, with lobbyists bundling almost $515,000 fo...


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    /news-article.aspx?ID=29832983

    HOUSE DEMOCRATS’ CAMPAIGN ARM ON PACE TO DOUBLE DONATIONS FROM CORPORATE LOBBYISTS

    Apr 23, 2019

    Corporate lobbyists collected almost $1 million for the Democratic Congressional Campaign Committee (DCCC) during the first quarter of 2019, according to an analysis by MapLight and Sludge. The amounts have been rising gradually since the first of the year, with lobbyists bundling almost $515,000for...


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    DRUG PRICES COME UNDER FIRE AS US PHARMA LOBBY NEARS SPENDING RECORDS

    Apr 23, 2019

    More ambitious changes may be needed to lower pharmaceutical prices as the Trump administration proposes new rules and approves a slew of new generic drugs. Large drug makers and the pharmaceutical industry’s primary trade group neared previous spending records on lobbying in the first three m...


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    DR REDDY'S GETS CHINESE REGULATOR NOD FOR ANTI-BLOOD CLOTTING DRUG

    Apr 23, 2019

    Sources said the company got approval earlier this month for generic Clopidogrel, which is used primarily to prevent blood clotting and acts against cardiovascular problems. Hyderabad-based Dr Reddy’s Laboratories (DRL), which is betting big on the Chinese drug market, recently got an approval...


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    /news-article.aspx?ID=29862986

    PROJECT AIMS TO REVIVE NATURAL PRODUCT DISCOVERY

    Apr 23, 2019

    The mid-20th century was the golden age of natural product discovery. Scientists discovered ground-breaking drugs, like penicillin and tetracycline, from sources in nature. But as the search for natural products continued, pharmaceutical companies kept finding the same products over and over again. ...


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    /news-article.aspx?ID=29872987

    PERKINS CAPITAL MANAGEMENT INC. CUTS POSITION IN ANI PHARMACEUTICALS INC (ANIP)

    Apr 22, 2019

    Perkins Capital Management Inc. trimmed its position in ANI Pharmaceuticals Inc (NASDAQ:ANIP) by 0.5% during the 1st quarter, according to the company in its most recent filing with the Securities and Exchange Commission (SEC). The firm owned 32,550 shares of the specialty pharmaceutical company&rsq...


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    PHARMABOARDROOM RELEASES 'HEALTHCARE AND LIFE SCIENCES REVIEW CHINA' APRIL 2019 PHARMA REPORT

    Apr 22, 2019

    From the world’s ninth largest pharma market in 2007 to its second-biggest merely 12 years later, China and its growth story are impossible to ignore. China now accounts for a significant share of revenues for most major multinational pharmaceutical companies and almost 40 percent of total glo...


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    /news-article.aspx?ID=29742974

    GOODWIN BIOTECHNOLOGY SECURES SIGNIFICANT INSTITUTIONAL INVESTMENT IN NEW ROUND OF GROWTH CAPITAL FINANCING

    Apr 22, 2019

    Goodwin Biotechnology, Inc. ("Goodwin") announced that it has completed its largest ever round of financing with growth capital which will help fund its next stage of expansion. Goodwin is a full GMP, FDA-registered biopharmaceuticals Contract Development and Manufacturing Organization (CD...


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    MONARCH BECOMES THE 1ST FDA-CLEARED DEVICE FOR ADHD

    Apr 22, 2019

    NeuroSigma’s Monarch eTNS might be the first device to treat ADHD, but it is one of a growing number of technologies that occupy the burgeoning bioelectronic medicine space. The Monarch external Trigeminal Nerve Stimulation (eTNS) System made history last week after it became the first device ...


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    FSD PHARMA RECEIVES CANNABIS SALES LICENSE FROM HEALTH CANADA

    Apr 22, 2019

    FSD Pharma Inc. (CSE:HUGE) (OTCQB:FSDDF) (FRA:0K9) (“FSD” or the Company”), announced today that its wholly-owned subsidiary FV Pharma Inc. has received its Sale for Medical Purposes license to sell cannabis under the Cannabis Act (Canada). The license went into effect on April 18,...


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    THE SUPERBUG IS RISING: WHERE ARE THE NEW ANTIBIOTICS?

    Apr 19, 2019

    According to Alan Westwood, chief executive of Matoke, a company hoping to develop a new form of antibiotic, the issue of antibiotic resistance is one of the most troubling issues of our times. It is one of the biggest threats to human health. In 30 years, it’s estimated 10 million people will...


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    DRUGMAKERS REVEAL LIST PRICES ONLINE AFTER PRESSURE FROM TRUMP

    Apr 19, 2019

    The world's biggest pharmaceutical companies are revealing prices of their prescription drugs on websites for the first time in a bid to stave off pressure from the Trump administration to make even more public disclosures. The move by companies ranging from pharma giant Pfizer to biotechnology ...


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    /news-article.aspx?ID=29682968

    PFIZER AND LILLY'S NON-OPIOID PAINKILLER SHOWS MIXED RESULTS IN PHASE III

    Apr 19, 2019

    Pfizer and Eli Lilly and Company announced top-line results from a Phase III clinical trial of two doses of tanezumab in moderate-to-severe osteoarthritis (OA) of the hip or knee. The results were mixed, with the 5 mg dose meeting two of the three co-primary efficacy endpoints but missing on the pat...


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    DISPENSED: INTRODUCING BUSINESS INSIDER'S 10 PEOPLE TRANSFORMING HEALTHCARE

    Apr 19, 2019

    Welcome to another dose of Dispensed, Business Insider's weekly healthcare newsletter! Before heading out for the holiday weekend, I wanted to highlight some of the great work the healthcare team here has been pulling together. The entire Business Insider newsroom got together to compile a list ...


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    POT STOCKS SOARING, CANNABIS INDUSTRY POISED FOR 'TONS OF GROWTH'

    Apr 19, 2019

    (CNN) - For decades, though nobody was really sure why, April 20 has been the unofficial holiday for marijuana users and a joke by and about them. Now, though, it's also a reminder of how quickly marijuana is moving from illegal and a joke to a multi-billion-dollar legal business and a good time...


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    HEALTHCARE COMPANIES SEARCH FOR NEW WAYS TO OPPOSE THE SPREAD OF CANCER

    Apr 17, 2019

    Cancer is among one of the leading causes of death in the world since many countries are burdened by the lack of access to adequate healthcare, which results in the high number of deaths. In 2018, the World Cancer Research Fund (WCRF) estimated that there were 18 million new cancer cases worldwide. ...

    PTCOMMUNITY
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    WIDESPREAD CLINICAL STUDIES CAN REINVIGORATE THE LEGALIZATION MOVEMENT FOR CANNABIS

    Apr 17, 2019

    Researchers and scientists are constantly developing new, innovative medicines to effectively treat patients. However, the cost to conduct clinical trials and then receive approval to commercialize a drug is absurdly expensive. The Tufts Center for the Study of Drug Development estimated that in 201...

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    RESEARCHERS USE GENE EDITING WITH CRISPR TO TREAT LETHAL LUNG DISEASES BEFORE BIRTH

    Apr 17, 2019

    Using CRISPR gene editing, a team from Children's Hospital of Philadelphia (CHOP) and Penn Medicine have thwarted a lethal lung disease in an animal model in which a harmful mutation causes death within hours after birth. This proof-of-concept study, published today in Science Translational Medi...

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    RESEARCHERS PINPOINT TUMOR-RELATED PROTEIN, SLOW PROGRESSION OF CANCERS

    Apr 17, 2019

    Locking a biochemical gate that admits fuel into immune-suppressing cells could slow tumor progression and assist the treatment of multiple cancers, says new research from the Wistar Institute, the University of Nebraska-Lincoln and others. Published April 17 in the journal Nature, the study found e...

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    /news-article.aspx?ID=29592959

    NEW STUDY TARGETS ACHILLES' HEEL OF PANCREATIC CANCER, WITH PROMISING RESULTS

    Apr 17, 2019

    Advanced pancreatic cancer is often symptomless, leading to late diagnosis only after metastases have spread throughout the body. Additionally, tumor cells are encased in a "protective shield," a microenvironment conferring resistance to many cancer treatment drugs. Now, Salk Institute res...

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    /news-article.aspx?ID=29602960

    LIONBRIDGE AGAIN NAMED ONE OF AMERICA'S BEST EMPLOYERS BY FORBES

    Apr 17, 2019

    Lionbridge Technologies is proud to announce it has again been named one of America's Best Employers by Forbes, which also recognized Lionbridge as a Best Employer for Women in 2018. The 2019 list recognizes organizations across a variety of industries that employ more than 1,000 people in the U...

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    6SENSE SECURES $27 MILLION TO ADVANCE BOLD VISION IN B2B AND ABM

    Apr 16, 2019

    6sense, a leading Account Based Orchestration Platform, powered by AI, announced $27 million in funding. The round was led by Industry Ventures and included participation from existing investors Bain Capital Ventures, Battery Ventures, Costanoa Ventures, Salesforce Ventures, and Venrock. “We b...

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    /news-article.aspx?ID=33053305

    ICC MAKES STRATEGIC INVESTMENT IN DISRUPTIVE BIOSYNTHESIS RESEARCH -- CFN MEDIA

    Apr 16, 2019

    He leading agency and financial media network dedicated to the North American cannabis industry, announces the publication of an article covering biosynthesis and International Cannabis Corp.’s recent biotechnology investment. Biosynthesis is the process of manipulating simple substances to pr...

    CFN MEDIA
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    /news-article.aspx?ID=29462946

    DNDI AND ATOMWISE COLLABORATE TO ADVANCE DRUG DEVELOPMENT USING AI FOR NEGLECTED DISEASES

    Apr 16, 2019

    A biotech company using artificial intelligence (AI) for drug discovery, and the Drugs for Neglected Diseases initiative (DND i ), a not-for-profit research and development organization working to deliver new treatments for neglected diseases, today announced that promising drug-like compounds have ...

    ATOMWISE, INC.
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    FLAGSHIP PIONEERING UNVEILS KINTAI THERAPEUTICS AND APPOINTS PHARMACEUTICAL DRUG DEVELOPER PAUL-PETER TAK, M.D., PH.D., AS CHIEF EXECUTIVE OFFICER

    Apr 16, 2019

    A unique life science innovation enterprise, today unveiled Kintai Therapeutics and named Paul-Peter Tak, M.D., Ph.D., as president, chief executive officer, and member of the board of directors. Kintai is focused on leveraging the body's diverse signaling networks to pioneer a new class of Prec...

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    /news-article.aspx?ID=29492949

    FRENCH BIOTECH CELLVAX IS NOW ABLE TO PROPOSE PRECLINICAL STUDIES IN LARGE ANIMALS

    Apr 16, 2019

    CellVax can now respond to the strong demand for optimal selection of models that represent the human disease best and is able to offer preclinical studies in large nonrodent species as well as diversified preclinical models or clinical trials. Large animal models are essential for the development o...

    BUSINESSWIRE
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    /news-article.aspx?ID=29502950

    BOOZ ALLEN HAMILTON AWARDED THE 2019 INFORMS PRIZE FOR OPERATIONS RESEARCH

    Apr 15, 2019

    The leading international association for operations research and analytics professionals, announced that Booz Allen Hamilton has been awarded the 2019 INFORMS Prize for their pioneering and enduring integration of operations research (O.R.) and analytics programs into their organization. Recognizin...

    EUREKALERT
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    THE ZUR ROSE GROUP NOMINATES THREE NEW BOARD MEMBERS

    Apr 15, 2019

    The Zur Rose Group is nominating Tobias Hartmann, Dr. Christian Mielsch and Florian Seubert as new members of the Board of Directors and proposing them for election at the General Meeting of Shareholders to be held on 23 May 2019. The nomination is intended to add proven expertise in technology, tra...

    PHARMIWEB
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    /news-article.aspx?ID=29352935

    SCIBITE LAUNCHES CENTREE TO REVOLUTIONISE ONTOLOGY MANAGEMENT FOR LIFE SCIENCES ORGANISATIONS

    Apr 15, 2019

    The award-winning semantic technology company, today announced the launch of CENtree, an innovative, collaborative platform which revolutionises the way Life Sciences organisations manage and release ontologies. Ontologies play a critical role in semantic enrichment, enabling unstructured scientific...

    PHARMIWEB
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    ALCHEM INTERNATIONAL SOLVES STABILITY DILEMMA FOR MICRONIZED DIGOXIN

    Apr 15, 2019

    Alchem's molecule is the sole micronized digoxin available globally that resolves the challenge of micro dosage formulation and the long-term stability and impurity issues with this specialist heart drug. Digoxin is commonly administered to treat various heart conditions including atrial fibrill...

    ALCHEM INTERNATIONAL
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    DEMOCRATS FEUD OVER DRUG PRICING POLICY, AS PROGRESSIVES PUSH PRAGMATISTS TO BE BOLDER

    Apr 15, 2019

    In recent weeks, tensions between the two camps have escalated, and some fights have even spilled into public view. In a high-profile tug of war, lawmakers hoping to strike an accord with the Trump administration have been forced to confront a faction pressing Democrats to instead pursue a bolder pr...

    STATNEWS
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    DIPLOMAT PHARMACY INC. (DPLO) AND THE MEDICINES COMPANY (NASDAQ:MDCO) COMPARING SIDE BY SIDE

    Apr 14, 2019

    Both Diplomat Pharmacy Inc. (NYSE:DPLO) and The Medicines Company (NASDAQ:MDCO) are Drugs – Generic companies, competing one another. We will contrast their risk, analyst recommendations, profitability, dividends, institutional ownership, earnings and valuation. Diplomat Pharmacy, Inc. operate...

    MCMONITOR
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    CANNABIS TRADE BODY WILL ALSO FOCUS ON CLINICAL TRIALS

    Apr 12, 2019

    The Centre for Medicinal Cannabis (CMC) has announced plans to extend its remit to focus on clinical trials. The CMC, which describes itself as an industry advocacy group and think tank, said its plans to “actively engage industry players” in clinical trials focusing on childhood epileps...

    THE CENTRE FOR MEDICINAL CANNABIS
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    /news-article.aspx?ID=29262926

    WASHINGTON WEEK: DRUGMAKERS, PBMS HAMMERED OVER HIGH DRUG PRICES

    Apr 12, 2019

    WASHINGTON -- Members of Congress blamed and shamed key players in the pharmaceutical market for high drug prices, while also asking for their help; and the Trump administration quietly advanced its block grant strategy for Medicaid. Drugmakers, PBMs Run the Gauntlet at House Hearing No punches were...

    MEDPAGETODAY
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    /news-article.aspx?ID=29282928

    STUDENTS AT WELSH ANNUAL PROFESSIONAL DEBATE VOTE AGAINST OTC SALE OF MEDICAL CANNABIS PRODUCTS

    Apr 11, 2019

    Pharmacists should not sell cannabis-derived medical products over the counter (OTC), according to pharmacy students at the 2019 Annual Professional Debate. Co-hosted by the Royal Pharmaceutical Society (RPS) in Wales and Healthcare Education and Improvement Wales (HEIW) Pharmacy eanery, this year&r...

    THE PHARMACEUTICAL JOURNAL
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    /news-article.aspx?ID=29272927

    PROTAGEN PROTEIN SERVICES AND BIO ANALYTIX MERGE TO CREATE GLOBAL ANALYTIC SERVICE PARTNER FOR BIO PHARMACEUTICALS

    Apr 11, 2019

    HEILBRONN, Germany and BOSTON, April 11, 2019 (GLOBE NEWSWIRE) -- Protagen Protein Services GmbH (PPS), a full-service contract research organization (CRO) in protein analytics and BioAnalytix Inc., a Cambridge (MA)-based specialized provider of advanced analytics in biopharmaceutical development an...

    BIOANALYTIX
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    JANSSEN PRESENTS NEW DATA FROM FIRST PHASE 3 TRIAL OF A SINGLE-TABLET

    Apr 11, 2019

    MIAMI, April 11, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson unveiled new 48-week data for SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg D/C/F/TAF) showing that a high proportion of HIV patients achieved...

    JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON
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    AS SANDERS OFFICIALLY REVIVES MEDICARE-FOR-ALL, PLAN B FOR DEMOCRATS GAINS TRACTION

    Apr 11, 2019

    As Democratic presidential primary candidates try to walk a political tightrope between the party’s progressive and center-left wings, they face increasing pressure to outline the details of their health reform proposals. On Wednesday, Sen. Bernie Sanders (I-Vt.) reaffirmed his stance by reint...

    KHN
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    /news-article.aspx?ID=29182918

    FDA ORDERS IMPORTANT SAFETY LABELING CHANGES FOR ADDYI

    Apr 11, 2019

    The U.S. Food and Drug Administration today issued a safety labeling change orderto Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the dru...

    U.S. FOOD AND DRUG ADMINISTRATION
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    HORIZON PHARMA PLC NAMED ONE OF THE 2019 BEST WORKPLACES IN HEALTH CARE AND BIOPHARMA BY FORTUNE AND GREAT PLACE TO WORK.

    Apr 11, 2019

    Horizon Pharma plc (NASDAQ:HZNP) today announced it has been selected as one of the 2019 Best Workplaces in Health Care and Biopharma by Great Place to Work® and FORTUNE Magazine. The company has also been awarded a 2019 Best Places to work in Chicago designation by Crain's Chicago Business....

    HORIZON PHARMA PLC
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    FDA REJECTS REGULATORY FILING FOR ZOGENIX EPILEPSY DRUG; GW PHARMA MOVES IN SYMPATHY

    Apr 09, 2019

    Zogenix, Inc.,which develops therapies for rare diseases, said Monday afternoon the FDA issued a refusal to file letter regarding its NDA for Fintepla, chemically fenfluramine hydrochloride, which is being evaluated for the treatment of seizures associated with Dravet syndrome. The FDA determined th...


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    OUT FROM UNDER NOVARTIS, ALCON IS ITS OWN COMPANY NOW

    Apr 09, 2019

    Alcon is officially a standalone company. The eye care specialist has officially spun out from Swiss pharma giant Novartis. Alcon began trading today on the SIX Swiss Exchange and New York Stock Exchange under the symbol “ALC.” David Endicott, Alcon’s chief executive officer, said ...


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    /news-article.aspx?ID=29092909

    SCOTLAND BACKS AIMOVIG FOR MIGRAINE AFTER NICE SAYS NO

    Apr 09, 2019

    People suffering from severe migraines in Scotland will be able to get treatment with Amgen and Novartis’ Aimovig if they fail other therapies, according to the country’s cost-effectiveness agency for medicines. The Scottish Medicines Consortium (SMC) has given its backing to routine use...


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    /news-article.aspx?ID=29102910

    TRIFECTA PHARMACEUTICALS USA AND WALMART LAUNCH DISTRIBUTION PARTNERSHIP

    Apr 08, 2019

    FORT LAUDERDALE, FL, UNITED STATES, April 8, 2019 /EINPresswire.com/ -- TRIFECTAPHARMACEUTICALS USA, a leading developer, manufacturer and distributor of specialty OTC topical ointments, creams and gels, today announces its inaugural distribution partnership with Walmart. Mayinglong hemorrhoid ointm...


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    /news-article.aspx?ID=29062906

    AMAZON ALEXA'S FIRST HIPAA-SANCTIONED SKILLS OPEN NEW DOORS FOR PHARMA

    Apr 08, 2019

    Amazon's new Alexa upgrade offers some HIPAA-compliant skills—and some potential new opportunities for drugmakers that want to jump on the voice-activated AI platform. Amazon announced six partners last week in its first HIPAA-compliant nod for the voice apps it calls "skills." T...


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    /news-article.aspx?ID=29022902

    PFIZER USES REAL-WORLD DATA TO SCORE IBRANCE BREAST CANCER NOD IN MALES

    Apr 05, 2019

    Breast cancer is a rare disease in men, making it tough for drugmakers to conduct clinical trials. But Pfizer came up with a solution. The pharma giant scored a new nod Thursday for big-seller Ibrance in males, based largely on real-world evidence. Along the way, regulators studied data from electro...

    FIERCEPHARMA
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    /news-article.aspx?ID=28962896

    JAZZ, LUNDBECK AND ALEXION SETTLE WITH FEDS FOR $122M-PLUS OVER CHARITY CONTRIBUTIONS

    Apr 05, 2019

    The federal government’s probe into pharma’s co-pay assistance charities has snared some of the biggest names in the business, and Thursday the Department of Justice said three drugmakers have inked settlements totaling $122.6 million. Jazz, Lundbeck and Alexion each struck deals with th...

    FIERCEPHARMA
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    /news-article.aspx?ID=28972897

    CHINA-US FEUD FORCES PATIENTSLIKEME TO FIND NEW INVESTOR – PRESS

    Apr 05, 2019

    Increasingly fraught Sino-American relations are beginning to have a real impact on the health sector, after it emerged that the health networking startup PatientsLikeMe is being forced to find a buyer after the Trump administration ordered its Chinese majority owner to divest its stake. According t...

    PHARMAPHORUM
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    /news-article.aspx?ID=29012901

    NOVARTIS' SMA GENE THERAPY WOULD NOT BE COST-EFFECTIVE IF PRICED OVER $1.5M: ICER

    Apr 04, 2019

    The pricing analysis done by the Institute for Clinical and Economic Research (ICER) on new therapies for spinal muscular atrophy (SMA) has been no small undertaking. One of the therapies ICER reviewed—Zolgensma from Novartis’ AveXis unit—isn't yet FDA-approved or priced, forci...

    FIERCEPHARMA
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    /news-article.aspx?ID=28922892

    EU REGULATORS TO FAST-TRACK JANSSEN’S MULTIPLE MYELOMA CAR-T

    Apr 04, 2019

    European regulators are to hasten development of Janssen’s CAR-T therapy for patients with multiple myeloma, after promising early-stage trial results. Janssen, the pharma arm of Johnson & Johnson, said the European Medicines Agency has granted a PRIME (PRIority MEdicines) designation for ...

    PHARMAPHORUM
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    /news-article.aspx?ID=28932893

    PBM CUTS INSULIN CO-PAY AS LAWMAKER CONFRONTATIONS LOOM

    Apr 04, 2019

    Express Scripts has announced a plan to cut patient co-pays for insulin products at $25 a month ahead of a pricing showdown with US politicians next week. The cap is part of a “patient assurance programme” that the pharmacy benefit manager (PBM) is launching for members of participating ...

    PHARMAPHORUM
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    /news-article.aspx?ID=28942894

    FORMER INSYS SALES EXEC TO SHELL OUT $9.5M IN OPIOID SPRAY KICKBACK SCHEME

    Apr 03, 2019

    Insys’ former VP of sales has settled and turned state's evidence in an Arizona kickback suit alleging an executive-driven scheme to buy scripts for the company’s powerful opioid spray, Subsys. Alec Burkaloff, who pleaded guilty in a Boston courthouse in November on federal racketeer...

    FIERCEPHARMA
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    /news-article.aspx?ID=28852885

    ROCHE FORCED TO EXTEND SPARK TENDER OFFER AS INVESTORS SUE OVER $4.3B MERGER

    Apr 03, 2019

    Roche’s $114.50-per-share offer for Spark Therapeutics represents a whopping 122% premium to the gene specialist’s closing price on the last trading day before the acquisition announcement. But some Spark investors still think the price is too low. So far, Spark investors have tendered o...

    FIERCEPHARMA
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    /news-article.aspx?ID=28862886

    FUSION RAISES $105M FOR RADIOPHARMACEUTICAL TRIALS

    Apr 03, 2019

    Bayer’s Xofigo (radium 223) was a trailblazer in this field following FDA approval in 2013 – a calcium mimic, the drug selectively binds to bone metastases in prostate cancer to deliver a localised dose of radiation. Novartis has placed its big bet in therapeutic radiopharmaceuticals wit...

    PHARMAPHORUM
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    /news-article.aspx?ID=28882888

    TEVA’S MIGRAINE DRUG AJOVY APPROVED IN EUROPE

    Apr 02, 2019

    Teva’s migraine drug Ajovy (fremanezumab) has been approved in Europe, taking on rivals from the same class from Novartis and Eli Lilly. Novartis already has Aimovig (erenumab) approved in Europe, along with Eli Lilly’s Emgality (galcanezumab), with both drugs available as monthly inject...

    PHARMAPHORUM
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    /news-article.aspx?ID=28802880

    NOVARTIS’ COSENTYX BEATS J&J, LILLY TO LAND FIRST-IN-CLASS CHINESE PSORIASIS NOD

    Apr 02, 2019

    Novartis’ psoriasis blockbuster Cosentyx has beaten out rivals from Eli Lilly and Johnson & Johnson as the first interleukin inhibitor approved in China. China’s National Medical Product Administration has approved Cosentyx to treat moderate-to-severe plaque psoriasis in adult patien...

    FIERCEPHARMA
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    /news-article.aspx?ID=28812881

    ABBVIE INVESTORS AGITATE FOR CHAIR-CEO SPLIT, FLAGGING BONUS PAY AND HUMIRA HIKES

    Apr 02, 2019

    AbbVie investors are calling for a separation of powers in the C-suite, citing Chairman and CEO Richard Gonzalez's outsized pay package and the company's "thicket" of Humira patents. In an SEC filing Monday, AbbVie investor and Rhode Island General Treasurer Seth Magaziner threw hi...

    FIERCEPHARMA
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    /news-article.aspx?ID=28822882

    BETTER 8 YEARS LATE THAN NEVER: MERCK KGAA NABS FDA NOD FOR MS DRUG MAVENCLAD

    Apr 01, 2019

    Up to 10 years of safety data has paid off for Merck KGaA’s oral multiple sclerosis treatment Mavenclad. The drug has returned from the dead, eight years after an FDA rejection dashed its dream of challenging Novartis’ then-newly-minted Gilenya—and according to one analyst, it migh...

    FIERCEPHARMA
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    /news-article.aspx?ID=28732873

    HERITAGE PHARMA SUES OVER CONTAINER OF REFRIGERATED DRUGS KNOCKED INTO RIVER

    Apr 01, 2019

    A refrigerated container of drugs was rolling on the river last year when a supply chain mishap resulted in eight shipping containers falling like dominoes from a ship into the Elizabeth River in Virginia. Now Heritage Pharmaceuticals wants reimbursement. The Eatontown, New Jersey-based drugmaker ha...

    FIERCEPHARMA
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    /news-article.aspx?ID=28742874

    BLUEBIRD BIO GETS CHMP NOD FOR GENE THERAPY ZYNTEGLO

    Apr 01, 2019

    A European Medicines Agency advisory panel has recommended a conditional approval for Zynteglo, bluebird bio’s lead gene therapy for thalassemia, a rare blood disorder. The Committee for Medicinal Products for Human Use (CHMP) confirmed on Friday that it had issued a positive opinion for the t...

    PHARMAPHORUM
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    /news-article.aspx?ID=28762876

    PLATELET BIOGENESIS EYES ENTERING THE CLINIC, DOUBLING EMPLOYMENT THIS YEAR

    Mar 28, 2019

    The polar vortex that brought bone-chilling temperatures to much of the United States earlier this winter highlighted a near constant concern – an inadequate supply of platelets at blood centers across the country. Platelets are essential for helping the body stop bleeds and are also excellent...


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    /news-article.aspx?ID=28672867

    SEATTLE GENETICS & ASTELLAS REPORT POSITIVE UROTHELIAL CANCER STUDY

    Mar 28, 2019

    Seattle Genetics and Tokyo-based Astellas Pharma announced positive topline data from the first cohort of its Phase II EV-201 trial. The trial is evaluating enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who had previously received both platinum-based chemothera...


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    /news-article.aspx?ID=28682868

    NEARLY 8,000 PACKETS OF ORKAMBI DESTROYED AS THE U.K. AND VERTEX HASH OUT PRICING CONCERNS

    Mar 28, 2019

    Cystic fibrosis drugmaker Vertex Pharmaceuticals was forced to destroy nearly 8,000 packs of its drug Orkambi after the medication had expired before they could be shipped to the United Kingdom due to a contentious pricing fight. Boston-based Vertex and the National Health Service in England have be...


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    /news-article.aspx?ID=28692869

    NHS DIGITAL TRANSFORMATION TEAM TO BEGIN WORK NEXT MONTH

    Mar 28, 2019

    England’s NHS is gearing up towards the ‘go live’ of a new digital transformation team that aims to drive service improvement using health data and technology. The government announced the creation of NHSX last month and there are now 11 days to go before the official launch said h...


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    /news-article.aspx?ID=28702870

    HEARTLIGHT X3 SYSTEM FOR RAPID AND ACCURATE CARDIAC ABLATION PROCEDURES CLEARED IN EUROPE

    Mar 27, 2019

    Ablation of cardiac tissue is one of the most common ways of treating atrial fibrillation. Interventional cardiologists have to work quite a bit to make sure the energy they’re delivering hits the correct areas. The HeartLight X3 System from CardioFocus is designed to make this process much fa...


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    /news-article.aspx?ID=28592859

    CELGENE REFILES POTENTIAL MS BLOCKBUSTER OZANIMOD WITH FDA

    Mar 27, 2019

    Celgene has filed its highly anticipated oral MS drug ozanimod with the US regulator, more than a year after the FDA rejected it because of a bureaucratic foul-up. Last February Celgene received a “Refuse to File” notice from the FDA after finding issues with the dossier submitted by the...


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    /news-article.aspx?ID=28602860

    HEALTH SECRETARY HINTS AT ‘CONSTRUCTIVE’ TALKS OVER CF DRUGS

    Mar 27, 2019

    Health secretary Matt Hancock has offered hope to thousands of people in the UK who have been denied access to powerful cystic fibrosis drugs because of a row over pricing with manufacturer Vertex, saying that fresh discussions with the firm have been “constructive”. Around three years a...


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    /news-article.aspx?ID=28622862

    IMPLANT ATTACHED TO HEART GENERATES ELECTRICITY TO POWER PACEMAKER

    Mar 26, 2019

    Pacemakers, defibrillators and other cardiac implants are life-saving devices, but the batteries inside of them remain their Achilles’ heel. Every five to ten years they have to be replaced in another invasive surgery that patients abhor and that put a high cost on the healthcare system. Harve...


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    /news-article.aspx?ID=28522852

    FOX FOUNDATION BACKS INFLAZOME PARKINSON’S PROJECT

    Mar 26, 2019

    Irish start-up Inflazome has won $1 million in funding from the Michael J. Fox Foundation (MJFF) to help it develop a brain imaging probe for Parkinson’s, as well as a new drug class for the disease. The cash injection will be used to support a positron emission tomography (PET) imaging techni...


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    /news-article.aspx?ID=28532853

    ALDEYRA’S CONJUNCTIVITIS DRUG IN PHASE III IS A SIGHT FOR SORE EYES

    Mar 26, 2019

    Aldeyra Therapeutics, headquartered in Lexington, Mass., announced positive results from its Phase III ALLEVIATE trial of reproxalap for allergic conjunctivitis. The trial evaluated reproxalap topical ophthalmic solution in two different concentrations, 0.25%, and 0.5%. The trial met the primary end...


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    /news-article.aspx?ID=28542854

    AIMMUNE'S PEANUT ALLERGY PRODUCT HITS PRIMARY ENDPOINTS IN EUROPEAN PHASE III TRIAL

    Mar 25, 2019

    Brisbane, Calif.-based Aimmune Therapeutics announced that its Phase III European clinical trial of AR101 for treatment of peanut allergy met its primary efficacy endpoint. In November 2018, the company had announced the publication of its successful Phase III PALISADE clinical trial of AR101 in the...


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    /news-article.aspx?ID=28442844

    THERMO FISHER SCIENTIFIC TO BUY BRAMMER BIO FOR $1.7 BILLION

    Mar 25, 2019

    Thermo Fisher Scientific, based in Waltham, Mass., is buying gene and cell therapy manufacturer Brammer Bio, located in Cambridge, Mass. for $1.7 billion in cash. Brammer Bio is a contract development and manufacturing organization (CDMO) focusing on manufacturing viral vectors for gene and cell the...


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    /news-article.aspx?ID=28452845

    FDA UNCONVINCED BY SANOFI’S ZYNQUISTA IN TYPE 1 DIABETES

    Mar 25, 2019

    Sanofi’s hopes of getting its dual SGLT inhibitor sotagliflozin approved alongside insulin for type 1 diabetes in the US have been dashed by the FDA. The US regulator has issued a complete response letter (CRL) for Lexicon Pharma-partnered sotagliflozin, a dual SGLT1 and SGLT2 inhibitor that h...


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    /news-article.aspx?ID=28462846

    UNDERSTANDING GENE INTERACTIONS HOLDS KEY TO PERSONALIZED MEDICINE, SCIENTISTS SAY

    Mar 25, 2019

    When the Human Genome Project was completed, in 2003, it opened the door to a radically new idea of health—that of personalized medicine, in which disease risk and appropriate treatment would be gleaned from one's genetic makeup. As more people had their genomes sequenced, disease-related ...


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    /news-article.aspx?ID=28472847

    NOVARTIS CONFIRMS ALCON EYE CARE UNIT SPIN OFF NEXT MONTH

    Mar 22, 2019

    Novartis has finalized plans for the long-awaited spin-off of its Alcon eye care business, announcing that the new company will list on April 9. The Swiss pharma has approval for listing on the SIX Swiss Exchange and the New York Stock Exchange, adding that Alcon is expected to list on Switzerland&r...


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    /news-article.aspx?ID=28362836

    FIRST CARDIAC CONTRACTILITY MODULATION DEVICE APPROVED BY FDA

    Mar 22, 2019

    Most cardiac implants, such as pacemakers and AICDs, are designed to correct the underlying heart’s rhythm and synchronize atrial and ventricular contractions. That’s how these devices can improve cardiac performance in people with heart failure. They don’t do anything to boost the...


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    /news-article.aspx?ID=28372837

    AI DRUG R&D FIRM EXSCIENTIA EXPANDS INTO JAPAN

    Mar 22, 2019

    AI drug R&D firm Ex Scientia has announced it has expanded into Japan, after clinching a major research deal with Celgene. Based in Oxford, UK, Ex Scientia said it has established a subsidiary, Ex Scientia K.K. which is to spearhead its pharmaceutical interests across Asia. Exscientia K.K. is he...


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    /news-article.aspx?ID=28382838

    ADVOCACY GROUP AND FDA ADVISOR CALL FOR A MORATORIUM ON OPIOID APPROVALS

    Mar 22, 2019

    As America continues to grapple with the opioid crisis, nonprofit advocacy group Public Citizen is calling for the U.S. Food and Drug Administration (FDA) to place a moratorium on the approval of any new opioid medications. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Produc...


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    /news-article.aspx?ID=28392839

    FRANCE’S DOCTOLIB IS NEW DIGITAL HEALTH UNICORN

    Mar 20, 2019

    Doctolib, the largest digital health service in Europe, has raised 150 million euros in a funding round, valuing it at over a billion euros. Thanks to the funding round led by growth equity firm General Atlantic, France’s Doctolib has become a privately-owned digital health “unicorn&rdqu...


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    /news-article.aspx?ID=28282828

    SEVEN FUTURE BLOCKBUSTER DRUGS TO LOOK OUT FOR IN 2019

    Mar 20, 2019

    AbbVie’s rheumatoid arthritis drug upadacitinib is at the top of a new list of drugs due to launch this year that are expected to make blockbuster sales by 2023. JAK1 inhibitor upadacitinib for rheumatoid arthritis will be a $2.2 billion product by that time, predicts Clarivate Analytics, desp...


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    /news-article.aspx?ID=28292829

    MORE OVARIAN CANCER WOES FOR MERCK KGAA AND PFIZER AS THEY HALT LATE-STAGE TRIAL

    Mar 20, 2019

    Merck KGaA, Darmstadt, Germany, and Pfizer discontinued a Phase III ovarian cancer drug trial after determining that the degree of benefit observed in the treatment during an interim analysis does not support the continuation of the trial. It was the second ovarian cancer trial the two companies col...


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    /news-article.aspx?ID=28302830

    NEW CLASS OF DRUGS COULD TREAT OVARIAN CANCER

    Mar 20, 2019

    A team of researchers across The University of Manchester have shown that a new class of drugs are able to stop ovarian cancer cells growing. The Cancer Research UK and Wellcome Trust-funded study, published in the journal Cancer Cell, showed that the drugs, called PARG inhibitors, can kill ovarian ...


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    /news-article.aspx?ID=28312831

    AZ BACKS DIABETES DRUG FARXIGA WITH NEW CARDIO ANALYSIS

    Mar 19, 2019

    AstraZeneca continues to make the case for its Farxiga diabetes drug, highlighting a cardiology analysis that it hopes will convince more doctors to prescribe it in a highly competitive market. Farxiga (dapagliflozin) is AZ’s fifth biggest-selling drug, making up around 7% of product sales. La...


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    /news-article.aspx?ID=28202820

    CELL MOGRIFY GETS £420K FUNDING FOR REGENERATIVE CELL THERAPIES

    Mar 19, 2019

    UK cell therapy company Cell Mogrify has been awarded £420,000 funding from Innovate UK to accelerate its data-driven cell conversion programmes. The funding from the UK’s innovation agency will be used to transition three products to the preclinical stage, with potential application in ...


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    /news-article.aspx?ID=28212821

    LIXIANA HITS THE MARK IN CATHETER ABLATION TRIAL

    Mar 19, 2019

    Daiichi Sankyo’s Lixiana was a late entrant to the novel oral anticoagulant (NOAC) category, but the Japanese drugmaker hopes new data in atrial fibrillation (AFib) could accelerate its growth. The ELIMINATE-AF trial compared uninterrupted treatment with Factor Xa inhibitor Lixiana (edoxaban) ...


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    /news-article.aspx?ID=28222822

    DR. REDDY'S LAB LAUNCHES CUSTOMER SERVICE PORTAL TO INCREASE OPERATIONAL EFFICIENCY FOR US CUSTOMERS

    Mar 18, 2019

    Hyderabad, India and Princeton, NJ, USA. March 18, 2019 - Dr. Reddy’s Laboratories Ltd. announces the launch of its advanced B2B Customer Service Portal “XCEED.” Fully focused on meeting the growing demand for Dr. Reddy’s portfolio of generic active pharmaceutical ingredients...


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    /news-article.aspx?ID=28142814

    PRALUENT APPROVED TO REDUCE CV RISK IN EUROPE

    Mar 18, 2019

    The European Commission has approved Sanofi and Regeneron’s Praluent for reducing cardiovascular risk in adults with established atherosclerotic CV disease (ASCVD), giving the drug another advantage in its battle against Amgen’s Repatha. The approval is based on results from the phase II...


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    /news-article.aspx?ID=28152815

    FIBROMYALGIA ACCURATELY SPOTTED IN AN EXPERIMENTAL BLOOD TEST: STUDY

    Mar 18, 2019

    Washington D.C.: In a first, researchers have found that fibromyalgia can reliably be detected in blood samples which could possibly lead to a simple and fast diagnosis. In the study that appears in the Journal of Biological Chemistry, researchers from The Ohio State University report success in ide...


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    /news-article.aspx?ID=28162816

    MERCK KGAA SIGNS ANOTHER AI DEAL

    Mar 15, 2019

    Merck KGaA is doubling down on AI through a new collaboration agreement with tech firm Iktos, using its generative modeling technology to speed up the discovery and design of promising new compounds.Iktos’ AI tech, which is based on deep generative models, automatically designs virtual novel m...


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    /news-article.aspx?ID=28052805

    TINY ROBOTIC TOOL TO DETECT, KILL CANCER CELLS

    Mar 15, 2019

    Toronto: Canadian scientists have developed a kind of magnetic tweezer that can precisely insert a minuscule bead robot into a live human cancer cell, pointing to a new option for diagnosing and killing cancer. The study, published in the journal Science Robotics, described the design in which a mag...


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    /news-article.aspx?ID=28062806

    TIP THAT LAUNCHED COLLEGE BRIBERY SCANDAL CASE CAME FROM PHARMA PUMP-AND-DUMP INVESTIGATION

    Mar 15, 2019

    The college bribery scandal that is currently lighting up the media was brought to light by a Securities and Exchange Commission (SEC) investigation into a pharmaceutical pump-and-dump case. The scandal, dubbed Operation Varsity Blues, revolves around dozens of wealthy parents paying a college consu...


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    /news-article.aspx?ID=28072807

    PRICES OF SELECT INSULIN SHOOTS UP TO 20% IN ONE YR

    Mar 15, 2019

    Chennai: Fluctuating US Dollar has pushed prices of insulin pens, cartridges, and basal insulin by up to 20% over the last few months, thereby pushing up medical bills of diabetics in India. Diabetologists say nearly a third of-of their insulin dependent patients are now paying more for their daily ...


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    /news-article.aspx?ID=28082808

    UK GETS EARLY ACCESS TO ROCHE’S BREAST CANCER IMMUNOTHERAPY

    Mar 14, 2019

    Hard on the heels of an FDA approval for Roche’s Tecentriq and Celgene’s Abraxane for triple-negative breast cancer (TNBC), the regimen has been cleared for early access in the UK. The green light means adult patients with PD-L1 positive, unresectable locally advanced or metastatic TNBC ...


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    /news-article.aspx?ID=27982798

    JUBILANT PHARMA'S RATINGS UNAFFECTED BY USFDA WARNING, FITCH SAYS

    Mar 14, 2019

    Jubilant Pharma’s credit profile remains unaffected by the US Food and Drug Administration's (USFDA) recent regulatory action at its Roorkee facility in India, Fitch Ratings has said. “The plant makes generic solid-dosage products and has limited contribution to JPL's revenue and...


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    INDIANA UNIVERSITY RESEARCHERS DEVELOP BLOOD TEST FOR PTSD

    Mar 14, 2019

    Researchers at Indiana University have developed a blood test that could help more accurately diagnose post-traumatic stress disorder, or PTSD. The study tracked more than 250 veterans in over 600 visits at the Richard L. Roudebush VA Medical Center in Indianapolis, attempting to identify a molecule...


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    CEO OF NOVARTIS’ GENERICS UNIT QUITS, SPARKING SALE SPECULATION

    Mar 14, 2019

    Richard Francis is stepping down as CEO of Novartis’ generics and biosimilars division Sandoz at the end of March, sparking further speculation about the unit’s future. The Swiss drugmaker said that current region head for Europe, Francesco Balestrieri, has been appointed ad-interim CEO ...


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    6SENSE ANNOUNCES SALESFORCE PARDOT INTEGRATION FOR REVENUE TEAMS TO LAUNCH COMPREHENSIVE ABM PROGRAMS

    Mar 14, 2019

    6sense, a leading Account Based Orchestration Platform, powered by AI, extends its relationship with Salesforce to include an all-new integration with Pardot, Salesforce’s marketing automation solution. This integration combines marketing execution from Salesforce Pardot with the time-based pr...

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    CANCER DOCTOR SHARPLESS TO TAKE REINS AT FDA NEXT MONTH

    Mar 13, 2019

    The director of the US National Cancer Institute, Norman “Ned” Sharpless has been announced as the acting FDA commissioner, following the shock resignation of incumbent Scott Gottlieb. Health and Human Services Secretary Alex Azar made the announcement in a hearing before a House committ...


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    ZYDUS CADILA GETS USFDA NOD TO MARKET POTASSIUM CHLORIDE CAPSULES

    Mar 13, 2019

    New Delhi: Drug firm Zydus Cadila Wednesday said it has received final approval from the US health regulator to market Potassium Chloride extended-release capsules, used to treat or prevent low amounts of potassium in the blood. Zydus Cadila said the newly-approved product will be manufactured at th...


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    SMITH & NEPHEW BUYS OSIRIS IN REGENERATIVE MEDICINE PUSH

    Mar 13, 2019

    Medical equipment company Smith & Nephew has agreed a $660 million deal to buy US biotech Osiris Therapeutics that expands its business into regenerative medicine. Osiris makes medical products used to treat skin, bone and cartilage damage, with the bulk of its revenues coming from Grafix and St...


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    FDA APPROVES GENERIC VALSARTAN AMID DRUG SHORTAGE

    Mar 13, 2019

    The U.S. Food and Drug Administration on Tuesday approved a new generic of heart medicine Valsartan and said it prioritized the drug's review to help relieve recent shortage as manufacturers around the world have pulled the treatment from the market. Several drugmakers, including Teva Pharmaceut...


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    CITY OF MEMPHIS SUES PHARMACEUTICAL COMPANIES FOR OPIOID CRISIS

    Mar 12, 2019

    The City of Memphis has filed a federal lawsuit against a group of more than 20 opioid drug manufacturers and distributors, accusing them of fueling the addiction crisis plaguing the community, according to court records. The lawsuit was filed in U.S. District Court for the Western District of Tenne...


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    OPIOID LITIGATION CONCERNS WEIGH ON PHARMACEUTICAL LOAN BORROWERS

    Mar 12, 2019

    The opioid crisis came to the loan market last week, as the potential fallout from lawsuits weighed on manufacturers of the drugs cited as a root cause of the epidemic. Pharmaceutical company Endo International's US$ 3.4 billion term loan was quoted at 97.75-98.5 on Monday, unchanged from Friday...


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    PHARMACEUTICALS IN THE ENVIRONMENT: COMMISSION TO ACT

    Mar 12, 2019

    The European Commission has adopted a Communication detailing actions to be taken to avoid the proliferation of pharmaceutical substances into the environment. The Strategic Approach to Pharmaceuticals in the Environment report covers every stage of the “pharmaceutical life cycle” in bot...


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    AZ JOINS WITH SERES TO RESEARCH ROLE OF GUT MICROBIOME IN CANCER

    Mar 12, 2019

    AstraZeneca has announced an immuno-oncology collaboration with US biotech Seres Therapeutics, which will focus on increasing understanding of the gut microbiome in order to increase the efficacy of cancer immunotherapy. The tie-up is based on preclinical and clinical evidence suggesting that the co...


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    ROCHE GETS FIRST CHECKPOINT INHIBITOR OK IN BREAST CANCER

    Mar 11, 2019

    Roche’s Tecentriq was the third PD-1/PD-L1 inhibitor to reach the market but is the first in class to be approved for any form of breast cancer. PD-L1 inhibitor Tecentriq (atezolizumab) has been cleared by the FDA for advanced triple-negative breast cancer (TNBC), in combination with Celgene&r...


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    MERCK & CO PENS $340M PAIN DRUG DEAL WITH KCL AND WELLCOME

    Mar 11, 2019

    Merck & Co has announced a deal with King’s College London (KCL) and Wellcome to investigate a new class of painkillers that could provide an alternative to opioids and their dangerous side-effects. Known as MSD outside of the US, the big pharma has signed a collaborative license deal with...


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    SMOKING DURING PREGNANCY DOUBLES THE RISK OF SUDDEN UNEXPECTED INFANT DEATH, STUDY WARNS

    Mar 11, 2019

    The first findings to result from a collaboration between Seattle Children's Research Institute and Microsoft data scientists provide expecting mothers new information about how smoking before and during pregnancy contributes to the risk of an infant dying suddenly and unexpectedly before their ...


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    NEW DIAGNOSTIC CLUES FOUND FOR LIFE LIMITING LUNG CONDITION

    Mar 11, 2019

    A new biomarker that could be used to provide an earlier diagnosis for a life-limiting lung condition has been identified by researchers at the University of Bradford. Pulmonary arterial hypertension (PAH) affects around 6,500 people in the UK and is caused by a narrowing of the arteries supplying b...


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    FDA ADVISORY PANEL GIVES MIXED REVIEW TO SANOFI’S DENGUE VACCINE

    Mar 08, 2019

    Sanofi has been hoping to secure approval from the U.S. Food and Drug Administration (FDA) for its dengue vaccine, but a mixed review from a panel of experts could sink the chances of a green light for the medication. The FDA is expected to rule on Sanofi’s Biologics License Application by May...


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    NEW SOFTWARE AIMS TO REPLACE HANDWRITTEN EXPERIMENT METHODS

    Mar 08, 2019

    The not-for-profit organization, the Pistoia Alliance, has announced new software that aims to make pharma labs work more efficiently, replacing handwritten experiment methods with digital documents. The MethodDB project has been launched in conjunction with pharma companies including Bristol-Myers ...


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    BEDROCK APPOINTS EMILY HOWMAN TO LEAD SCIENTIFIC SERVICES TEAM

    Mar 08, 2019

    Bedrock Healthcare Communications has appointed Emily Howman to lead its scientific services team in a move designed to reinforce its core medical communications offering. In taking up the newly-created position of head of scientific services Howman will also join the med comms agency’s senior...


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    INVESTMENT FIRM APPALOOSA AGAIN CALLS FOR LEADERSHIP CHANGES AT ALLERGAN

    Mar 08, 2019

    After Allergan reported that its late-stage adjunctive treatment for major depressive disorder failed to distinguish itself against placebo, hedge fund investor Appaloosa LP is again calling on the Ireland-based company to make some changes to its board of directors, including tapping a new chairman...


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    IN AN ATTEMPT AT CLARITY, FDA MAKES THE BIOSIMILAR NAMING CONVENTION EVEN MORE CONFUSING

    Mar 08, 2019

    The U.S. Food and Drug Administration (FDA) and some biosimilar and generic drug advocates were concerned that the naming for biosimilars the branded drug’s name and a unique, four-letter suffix made the drugs sound inferior to consumers than their branded counterparts. So in January 2017, the...


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    IPSEN LAUNCHES NEW SYRINGE FOR RARE DISEASE BLOCKBUSTER

    Mar 07, 2019

    Ipsen will be launching a new pre-filled syringe for its blockbuster rare disease drug Somatuline (lanreotide) in the EU. The new design was based on several studies, involving patients, their caregivers, nurses and other healthcare professionals that aimed to inform and test enhancements to the exi...


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    TREATING TRIPLE-NEGATIVE BREAST CANCER BY REPURPOSING OLD DRUGS FOR DIABETES AND RARE BLOOD DISORDER

    Mar 07, 2019

    Triple-negative breast cancer patients lack three common markers estrogen, progesterone, and HER2 making them unresponsive to targeted therapies. A team led by University of Chicago scientists may have found a new option for these patients, and it's one that involves combining two old FDA-approv...


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    ALNYLAM TO SEEK APPROVAL FOR SECOND RNAI DRUG

    Mar 07, 2019

    Alnylam thinks it has strong enough clinical data for its gene-silencing drug for rare disease acute hepatic porphyria (AHP), and plans to move ahead with regulatory filings in the US and Europe. The US biotech made a bit of biotech history last August after getting the first-ever FDA approval for a...


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    ROCHE STUDY SHOWS AI CAN DETECT SEVERITY OF DIABETIC MACULAR EDEMA

    Mar 07, 2019

    A new study conducted by researchers from Genentech and Roche shows first-time proof that artificial intelligence can detect the severity of diabetic macular edema, which is a leading cause of blindness. On Monday, researchers from Genentech and its parent company Roche published the study, Deep Lea...


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    MERCK KGAA ADMITS TO ‘CHALLENGING’ 2018, AS CURRENCIES HIT SALES

    Mar 07, 2019

    Germany’s Merck KGaA has described 2018 as a “challenging” year, which saw profits hit by currency headwinds and the company struggling to convince shareholders at semiconductor Versum firm to allow a merger. In its full-year results for 2018, Merck KGaA said sales rose in 2018 by ...


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    GENE-EDITING STARTUP BEAM BAGS $135M IN SERIES B TOP-UP

    Mar 06, 2019

    Beam Therapeutics has raised a healthy $135 million in second-round financing that will be used to advance its single-base approach to gene editing. The Cambridge, Massachusetts, biotech—which was one of our Fierce 15 winners last year—says the new funding will be used to expand its pipe...


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    ALNYLAM'S GIVOSIRAN LOOKS POSITIVE OVERALL IN PHASE III TRIAL FOR RARE DISEASE

    Mar 06, 2019

    Despite releasing positive data on its Phase III ENVISION trial, Alnylam Pharmaceuticals stock dropped 7.5 percent. Although not completely clear why the drop may be related to a high percentage of serious adverse events observed in the trial. The ENVISION Phase III trial evaluated givosiran, an inv...


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    MEDITERRANEAN DIET BOOSTS ENDURANCE EXERCISE WITHIN DAYS

    Mar 06, 2019

    Researchers at Saint Louis University have found that eating a Mediterranean diet can improve athletes' endurance exercise performance after just four days. In a small study published in the Journal of the American College of Nutrition, investigators found that participants ran a 5K six percent ...


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    VERTEX TRIPLE COMBINATION CF DRUGS HIT THE MARK IN PHASE III TRIALS

    Mar 06, 2019

    A Vertex triple-combination treatment for cystic fibrosis hit the mark in two Phase III trials, setting the stage for the company to secure approval for another treatment for the life-shortening genetic disease that affects approximately 75,000 people in North America, Europe, and Australia. This mo...


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    BRISTOL-MYERS SQUIBB STRIKES BACK! RESPONSE TO CRITICS OF CELGENE DEAL

    Mar 06, 2019

    Bristol-Myers Squibb announced its bid to acquire Celgene on January 3, 2019. However, the deal hit a snag. One of its biggest shareholders, Wellington Management Company LLP, has objected to the acquisition. Wellington owns about an 8 percent stake in Bristol-Myers. Another BMS shareholder, Starboa...


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    DIRECTIVE RANKS #1 IN CLUTCH’S TOP B2B MARKETING SERVICE PROVIDERS

    Mar 06, 2019

    Directive, the leading B2B and enterprise search marketing agency, has recently been honored as the number one B2B marketing and advertising service provider in Los Angeles, according to Clutch. Clutch is a B2B research, ratings and reviews site that identifies leading IT and marketing service provi...

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    STEM CELL TRANSPLANT POTENTIALLY "CURES" SECOND HIV PATIENT

    Mar 05, 2019

    Although cautious about using the word “cure,” researchers have described a second person globally to be cleared of HIV, the virus that causes AIDS. The first patient was Timothy Ray Brown, also dubbed the “Berlin Patient,” who was cured of HIV in 2007. The new study was publ...


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    FOCUSED ULTRASOUND AND MICROBUBBLES PUSH DRUGS ACROSS BLOOD-BRAIN BARRIER

    Mar 05, 2019

    The blood-brain barrier is an important defense mechanism that prevents infections and contamination within the brain. It is also responsible for making it extremely difficult to get therapeutic drugs, including chemo agents, into the brain. Now researchers at Washington University in St. Louis have...


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    KEYTRUDA COULD GET PATIENT-FRIENDLY 6 WEEK DOSING SCHEDULE IN EU

    Mar 05, 2019

    US-based Merck & Co is putting further pressure on its arch-rival Bristol-Myers Squibb with a potential new six-week dosing schedule for some European patients taking its Keytruda (pembrolizumab) cancer immunotherapy. Late last week the European Medicines Agency’s Committee for Medicinal P...


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    GILEAD EXPANDS CAR-T DEAL WITH MAXCYTE, PRECISION FILES FOR $100M IPO

    Mar 05, 2019

    It has been a busy month already in the field of CAR-T therapy, with Gilead expanding a partnership with MaxCyte, and Precision BioSciences filing for a $100 million IPO for its ‘off-the-shelf’ cancer cell therapies. Gilead’s subsidiary Kite Pharma has revised a deal with London-li...


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    FORMER AGIOS EXECUTIVE TO TAKE OVER DECIPHERA AFTER CEO STEPS DOWN

    Mar 05, 2019

    After five years at the reins, Mike Taylor will step down from his role as president and chief executive officer of Waltham, Mass.-based Deciphera Pharmaceuticals. Taylor’s last day in the role will by March 18, the company announced late Monday. Steve Hoerter, the chief commercial officer of ...


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    PRECISION BIOSCIENCES FILES FOR $100 MILLION IPO TO FUND OFF-THE-SHELF CAR-T TRIALS

    Mar 04, 2019

    Durham, NC-based Precision BioSciences filed on Friday with the U.S. Securities Exchange Commission for an initial public offering (IPO). The company, which focuses on gene-edited CAR-T cell therapies for cancer, plans to raise $100 million. Precision’s technology is based on its ARCUS tech pl...


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    CHMP OKAYS SANOFI’S ZYNQUISTA IN TYPE 1 DIABETES

    Mar 04, 2019

    Sanofi has moved a step closer to getting its new diabetes therapy Zynquista approved in Europe, with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The European Medicines Agency (EMA) drugs advisory panel has recommended the oral SGLT1/2 inhibitor as an adjunct t...


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    NEW CARCINOGENS FOUND IN BLOOD PRESSURE MEDICATIONS, RECALL ISSUED

    Mar 04, 2019

    More carcinogens have been discovered in blood pressure medications, which has prompted another recall by the U.S. Food and Drug Administration (FDA). On Friday, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals. T...


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    ERGOJACK SMART VEST PREVENTS INJURIES AT WORK

    Mar 04, 2019

    Construction, factory, and farm workers, among others, tend to put a lot of strain on their backs. It’s no surprise that back problems are common in such professions. Paying attention to one’s posture and being careful to avoid putting too much demand on the bones and muscles of the back...


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    ASCENDIS PHARMA’S TRANSCON GROWTH HORMONE PASSES PHASE III WITH FLYING COLORS

    Mar 04, 2019

    Ascendis Pharma, based in Copenhagen, Denmark, announced that its once-weekly TransCon Growth Hormone (HGH) hit its primary endpoints in its Phase III height Trial in children with pediatric growth hormone deficiency (GHD). The trial compared Ascendis’ TransCon hGH to a daily growth hormone, G...


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    NAPP LAUNCHES NEULASTA BIOSIMILAR IN UK

    Mar 04, 2019

    Napp’s Pelmeg, a biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), has been launched in the UK following approval late last year. This is Napp’s first launch of a product developed by Cinfa Biotech, which was acquired by its parent network Mundipharma in October. Aside fr...


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    LUCID GROUP ACQUIRES CREATIVE AND DIGITAL CONSULTANCY BLUEDOG

    Mar 01, 2019

    UK-based medical communications group Lucid has made its first acquisition, adding creative and digital consultancy Bluedog to the fold. The consultancy was set up over 23 years ago and counts UCB Pharma, Reckitt Benckiser, Estée Lauder and Visa among its clients. Bluedog’s managing dir...


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    INDIANA UNIVERSITY RESEARCH ADVANCES SEARCH FOR NEW ANTIBIOTICS

    Mar 01, 2019

    Indiana University researchers are advancing knowledge about how bacteria build their cell walls that could contribute to the search for new antibacterial drugs. They have created a new tool to observe living cells in real time under a microscope. "If you look at the history, no one's reall...


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    RANI COMPLETES FIRST TRIAL OF CAPSULE THAT COULD REPLACE INJECTIONS

    Mar 01, 2019

    Results of the first human study of a capsule designed to replace injections of biologics have been announced, using an automatic pill designed by Silicon Valley-based Rani Therapeutics. Backed by Google’s parent company Alphabet, Rani has begun clinical trials of the RaniPill, which is capabl...


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    PFIZER IS TARGET OF FEDERAL CIVIL PROBE INTO EPIPEN MALFUNCTIONS

    Mar 01, 2019

    Problems for the troubled Pfizer unit that makes EpiPen injectors for Mylan have opened on a new front. The U.S. Attorney for the Southern District of New York is now digging into the issues of why Pfizer continued to produce pens after receiving dozens of complaints that many were failing during li...


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    IMMUNOGEN PLUNGES AFTER PHASE III OVARIAN CANCER TREATMENT FAILS TO HIT PFS ENDPOINT

    Mar 01, 2019

    Shares of Waltham, Mass.-based ImmunoGen, Inc. have plunged nearly 50 percent in premarket trading after the company’s Phase III ovarian cancer treatment failed to meet the primary endpoint of progression-free survival. ImmunoGen’s FORWARD I trial was testing the safety and efficacy of m...


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    TOWARDS A BLOOD TEST FOR EARLY-STAGE LIVER DISEASE

    Mar 01, 2019

    One in four people in Western and Asian societies develop a build-up of fat in the liver as a result of an unhealthy diet. This disease - referred to as non-alcoholic fatty liver disease (NAFLD) - causes no symptoms initially but can develop into end-stage liver cirrhosis with limited treatment opti...


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    LARGEST BMS SHAREHOLDER OPPOSES CELGENE DEAL

    Mar 01, 2019

    Bristol-Myers Squibb’s (BMS) largest shareholder has come out against the company’s planned merger with Celgene, putting the future of the deal in doubt. The $74 billion deal, announced in January, would be one of the largest ever pharma mergers, and the combined company would be the wor...


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    GENE THERAPY FOR DEAFNESS, AUTISM GENES, BREAKTHROUGHS IN PARKINSON’S AND ALS, AND MORE

    Mar 01, 2019

    Researchers with the Institut Pasteur and several other institutions restored the hearing in adult mice with a specific congenital form of deafness using gene therapy. Researchers with Institut Pasteur, University of Florida, University of California, San Francisco (UCSF), Columbia University Medica...


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    BACTERIOPHAGES TO THE RESCUE: A POSSIBLE APPROACH TO ANTIBIOTIC RESISTANCE

    Feb 27, 2019

    Ella Balasa, a 26-year-old from Richmond, Virginia, recently made the news when she was apparently successfully treated for a lung infection using a kind of virus called a bacteriophage. The word “apparently” is important in terms of determining exactly how effective the treatment was, i...


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    ADVISERS URGE FDA TO DELAY DECISION ON KARYOPHARM CANCER DRUG

    Feb 27, 2019

    Advisers to the US drugs regulator have said a decision on whether to approve Karyopharm’s multiple myeloma combination should be delayed until the results of a phase 3 trial, due late this year or in 2020. The FDA’s Oncologic Drugs Advisory Committee (ODAC) was discussing Massachusetts-...


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    A NEW METHOD FOR PRECISION DRUG DELIVERY: PAINTING

    Feb 27, 2019

    If traditional drug delivery were a type of painting, it might be akin to paintball. With good aim, a majority of the paint ends on the bullseye, but it also drips and splashes, carrying streams of paint across the target. If the drug needs to enter the bloodstream and circulate throughout your body...


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    APPLYING ANTIMALARIAL DRUGS TO BED NETS COULD LEAD TO DROP IN MALARIA TRANSMISSION

    Feb 27, 2019

    Mosquitoes that landed on surfaces coated with the anti-malarial compound atovaquone were completely blocked from developing Plasmodium falciparum (P. falciparum), the parasite that causes malaria, according to new research led by Harvard T.H. Chan School of Public Health. The study showed that atov...


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    MYLAN REPORTS LOWER THAN EXPECTED EARNINGS

    Feb 27, 2019

    Mylan has reported lower than expected full-year earnings and 2019 forecasts, thanks partly to delays in its generic Advair approval and continuing problems at its US manufacturing plant. Total revenues were $11.43 billion, down 4% compared to the prior year. North America segment net sales were dow...


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    DR. REDDY'S SOLID DOSE PLANT PINCHED BY FDA FOR MISSTEPS

    Feb 27, 2019

    The FDA keeps rolling through the Indian manufacturing plants of Dr. Reddy’s Laboratories and the Form 483s keep falling out. The FDA this week posted a Form 483 (PDF) for Dr. Reddy’s solid dose plant in Pradesh that was issued after an inspection in January. There were only four observa...


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    COHEN DROPS TESTIMONY ON NOVARTIS DEAL: THEY WANTED ‘ACCESS’ TO TRUMP

    Feb 27, 2019

    As much as Novartis might want the issue to go away, the company’s questionable $1.2 million consulting contracts with President Donald Trump’s former attorney Michael Cohen caught the spotlight again Wednesday as Cohen testified to Congress. Pressed by lawmakers in the House of Represen...


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    EU STEPS CLOSER TO GENERICS AND BIOSIMILARS MANUFACTURING WAIVER

    Feb 27, 2019

    A change to European rules on drug manufacturing that could benefit makers of generics and biosimilars is edging closer after lawmakers agreed on draft legislation that tweaks rules on export and manufacture of drugs that are off-patent outside the EU. The draft of the so-called supplementary protec...


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    MICROFLUIDIC DEVICE PULLS EXOSOMES FROM BLOOD TO TEST FOR CANCER

    Feb 27, 2019

    Exosomes are tiny vesicles that seemingly all the cells in our bodies produce. Initially, exosomes were thought to be a way for cells to expunge built-up trash, but over the past decade or so scientists have discovered that they seem to play an important role in regulating a variety of biochemical p...


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    NOVARTIS' SHIFT TO SUPERPRICEY CELL AND GENE THERAPIES DRAWS INVESTOR IRE

    Feb 27, 2019

    It's not unusual for critics to challenge top drugmakers for price hikes on old drugs, but Novartis is contending with a different kind of pricing pressure from a Swiss shareholder activist group. In this case, it's the company's move into ultra-expensive, one-time treatments that has cr...


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    LUNDBECK JOINS WITH ELSEVIER TO HELP MANAGE R&D DATA

    Feb 27, 2019

    Denmark’s Lundbeck has signed an agreement with information business Elsevier, that aims to help organize the masses of scientific data it has available, and make drug research more productive and efficient. The companies have created a big data project that creates a comprehensive database of...


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    SANDERS ESCALATES FIGHT WITH CATALYST, ASKING FDA TO ALLOW UNBRANDED COPIES OF $375K FIRDAPSE: REPORT

    Feb 27, 2019

    After a seemingly vain attempt to appeal to Catalyst Pharmaceuticals’ conscience, Sen. Bernie Sanders, I-Vt., has turned to the FDA, asking the agency to allow cheaper, unapproved versions of Catalyst’ Firdapse to be distributed as they had been over the past three decades. In a bid to c...


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    FORMER TRUMP LAWYER COHEN SAYS NOVARTIS ‘WANTED HIM TO BE LOBBYIST’

    Feb 27, 2019

    Novartis’ dodgy dealings with the Trump administration have come under fresh scrutiny, as his former personal lawyer Michael Cohen told politicians that the pharma company had wanted to use him to lobby the government and president. Cohen was testifying against the president in a much-anticipa...


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    NEW INSIGHT INTO HOW BIOGEN'S TECFIDERA WORKS MAY LEAD TO BETTER MS THERAPIES

    Feb 27, 2019

    Biogen’s top-selling Tecfidera (dimethyl fumarate) has proven to be an effective treatment for multiple sclerosis, bringing in $4.27 billion in sales in 2018, but its exact mechanism of action remains a mystery. Now scientists from the City University of New York and the Icahn School of Medici...


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    FDA FINDS AUROBINDO STERILE DRUG PLANT CONTINUES TO HAVE PROBLEMS

    Feb 26, 2019

    Aurobindo pledged to resolve issues at a sterile manufacturing plant in India last year after an FDA inspection cited it for problems that could lead to contamination. It didn’t do enough. The FDA has made another trip to the key Aurobindo facility and once again found it lacking. The agency h...


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    AZ/MERCK & CO’S LYNPARZA DELAYS SPREAD OF PANCREATIC CANCER

    Feb 26, 2019

    AstraZeneca and Merck & Co’s Lynparza could offer a new option for certain patients with pancreatic cancer after a trial showed it slowed progression of the disease. Lynparza (olaparib) is a poly (ADP-ribose) polymerase, or PARP inhibitor class drug and is already established as a therapy ...


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    AMGEN PERSUADES JURY TO BACK PCSK9 PATENTS, PUTTING SANOFI AND REGENERON BACK ON DEFENSE

    Feb 26, 2019

    Give the latest round of the PCSK9 patent fight to Amgen. A California jury decided Monday that two key patents protecting its Repatha cholesterol drug are indeed valid—and that puts Sanofi and Regeneron in a tough spot. The partners, which sell a rival PCSK9 inhibitor called Praluent, previou...


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    IVASCULAR’S NAVITIAN CORONARY MICROCATHETERS FOR CHRONIC TOTAL OCCLUSIONS CLEARED IN EU

    Feb 26, 2019

    iVascular, a Spanish company that makes catheter-based devices, won the European CE Mark for its new Navigation coronary microcatheter. The device is indicated as support for guidewires, helping to exchange guidewires, and for injection of radiopaque contrast agents, as well as the saline solution. ...


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    SENSOR DETECTS SEPSIS BIOMARKER IN LESS THAN THREE MINUTES

    Feb 26, 2019

    Fulminate sepsis is a dangerous condition, usually caused by a bacterial infection. The runaway behavior of the immune system in sepsis is still poorly understood. The trick is to diagnose it early and to use antibiotics to fight it off. These days it can take up to three days to diagnose sepsis, us...


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    M&A FLURRY CONTINUES WITH $21BN DANAHER BID FOR GE UNIT

    Feb 26, 2019

    GE Healthcare was supposed to be heading for an initial public offering (IPO) this year, but that looks less likely after a $21.4 billion buyout offer for its biopharma unit from medtech company Danaher. The business, which makes equipment for researching, developing and manufacturing biopharmaceuti...


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    NOTABLE LABS BRINGS ON 2 DEVELOPMENT EXECUTIVES AHEAD OF ITS FIRST BLOOD CANCER TRIALS

    Feb 26, 2019

    After launching its first in-house R&D program last month, cancer drug-testing startup Notable Labs has brought on two biopharma executives to take charge of its clinical operations and drug development work. Incyte’s Hiroomi Tada joined as a chief medical officer, while Aquinox’s Ll...


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    NOVARTIS PAYS $150M TO LICENSE AKCEA-IONIS CARDIAC DISEASE DRUG

    Feb 25, 2019

    Novartis has taken up its option to license antisense oligonucleotide TQJ230, triggering a $150 million payout that Akcea Therapeutics will share with Ionis Pharmaceuticals. The decision sets Novartis up to test the RNA-targeting drug in phase 3 cardiovascular outcomes trial. TQJ230, formerly known ...


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    ROCHE TO BUY GENE THERAPY FIRM SPARK FOR $4.8 BILLION

    Feb 25, 2019

    Roche is to buy gene therapy firm Spark Therapeutics for $4.8 billion, adding an already-approved treatment for inherited blindness to its portfolio, and boosting its pipeline with a series of potential rare disease drugs. The Swiss pharma has reached a deal to buy Spark in an all-cash transaction a...


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    DOES VACCINATING AGAINST ROTAVIRUS ALSO PROTECT AGAINST TYPE 1 DIABETES?

    Feb 25, 2019

    The rotavirus vaccine may be pulling double duty; it not only protects young children against a potentially life-threatening rotavirus infection but may also reduce their likelihood of developing type 1 diabetes. A study published in JAMA Pediatrics in late January noted a decrease in the prevalence...


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    PRICE HEARING CHEAT SHEET: CEOS PREP FOR GRILLING, HISTORY REPEATS ITSELF AND MORE

    Feb 25, 2019

    The nation's capital is abuzz as Big Pharma CEOs rehearse their testimony for Tuesday's big drug-pricing hearing. What to expect? High political theater, for one thing, as Republicans and Democrats both take their shots. But don't dismiss the event as mere grandstanding, analysts say. Se...


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    ABBVIE UPSCALES VOYAGER ALLIANCE WITH NEW TARGET, MORE CASH

    Feb 25, 2019

    AbbVie has extended its collaboration with gene therapy specialist Voyager Therapeutics, adding a new programme in Parkinson’s disease and another $1.5 billion in potential fees. The two started working together on “vectorized” antibodies targeting tau protein for Alzheimer’s...


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    DANAHER PLUNKS DOWN $21.4 BILLION TO ACQUIRE GENERAL ELECTRIC’S BIOPHARMA BUSINESS

    Feb 25, 2019

    Shares of General Electric jumped as much as 13 percent in trading this morning after Danaher announced it was acquiring the conglomerate’s biopharma business, GE Biopharma, for $21.4 billion. GE Biopharma includes a wide-range of dealings, including the development and sale of medical instrum...


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    FDA DRAFTS ‘LEAPFROG’ GUIDANCE ON BRAIN-COMPUTER INTERFACE TECH

    Feb 25, 2019

    The FDA is hoping to help the industry take a leap toward what was once pure science fiction: interfaces that link brains and computers, allowing a person to directly control devices with their thoughts. To promote the development of a new generation of fully integrated implants, the agency publishe...


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    OPIANT’S MID-STAGE TREATMENT FOR A SEVERE EATING DISORDER FAILS TO REACH ENDPOINTS

    Feb 22, 2019

    Shares of Opiant Pharmaceuticals fell in trading Thursday and continue to slide in premarket trading this morning after the company announced its Phase II trial evaluating a naloxone nasal spray for the treatment of bulimia nervosa failed to meet primary endpoints and will discontinue the program. S...


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    BAYER PAIRS ITS PRODUCTS IN FIRST-EVER TV AD FOR HORMONE-RELEASING IUDS

    Feb 22, 2019

    Bayer is taking on myths about intrauterine devices (IUDs) in a new two-product ad campaign. The first-ever campaign featuring both the Mirena and Kyleena branded IUDs recently began as Bayer looks to not only explain what the levonorgestrel-releasing IUDs do but also impart basic knowledge about IU...


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    HEALTH POLICY ANALYSTS CALL FOR MORE STRINGENT RULES FOR AI MEDICAL APPLICATIONS

    Feb 22, 2019

    A trio of health policy analysts from the University of Pennsylvania and the University of California has published a Policy Forum piece in the journal Science calling for more stringent rules for the introduction of AI medical applications. In their paper, Ravi Parikh, Ziad Obermeyer and Amol Navat...


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    ABBVIE’S CANCER DRUG VENCLEXTA BLOCKS DIABETES IN MICE BY TARGETING BETA CELL ‘SENESCENCE’

    Feb 22, 2019

    Diabetes researchers have long believed that the disease starts when the immune system attacks insulin-producing beta cells in the pancreas. But that theory never made much sense to Anil Bhushan, Ph.D., a professor at the University of California, San Francisco, Diabetes Center. So he and a team of ...


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    PORTABLE, BATTERY POWERED VIRAL DETECTOR TAKES ONLY A DROP OF BLOOD

    Feb 22, 2019

    Performing a lab-quality test for many infectious diseases, particularly viral ones, is difficult in remote regions. Much lab equipment requires some kind of infrastructure, including clean rooms, trained staff, and money. Researchers at Purdue University have developed a device that can perform RNA...


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    MENDELIAN GETS £500,000 FOR RARE DISEASE SCREENING TECH

    Feb 22, 2019

    UK health technology startup Mendelian has received a £500,000 grant from a government agency to build products that will help GPs identify patients with rare or hard to diagnose conditions and diseases. Mendelian will use the grant from Innovate UK to get a specialized screening system for ra...


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    MARKET ACCESS ROUNDUP: UK HTA SHAKEUPS AS BREXIT FEARS DEEPEN

    Feb 22, 2019

    With a Brexit deal still out of sight, there have been intensified warnings in the UK about potential disruptions to medical supplies that could follow a no-deal scenario. One government minister has said that a no-deal Brexit could disrupt medicines supplies to the UK for at least six months becaus...


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    FDA ADVANCES NEW PROPOSED REGULATION TO MAKE SURE THAT SUNSCREENS ARE SAFE AND EFFECTIVE

    Feb 21, 2019

    This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Among its provisions, the...


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    PATIENTS SWITCH TO LOWER DOSE OF PFIZER’S RA PILL AFTER SAFETY SIGNAL

    Feb 21, 2019

    Pfizer is moving rheumatoid arthritis patients to a lower dose of its blockbuster inflammatory diseases pill Xeljanz in a clinical study after a safety signal emerged in the trial of patients at high risk of cardiovascular events. A Janus kinase inhibitor class drug, Pfizer has produced Xeljanz as a...


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    CONGRESSMAN AIMS TO BREAK PHARMA’S INSULIN ‘PRICING MONOPOLY’ BY LEGALIZING CANADIAN IMPORTS

    Feb 21, 2019

    U.S. legislators have been introducing bills left and right proposing a variety of methods for bringing down drug prices. Now, Vermont's congressman is zeroing in on a specific class of diabetes medicines that he says have become far too expensive: insulin. Rep. Peter Welch introduced a bill on ...


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    NEXUS PHARMACEUTICALS RECEIVES FDA APPROVAL FOR PROCHLORPERAZINE EDISYLATE INJECTION, USP

    Feb 21, 2019

    Nexus Pharmaceuticals, Inc. announced today it has received U.S. Food and Drug Administration (FDA) approval for Prochlorperazine Edisylate Injection, USP in 10mg/2mL vial. “The launch further expands our generic injectable portfolio but more importantly, it shows our commitment to meeting the...


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    VICAL SLASHES STAFF AFTER CULLING PHASE II ANTIFUNGAL

    Feb 21, 2019

    US biotech Vical is planning another round of job cuts after deciding to abandon its antifungal drug VL-2397, its last remaining clinical-stage asset. The San Diego company only started the phase II trial of VL-2397 last year but says a slow uptake of patients into the trial, coupled with a need to ...


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    MERCK’S KEYTRUDA FAILS IN LATE-STAGE HCC TRIAL

    Feb 20, 2019

    Merck’s vaunted PD-1 inhibitor Keytruda took a stumble in a late-stage trial as a treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy. In the pivotal Phase, III KEYNOTE-240 trial, Keytruda plus best supportive care failed to hit ...


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    RESEARCH SHOWS MANY PATIENTS WERE IMPROPERLY PRESCRIBED FENTANYL

    Feb 20, 2019

    Fentanyl is a powerful form of opioid given to patients who are suffering from severe pain. The medication is about 100 times more powerful than morphine. A new study shows that a large number of patients who should not have received something so powerful were still prescribed the drug. Researchers ...


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    ABBVIE’S JAK INHIBITOR UPADACITINIB GETS PRIORITY REVIEW

    Feb 20, 2019

    AbbVie’s attempts to diversify beyond Humira have been boosted as its investigational drug upadacitinib has been granted Priority Review by the FDA for moderate to severe rheumatoid arthritis (RA). Trial data has suggested that upadacitinib, a JAK1-selective inhibitor, is more effective at tre...


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    FDA CRACKS DOWN ON UNAUTHORIZED USE OF PLASMA TREATMENTS FOR AGING, OTHER ILLNESSES

    Feb 20, 2019

    In the seventeenth century, Hungarian Countess Elizabeth Bathory bathed in the blood of young women she murdered in order to sustain her beauty. Blood, albeit more freely given, continues to be an attractive tool for some who want to stave off the effects of age. Individuals have been using plasma i...


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    KEYTRUDA GETS OKAY FROM FDA FOR ADJUVANT MELANOMA

    Feb 20, 2019

    The US FDA has approved Merck & Co’s Keytruda as an adjuvant treatment for patients with melanoma who have had surgery but still show some evidence of cancer in their lymph nodes. It’s the first time that PD-1 inhibitor Keytruda (pembrolizumab) has been approved in the US for adjuvan...


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    INTERCEPT PHARMA IS ONE STEP CLOSER TO FILING FOR APPROVAL OF FIRST NASH TREATMENT

    Feb 19, 2019

    Shares of Intercept Pharmaceuticals have exploded this morning after the company announced positive news from its Phase III nonalcoholic steatohepatitis (NASH) trial. The stock has shot up more than 20 percent in premarket trading to $133 per share as investors see the potential for the first approv...


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    CIPLA TAPS WELLTHY FOR DIGITAL THERAPEUTICS EXPERTISE

    Feb 19, 2019

    Indian pharma company Cipla has made another play in the digital medicine category by taking a near-12% stake in start-up Wellthy Therapeutics. Under the terms of their agreement Wellthy and Cipla – which is India’s third-biggest pharma company – will work together on combined drug...


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    TAPEWORM DRUG COULD BE AN EFFECTIVE TREATMENT FOR CERTAIN CANCERS

    Feb 19, 2019

    Could a drug used to treat tapeworms be effective at treating a type of cancer? Researchers in Singapore think they are on the right track in demonstrating just that. Scientists from A*STAR’s Institute of Molecular and Cell Biology (IMCB) recently discovered that the use of niclosamide, which ...


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    INVENTIVA DISCONTINUES SYSTEMIC SCLEROSIS DRUG AFTER MID-STAGE FLOP

    Feb 19, 2019

    Shares of France-based Inventiva have plunged more than 45 percent after the company reported that its experimental treatment for a rare autoimmune disease failed to hit primary and secondary endpoints in a mid-stage trial. Inventiva said its FASST (For A Systemic Sclerosis Treatment) clinical trial...


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    KEYTRUDA COMBO SET TO BECOME “STANDARD OF CARE” IN KIDNEY CANCER

    Feb 18, 2019

    Analysts are predicting that a combination of Merck’s Keytruda and Pfizer’s Inlyta will become the standard of care in renal cell carcinoma (RCC) thanks to impressive trial results and a price advantage over BMS’ rival drug. The combination of anti-PD-1 therapy Keytruda with tyrosi...


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    CHOLESTEROL CAN BE A PROBLEM FOR SOME CANCER CELLS, RESEARCHERS REVEAL

    Feb 18, 2019

    For millions of people across the globe, cholesterol has become a significant health issue. It also turns out that cholesterol can be a problem for some cancer cells. New research coming from Rockefeller University reveals that a rare tumor type is unable to synthesize cholesterol, which is somethin...


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    TRIAL COULD UNLOCK NEW PROSTATE CANCER SALES FOR PFIZER/ASTELLAS’ XTANDI

    Feb 18, 2019

    Pfizer and Astellas’ Xtandi has shown it is effective in men with prostate cancer that has spread but has not yet become hormone resistant, stepping up pressure on rival therapy Zytiga from Johnson & Johnson. The results of the ARCHES trial show that giving androgen receptor antagonist Xta...


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    MAPPING BRAIN CIRCUITS IN NEWBORNS MAY AID EARLY DETECTION OF AUTISM

    Feb 18, 2019

    A new map of newborn babies' brains offers details of structure that will provide a new reference for researchers studying both typical brain development and neurological disorders. Using noninvasive, 20-minute magnetic resonance imaging (MRI) scans, researchers have revealed some of the complex...


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    LUNDBECK AND OTSUKA'S ANTIPSYCHOTIC DRUG REXULTI FAILS TWO BIPOLAR PHASE III TRIALS

    Feb 15, 2019

    Denmark’s H. Lundbeck A/S and Japan’s Otsuka Pharmaceutical announced that their brexpiprazole failed to meet its primary endpoint in two Phase III clinical trials to treat manic episodes in patients with bipolar I disorder. The drug was approved by the U.S. Food and Drug Administration ...


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    PRICE CUT UNLOCKS NICE NOD FOR PERJETA IN POST-SURGERY BREAST CANCER

    Feb 15, 2019

    Roche has finally won NICE backing for the use of Perjeta (pertuzumab) to prevent early-stage HER2-positive breast cancer from recurring after surgery, at the third attempt. The new draft guidance means that the HER2 inhibitor can be given as an adjuvant therapy to people with early-stage HER2-posit...


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    WHO PLANS TO DEVELOP OVERSIGHT STANDARDS FOR GENE EDITING FOLLOWING CHINESE RESEARCHER’S EXPERIMENT

    Feb 15, 2019

    Following international concern and outrage over a gene-editing treatment of human embryos in China, the World Health Organization (WHO) is taking action. On Thursday, WHO announced it was assembling a panel of experts to form an advisory committee to develop global standards for the governance and ...


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    STATINS COULD PROTECT AGAINST MOTOR NEURONE DISEASE, SCIENTISTS SUGGEST

    Feb 15, 2019

    High cholesterol could be a risk factor in the development of motor neuron disease, according to a study of genetic data by UK scientists. A team led by the Queen Mary University of London, in collaboration with the National Institutes of Health in the US, said that cholesterol-lowering drugs such a...


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    BIOGEN FACES MULTIBILLION-DOLLAR TECFIDERA LOSS IF MYLAN WINS LATEST PATENT THREAT

    Feb 07, 2019

    Cash cow Tecfidera has been pumping out blockbuster sales as Biogen plows ahead with pricey Alzheimer's trials and scouts for new pipeline assets. But what if those sales took a big hit early next year, instead of eight years later? That's the threat from a Mylan challenge at the U.S. Patent...


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    HIBERCELL LAUNCHES WITH $60.75 MILLION SERIES A TO TARGET DORMANT METASTATIC CANCER CELLS

    Feb 07, 2019

    HiberCell, based in New York City, launched with a $60.75 million Series A funding. The funding was led by ARCH Venture Partners. Additional investors included Hillhouse Capital, 6 Dimensions Capital, Celgene Corporation, the NYC Life Sciences Fund, and other undisclosed investors. HiberCell focuses...


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    AN ORAL INSULIN DELIVERY SYSTEM INSPIRED BY TORTOISES

    Feb 07, 2019

    Despite nearly a century of research, researchers have so far failed to develop an oral form of insulin that would allow patients with diabetes to avoid multiple daily injections. Now researchers from the Massachusetts Institute of Technology, Brigham and Women’s Hospital, and Novo Nordisk say...


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    FDA PUBLISHES PREMARKET GUIDANCE ON COMBINATION PRODUCTS

    Feb 07, 2019

    The FDA has published new premarket guidance on efficient development and review of combination products, which often combine drugs or biologic medicines with a device. In a statement, the FDA referred to the technologies such as digital pills from Proteus Digital Health, which track when patients t...


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    NEW RESEARCH PULLS BACK THE CURTAIN ON ENTERPRISE CONTENT MARKETING IN 2019

    Feb 07, 2019

    With thousands of employees, working across multiple brands, products lines, offices and silos, enterprise marketers face unique content marketing challenges, yet many are scoring wins year after year. That’s according to the findings in the Content Marketing Institute’s new research rep...

    SOURCE
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    GSK CUTS SIX RESPIRATORY ASSETS AS IT CONTINUES TO FOCUS ON ONCOLOGY TREATMENTS

    Feb 06, 2019

    GlaxoSmithKline has been in the midst of a significant reshaping to focus on pharmaceuticals, particularly a renewed interest in oncology treatments. As a result, the company has made some cuts to its pipeline, including six quietly announced this morning in the company’s year-end report.In a ...


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    CALL FOR BETTER REGULATION OF AI-BASED MEDICAL PRODUCTS

    Feb 06, 2019

    Products based on artificial intelligence should be regulated like drugs, and those that are deemed unsafe should be removed from the market, according to a new report. The report commissioned by NHS Digital noted that AI-based products are likely to fall under the remit of the UK’s regulator,...


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    AMPROLOGIX SECURES FUNDING TO DEVELOP NEW ANTIBIOTIC WITH INGENZA

    Feb 06, 2019

    Ingenza is pleased to announce that University of Plymouth spin-out Amprologix, in which it has a stake, has been awarded a £1.2 million contract from the UK Department of Health and Social Care to accelerate the development and scale up its lead antibiotic candidate, Epidermicin NI01. The fun...


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    TAKEDA ORDERED TO PAY BAYER $155M FOR HEMOPHILIA PATENT INFRINGEMENT

    Feb 06, 2019

    It may not be what Takeda bargained for with its massive Shire buyout, but early into its ownership of the rare disease specialist, a jury ordered the Japanese drugmaker to pay hemophilia rival Bayer $155 million for patent infringement. The case dates back to a December 2016 lawsuit Bayer filed aga...


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    ROCHE SEEKS KADCYLA BOOST TO FEND OFF HERCEPTIN BIOSIMILARS

    Feb 05, 2019

    As biosimilar competition to Herceptin ramps up, Roche is looking to bolster its position in HER2-positive breast cancer with a new indication for Kadcyla. The Swiss pharma firm has announced that it has submitted a supplemental Biologics License Application to the US FDA that could broaden the drug...


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    ALLERGAN TRIES TO BLUNT IMPACT OF BOTOX COMPETITOR WITH COMPLAINT OF PILFERED MANUFACTURING SECRETS

    Feb 05, 2019

    It may not be a trend as yet, but for the second time recently, drugmakers have tried to put the kibosh on a competitor’s launch by alleging their product was made using stolen manufacturing secrets. The most recent is a complaint filed Jan. 30 by Allergan and its Botox partner Medytox against...


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    IN-HOUSE DEVELOPED MULTIPLE MYELOMA DRUG LEADS THE WAY FOR SANOFI

    Feb 05, 2019

    Paris-based Sanofi announced positive results from its pivotal Phase III trial of isatuximab in patients with relapsed/refractory multiple myeloma. The drug, in combination with Celgene’s Pomalyst/Imnovid (pomalidomide) and low-dose dexamethasone, met the primary endpoint of prolonging progres...


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    LESS ANESTHESIA DURING SURGERY DOESN'T PREVENT POST-OP DELIRIUM

    Feb 05, 2019

    Many older adults who have major surgery experience postoperative delirium in the days after their operations. Previous research has suggested that closely monitoring the brain during surgery and making adjustments to protect the brain from too much anesthesia could reduce the risk of postoperative ...


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    DRUG TARGET IDENTIFIED FOR CHEMOTHERAPY-RESISTANT OVARIAN, BREAST CANCER

    Feb 04, 2019

    People who inherit a faulty copy of the so-called "breast cancer genes" BRCA1 and BRCA2 are at high risk of cancer. About 10 percent of breast cancer cases and 15 percent of ovarian cancers can be traced back to a flaw in one of these genes. A class of drugs known as PARP inhibitors was de...


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    TEVA’S MIGRAINE DRUG AJOVY LOOKS SET FOR EU APPROVAL

    Feb 04, 2019

    Teva’s migraine drug Ajovy (fremanezumab) has moved closer to the EU market after the influential CHMP regulatory committee gave it the green light. The decision paves the way for European approval, which usually follows a positive opinion from the CHMP within a few months. Ajovy is one of a g...


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    INSIGHT INTO PROTEIN FORMATION COULD AID UNDERSTANDING OF DISEASES

    Feb 04, 2019

    Scientists have shed light on a biological process that helps the production of healthy cells, which may aid the understanding of neurological diseases and other conditions. Researchers examined a housekeeping mechanism which removes faulty proteins as they form. This process, which is common to man...


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    FUNCTIONAL INSULIN-PRODUCING CELLS GROWN IN LAB

    Feb 04, 2019

    UC San Francisco researchers have for the first time transformed human stem cells into mature insulin-producing cells, a major breakthrough in the effort to develop a cure for type 1 (T1) diabetes. Replacing these cells, which are lost in patients with T1 diabetes, has long been a dream of regenerat...


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    NOVO ACCELERATES LAUNCH PLANS FOR ORAL SEMAGLUTIDE

    Feb 01, 2019

    Novo Nordisk has said it is accelerating launch preparations for its new diabetes pill semaglutide, after investing in a voucher that will allow a fast review of the drug in the US. The FDA grants priority reviews for drugs that it considers to be a significant improvement over available therapies f...


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    HHS SECRETARY AZAR FLOATS PLAN TO LOWER PRESCRIPTION DRUG COSTS

    Feb 01, 2019

    As lawmakers in Congress are exploring potential price-lowering options for prescription drugs, Department of Health and Human Services Secretary Alex Azar is floating a proposed rule to lower the prices and out-of-pocket expenses by encouraging manufacturers to pass discounts to patients instead of...


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    A DEEPER LOOK AT DRUG SHORTAGES IN THE U.S.

    Feb 01, 2019

    Drug shortages can occur for a number of reasons. The Pharmaceutical Research and Manufacturers of America (PhRMA) lists the most common as changes in clinical practices, inventory practices of wholesalers and pharmacies, raw material shortages, changes in hospital and pharmacy contractual relations...


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    BD UNVEILS NANO PEN NEEDLE FOR ACCURATE SUBCUTANEOUS INSULIN INJECTIONS

    Jan 31, 2019

    BD is releasing its new Nano pen needle designed for achieving consistent depth during subcutaneous injections, particularly for diabetic patients on insulin. Intramuscular injections can occur when a patient applies too much force too many of the existing injection devices. The new BD Nano compensa...


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    SYLENTIS' DRY EYE DRUG MISSES PRIMARY GOALS IN PHASE 3

    Jan 31, 2019

    A phase 3 trial of Sylentis’ dry eye disease candidate tivanisiran has missed (PDF) its primary endpoints. The PharmaMar subsidiary failed to link the siRNA eye drops to improved scores on scales of ocular pain and corneal staining compared to artificial tears. Sylentis advanced tivanisiran in...


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    ADURO CUTS 37% OF EMPLOYEES AS IT REFOCUSES ON CANCER PIPELINE

    Jan 31, 2019

    Aduro Biotech has hit the reset button, laying off about 37% of its workforce to throw all of its resources behind a handful of lead programs: assets that target the STING and APRIL pathways for the treatment of cancer. “Over the years, Aduro has demonstrated a proven track record in the disco...


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    ON HEELS OF DRUG PRICING HEARINGS, DEMOCRATIC LAWMAKERS KICK OFF INSULIN PROBE

    Jan 31, 2019

    Sanofi, Novo Nordisk, and Eli Lilly have faced years of scrutiny over insulin prices, but their responses haven't satisfied two Democratic lawmakers who this week kicked off a fresh investigation into pricing for the products. The probe comes as drug pricing creates daily headlines in Washington...


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    ALLERGAN ABANDONS WOMEN’S HEALTH SALE PLAN AS PROFIT SLUMPS

    Jan 30, 2019

    Shares in Allergan fell after the company said it had swung to a loss in the last quarter of 2018 and forecast 2019 revenues below analyst expectations. The Ireland-headquartered specialty drugmaker, best known for its Botox wrinkle treatment, reported a loss of $4.3 billion that reversed a profit o...


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    READY FOR BOTOX, MILLENNIALS? ALLERGAN HAS LAUNCHED ITS FIRST CAMPAIGN TARGETING YOU

    Jan 30, 2019

    Allergan’s latest target for Botox Cosmetic is millennials. If there's any doubt, just look at the crowd of 20-somethings in its newly launched TV ad: Young people exaggerate their facial expressions surprised, embarrassed or laughing with no noticeable frown lines or forehead wrinkles. Th...


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    SENATE FINANCE COMMITTEE AND HOUSE OVERSIGHT COMMITTEE TAKE AIM AT DRUG PRICING

    Jan 30, 2019

    The U.S. Senate Finance Committee and the House Oversight Committee started hearings on Tuesday, January 29, focused on dealing with high drug prices. In the Finance Committee hearing, chair of the committee, Sen. Chuck Grassley, (R-IA), began by saying tackling high prescription drug prices was a p...


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    IS BIOGEN’S ADUCANUMAB FOR ALZHEIMER’S THE HOLY GRAIL OR COLD FUSION?

    Jan 30, 2019

    Whenever a drug fails an Alzheimer’s clinical trial, analysts, investors, and industry watchers immediately turn to look at Biogen. Will the company’s aducanumab be the one? Will it be the drug that will actually break the string of more than 150 drug failures? Today, Roche announced tha...


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    GATES FOUNDATION, GILEAD AND OTHERS DROP $55 MILLION ON SERIES B FOR LYNDRA THERAPEUTICS

    Jan 29, 2019

    Lyndra Therapeutics, based in Watertown, Mass., announced the closing of a Series B financing round worth $55 million. All original investors from the $23 million Series A round led by Polaris Partners were involved. New investors include HOPU Investments, Gilead Sciences, Invus, the Bill & Meli...


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    CELGENE STRIKES DEAL WORTH NEARLY $1 BILLION FOR BLOOD CANCER TREATMENT

    Jan 29, 2019

    Celgene has struck another collaborative deal, even as the large pharmaceutical company is in the process of being folded into the operations of its new owner, Bristol-Myers Squibb. This morning, privately-owned drug developer Triphase Accelerator, along with its majority shareholder FACIT, announce...


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    TAKEDA'S PHASE III DENGUE VACCINE RESULTS BRING THEM "ONE STEP CLOSER" TO STOPPING TROPICAL DISEASE

    Jan 29, 2019

    Takeda Pharmaceutical announced that its vaccine for dengue fever hit its primary efficacy endpoint in its Phase III clinical trial. Dengue fever affects as many as 400 million people annually, according to the U.S. Centers for Disease Control and Prevention (CDC). It is caused by one of four relate...


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    ABBVIE AND J&J CLAIM NEW IMBRUVICA OKAY IN US

    Jan 29, 2019

    AbbVie and Johnson & Johnson’s Imbruvica has become the first chemo-free treatment for first-line chronic lymphocytic leukemia (CLL) to be approved by the FDA, its tenth indication. The green light from the US regulator is for a regimen based on BTK inhibitor Imbruvica (ibrutinib) and Roch...


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    FDA GIVES GREENLIGHT TO JANSSEN AND ABBVIE'S IMBRUVICA FOR THE 10TH TIME

    Jan 28, 2019

    Leukemia drug Imbruvica snagged another approval from the U.S. Food and Drug Administration (FDA). The regulatory agency gave the green light for Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. The approval of the c...


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    NO NEW PATIENTS SHOULD TAKE LILLY’S CANCER DRUG LARTRUVO, SAY REGULATORS

    Jan 28, 2019

    Regulators on both sides of the Atlantic have ruled that no new patients should start treatment with Eli Lilly’s Lartruvo (olaratumab) for soft tissue sarcoma, after a study that was supposed to confirm its efficacy failed. Late last week the FDA joined the European Medicines Agency by ruling ...


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    ALEXION'S ULTRA-RARE KIDNEY DISEASE DRUG PASSES PHASE III WITH FLYING COLORS

    Jan 28, 2019

    Boston-based Alexion’s Ultomiris (ravulizumab-cwvz) hit its primary objective in its Phase III study of complement inhibitor-naïve patients with the atypical hemolytic uremic syndrome (aHUS). aHUS is a chronic, progressive and debilitating ultra-rare disease. It affects children and adult...


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    PFIZER’S CANCER PORTFOLIO EXPECTED TO RAKE IN $8.3 BILLION IN 2019

    Jan 28, 2019

    Pfizer is a big company with a diverse portfolio, but it hasn’t really been noted for its presence in the oncology market. The majority of its successful drugs are in primary care and heart medicine, like Lipitor (atorvastatin) for cholesterol, Lyrica (pregabalin) for neuropathic pain and fibr...


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    OPTIMAL-G PRO ROBOTIC GAIT REHAB SYSTEM UNVEILED

    Jan 24, 2019

    Motorika, a company out of Mount Laurel, New Jersey, is introducing its Optimal-G Pro robotic walking rehabilitation system at the American Physical Therapy Association’s Combined Sessions Meeting this week in Washington DC. The device helps to train the walking gait of people who have suffere...


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    UEXPLORER WHOLE BODY PET-CT CLEARED BY FDA FOR CLINICAL AND RESEARCH USE

    Jan 24, 2019

    United Imaging Healthcare, a company out of Shanghai, China, won FDA clearance for its uEXPLORER combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner. The device can perform whole-body scans using both imaging modalities at the same time. The system is expected to be used...


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    FDA APPROVES CONSUMER COLORECTAL CANCER TEST

    Jan 24, 2019

    The FDA will allow consumer DNA testing company 23andMe to give customers reports on their risk of hereditary colorectal cancer. The California-based company, which allows customers to test their own DNA via mail, will now be able to tell its users whether they have the two most common genetic varia...


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    NICE BACKS DIGITAL CBT FOR YOUNGSTERS WITH DEPRESSION

    Jan 23, 2019

    NICE has recommended digital cognitive behavioural therapy (CBT) should be used as a first-line treatment for children and young people with mild depression. The draft guideline is an overarching document that paves the way for more use of this technology and is part of NICE’s drive to encoura...


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    FDA PUTS TRANSLATE BIO’S RARE DISEASE MRNA DRUG ON HOLD

    Jan 23, 2019

    The FDA has placed a clinical hold on the IND for Translate Bio’s mRNA treatment for ornithine transcarbamylase (OTC) deficiency, a genetic disease that causes too much ammonia to build up in the blood. The hold comes just nine months after the agency lifted a clinical hold on a different prog...


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    NEW REPORT SHOWS PRICE OF INSULIN DOUBLED FROM 2012 TO 2016

    Jan 23, 2019

    In October, Minnesota Attorney General Lori Swanson filed a lawsuit against three of the biggest insulin manufacturers over price gouging claims. In the lawsuit, Swanson said Eli Lilly, Sanofi and Novo Nordisk “deceptively raise the list price of insulin” and that the hikes have made the...


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    VERTEX’S CF DRUG GETS LABEL EXTENSION AS PRICING ROW CONTINUES

    Jan 23, 2019

    While UK cystic fibrosis patients continue their long wait for access to Vertex’s Orkambi, the drug has received a label extension from the European Commission allowing it to be used in younger children. The Commission has approved the drug for the treatment of children with cystic fibrosis (C...


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    FDA SLAPS CLINICAL HOLD ON TRANSLATE BIO’S MRNA THERAPY FOR RARE LIVER DISEASE

    Jan 22, 2019

    Translate Bio had been hoping that it would initiate clinical trials for its rare liver disease treatment asset MRT5201 this year. However, that hope has been delayed after the U.S. Food and Drug Administration (FDA) placed a hold on the trial. This morning, Lexington, Mass.-based Translate Bio anno...


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    A BLOOD TEST THAT CAN ID ALZHEIMER'S RISK UP TO 16 YEARS BEFORE SYMPTOMS

    Jan 22, 2019

    As researchers struggle to find a treatment for Alzheimer’s disease, the field struggles with the difficulties of early diagnosis. There are a number of biomarkers identified that show a tendency toward the disease, such as ApoE, but not definitive tests. Researchers with the German Center for...


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    NOVO HOLDINGS INVESTS IN THREE MORE AMR BIOTECHS

    Jan 22, 2019

    Novo Holdings’ REPAIR Impact Fund, which helps fund companies tackling antimicrobial resistance (AMR), has announced three new investments. The first beneficiary is AstraZeneca spin-off Entasis Therapeutics, whose programmes include a new class of non-β-lactam PBP inhibitors (NBP) targeti...


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    TAKEDA MULLING SALE OF EMERGING MARKET DRUGS – REPORT

    Jan 22, 2019

    Takeda could be considering selling some emerging-market drugs in a bid to cut debts following its merger with the Shire that completed earlier this month, according to a press report. In order to finance the $62 billion takeovers, Takeda had to take out bank loans of around $31 billion and needs to...


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    NEW NANOPARTICLE TARGETS TUMOR-INFILTRATING IMMUNE CELLS, FLIPS SWITCH

    Jan 21, 2019

    Immunotherapy's promise in the fight against cancer drew international attention after two scientists won a Nobel Prize this year for unleashing the ability of the immune system to eliminate tumor cells. But their approach, which keeps cancer cells from shutting off the immune system's power...


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    HOW GUT BACTERIA AFFECT THE TREATMENT OF PARKINSON'S DISEASE

    Jan 21, 2019

    Patients with Parkinson's disease are treated with levodopa, which is converted into dopamine, a neurotransmitter in the brain. In a study published on 18 January in the journal Nature Communications, scientists from the University of Groningen show that gut bacteria can metabolize levodopa into...


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    NHS FACES UPHILL BATTLE IN PREVENTION – SURVEY

    Jan 21, 2019

    A new survey has revealed confusion amongst the UK public on how to maintain a healthy lifestyle, suggesting the NHS has a long way to go to meet its goal of more disease prevention. The survey, commissioned by Sanofi, reveals that while just over half (52%) of people think they lead a healthy lifes...


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    RESEARCH INTO OPIOID PAINKILLERS COULD PROVIDE CLUES FOR SAFER DRUG DEVELOPMENT

    Jan 21, 2019

    Researchers have taken a step closer to understanding the body's response to opioid painkillers such as morphine and fentanyl, which could lead to the development of safer opioid drugs. Opioids are a class of powerful painkillers used to treat moderate to severe pain. They act on the nervous sys...


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    BRAIN-EATING AMOEBA INFECTIONS ARE RARE, BUT DEADLY—RESEARCH IS WORKING ON A CURE

    Jan 18, 2019

    The rate of incidence of infection by Naegleria fowleri in the U.S. is very, very low. But there’s something about picking up an incurable, brain-eating amoeba by swimming in freshwater lakes and rivers that understandably freaks people out. N. fowleri causes primary amebic meningoencephalitis...


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    J&J PARTNERS WITH APPLE FOR ECG MONITORING PROJECT

    Jan 18, 2019

    Apple has a new big pharma partner to help put its new Apple Watch with the built-in electrocardiogram (ECG) through its paces, signing an alliance with Johnson & Johnson. The collaboration centers on seeing if the Apple Watch’s heart rate monitoring ECG functions can be used for earlier d...


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    NOVARTIS AND OXFORD UNIVERSITY BEGIN R&D TIE-UP

    Jan 18, 2019

    Novartis and Oxford University have begun a partnership that will attempt to use artificial intelligence to predict how patients will respond to new and existing treatments for inflammatory diseases such as multiple sclerosis (MS) and psoriasis. The Swiss pharma has joined with the university’...


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    JANUARY 18 RESEARCH ROUNDUP: SKIN CANCER, TURNING CANCER CELLS INTO FAT CELLS, AND A LONGEVITY TEST

    Jan 18, 2019

    Researchers with American University have identified genetic factors that lead to squamous cell carcinoma, a form of skin cancer. They published their work in the journal Oncogenesis. Squamous cell carcinoma is the second most common form of cancer in the U.S. and has the highest mortality rate of n...


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    SUN PHARMA DROPS TO 6-YEAR LOW ON REPORT OF ANOTHER WHISTLEBLOWER COMPLAINT

    Jan 18, 2019

    Just weeks after Sun Pharma’s stock was hit by whistleblower allegations of insider trading, a second complaint reportedly filed to Indian regulators sent the drugmaker’s shares tumbling to a new six-year low. A whistleblower alleged in a 172-page complaint that dubious transactions amou...


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    UK RESEARCHERS INVESTIGATE ALTERNATIVES TO LONG-TERM OPIOID USE

    Jan 17, 2019

    A UK university has been awarded £2.4 million to research overprescribing of opioids, and how to improve treatment of patients with persistent pain without long-term use of these morphine-like drugs. The government-backed National Institute of Health Research (NIHR) awarded the money to resear...


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    TELEHEALTH FIRM SECURES MORE CASH TO EXPAND IN CHINA, JAPAN AND US

    Jan 17, 2019

    Telehealth firm Tyto Care has secured additional funding to help with the launch of its technology allowing for remote medical examinations. This latest $9 million funding round is an extension of an oversubscribed Series C round last year and brings the total funds raised to $33.5 million. Strategi...


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    UNITED NEUROSCIENCE INCHES CLOSER TO ALZHEIMER’S VACCINE PRIZE

    Jan 17, 2019

    A vaccine for Alzheimer’s disease developed by United Neuroscience has cleared a phase IIa trial and seems to be free of the toxicity that has scuppered earlier candidates. To be clear, there’s no solid evidence yet that United’s UB-311 candidate has an impact on cognition and memo...


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    FDA COMMITTEE VOTES 18-1 FOR AMGEN'S OSTEOPOROSIS DRUG

    Jan 17, 2019

    The U.S. Food and Drug Administration (FDA)’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 18 to 1 to recommend Amgen and UCB’s Evenity (romosozumab) to treat postmenopausal women with osteoporosis. This follows a 2017 rejection by the agency, requesting more d...


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    LILLY’S VERZENIOS APPROVED BY NICE

    Jan 17, 2019

    NICE has published draft guidance that now recommends Eli Lilly’s breast cancer drug Verzenios for use on the NHS. The guidance concludes that Verzenios (abemaciclib) is as effective as its rivals, Pfizer’s Ibrance (palbociclib) and Novartis’ Kisqali (ribociclib), which NICE approv...


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    APTINYX’S MID-STAGE NMDA RECEPTOR FAILS TO HIT ENDPOINTS IN NEUROPATHIC PAIN STUDY

    Jan 16, 2019

    Shares of Illinois-based Aptinyx have plunged more than 67 percent in premarket trading after the company announced its mid-stage treatment for painful diabetic peripheral neuropathy failed to show statistical significance. Aptinyx’s NYX-2925 is a novel NMDA receptor, which earned Fast Track d...


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    DIFFICULTIES WITH AUDIOVISUAL PROCESSING CONTRIBUTES TO DYSLEXIA IN CHILDREN

    Jan 16, 2019

    A University at Buffalo psychologist has published a neuroimaging study that could help develop tests for early identification of dyslexia, a disorder that affects 80 percent of those diagnosed with difficulties reading, writing and spelling. Tasks which require audiovisual processing are especially...


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    MERCK BUMPS KEYTRUDA CREDIBILITY WITH REAL DOCTOR APPEARANCE IN LATEST ‘TRU’ PATIENT ADS

    Jan 16, 2019

    Merck & Co. is changing the game again in oncology ads, this time putting a real doctor to work in its Keytruda patient campaign. The latest additions to the multichannel "It's Tru" work include two TV ads, one with oncologist Goetz Kloecker, M.D., alone and a second where he appea...


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    OXYCONTIN MAKER SOUGHT 'BLIZZARD OF PRESCRIPTIONS’, COURT DOCUMENTS SHOW

    Jan 16, 2019

    The notorious legacy of OxyContin continues to be a major black mark against Purdue Pharma. And that mark is only getting worse as a court case against the opioid manufacturer has revealed company officials used deceptive marketing practices to boost sales of the drug. Documents in a Massachusetts c...


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    LIONBRIDGE AUGMENTS ARTIFICIAL INTELLIGENCE OFFERING THROUGH ACQUISITION OF GENGO AND GENGO.AI

    Jan 16, 2019

    Today, Lionbridge, one of the world’s most trusted global communications platforms, announced its acquisition of Gengo, a Tokyo-based, leading edge technology company providing crowdsourcing, machine learning and localization services to global customers. Lionbridge has a 20-year history of le...

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    PFIZER SET FOR JULY FDA VERDICT ON RARE HEART DISEASE DRUG

    Jan 15, 2019

    Pfizer is finally closing on approval of its rare disease therapy tafamidis in the US, several years after it first reached the market in Europe. The FDA has accepted two separate marketing applications for the drug – both for cardiomyopathy associated with the rare disease ATTR amyloidosis &n...


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    DESPITE GOVERNMENT SHUTDOWN, EXELIXIS SNAGS FDA APPROVAL FOR HCC DRUG CABOMETYX

    Jan 15, 2019

    Shares of Alameda, Calif.-based Exelixis are climbing after the U.S. Food and Drug Administration (FDA) approved its hepatocellular carcinoma (HCC) treatment Cabometyx (cabozantinib). It was previously approved for the treatment of patients with advanced renal cell carcinoma. The approval came despi...


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    AHA SAYS PENALTIES AS WELL AS INCENTIVES ARE NEEDED TO FACE DOWN 'PERSISTENT' DRUG SHORTAGES

    Jan 15, 2019

    Persistent drug shortages have become dangerous and costly, the American Hospital Association says, forcing staff to use drugs with which they have less experience and that are sometimes more expensive. Responding to an FDA request for comment, the AHA, which represents 5,000 hospitals and 270,000 p...


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    FDA APPROVES RECORD-BREAKING 59 NOVEL DRUGS IN 2018

    Jan 15, 2019

    The past year proved to be a big one for the U.S. Food and Drug Administration (FDA) and the approval of novel drugs. Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s dia...


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    AIMMUNE’S PEANUT ALLERGY TREATMENT DELAYED AS GOVERNMENT SHUTDOWN CONTINUES

    Jan 15, 2019

    The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U.S. Food and Drug Administration (FDA) grows more incapable of reviewing some medications for approval. On Monday, California-based Aimmune Therapeut...


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    SMARTPHONE APP DETECTS OPIOID OVERDOSE

    Jan 14, 2019

    Researchers at the University of Washington have developed a smartphone app that can detect if someone is experiencing an opioid overdose. The app uses sonar to monitor the breathing rate of a user, which it can do from up to three feet away, to assess if someone is experiencing an overdose. So far,...


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    BRAINCARTA MAPS CREATES MAPS FOR BRAIN SURGERIES: CES 2019

    Jan 14, 2019

    Brain surgery is a complicated business, requiring utmost precision when excising tumors and other maladies. BrainCarta, a Dutch firm, is showing off its Elonav technology that uses functional magnetic resonance imaging (fMRI) scans to create maps of lesions and provide helpful analysis about the ne...


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    FDA GIVES AMNEAL'S GENERIC ALZHEIMER’S & PARKINSON’S PATCH A THUMBS-UP

    Jan 14, 2019

    The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases. The two companies were involved in pate...


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    FOR THE FIRST TIME, WE'RE MORE LIKELY TO DIE FROM ACCIDENTAL OPIOID OVERDOSE THAN MOTOR VEHICLE CRASH

    Jan 14, 2019

    National Safety Council analysis reveals trends that worsen the odds of dying accidentally. For the first time in U.S. history, a person is more likely to die from an accidental opioid overdose than from a motor vehicle crash, according to National Safety Council analysis. The odds of dying accident...


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    MORE ACCURATE LEUKEMIA DIAGNOSIS EXPECTED AS RESEARCHERS REFINE LEUKEMIA CLASSIFICATION

    Jan 14, 2019

    Like cartographers completing a map, investigators have identified multiple new subtypes of the most common childhood cancer research that will likely improve the diagnosis and treatment of high-risk patients. St. Jude Children's Research Hospital scientists led the study, which appears as an ad...


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    PHARMA FEELS IMPACT OF GOVERNMENT SHUTDOWN AS FDA DRUG REVIEW WORK SLOWS

    Jan 11, 2019

    As the partial government shutdown enters its 21st day, tying it for the longest U.S. shutdown in history, the impact is becoming more and more realized within the pharmaceutical industry. Most noticeably for pharma and biotech, the partial shutdown has brought a halt to some of the operations of th...


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    KYOWA HAKKO KIRIN SIGNS AI DRUG R&D DEAL WITH INVENIAI

    Jan 11, 2019

    Artificial intelligence and machine learning company InveniAI has joined with Kyowa Hakko Kirin to harness the power of technology for drug discovery. The companies are the latest to use AI and machine learning to make the drug development process more effective. In this case, Kyowa Hakko Kirin will...


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    NEOLEUKIN THERAPEUTICS HOPES TO IMPROVE ON NATURE'S APPROACH TO BATTLING CANCER

    Jan 11, 2019

    One of the key immune regulatory proteins is interleukin 2 (IL-2). It has used in treating cancer and autoimmune disease but has toxic side effects that limit its use. Researchers at the University of Washington Medicine’s Institute for Protein Design recently created a protein that mimics the...


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    DOES OPIOID USE IN PETS CREATE HIGHER RISK FOR ABUSE IN HUMANS?

    Jan 11, 2019

    The increase in opioid prescriptions for people over the past decade may have been paralleled by an increase in opioid prescriptions for pets, according to a study from researchers at the University of Pennsylvania's Perelman School of Medicine and the School of Veterinary Medicine. The findings...


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    RESEARCHERS ANSWER DECADES-OLD QUESTION ABOUT PROTEIN FOUND IN ALZHEIMER'S BRAIN PLAQUES

    Jan 11, 2019

    Alzheimer's-affected brains are riddled with amyloid plaques, protein aggregates consisting mainly of amyloid-β. However, amyloid-β is a fragment produced from a precursor protein whose normal function has remained enigmatic for decades. A team of scientists at VIB and KU Leuven led by...


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    EUSA PHARMA BUYS RIGHTS TO JANSSEN RARE DISEASE DRUG

    Jan 10, 2019

    UK-based EUSA Pharma has bought worldwide rights to Janssen’s rare diseases drug Sylvant (siltuximab) for $115 million. EUSA already markets two oncology drugs and is seeking to build its presence in the rare disease market with Sylvant, which has been approved in the US since 2014 to treat mu...


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    NICE REJECTS NOVARTIS’ MIGRAINE PREVENTION DRUG AIMOVIG

    Jan 10, 2019

    Some migraine sufferers in the UK hoping to get access to Novartis’ new migraine prevention drug Aimovig are facing disappointment after NICE rejected it in the draft guidance. The cost-effectiveness watchdog says that it can’t recommend routine NHS use of Aimovig (erenumab) for people s...


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    ALZHEIMER’S: NEW APPROACHES AND NEW HOPE

    Jan 10, 2019

    Unfortunately, 2018 marked yet another bad year for Alzheimer’s disease drug development. There were easily half-a-dozen major clinical drug trial failures, leading one analyst to call Alzheimer’s drug development “an unrelenting disaster zone.” These failures included: Taked...


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    /news-article.aspx?ID=24112411

    HRT TABLETS LINKED TO HIGHER BLOOD CLOT RISK: STUDY

    Jan 10, 2019

    Certain types of hormone replacement therapy (HRT) could lead to an increased risk of venous thromboembolism (VTE), a new study has suggested. HRT is used to prevent a range of symptoms experienced by many women during the menopause, such as hot flushes and night sweats. The study, by researchers fr...


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    NOVARTIS DEFENDS ITSELF AGAINST KICKBACK ALLEGATIONS FROM FORMER EMPLOYEE

    Jan 10, 2019

    Swiss pharma giant Novartis has found itself at the center of a legal battle that could determine if the company engaged in a research project that was a kickback in disguise. Former Novartis executive Min Amy Guo has alleged that in 2012, the company initiated a study of breast cancer drug Afinitor...


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    GREEN ALTERNATIVE FOR DRUG PRODUCTION

    Jan 09, 2019

    For the production of drugs, pesticides, and smartphone displays, most of the processes are cost-intensive and generate a large amount of waste. Scientists at the University of Göttingen have now succeeded in developing a resource-saving "green" alternative. The results were published...


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    UNDERSTANDING INFECTIOUS DISEASE BY STUDYING BACTERIAL IMMUNITY

    Jan 09, 2019

    Patients with cystic fibrosis are often infected by Pseudomonas aeruginosa, a bacterium that infects the lungs and prevents breathing, often causing death. P. aeruginosa itself can also be infected by viruses, which can affect the clinical outcomes of cystic fibrosis patients. “Just like human...


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    NEAR INFRARED FOOD SHELF LIFE SCANNER

    Jan 09, 2019

    Spoiled food is a global problem and people end up sick all the time. Modern methods of detecting spoiled food include smelling it, looking for moldy spots, and arguing with your spouse whether a given item is ready to be thrown in the trash. Researchers at Fraunhofer Institute for Optronics, System...


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    NOVARTIS’ SICKLE CELL DRUG GETS BREAKTHROUGH THERAPY DESIGNATION

    Jan 09, 2019

    The FDA has granted Breakthrough Therapy designation to Novartis’ crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease. Also known as sickle cell pain crises, VOCs are unpredictable and extremely painful events that can lead to ...


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    TAKEDA’S SHIRE TAKEOVER COULD HERALD NEW ERA OF PHARMA M&A

    Jan 09, 2019

    Takeda has officially taken over the Shire in a deal that could re-establish the trend for mega-mergers in big pharma. The merger was approved yesterday in a court hearing in Jersey, where the Shire was officially based, although it was listed on the London Stock Exchange and domiciled in Ireland fo...


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    IT’S A WRAP! TAKEDA-SHIRE MERGER IS A DONE DEAL, MAKING TAKEDA THE LARGEST MASS. BIOTECH EMPLOYER

    Jan 08, 2019

    Last year’s sole mega-deal, the acquisition of Dublin-based Shire by Japan-based Takeda Pharmaceutical is finally closed. Takeda, 237 years old, is now a top 10 international drug company. The entire deal began in March 2018, with Takeda expressing an interest in buying the Shire. Once it was ...


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    NOVARTIS TALKS MOVE TO CELL AND GENE THERAPIES AT JPM

    Jan 08, 2019

    Following a strong post-hoc analysis of mid-stage data in the fall of 2018, Novartis announced this morning the company’s experimental humanized anti-P-selectin monoclonal antibody was crizanlizumab granted Breakthrough Therapy Status by the U.S. Food and Drug Administration (FDA). Crizanlizum...


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    UROGEN APPOINTS FORMER NOVARTIS CANCER CHIEF BARRETT AS CEO

    Jan 08, 2019

    Novartis’ former oncology CEO Liz Barrett has left to join little-known biotech, UroGen, to help bring its potential urothelial cancer drug to market. Barrett raised eyebrows last month when she announced her decision to leave Novartis after less than a year in charge of its oncology unit, but...


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    2018 SET BENCHMARK FOR DIGITAL HEALTH INVESTMENT – REPORT

    Jan 08, 2019

    Last year was the biggest ever for digital health investment, according to a report that has been tracking the market since the beginning of the decade. According to the report by Startup Health Insights, investment in digital health has increased 14-fold since 2010. In 2018, funding for digital hea...


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    AFTER ANNOUNCING A NEW CEO, UROGEN TOUTS POSITIVE PHASE III DATA FOR UROTHELIAL CANCER

    Jan 08, 2019

    UroGen Pharma, based in New York, announced positive topline results from its Phase III OLYMPUS clinical trial. The trial evaluated UGN-101 (mitomycin gel) for installation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). Of the 71 patients in the trial, 61 have been...


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    SANOFI AND REGENERON RESTRUCTURE IMMUNO-ONCOLOGY COLLABORATION TO ADD TWO NEW PRODUCTS

    Jan 07, 2019

    Tarrytown, NY-based Regeneron Pharmaceuticals and Paris-based Sanofi restructured a 2015 agreement to develop immuno-oncology (I/O) treatments. That deal was scheduled to wrap in 2020, but the revision adds two clinical-stage bispecific antibodies to the collaboration. The revision lets Regeneron ho...


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    NHS LOOKS TO DIGITAL AND GENOMICS TO SECURE ITS FUTURE

    Jan 07, 2019

    Genomics, digital tech, and artificial intelligence are at the forefront of the government’s long-term plan for the NHS, unveiled today. In a statement, the health service said it believed the plans would save almost half a million more lives and would make the NHS ‘fit for the future&rs...


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    PAIR OF DEALS BOOSTS BIOGEN’S EARLY-STAGE CNS PIPELINE

    Jan 07, 2019

    Biogen has signed a brace of collaborations to expand its central nervous system (CNS) pipeline, adding new candidates for Alzheimer’s, multiple sclerosis and other neurological diseases. The first of the new deals is a $415 million collaboration with protein degradation specialist C4 Therapeu...


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    TAKEDA UNLIKELY TO SELL OTC UNIT TO PAY SHIRE MERGER DEBTS

    Jan 07, 2019

    Takeda’s $59 billion takeover of Shire is due to close tomorrow (Tuesday) and the company’s CEO Christophe Weber has already given some strong clues about the company’s strategy once the deal completes. Last week Takeda announced three new research collaborations in immuno-oncology...


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    OBSESSIVE-COMPULSIVE SYMPTOMS IN YOUTH: A PSYCHOLOGICAL RED FLAG?

    Jan 07, 2019

    Engaging in repetitive and ritualistic behaviors is part of typical child development. However, behaviors that develop into obsessive and compulsive symptoms (OCS) may represent a red flag for serious psychiatric conditions. Researchers at the Lifespan Brain Institute (LiBI) of Children’s Hosp...


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    SELECTA BIOSCIENCES' NEW CEO RESTRUCTURES, CUTS 36% OF STAFF

    Jan 04, 2019

    Selecta Biosciences, based in Watertown, Mass., announced that as part of restructuring efforts it is cutting its current workforce by 36 percent. The company believes that the cuts, along with a reprioritization of its pipeline, will decrease its yearly cash burn by 19 percent. At its third-quarter...


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    AMPLIPHI BIOSCIENCES AND C3J THERAPEUTICS AGREE TO MERGE

    Jan 04, 2019

    AmpliPhi Biosciences Corporation (“AmpliPhi”) (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, and C3J Therapeutics, Inc. (“C3J”), a private clinical ...


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    X-CHEM AND VERTEX EXPAND EXISTING PARTNERSHIP

    Jan 04, 2019

    X-Chem Inc., a privately held biotechnology company focused on applying its industry-leading DNA-encoded (DEX™) drug discovery engine to the generation of novel small molecule therapeutics, today announced the expansion of its collaboration with Vertex Pharmaceuticals Incorporated (NASDAQ: VRT...


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    BIONTECH TEAMS UP WITH SANOFI TO TARGET SOLID TUMORS IN $91.5 MILLION DEAL

    Jan 04, 2019

    Days ahead of the J.P. Morgan Healthcare Conference, Germany-based BioNTech extended its three-year-old collaboration with Sanofi as the companies look to co-develop the first cancer immunotherapy candidate for solid tumors. As part of the deal, the French pharma giant will invest about $91.5 millio...


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    ABBVIE FORGES $105 MILLION+ CD39 INHIBITOR ALLIANCE WITH TIZONA

    Jan 04, 2019

    Privately-held Tizona Therapeutics snagged $105 million in upfront cash as its cancer antibody TTX-030 is the centerpiece of a collaborative effort with Illinois-based AbbVie. The two companies intend to combine their R&D capabilities with a focus on CD39-targeted therapeutics. CD39 is the enzym...


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    AMRA PROFILER CLEARED BY FDA FOR BODY COMPOSITION ANALYSIS FROM MRI SCANS

    Jan 03, 2019

    AMRA Medical, a company based in Linköping, Sweden, won FDA clearance to introduce its AMRA Profiler technology for fat and muscle composition analysis. The product relies on a six-minute MRI scan, performed using a compatible scanner, with the imaging data being sent to AMRA’s servers. A...


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    SANOFI PALMS OFF MYOKARDIA HEART DISEASE PACT

    Jan 03, 2019

    Sanofi has walked away from a four-year-old alliance with US biotech MyoKardia, handing back rights to three drugs for heart disease. The decision comes ahead of data readouts for two of the clinical candidates – mavacamten and MYK-491 – within the next 12 to 24 months and comes as Sanof...


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    GIVE IT TO US STRAIGHT, DOCTORS TELL PHARMA ADVERTISERS—BUT BEING FUNNY IS OK, TOO

    Jan 03, 2019

    Want to catch doctors’ attention with flashy advertising and intellectual jargon? Don’t bother. A new study finds that physicians prefer simple and clear messages, with more than half (51%) admitting they don’t always understand what’s being communicated in pharma advertising...


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    GLASSY CARBON MICRONEEDLES: A NEW TRANSDERMAL DRUG DELIVERY DEVICE

    Jan 03, 2019

    Microneedles are designed to infuse medications transdermally (through the skin) and relatively painlessly during clinical applications. In a recent study, Richa Mishra and her colleagues developed a new technique to convert polymer films into a fracture-resistant glassy form of carbon to develop mi...


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    SURPRISE DISCOVERY REVEALS SECOND VISUAL SYSTEM IN MOUSE CEREBRAL CORTEX

    Jan 03, 2019

    The visual system is probably the best-understood part of the brain. Over the past 75 years, neuroscientists have assembled a detailed account of how light waves entering your eyes allow you to recognize your grandmother's face, to track a hawk in flight, or to read this sentence. But a new stud...


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    BIOXCEL’S AGITATION DRUG GETS FDA FAST TRACK

    Jan 02, 2019

    The FDA has granted Fast Track Designation to BioXcel Therapeutics’ BXCL501 for the treatment of acute agitation resulting from neurological and psychiatric disorders like Alzheimer’s and schizophrenia. BioXcel is a clinical-stage biopharmaceutical development company utilizing novel art...


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    PROMETHERA LOOKS TO ASIA WITH €10M INVESTMENT

    Jan 02, 2019

    Belgium-based liver disease specialists Promethera Biosciences have received a leg-up for the Asian market in the form of a €10 million investment from Japanese business conglomerate ITOCHU Corporation. ITOCHU is the first lead investor in Promethera’s Series D round, which the company ex...


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    MSD AND PFIZER TOP DOW FOR 2018

    Jan 02, 2019

    MSD and Pfizer were 2018’s top gainers on the Dow Jones Industrial Average for the calendar year, with both companies bucking the trend of an otherwise lacklustre year for the index. MSD was the biggest Dow winner, with shares of the company surging more than 30%, with a dividend yield of 2.9%...


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    TEVA AND NEOS SETTLE OVER COTEMPLA PATENT DISPUTE

    Jan 02, 2019

    Teva and Neos Therapeutics have reached a confidential settlement and licensing agreement that resolves a patent dispute over the Israeli firm’s generic version of Neos’ ADHD drug Cotempla XR-ODT (methylphenidate). Under the settlement and license agreement, Neos has granted Teva the rig...


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    MYCENAX’S ACTEMRA BIOSIMILAR EDGES CLOSER TO APPROVAL

    Dec 31, 2018

    Mycenax’s biosimilar of Roche’s Actemra (tocilizumab), LusiNEX, has been shown to match its originator’s profile in a phase I PK trial, meaning it is on track to become the first approved biosimilar for the drug. Actemra, marketed as RoActemra in the EU, is approved for immunology ...


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    NUCLEUS-SPECIFIC X-RAY STAIN FOR 3-D VIRTUAL HISTOLOGY

    Dec 27, 2018

    Histology is used to identify structural details of tissue at the microscale in the pathology lab, but analyses remain two-dimensional (2D) as they are limited to the same plane. Nondestructive 3D technologies including X-ray micro and nano-computed tomography (nanoCT) have proven validity to unders...


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    PROPORTION OF CANCERS ASSOCIATED WITH EXCESS BODY WEIGHT VARIES CONSIDERABLY BY STATE

    Dec 27, 2018

    A new study looking at the share of cancers related to obesity finds an at least 1.5-fold difference between states with the highest and lowest proportions. The proportion of cancer cases that could be attributable to excess body weight ranged from a high of 8.3% in the District of Columbia to a low...


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    YOUR BRAIN REWARDS YOU TWICE PER MEAL: WHEN YOU EAT AND WHEN FOOD REACHES YOUR STOMACH

    Dec 27, 2018

    We know a good meal can stimulate the release of the feel-good hormone dopamine, and now a study in humans from the Max Planck Institute for Metabolism Research in Germany suggests that dopamine release in the brain occurs at two different times: at the time the food is first ingested and another on...


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    SLEEPING SICKNESS PARASITE USES MULTIPLE METABOLIC PATHWAYS

    Dec 27, 2018

    Parasitic protozoa called trypanosomes synthesize sugars using an unexpected metabolic pathway called gluconeogenesis, according to a study published December 27 in the open-access journal PLOS Pathogens by David Horn of the University of Dundee in the UK, and colleagues. The authors note that this ...


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    ACORDA SNAGS APPROVAL FOR NEW TREATMENT OF OFF EPISODES OF PARKINSON’S DISEASE

    Dec 26, 2018

    Acorda Therapeutics can breathe a bit easier. The U.S. Food and Drug Administration (FDA) approved Inbrija, the first inhaled formula of levodopa (L-dopa) for the intermittent treatment of OFF episodes in Parkinson’s disease patients. The approval came about two weeks before its PUDFA date. Th...

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    POINT-COUNTERPOINT: SENATOR WARREN'S GENERIC DRUG PROPOSAL

    Dec 26, 2018

    Senator Elizabeth Warren (D-MA), proposed The Affordable Drug Manufacturing Act, which would allow the Department of Health and Human Services (HHS) to manufacture or contract out the manufacture of generic drugs. Warren argues that the generic drug system was designed to promote competition, which ...


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    THE FDA APPROVES TWO ORPHAN BLOOD DISORDER DRUGS

    Dec 26, 2018

    The U.S.Food and Drug Administration (FDA) approved two drugs for separate blood disorders, Alexion Pharmaceuticals’ Ultomiris for the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), and Stemline Therapeutics’ Elzonris for blastic plasmacytoid dendritic cell neoplasm (BPDC...


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    FDA ACTION ALERT: WRAPPING UP 2018 AND HEADING INTO 2019

    Dec 26, 2018

    With the holidays upon us, along with the end of 2018 and the beginning of 2019, the U.S. Food and Drug Administration (FDA) squeezed some target action dates into the last weeks and beginning of the new year. As it turned out, these appear to be a mixed bag of extensions, resubmissions and suppleme...


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    DUSA PHARMACEUTICALS, INC. AWARDED PRELIMINARY INJUNCTIVE RELIEF PROHIBITING BIOFRONTERA FROM USING ITS TRADE SECRETS

    Dec 26, 2018

    MUMBAI, India and PRINCETON, New Jersey, December 26, 2018 /PRNewswire/ -- DUSA Pharmaceuticals, Inc., ("DUSA"), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715) announced that DUSA has been granted prelim...


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    FRAMINGHAM SUES DRUG MAKERS, DISTRIBUTORS OVER OPIOID EPIDEMIC

    Dec 24, 2018

    City officials are pressing their case against drug makers and distributors for what they describe as reckless conduct that fueled the nation’s opioid epidemic. A pair of law firms representing the city recently filed a lawsuit in Middlesex Superior Court seeking damages from a range of major ...


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    IBM RESEARCH SHOWS HOW HEALTH INSIGHTS MAY COME FROM FINGERNAIL WEARABLE

    Dec 24, 2018

    A tiny fingernail sensor has been worked up that monitors diseases and movement disorders. IBM Research tells their prototype story in a December video. The IBM team designed the tiny fingernail sensors to help clinicians detect and monitor the progression of disease via AI analysis and grip strengt...


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    CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY TREATMENT MARKET IS EXPECTED TO EXPERIENCE A RAPID GROWTH BY 2025

    Dec 24, 2018

    Global and China Chemotherapy Induced Peripheral Neuropathy Treatment Market Research by Company, Type & Application 2013-2025 is latest research study released by HTF MI evaluating the market, highlighting opportunities, risk side analysis, and leveraged with strategic and tactical decision-mak...


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    PARAMEDICS CAN SAFELY EVALUATE PSYCHIATRIC PATIENTS' MEDICAL CONDITION IN THE FIELD

    Dec 24, 2018

    Emergency medical personnel in Alameda County, California, use a screening process for determining whether to "medically clear" patients experiencing psychiatric emergencies before transporting them. They identify patients who are at low risk for medical emergencies and take them directly ...


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    CHOLESTEROL-LOWERING DRUGS REDUCE BROWN ADIPOSE TISSUE

    Dec 21, 2018

    ETH Zurich scientists have shown that statins, one of the most commonly prescribed classes of pharmaceuticals, reduce beneficial brown adipose tissue. But this is no reason to demonize these drugs, the researchers insist. A certain proportion of the adult population has not only white adipose (or fa...


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    TOWARD VACCINATION AGAINST THE CHIKUNGUNYA VIRUS

    Dec 21, 2018

    A live vaccine genetically engineered from a common measles vaccine promises to be effective against the chikungunya virus. Such is the central finding of a recently completed Phase II trial now published in the prestigious journal The Lancet. Two MedUni Vienna departments were also involved in the ...


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    NOVARTIS OFFERS TO BUY KYMRIAH MANUFACTURER

    Dec 21, 2018

    Following its success in the burgeoning area of CAR-T therapies, Novartis is looking to strengthen its cell and gene manufacturing capabilities by offering to acquire CDMO CellforCure, manufacturers of its CAR-T drug Kymriah. Under the proposed agreement, Novartis would acquire the share capital of ...


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    GENE DISCOVERY REVEALS NEW TARGETS FOR TREATING ATHEROSCLEROSIS, INFLAMMATORY DISEASES

    Dec 21, 2018

    A group of genes that have been largely ignored by scientists could play critical roles in atherosclerosis (hardening of the arteries), inflammation, and likely obesity and other metabolic diseases, new research suggests. The discovery was made by researchers at the University of Virginia School of ...


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    RESEARCHERS DEVELOP SIGHT-SAVING TREATMENT FOR EYE INFECTION OR TRAUMA

    Dec 21, 2018

    Scientists at the University of Birmingham have developed a novel eye drop that rapidly reduces sight-threatening scarring to the surface of the eye. The surface of the eye (the cornea) is usually transparent, but scars resulting from eye infection or trauma make it opaque causing blurred vision or ...


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    AZ/MERCK & CO GET NEW US USE FOR OVARIAN CANCER DRUG

    Dec 20, 2018

    After several disappointments this year AstraZeneca has ended 2018 on a positive note, gaining a new use for its ovarian cancer drug Lynparza in the US and the first approval in China for its new anemia drug. While AZ’s immunotherapy drug Imfinzi has made some missteps recently, most notably i...


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    AS IMMUNO-ONCOLOGY HEADS INTO 2019, ONE THING IS CLEAR: IT’S GOOD TO BE MERCK

    Dec 20, 2018

    When 2018 began, there was still plenty of uncertainty surrounding the previously untreated lung cancer market—the holy grail for immuno-oncology drugmakers, thanks to its sheer size. Merck had the lead with two approvals for Keytruda, but three other companies were awaiting combo data and aim...


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    AFTER NEW YEAR'S, EXPECT MORE DRUG PRICING FIREWORKS IN 2019

    Dec 20, 2018

    For several years, pharma watchers have witnessed drug pricing grow into a top issue facing the industry, dominating discussion almost daily. The conversation isn’t likely to subside next year, either. Lawmakers on both sides of the aisle including the newly Democratic House—and the Trum...


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    SCOTLAND’S NHS COULD REIMBURSE VERTEX CF DRUGS, PRICE ROW ONGOING IN ENGLAND

    Dec 20, 2018

    Vertex is to file its two latest cystic fibrosis drugs with Scotland’s drug cost watchdog in a bid for NHS reimbursement – but an ongoing row over price in England is still unresolved. The US pharma said it will submit files for Orkambi (lumacaftor+ivacaftor), and Symkevi (tezacaftor+iva...


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    SCIENTISTS ADVISE CAUTION IN IMMUNOTHERAPY RESEARCH

    Dec 20, 2018

    In a new study, Yale Cancer Center (YCC) scientists suggest that as the number of clinical trials in cancer immunotherapy grows exponentially, some caution should be exercised as we continue to better understand the biology of these new therapeutic targets. The findings are published today in the jo...


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    PATIENT-SPECIFIC ORGANOID MODELS APPENDIX CANCER TREATMENT

    Dec 19, 2018

    Scientists at the Wake Forest Institute for Regenerative Medicine (WFIRM) have recently developed a process that may change the way cancer of the appendix is treated in the future. Researchers at WFIRM, in collaboration with the Department of Surgery – Surgical Oncology at Wake Forest Baptist ...


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    DETECTING LUNG CANCER – THINKING OUTSIDE THE TUMOR

    Dec 19, 2018

    Scientists in Anant Madabhushi's computational imaging lab at Case Western Reserve University have started thinking outside the box--or in their case, looking outside the tumor. They're hoping that this novel computerized approach represents a historic leap in diagnosing cancer using just ro...


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    ZIKA VACCINE PROTECTS MOUSE FETUSES AGAINST BRAIN INFECTIONS AND MALFORMATIONS

    Dec 19, 2018

    In 2015 and 2016, the world was shocked by the sudden and massive outbreak of the Zika virus in Latin America. “The Zika virus is transmitted by the tiger mosquito and, in most cases, the patient experiences no or only mild symptoms,” says Professor Johan Neyts. “But when a pregnan...


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    PREGNANT WOMEN AND EXTREMELY OBESE PEOPLE AT HIGH RISK OF FLU COMPLICATIONS

    Dec 19, 2018

    Pregnant women and the extremely obese are among those at high risk for complications from the flu – including death – and should be tested and begin antiviral treatment promptly if they are sick enough to be hospitalized with flu symptoms, according to updated guidelines released by the...


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    TETRA, SHIONOGI INK $40M PACT ON PDE4 DRUG FOR ALZHEIMER’S, FRAGILE X

    Dec 19, 2018

    Tetra Discovery Partners is teaming up with Shionogi to advance its PDE4-targeting drug in Alzheimer’s disease and fragile X syndrome. In return for the rights to the drug in three Asian countries, Shionogi will hand over a $5 million upfront payment and $35 million in equity. If all goes well...


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    AXOVANT BUYS MORE GENE THERAPIES, SETTING IT UP FOR A BUSY 2019

    Dec 14, 2018

    Axovant has licensed two gene therapies from the University of Massachusetts Medical School (UMMS). The deal accelerates Axovant’s evolution into a gene therapy specialist by giving it control of two assets that are in or near the clinic. Following the failures of intepirdine and nelotanserin,...


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    WUXI APPTEC EYES ACQUISITIONS AFTER $1BN HONG KONG IPO

    Dec 14, 2018

    Chinese biotech WuXi AppTec has completed its listing on Hong Kong’s HKEX, raising $967m just months after making its debut on the Shanghai exchange. The company which provides contract research, development, and manufacturing services to pharma, medical device and biotech firms – said t...


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    IPSEN WARNS OVER MEDICINE SUPPLIES AMID BREXIT UNCERTAINTY

    Dec 14, 2018

    France’s Ipsen has become the latest pharma company to warn about the impact of Brexit on the pharma industry and patients’ access to medicines. As Theresa May attempts to drum up support for her Brexit deal, the French pharma said it was taking steps to minimize disruption to supplies o...


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    RESEARCHERS ZERO IN ON POTENTIAL THERAPEUTIC TARGET FOR DIABETES, ASSOCIATED DISEASES

    Dec 14, 2018

    A recent study led by researchers in Texas A&M University's department of nutrition and food science shows how a novel regulatory mechanism serves as an important biomarker for the development of diabetes, as well as a potential therapeutic target for its prevention. The study can be found o...


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    EARLY PHYSICAL THERAPY CAN REDUCE RISK, AMOUNT OF LONG-TERM OPIOID USE, STUDY FINDS

    Dec 14, 2018

    Patients who underwent physical therapy soon after being diagnosed with pain in the shoulder, neck, low back or knee were approximately 7 to 16 percent less likely to use opioids in the subsequent months, according to a new study by researchers at the Stanford University School of Medicine and the D...


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    MATERIALISE AND CARESTREAM TO RELEASE BROWSER-DRIVEN PRE-OP AND 3D PRINTING SOFTWARE

    Dec 13, 2018

    Materialise, a company that 3D prints millions of unique medical parts every year, has partnered with Carestream Health to release a browser-driven pre-operative planning solution. The product will give orthopedic surgeons the ability to plan surgeries and order custom surgical guides and other 3D p...


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    MYLAN, BIOCON COPY INCHES CLOSER TO CHALLENGING SANOFI'S LONG-SUFFERING LANTUS

    Dec 13, 2018

    Sanofi’s Lantus is already facing off against generic competition from Eli Lilly and Boehringer’s Basaglar, but now Mylan is adding to the pressure by prevailing in a patent challenge at the U.S. Patent and Trademark Office. The PTO’s Patent Trial and Appeal Board invalidated two L...


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    GARMIN TO DEVELOP WEARABLES FOR CLINICAL TRIALS WITH ACTIGRAPH

    Dec 13, 2018

    Tech-giant Garmin is stepping into the medical wearables space through a new collaboration with ActiGraph. The partnership will explore health and activity monitoring innovations combining Garmin wearables with ActiGraph‘s Centrepoint data analytics platform for academic research, clinical tri...


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    FDA HAILS 2018 AS BUMPER YEAR FOR DRUG DEVELOPMENT SUCCESSES

    Dec 13, 2018

    The FDA has hailed 2018 as a standout year for drug development and approvals, both in terms of the quantity and quality of activity. With the FDA approving 55 new molecular entities (NMEs) over the first 11 months of the year, 2018 has eased past 1996 to become the busiest year ever. Perhaps more i...


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    MERCK AND BRAZIL'S INSTITUTO BUTANTAN TEAM TO DEVELOP AT LEAST TWO DENGUE VACCINES

    Dec 13, 2018

    Merck & Company inked a research collaboration deal with Instituto Butantan, based in Sao Paulo, Brazil, to develop vaccines against dengue virus disease. Dengue fever infects as many as 400 million people annually, according to the U.S. Centers for Disease Control and Prevention (CDC). It is th...


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    JOHNSON & JOHNSON CHIEF FIGURES AMAZON COULD SHAKE UP PHARMA'S DISTRIBUTION, REBATES AND MORE

    Dec 11, 2018

    There’s been plenty of speculation about Amazon's intentions in pharmaceuticals, and now Johnson & Johnson’s CEO has weighed in on how the tech giant could affect drug markets by shaking up pharma distribution and reimbursement. Speaking with Fortune’s Susie Gharib, J&J...


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    ABBVIE CONTINUES CHARITABLE GIVING, DONATES $50 MILLION TO ST. JUDE

    Dec 11, 2018

    Christmas came a little early for St. Jude Children's Research Hospital in the form of a $50 million contribution from pharma giant AbbVie – the largest single contribution made to the famed hospital. The multi-million donation will be used to support the construction of a new Family Commo...


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    NICE REVEALS NEW STANDARDS FOR DIGITAL TECH

    Dec 11, 2018

    NICE has published new standards set out the requirements needed to develop digital health technologies for the NHS and speed up the uptake of products like healthcare apps and wearable devices. Working collaboratively NHS England, NICE, NHS Digital, MedCity, Public Health England, and DigitalHealth...


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    AKORN SEARCHES FOR NEW CEO AFTER FAILED FRESENIUS MERGER

    Dec 11, 2018

    US generics firm Akorn is searching for a new CEO in the wake of a failed merger with Fresenius Kabi last year. Akorn had been set to merge with Fresenius Kabi in 2017, but the German pharma axed the deal citing problems with data integrity at the US pharma. The deal was undone when whistleblowers f...


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    BOEHRINGER FOLLOWS SANOFI WITH JOB CUTS IN FRANCE

    Dec 11, 2018

    Boehringer Ingelheim has confirmed it plans to axe more than 10% of its workforce in France, or more than 300 jobs, adding to several hundred losses at Sanofi last week. The privately-held German drugmaker says it will eliminate 327 positions – 197 in human health and 130 in its animal health ...


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    AXOVANT ABANDONS ANOTHER DEMENTIA DRUG AFTER FAILED TRIAL

    Dec 10, 2018

    There is very little doubt that developing drugs for neuroscience disorders in general and dementias, in particular, is a high-risk business. Axovant Sciences, unfortunately, seems to be finding that out the hard way. The company announced today that its Phase II clinical trial of nelotanserin for t...


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    QED THERAPEUTICS ANNOUNCES A COLLABORATION WITH FOUNDATION MEDICINE TO DEVELOP COMPANION DIAGNOSTICS FOR INFIGRATINIB

    Dec 10, 2018

    QED Therapeutics today announced that it has entered into an agreement with Foundation Medicine to develop a companion diagnostic for infigratinib, an FGFR1-3 selective tyrosine kinase inhibitor, in patients with cholangiocarcinoma. The companion diagnostic, which will include detectio