TRENDING NEWS

CHAOS-INDUCING GENETIC APPROACH STYMIES ANTIBIOTIC-RESISTANT SUPERBUGS

A genetic disruption strategy developed by University of Colorado Boulder researchers effectively stymies the evolution of antibiotic-resistant bacteria such as E. coli, giving scientists a crucial leg up in the ongoing battle against deadly superbugs. These multidrug-resistant pathogens—which...

DECTIN-1 PATHWAY MAY BE CRUCIAL FOR TREATING FUNGAL INFLAMMATION AND PAIN

Researchers from Osaka University identified how the Dectin-1 to TRP channel pathway is a signaling mechanism in the onset of pain, and how inhibition of the VNUT ATP transporter blocks candidiasis-mediated pain. Candidiasis, Candida albicans infection, can cause skin, genital or oral pain. Many stu...

ASTRAZENECA IMPROVES DIABETES PEN TO MAINTAIN ITS MARKET SHARE

The European Commission (EC) has approved AstraZeneca’s Bydureon BCise, a new weekly formulation of established GLP-1 diabetes drug with the added benefit of glucose reduction, better weight loss results and a new injection pen. AstraZeneca announced that the EC green-lighted the new formulati...

PFIZER DRUG REDUCES MORTALITY IN PATIENTS WITH FATAL HEART DISEASE

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a rare, fatal under-diagnosed disease that usually affects men aged 60-plus, whereby amyloid fibrils made from misfolded transthyretin protein accumulate in the heart. In most patients, death is caused by sudden heart failure or heart-related issues....

FDA WARNS OF COMMON DIABETES MEDS' LINK TO DANGEROUS GENITAL INFECTION

(HealthDay) Rare but serious genital infections, as well as one death, have been reported in some patients taking a certain class of type 2 diabetes medicine, the U.S. Food and Drug Administration says. As a result, the FDA has ordered a new warning about this risk to be added to the prescribing inf...

DIGITAL HEALTH TECHNOLOGY HAS POTENTIAL TO TRANSFORM CANCER CARE

Digital and connected health technology has real potential to transform cancer care, writes Piotr Wnuk. Start-ups are utilizing well-established devices from technology firms like Microsoft and Apple to implement their specialized software, targeting particular conditions. Recent developments and in...

HOW UNSECURED, OBSOLETE MEDICAL RECORD SYSTEMS AND MEDICAL DEVICES PUT PATIENT LIVES AT RISK

A team of physicians and computer scientists at the University of California has shown that it is easy to modify medical test results remotely by attacking the connection between hospital laboratory devices and medical record systems. These types of attacks might be more likely used against high-pro...

LIVIO AI HEARING AIDS WITH PHYSICAL AND COGNITIVE HEALTH MONITORING

Starkey, one of the big hearing aid firms, is releasing a new device that works as a combination hearing aid, fitness monitor, and, surprisingly, as a tracker of cognitive health. In addition to all this, the new Livio AI hearing aids feature integrated language translation, connectivity to Amazon A...

SECOND TIME LUCKY? ALZHEON TRIES FOR MUCH-REDUCED IPO

After an aborted attempt earlier this year, Alzheon is having another go at an IPO to help fund new trials of its Alzheimer’s candidate tramiprosate. However, the biotech has dialed down its target for the fundraising, and bookrunners on the IPO have also changed from Piper Jaffray and Citi to...

FIRMS URGED TO STOCKPILE DRUGS TO PREVENT BREXIT SHORTAGES

The UK government has outlined how it will ensure the supply of medicines continues in the event of a “no deal” Brexit, urging companies to stockpile six weeks’ worth of medicine. With the March 2019 Brexit deadline looming ever closer, there are mounting concerns that the UK will ...

EBOLA SPECIES FOUND IN BATS AHEAD OF ANY POTENTIAL OUTBREAK

For the first time, scientists discovered a new ebolavirus species in a host prior to detection in an infected human or sick animal. The discovery of the Bombali virus in bats in Sierra Leone and the sequencing of the complete genome was officially published today in the journal Nature Microbiology....

FOR FIRST TIME IN 40 YEARS, CURE FOR ACUTE LEUKEMIA WITHIN REACH

Acute myeloid leukemia is one of the most aggressive cancers. While other cancers have benefitted from new treatments, there has been no encouraging news for most leukemia patients for the past 40 years. Until now. As published today in the scientific journal Cell, Professor Yinon Ben-Neriah and his...

TRACKING THE EVOLUTION AND TRANSMISSION OF YELLOW FEVER

A pioneering Oxford University research collaboration into yellow fever virus (YFV) has shed new light on the exceptional recent outbreak in Brazil and how the virus spreads. The findings have implications for monitoring viral transmission and could potentially contribute to a strategy for eliminati...

KEEPING CANCER OUT OF BREATH BLOCKS DRUG RESISTANCE

A new combination of existing drugs shows promise that it could reduce the size of cancerous tumors much more effectively than current treatments. As cancer patients know all too well, many highly effective anti-cancer drugs don't stay effective long. Most tumors will become drug resistant over ...

CELLULAR CHANGES LEAD TO CHRONIC ALLERGIC INFLAMMATION IN THE SINUS

Chronic rhinosinusitis is distinct from your average case of seasonal allergies. It causes the sinuses to become inflamed and swollen for months to years at a time, leading to difficulty breathing and other symptoms that make patients feel miserable. In some people, this condition also produces tiss...

NEW IMPLANT FOR GERD AVOIDS SWALLOWING COMPLICATIONS

A new implantable device has been approved for use in Europe to help treat acid reflux disease. The IM RefluxStop device from Implantica, a company based in Zug, Switzerland, is designed to avoid some of the limitations of current minimally invasive reconstructive acid reflux procedures, such as dif...

DEHYDRATION ALTERS HUMAN BRAIN SHAPE AND ACTIVITY, SLACKENS TASK PERFORMANCE

When dehydration strikes, part of the brain can swell, neural signaling can intensify, and do monotonous tasks can get harder. With the help of brain scans and a simple, repetitive task to test responsiveness, exercise physiologists at the Georgia Institute of Technology studied volunteer subjects w...

NO CANCER RISK FOR TELOMERASE GENE THERAPY

Representative images of lungs treated with gene therapy vectors. The nuclei are in blue, alveolar type II cells in green and telomeres in red. Notice that lung cells treated with active telomerase present more intense telomeres indicating that they are longer as compared to lung cells treated with ...

NEW DEVICE FOR STUDYING BACTERIAL BIOFILM FORMATION

Biofilms are large groups of bacterial cells that stick together and protect each other like a Roman legion. Drugs and other therapies can poke at the exterior of a biofilm, but killing the mass can be extremely challenging. Researchers at the Okinawa Institute of Science and Technology in Japan dec...

BRAINSWAY TRANSCRANIAL STIMULATION CLEARED IN U.S. FOR OBSESSIVE COMPULSIVE DISORDER

Brainsway, Israel’s leading magnetic stimulation company, won FDA de novo clearance for its system to be used to treat obsessive compulsive disorder (OCD) in the United States. The company’s Deep Transcranial Magnetic Stimulation system is used to deliver magnetic field pulses to the fro...

REGENERON/TEVA PAIN DRUG FASINUMAB ON TARGET IN PHASE 3

Regeneron and Teva have announced positive top-line phase 3 results from their fasinumab, as the companies chase Pfizer and Lilly in the race to market a new class of non-opioid painkillers. Fasinumab is from a class of drugs targeting nerve growth factor (NGF), which plays a central role in the reg...

HACKERS COULD TAKE CONTROL OF MEDICAL DEVICES, MCAFEE WARNS

Research published by the cybersecurity company, McAfee, shows it is possible to modify real-time patient heart monitor data by hacking into a hospital network and gaining control of medical devices. The report published by McAfee proves that hackers could easily alter patients’ vital signs by...

ACTISOUND INTENSE THERAPEUTIC ULTRASOUND DEVICE CLEARED IN EUROPE

Guided Therapy Systems, based in Mesa, Arizona, landed EU CE mark approval (via Ardent Sound Inc., Guided’s partner, and manufacturer) for the Actisound Intense Therapeutic Ultrasound device. It’s intended to help recover from a variety of injuries and chronic pain resulting from interna...

GN HEARING UNVEILS RESOUND LINX QUATTRO ADVANCED HEARING AID

GN Hearing, a company that makes audio technology that appears under names such as Beltone, Interton, and Jabra, just announced new hearing aid called ReSound LiNX Quattro. The firm describes it as “the world’s first Premium-Plus hearing aid,” delivering what it believes is the bes...

STUDY REVEALS BROAD 'GENETIC ARCHITECTURES' OF TRAITS AND DISEASES

Scientists at Johns Hopkins Bloomberg School of Public Health have developed a powerful method for characterizing the broad patterns of genetic contributions to traits and diseases. The new method provides a "big picture" of genetic influences that should be particularly helpful in designi...

HAILIE INHALER MONITORING SYSTEM NOW AVAILABLE DIRECT TO CONSUMERS

Adherium, a Silicon Valley firm, is releasing its Hailie system for inhaler monitoring in the United States. The company received FDA clearance to sell the product over the counter, allowing patients to work toward improved compliance with regards to their medications. The system includes a sensor t...

FIRST PATIENT RECEIVES MEDTRONIC’S EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

A pilot study is getting underway to evaluate a new Medtronic implantable cardioverter defibrillator that doesn’t require leads to be placed inside the heart or veins. The Extravascular Implantable Cardioverter Defibrillator (EV ICD) system can deliver defibrillation shocks as well as pacing s...

NEW DEVICE FOR TESTING IMMUNOTHERAPIES ON TUMOR FRAGMENTS

Immuno-oncology, a rapidly developing field that harnesses the body’s immune system to attack cancers, lacks effective methods of testing potential therapies. In addition to animal studies, tiny bits of tumors are placed, along with chemical compounds being tested, within multiwell plates and ...

MOLECULAR SENSOR TO DETECT IF CANCER DRUG IS WORKING

Being able to monitor the chemical content of cancer cells may help scientists develop new anti-cancer medications. Additionally, it may also lead to personalized drug therapies for cancer patients that all too often end up trying multiple medications before finding one that works. Chemists at MIT h...

WRISTBAND PERFORMS BLOOD CELL COUNTS TO MONITOR HEALTH ANYWHERE

The popularity of smartwatches, activity trackers, and other wearable devices is in large part due to the hope that such tools can help monitor health. While new products keep coming out, progress on embedding sensors that can monitor things other than one’s heart rate and activity level has s...

NOVEL PET IMAGING COULD GUIDE THERAPY FOR TYPE 1 DIABETES

Researchers have discovered a new positron imaging tomography (PET) imaging method to improve the care of patients with type 1 diabetes. The new PET method could measure beta-cell mass which would enhance the ability to monitor a diabetes patient and guide their therapy. Dr. Jason Bini, Yale Un...

GENETIC DIVERSITY IMPACTS DISEASE SEVERITY

New research offers clues as to why some diseases are highly variable between individuals. The phenomenon is apparent in people with retinitis pigmentosa, a condition that causes the light-sensing cells in the eye to degenerate. While some only develop night blindness, others completely lose their s...

FLOW DIVERTER WITH HEMODYNAMIC SENSOR TO MONITOR ANEURYSM TREATMENT

Flow diverters are implants that are commonly used to prevent blood from flowing into aneurysms. They look very similar to stents and are often combined into one device, but instead of providing structural strength, they provide a way for blood to pass from one part of a vessel to another without fl...

REGENERON FORGES CAR-T R&D PARTNERSHIP WITH BLUEBIRD BIO

Regeneron is pushing forward with its investment in cancer immunotherapy, striking a deal with bluebird bio to develop cell therapies. Through its partnership with Sanofi, Regeneron is poised to bring the sixth checkpoint inhibitor therapy to the market with its cemiplimab, which the FDA is set to m...

REGENERA PHARMA STARTS PHASE III STUDY, LOOKS TO TAP US VENTURE CAPITAL

An Israeli drugmaker has come out of stealth and enrolled the first patient in its Phase III study that aims to treat an eye disorder using a drug derived from a type of tree resin. Regenera Pharma announced Thursday the enrollment of the first patient in the 234-patient study of RPh201 in nonarteri...

HOW HOSPITALS ARE INTEGRATING AUGMENTED REALITY AND OTHER TECH TO IMPROVE THE PATIENT EXPERIENCE

New, emerging technologies are turning patients into savvy healthcare consumers with higher expectations around the services they receive. From wearables to telemedicine, virtual and augmented reality, 3D imaging, and artificial intelligence, patients are increasingly drawn to cutting-edge experienc...

NEW TUBERCULOSIS DRUG COULD HELP ERADICATE GLOBAL KILLER

A groundbreaking drug, rifampin, could help to end the global tuberculosis epidemic, according to researchers. Clinical trials carried out at the McGill University Health Centre showed that rifampin is less toxic and is more effective than the standard of care treatment, isoniazid. The results of tw...

FDA GRANTS LEUKAEMIA DRUG ‘BREAKTHROUGH’ STATUS

A leukemia drug has been granted ‘breakthrough therapy’ status by the US drug regulator. Daiichi Sankyo announced that it had been awarded the designation by the US Food and Drug Administration (FDA) for quizartinib, which is used to treat acute myeloid leukemia (AML). This means the pro...

JOHNSON & JOHNSON LEADS THE WAY TO A WORLD WITHOUT DISEASE

Cat Oyler, Global Head of External Innovation Strategy and Operations at Johnson & Johnson (J&J), has an ambitious and compelling vision for the future of healthcare: a world without disease. She spoke to pharmaphorum as part of the latest in the eye-on-innovation series of articles. As one ...

FDA APPROVES FIRST DRUG TO TREAT RARE ADRENAL CANCER

Azedra has received FDA approval to become the first and only treatment for a type of rare adrenal cancer. Progenics Pharmaceuticals shares soared after its drug Azedra, a new version of the radiopharmaceutical injectable drug iobenguane I-131, was given the green light by the US Food and Drug Admin...

A MINIATURIZED SEMICONDUCTOR BIOCHIP TO IDENTIFY DRUG-RESISTANT PATHOGENS

Evolving strains of multi-drug resistant pathogens are a growing global concern, outpacing drug discovery efforts and undermining the efficacy of existing antibiotics. The development of comprehensive diagnostics for clinical applications will become crucial to control escalating health risks. Exist...

PARKINSON'S DISEASE: BREATH TEST FOR EARLY DIAGNOSIS STEPS CLOSER

Scientists in Israel have developed a breath test that can detect people with early-stage Parkinson's disease. Neurons in Parkinson's disease The team from Technion Israel Institute of Technology had previously shown that the test can detect people with Parkinson's disease who are alread...

NANO-OPTIC ENDOSCOPE SEES DEEP INTO TISSUE AT HIGH RESOLUTION

The diagnosis of diseases based on internal organs often relies on biopsy samples collected from affected regions. But collecting such samples is highly error-prone due to the inability of current endoscopic imaging techniques to accurately visualize sites of disease. The conventional optical elemen...

HOW CELLS ACTIVELY STOP BREAST CANCER FROM BECOMING INVASIVE

A new study shows that the cells surrounding the breast's milk ducts form an active barrier that extends and grabs cancer cells before they spread to the rest of the body. The American Cancer Society estimates that in 2017, there were over 310,000 new cases of breast cancer among American women....

BLOCKING ONE ENZYME COULD HELP TREAT MANY CHRONIC DISORDERS

Researchers have identified an enzyme that plays a key role in a biological mechanism common to many chronic inflammatory disorders. The discovery — which has been reported in a paper now published in the journal Nature — could lead to new drugs for treating diverse inflammation-related ...

MERCK & CO’S KEYTRUDA SHOWS POTENTIAL IN HEAD AND NECK CANCER USE

Merck & Co might be able to find another use for its immunotherapy Keytruda in first-line head and neck cancer, after revealing promising phase 3 trial results. US-based Merck said the pivotal phase 3 trial investigating Keytruda monotherapy as a first-line treatment in recurrent or metastatic h...

HOW DO JUMPING GENES CAUSE DISEASE, DRIVE EVOLUTION?

Almost half of our DNA sequences are made up of jumping genes also known as transposons. They jump around the genome in developing sperm and egg cells and are important to evolution. But their mobilization can also cause new mutations that lead to diseases, such as hemophilia and cancer. Remarkably ...

MADE AT THE UNIVERSITY OF IOWA TURNS CLINICIANS’ IDEAS INTO MEDICAL PRODUCTS

New medical devices and technologies are being unveiled on a daily basis, as readers of Medgadget know well. Medical professionals are provided so much newly discovered knowledge that they end up creating new devices to take advantage of that knowledge. The medical device industry has a problem keep...

ACCU-CHEK SOLO TUBE-FREE INSULIN MICROPUMP CLEARED IN EUROPE

Roche will soon release in Europe its tube-free Accu-Chek Solo insulin micropump following the CE marking of the device. The micropump comes with a smartphone-like wireless remote control that features glucose monitoring and provides advice on how much insulin to administer. Moreover, the remote con...

THE DARK SIDE OF ANTIBIOTIC CIPROFLOXACIN

`The use of ciprofloxacin and other antibiotics of the class of fluoroquinolones may be associated with disruption of the normal functions of connective tissue, including tendon rupture, tendonitis, and retinal detachment. These observations reported in a number of journals resulted in the drugs cur...

POSSIBLE BREAKTHROUGH IN UNDERSTANDING HOW ANTIBIOTICS TREAT BACTERIA

Scientists from Newcastle University and the UK's ISIS Neutron and Muon research facility have worked together on a new project that is increasing our understanding of how antibiotics treat bacteria. With the number of antibiotic-resistant bacteria increasing in recent years, the ability to deve...

ANTIBIOTIC RESISTANCE IN A LEECH'S GUT: EVEN TRACE AMOUNTS OF ANTIBIOTICS BOOST RESISTANT BACTERIA

Plastic surgery patients were getting infections with antibiotic-resistant bacteria, and no one knew why. UConn microbiologists found the answer in a leech's gut. Their research, published today in mBio, provides proof that tiny levels of antibiotics found in the environment can encourage bacter...

LOW-DOSE ASPIRIN IMPROVES MEMORY IN MICE WITH ALZHEIMER’S SYMPTOMS

Aspirin is one of the most widely used drugs. Besides providing pain relief, it has been shown to reduce the risk of colon cancer and heart attacks. Some suggest that aspirin might also protect against Alzheimer’s disease because the disease is less common in aspirin users than nonusers. But w...

FDA OPENS DOOR TO IMPORTING DRUGS

Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines. For years, consumer advocates and state officials have pushed for access to less expe...

LINK BETWEEN DIABETES AND CANCER RISK FIRMLY ESTABLISHED

That diabetes and cancer are linked in some way is by no means a new idea, but it had never previously been confirmed. Now, a major new study draws a firm conclusion: diabetes raises a person's risk of developing cancer. The person taking blood sugar test New research warns that the risk of canc...

NOVARTIS PAYS UP TO $1 BILLION FOR POTENTIAL ECZEMA DRUG

Swiss pharma Novartis is to pay up to $1 billion to Galapagos and MorphoSys for exclusive rights to a skin drug, which will further strengthen Novartis’s leadership position in the immunology field. Belgo-Dutch biotech Galapagos and Germany’s MorphoSys have signed a global license agreem...

AZ SUFFERS SETBACK AS NICE SLAPS RESTRICTIONS ON FASENRA

NICE has recommended in a draft decision that AstraZeneca’s latest lung drug Fasenra can be funded by the NHS in severe asthma – but only in patients that are ineligible for GlaxoSmithKline’s rival. AstraZeneca’s Fasenra (benralizumab) is one of a group of new drugs it hopes ...

RISK OF HEART ATTACK RISING FOR PREGNANT WOMEN

Heart disease is the leading cause of death among women in the United States who are pregnant or have given birth. Heart disease can lead to heart failure, heart attack, stroke, and sudden cardiac arrest. A recent study from the NYU School of Medicine shows that heart attack rates are on the rise in...

IMMUNOTHERAPY INCREASES SURVIVAL OF MELANOMA BRAIN METASTASES PATIENTS

Melanoma, a form of skin cancer, accounts for about 1% of all skin cancer cases and a vast majority of skin cancer deaths. In Stage IV melanoma more than 60% of patients will develop brain metastases, which is difficult to treat and carries an overall survival of about 4-5 months. A recent study out...

CANCER: CAN TESTOSTERONE IMPROVE PATIENTS' QUALITY OF LIFE?

Studies have noted that "[a]pproximately half of all patients with cancer experience cachexia," severely impairing their quality of life. It appears to be "responsible for the death of 22 [percent] of cancer patients." What exactly causes this condition which appears in some pati...

TACKLING CANCER AT GROUND ZERO WITH DESIGNER MOLECULES

A new molecule designed by University of Adelaide researchers shows great promise for future treatment of many cancers. The new molecule successfully targets a protein that plays a major role in the growth of most cancers. This protein target is called proliferating cell nuclear antigen (PCNA), othe...

TREATMENT PREVENTS SYMPTOMS OF SCHIZOPHENIA IN TESTS WITH RATS

Researchers at the Federal University of São Paulo (UNIFESP) in Brazil have tested a treatment with sodium nitroprusside in a strain of rats that spontaneously develop some of the symptoms associated with schizophrenia. The results obtained with a group of adolescent animals suggest that prev...

FDA ANNOUNCES VOLUNTARY RECALL OF SEVERAL MEDICINES CONTAINING VALSARTAN

The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), whi...

SCIENTISTS A STEP CLOSER TO PREDICTING EPIDEMICS

Ecologists at the University of Georgia have taken an important step in their efforts to develop an early warning system for infectious disease outbreaks. A team led by Eamon B. O'Dea created a mathematical model that analyzes statistical patterns in public health reports to identify when a popu...

RESMED JOINS GOOGLE TO RESEARCH SLEEP APNOEA THERAPIES

Sleep apnoea firm ResMed has joined with Google’s life science division Verily to form a new joint venture studying the health and financial impact of the undiagnosed and untreated disease and find new ways to treat it. The joint venture will combine ResMed’s expertise in sleep apnoea an...

PFIZER BACKED OFF, BUT THE PRICE HIKE GAME CONTINUES

Donald Trump may have convinced the US pharma giant Pfizer to defer a price increase for dozens of drugs, but there are others that have escaped such intense scrutiny according to a report. According to the story published today by Bloomberg at least ten other leading pharmaceutical companies increa...

RESEARCHERS NARROW IN ON GENETIC FACTORS THAT CAUSE PRETERM BIRTH

Mutations in a gene involved in steroid signaling likely contribute to preterm birth, report Johanna Huusko of the University of Oulu and Cincinnati Children's Hospital Medical Center and colleagues, in a study of European women who had experienced at least one early delivery. The researchers re...

AZ HOPES DIABETES DRUG COULD BE AS EFFECTIVE AS GASTRIC BAND

AstraZeneca is preparing an assault on the growing market for GLP-1-class diabetes drugs with a dual action molecule that the firm hopes could be as effective as a gastric band – and may even have potential in the lucrative market to treat “fatty liver” disease nicknamed NASH. In a...

JOHNSON & JOHNSON, LOOKING FOR ITS TREMFYA NICHE, STARTS UP NEW TRIAL PROGRAM IN CROHN'S

Johnson & Johnson immunology newcomer Tremfya is looking to follow in the footsteps of its big brother. MorphoSys, partnered with the New Jersey drugmaker’s Janssen unit, said Tuesday that the drug giant had started up a phase 2/3 clinical trial program in Crohn’s disease, reaching f...

AXOVANT AND BENITEC ESTBALISH GENE THERAPY PARTNERSHIP

Pharmaceutical company Axovant Sciences has signed a gene therapy licensing and development deal with Australia-based Benitec Biopharma to expand its pipeline of products. Under the terms of the collaboration, Axovant will have exclusive global licensing rights to Benitec’s Silence-and-Replace...

BLOOD PRESSURE DRUG VERAPAMIL MAY HELP TYPE 1 DIABETICS

A human clinical trial has found that a common blood pressure drug called verapamil can decrease insulin requirements and hypoglycaemic episodes in adults with recent-onset type 1 diabetes. The study, conducted by the University of Alabama at Birmingham Comprehensive Diabetes Center, revealed oral v...

MORE RESEARCH WITH LAB-GROWN ORGANOIDS

When researching diseases that affect the brain, it's difficult to ethically use human patients. There are experiments that cannot be performed on living subjects. Brain banks are an option for tissue samples, but the need is greater than the supply. What researchers often need to do is cre...

PHARMA TAKES LEADING ROLE IN NHS 70TH ANNIVERSARY CELEBRATIONS

The pharmaceutical industry celebrated the 70th anniversary of the NHS by recognizing the myriad contributions that the sector has made to the lives of many people. The Association of the British Pharmaceutical Industry (ABPI) ran a series of announcements headlining the life-changing effects o...

ORION HAS STARTED A PHASE III TRIAL TO DEVELOP A DRUG FOR ALS

Orion has recruited the first patients in the Phase III clinical trial (REFALS) in which orally administered levosimendan (ODM-109) is being evaluated for the treatment of symptoms of amyotrophic lateral sclerosis (ALS). The purpose of the trial is to demonstrate that orally administered levosimenda...

NICE REJECTS BMS IMMUNOTHERAPY IN ADVANCED BLADDER CANCER

Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) will not be available to advanced bladder cancer patients for at least three years in much of the UK after NICE published final guidance that rejected the drug for regular NHS funding in this use. Following its usual review process, NICE ...

PFIZER INCREASES PRICES IN THE US FOR THE SECOND TIME THIS YEAR

The largest standalone drug maker in the US, announced it increase the prices of around 100 drugs for the second time this year, despite president Donald Trump’s pledge to slash the cost of drugs and treatments. The Financial Times reported on Monday that Pfizer upped the prices of prescriptio...

ABBVIE, PARTNER ORDERED TO PAY $448M IN ANDROGEL ANTITRUST CASE BROUGHT BY FTC

Even as AbbVie defends against thousands of AndroGel liability cases, the company and partner Besins Healthcare must pay nearly $450 million for illegally blocking generic competition to the testosterone product with "baseless" patent litigation, a judge said.U.S. District Judge Harvey Bar...

JOHNSON & JOHNSON SHAKEUP LEAVES JOAQUIN DUATO WITH LARGEST PORTFOLIO

The executive pyramid at Johnson & Johnson is going through a significant revamp with head of pharmaceuticals Joaquin Duato taking on most of the responsibilities held by Group Worldwide Chairman Sandra Peterson as she prepares to retire. Duarto will become a vice chairman of the executive commi...

IN RARE SLIP, PFIZER STEAMROLLER IBRANCE FAILS TO SHOW IT HELPS PATIENTS LIVE LONGER

More than two years ago, Pfizer’s Ibrance won an FDA nod to treat some breast cancer patients whose disease had progressed after endocrine therapy. But new study results suggest the drug may not actually help patients live longer.On Monday, Pfizer said Ibrance, in combination with fulvestrant,...

FDA GREENLIGHTS GW'S EPIDIOLEX, THE FIRST U.S. DRUG MADE FROM MARIJUANA

The FDA just approved Epidiolex, the GW Pharma seizure drug derived from cannabis, giving children with two rare and serious forms of epilepsy a new treatment—and companies looking to develop marijuana-based drugs a model for their own path to market. The agency approved Epidiolex, or purified...

OPIOID MAKER PURDUE DEEP-SIXES SALES TEAM AMID MASS LAYOFF AND MOUNTING LEGAL WOES

Even though opioid addiction emerged years ago as an epidemic, it wasn’t until February of this year that OxyContin maker Purdue Pharma finally stopped promoting the drug to physicians and laid off 200 salespeople. Now the company—which is facing a mountain of legal woes related to the o...

UNIVERSAL FLU VACCINE BIOTECH SEEKS BIG PHARMA PARTNERSHIP FOR PHASE 3 TESTING: CEO

Problems with seasonal flu shots have been well documented, and now U.K. biotech Imutex believes it has the next big advance for flu vaccine technology. The company this week reported phase 2b data showing that its universal flu shot, FLU-v, boosted immune responses and lowered infection rates. Imut...

VALEANT DEALT 'A MAJOR SETBACK' AS PSORIASIS DUAL-DRUG LOTION DUOBRII FAILS TO IMPRESS FDA

Besides getting a new name, troubled Valeant is also in desperate need of some regulatory success to rebuild its image. But it’s not going to get it from a key plaque psoriasis combo drug Doubrii—at least not soon. The FDA has just rejected Doubrii, one of the seven products that Valeant...

CORPORATE RESPONSIBILITY INVESTOR GROUP TOUTS SUPPORT OF FIRST-YEAR RESOLUTIONS OVER EXECUTIVE PAY, DRUG PRICING

After pressing five pharma companies for answers about how executive pay plays into drug pricing decisions, the Interfaith Center on Corporate Responsibility has generated some interest in the issue among the investor community. A group of investors at AbbVie, Amgen, Biogen, Bristol-Myers Squibb and...

NICE DOGS ROCHE'S PERJETA AGAIN, THIS TIME IN POSTSURGERY BREAST CANCER PATIENTS

Earlier this month, European regulators approved Roche’s Perjeta for some postsurgery patients with early breast cancer. But England’s cost watchdogs are blocking its path.Friday, the National Institute for Health and Care Excellence released draft guidance recommending against NHS use o...

CAN SANOFI COMPETE IN LUNG CANCER? WITH I-O MED CEMIPLUMAB, IT’S AIMING FOR THIRD

Same or different that’s a big question rattling around the immuno-oncology field, where PD-1 and PD-L1 checkpoint inhibitors have put up differing results in clinical trials.The assessment from Sanofi? The PD-1 drugs themselves are essentially equal. It’s the trial designs that make the...

TRUST PHARMA? NOT SO MUCH, ANNUAL SURVEY SHOWS, WITH BIGGEST LOSS EVER

Trust has hit a new low for pharma in Edelman’s annual Trust Barometer survey. The 13-point drop from 51% to 38% in the U.S. was the category’s biggest plummet in the five years the public relations and marketing firm has been tracking sentiment.Plus, it’s a turnaround in the wrong...

SPROUT'S OLD CEO IS BACK, AND SHE'S GOT SOME NEW MARKETING IDEAS FOR FEMALE LIBIDO DRUG ADDYI

Now that former shareholders of Sprout Pharmaceuticals, maker of controversial female libido pill Addyi, have the company back in their hands, they’ve reinstalled a familiar face at the helm. Cindy Eckert, who went by Cindy Whitehead during her last stint as CEO, is once again in the company&r...

DOCTORS ARE COMING AROUND TO TEVA'S AUSTEDO AS TD DRUGS GET MORE PLAY: ANALYST

In the brand-new tardive dyskinesia market, doctors initially preferred Neurocrine’s Ingrezza over Teva’s Austedo. But that edge is weakening, one analyst says. These days, doctors are viewing the two drugs as “more similar than different,” Leerink Partners analyst Ami Fadia ...

CITING 'SUBSTANTIAL BENEFIT' FOR PATIENTS, SANOFI HIKED FLUBLOK PRICE 12.5% LAST SEASON

Amid an industrywide look into pharma's pricing, Sanofi has pledged to limit its drug price hikes to the rate of medical inflation. The company recently tweaked its policy to provide rationale for any hikes above that level, and in the first year of the policy, detailed a 12.5% increase for a fl...

ROCHE'S MULTIPLE SCLEROSIS DRUG OCREVUS LOWERED PATIENTS' VACCINE RESPONSES: STUDY

Roche’s multiple sclerosis newcomer Ocrevus was approved by the FDA last March bearing a warning about immunization. Now, researchers have gathered clinical data showing it could weaken the effectiveness of certain vaccines. In a Roche-sponsored phase 3b study, scientists examined over 100 MS ...

ASTRAZENECA PRESSURES FELLOW PHARMAS WITH VOW TO REVEAL DOCTOR PAYMENTS WORLDWIDE

Pharmas’ payments to doctors raise concerns about prescription bias and have triggered bribery investigations, too. So, to win patients' trust, transparency matters. And now, AstraZeneca is going beyond its Big Pharma fellows to disclose all its doc payments, even in regions where it's...

MEDICARE WANTS INSURERS TO MONITOR SUSPICIOUS PRESCRIBING OF LAUGHING DRUG NUEDEXTA

For years, the Centers for Medicare & Medicaid Services has been hearing concerns that laughing drug Nuedexta was being aggressively pushed by maker Avenair Pharmaceuticals and some doctors for questionable use on dementia patients. Now, the CMS is asking insurers to be on alert for that kind of...

AMGEN IS THE LATEST DRUGMAKER TO HAVE A HERCEPTIN BIOSIM SIDELINED BY A CRL

Amgen, in a two-sentence announcement today, said it received a complete response letter for the biosimilar of Roche’s cancer med Herceptin it developed with Allergan. It marks the third Herceptin biosimilar that has been stalled by the FDA but has won approval in Europe. The Thousand Oaks, Ca...

GILEAD WINS CHINESE APPROVAL FOR EPCLUSA, BUT THE EMERGING MARKET IS GETTING CROWDED

Epclusa was just greenlighted by China’s Drug Administration (CDA). For hepatitis C patients in China, that means the first pangenotypic treatment will soon be available to them. But for Gilead, it might be too little, too late.The Chinese authority based its decision on five international pha...

JOHNSON & JOHNSON HAS THE MOST BUCKS FOR BIOPHARMA M&A, ASTELLAS THE EASIEST TARGET: ANALYST

The $62 billion Takeda-Shire deal surprised everyone—and worries some—as Takeda is borrowing an enormous $31 billion to help pay for the purchase. Does it refresh the industry’s understanding of M&A affordability and open up more possibilities for future deals? Leerink’s ...

FDA HITS CHINESE API MAKER JILIN SHULAN SYNTHETIC PHARMA WITH WARNING LETTER

Chinese API maker Jilin Shulan Synthetic Pharma was hit with a warning letter by the FDA, which cited numerous quality control and data integrity issues.The letter, which was posted on the regulatory agency’s website, came in reaction to the company’s response to an FDA inspection conduc...

NOVARTIS' UNDER-PRESSURE SANDOZ UNIT OFFLOADS QUEBEC PLANT TO FAST-GROWING AVARA

Novartis has been looking to jettison some assets in its North American generics business, but as it turns out, it is a manufacturing facility in Canada that will be sold off first. Avara Pharmaceutical Services has inked a deal to buy Novartis Technical Operations’ sterile manufacturing facil...

HELLO, $200B: SUPER-PRICEY NEW CANCER DRUGS DRIVE MEGA INCREASES IN TREATMENT SPENDING

It wasn't all that long ago that a six-figure price on a debut cancer drug was big news. Now, it would be more surprising if an oncology launch didn't carry a price tag of $100,000 or more—and the high cost of those new rollouts is helping drive cancer treatment costs toward $100 billi...

LILLY'S CANCER BUSINESS LOSES ITS CHIEF JUST AS IT'S LEANING ON ONCOLOGY FOR GROWTH

Eli Lilly is leaning on oncology as a key pillar for growth going forward, but with news that its president of the business, Sue Mahony, is retiring, the drugmaker will need to find new leadership for the unit. During her 18 years at Lilly, Mahony has ascended the ranks—earning a spot on the e...

ASTELLAS CUTS 600 POSITIONS IN JAPAN AS NEW CEO MAKES HIS MARK

Joining a host of other drug companies announcing slim-down efforts in recent months, Astellas is shedding 600 positions in Japan in R&D and sales and marketing. The company announced an early retirement program for eligible employees, hoping to enroll 600 staffers for an early exit.As part of t...

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