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    FINAL NICE GUIDANCE ISSUED FOR AKCEA’S TEGSEDI

    May 24, 2019

    Akcea Therapeutics UK has announced that the National Institute for Health and Care Excellence (NICE) has published a final guideline for its nerve damage drug, Tegsedi (inotersen).The Highly Specialised Technologies (HST) Guidance is for the treatment of stage I or II polyneuropathy in adult patien...

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=31233123

    GSK UPDATES ITS SALES REP INCENTIVES

    May 24, 2019

    GlaxoSmithKline has announced changes to its current sales representative incentives programme.The company stated that it will keep its existing pay structure, where 75% of a sales representative’s pay is fixed and 25% is variable, but sales reps involved in areas such as oncology and vaccines...

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=31243124

    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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    https://Pharmaceutical.report/news-article.aspx?ID=31253125

    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...

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=31263126

    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...

    BUSINESSWIRE
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    https://Pharmaceutical.report/news-article.aspx?ID=31193119

    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...

    RAPS.ORG
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    https://Pharmaceutical.report/news-article.aspx?ID=31203120

    BIG PHARMA POURED £57M INTO UK PATIENT CHARITIES WHICH COULD INFLUENCE NHS DRUG DECISION MAKERS, REPORT FINDS

    May 23, 2019

    Drug companies poured £57m into UK patient groups who research and lobby for new treatments into specific conditions – in many cases the same drugs being marketed by their donors.
    An investigation by Bath University researchers into donations by big pharmaand other industry bodies...

    INDEPENDENT
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    https://Pharmaceutical.report/news-article.aspx?ID=31213121

    THREE OPPORTUNITIES FOR THE HEALTHCARE AND PHARMA INDUSTRY

    May 23, 2019

    Demographic shifts and the rise of tech-led competition are applying pressure to the costs and margins of the world of healthcare and pharmaceuticals, while regulatory scrutiny rises as watchdogs look to clamp down on poor service provision. Joaquim Grau, a Manager at Spanish management consultancy ...

    CONSULTANCY
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    https://Pharmaceutical.report/news-article.aspx?ID=31223122

TRENDING NEWS


    COSENTYX SUCCESSFUL IN PLAQUE PSORIASIS TRIAL

    Jun 26, 2019

    Novartis has announced new data showing that its IL-17A antibody, Cosentyx, improves inflammation and rapidly suppresses IL-23 in plaque psoriasis. The announcement states that the drug successfully modulates gene expression leading to substantial improvement of inflammation, as early as week 12 by ...


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    http://www.pharmatimes.com/news/cosentyx_successful_in_plaque_psoriasis_trial_12926203222

    OXFORD BIOMEDICA, SANTEN ENTER RETINAL DISEASE R&D ALLIANCE

    Jun 26, 2019

    Oxford Biomedica and Santen have announced plans to enter into a research and development collaboration and option & licence agreement for development of gene therapy vectors for inherited retinal disease. The aim of the collaboration is to generate pre-clinical proof of concept to treat an inhe...


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    http://www.pharmatimes.com/news/oxford_biomedica,_santen_enter_retinal_disease_r_and_d_alliance_12926183223

    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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    https://www.fiercepharma.com/pharma/sanofi-and-regeneron-s-dupixent-scores-third-fda-approval-sinusitis-nasal-polyps3224

    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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    https://www.fiercepharma.com/pharma/after-roche-s-spark-delay-and-bristol-s-otezla-sale-what-does-abbvie-need-to-let-go-to-win3225

    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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    http://www.pharmatimes.com/news/bms_opdivo_disappoints_in_late-stage_trial_12926133226

    ABBVIE, NEARING THE END OF HUMIRA'S HISTORIC RUN, SCOOPS UP A STRUGGLING ALLERGAN FOR $63B

    Jun 25, 2019

    Rumors have been swirling that after years of turmoil and resistance, Allergan could be getting ready to split. But it looks like the drugmaker had other ideas. AbbVie, looking for new medicines to supplant its aging megablockbuster Humira, has stepped in to buy the floundering drugmaker in a $63 bi...


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    https://www.fiercepharma.com/pharma/no-allergan-split-abbvie-buys-struggling-drugmaker-for-63b3217

    NOVARTIS' GILENYA STAVES OFF GENERIC CHALLENGERS⁠—FOR NOW⁠—AFTER FEDERAL INJUNCTION

    Jun 25, 2019

    Novartis’ multiple sclerosis med Gilenya is facing U.S. generic challengers on all sides to its blockbuster sales, and the company hoped a court order could stave them off. The Swiss drugmaker got what it asked for—and it might just keep the med at the top of Novartis’ bestseller l...


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    https://www.fiercepharma.com/pharma/novartis-gilenya-staves-off-generic-challengers-after-federal-injunction3218

    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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    https://pharmaphorum.com/news/almirall-takes-option-on-dermiras-eczema-drug-lebrikizumab/3219

    FDA PRIORITY REVIEW GRANTED FOR GSK’S ZEJULA

    Jun 25, 2019

    The US Food and Drug Administration (FDA) has accepted Glaxo Smith Kline’s 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)...


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    http://www.pharmatimes.com/news/fda_priority_review_granted_for_gsks_zejula_12924463220

    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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    http://www.pharmatimes.com/news/nhs_to_open_young_peoples_gambling_addiction_service_12924283221

    SANOFI, REGENERON SUCCESSFUL IN PHASE II ASTHMA TRIAL

    Jun 24, 2019

    Sanofi and Regeneron have announced that the investigational IL-33 antibody REGN3500 (SAR440340) met its primary and secondary endpoints in the joint phase II proof-of-concept trial. The companies are currently studying REGN3500 in respiratory and dermatological diseases where inflammation is though...


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    http://www.pharmatimes.com/news/sanofi,_regeneron_successful_in_phase_ii_asthma_trial_12922873208

    FDA EXPANSION FOR SYMDEKO IN CYSTIC FIBROSIS

    Jun 24, 2019

    The US Food and Drug Administration (FDA) has extended the indication for Vertex Pharmaceuticals Symdeko (tezacaftor/ivacaftor) for the treatment of pediatric patients ages six years and older with cystic fibrosis who have certain genetic mutations. The approval comes after the FDA last year approve...


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    http://www.pharmatimes.com/news/fda_expansion_for_symdeko_in_cystic_fibrosis_12922813209

    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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    https://www.fiercepharma.com/pharma/gsk-wins-fda-priority-review-for-zejula-late-stage-ovarian-cancer3210

    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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    https://www.fiercepharma.com/pharma/bristol-myers-opdivo-fails-to-beat-nexavar-earlier-use-liver-cancer3211

    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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    https://www.fiercepharma.com/pharma/say-goodbye-to-otezla-bms-agress-to-sell-psoriasis-med-as-part-celgene-merger-deal3212

    ROCHES GENENTECH TARGETS CANCER CELLS VIA VIDEO GAME WITH TUMOR QUEST

    Jun 21, 2019

    Roches Genentechs latest innovation targets cancer cells in a video game. Called Tumor Quest, the game is aimed at engaging people in an out of the-ordinary way to talk about tumor types and biomarker testing. The game begins with a short intro video about genomic profiling and testing, with players...


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    https://www.fiercepharma.com/marketing/roche-s-genentech-targets-cancer-cells-via-video-game-looks-to-boost-personalized3203

SPOTLIGHT

According to the World Health Organization (WHO) definition, a medical device is “an article, instrument, apparatus, or machine that is used in the prevention, diagnosis, or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of

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