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Amarin plunges as FDA denies appeal on ANCHOR trial SPA

14-09-2014

Shares of US biotech firm Amarin Corp tanked 23.7% to $1.38 on Friday in heavy trading, when the company…

AmarinCardio-vascularGlaxoSmithKlineLovazaPharmaceuticalRegulationVascepa

EMA’s PRAC concludes review of Valdoxan/Thymanax

14-09-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded its regular…

EuropeNeurologicalPharmaceuticalRegulationServierThymanaxValdoxan

Further guidance on adaptive licensing pilot project available from EMA

12-09-2014

Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines…

EuropePharmaceuticalRegulation

HAI takes issue with move of pharma policy to DG Enterprise and Industry

HAI takes issue with move of pharma policy to DG Enterprise and Industry

12-09-2014

Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s…

EuropePharmaceuticalPoliticsRegulationResearch

ABPI and Department of Health announce second PPRS payment

ABPI and Department of Health announce second PPRS payment

12-09-2014

The Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health have announced…

Association of the British Pharmaceutical IndustryNHS EnglandPharmaceuticalRegulationUK

FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

FDA advisory votes to approve Novo Nordisk diabetes drug for obesity

12-09-2014

There was good news for Danish diabetes care giant Novo Nordisk yesterday, when the US Food and drug…

liraglutideMetabolicsNovo NordiskPharmaceuticalRegulationSaxenda

Indian clinical trial rules counter-productive, says ASSOCHAM

Indian clinical trial rules counter-productive, says ASSOCHAM

10-09-2014

The Associated Chambers of Commerce and Industry of India (ASSOCHAM ) has expressed concern at the setback…

IndiaPharmaceuticalPoliticsRegulationResearch

FDA Advisory votes against approving Actavis nebivolol/valsartan combo

FDA Advisory votes against approving Actavis nebivolol/valsartan combo

10-09-2014

Ireland-based generic drug major Actavis yesterday confirmed that the US Food and Drug Administration's…

ActavisCardio-vascularnebivololPharmaceuticalRegulationUSAvalsartan

Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

09-09-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published new draft…

AbraxaneBiotechnologyCelgene Corp.OncologyPaclitaxelPricingRegulationUK

Roche’s RoActemra gains EU approval for use in early RA

Roche’s RoActemra gains EU approval for use in early RA

08-09-2014

The European Commission has approved Swiss pharma major Roche’s RoActemra (tocilizumab) for use in…

ActemraAnti-Arthritics/RheumaticsEuropeInterleukin 6PharmaceuticalRegulationRoActemraRoche

Astellas' isavuconazole NDA accepted by US FDA

Astellas' isavuconazole NDA accepted by US FDA

08-09-2014

The US Food and Drug Administration has accepted a New Drug Application filing by Japanese drug major…

Astellas PharmaFungal diseasesInvasive aspergillosisInvasive mucormycosisisavuconazoleOncologyPharmaceuticalRegulationUSA

New report debunks some common perceptions of R&D productivity

New report debunks some common perceptions of R&D productivity

08-09-2014

The 2014 edition of the Thomson Reuters CMR Pharmaceutical R&D Factbook, published today, contains some…

GlobalMarkets & MarketingPharmaceuticalRegulationResearch

FDA accepts Actavis’ NDA for ceftazidime-avibactam

FDA accepts Actavis’ NDA for ceftazidime-avibactam

05-09-2014

Ireland-headquartered generic drugs major Actavis today confirmed that the US Food and Drug Administration…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamPharmaceuticalRegulationResearchUSA

FDA lifts partial clinical hold on OncoMed's ipafricept

05-09-2014

Shares of US biotech companies OncoMed Pharmaceuticals rose 5.6% to $17.68 on news that the US Food and…

BayerBiotechnologyipafriceptOncologyOncoMed PharmaceuticalsRegulationResearchUSA

Australia's federal court rules that companies can patent genetic material

Australia's federal court rules that companies can patent genetic material

05-09-2014

The Full Bench of the Federal Court of Australia has decided a private company may hold a patent on a…

AustraliaBiotechnologyIntellectual propertyLegalPatentsPharmaceutical sciencesRegulation

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

05-09-2014

The US Food and Drug Administration has granted accelerated approval for pharma giant Merck & Co’s…

KeytrudaMerck & CoOncologypembrolizumabPharmaceuticalRegulationUSA

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