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US FDA again delays action on Takeda's alogliptin diabetes drug


Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has received a complete response…

ActosalogliptinDiabetesNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticals

First Cushing's drug, Novartis' Signifor, approved in the EU


The European Commission has approved Swiss drug major Novartis' (NOVN: VX) Signifor (pasireotide) for…

EuropeNovartisOncologyPharmaceuticalRare diseasesRegulationSignifor

FDA extends review of Ironwood and Forest's linaclotide to September


The US Food and Drug Administration has told USA-based drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD)…

Forest LaboratoriesGastro-intestinalsIronwood PharmaceuticalslinaclotideNorth AmericaPharmaceuticalRegulation

Canada's drug review process needs enhancements, says diabetes charity


According to a new report by the charity the Canadian Diabetes Association, despite improvements to Canada's…

North AmericaPharmaceuticalRegulation

FDA strengthens monitoring of post-approval drug safety


In what is seen as a response to criticism that the agency lacks teeth in monitoring drugs once they…

BiotechnologyMarkets & MarketingNorth AmericaPharmaceuticalRegulation

Positive Ph III results for Novo Nordisk's degludec; US advocacy calls for Victoza's withdrawal


Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Crucial need for global development of biosimilars, says head of European generics group


"The need for a framework which allows global biosimilars development is now crucial," argued European…


US Senators Burr and Coburn introduce legislation to reform FDA


US Senators Richard Burr (Republican, North Carolina) and Tom Coburn (Republican, Oklahoma) this week…

BiotechnologyLegalNorth AmericaPharmaceuticalPoliticsRegulation

Leahy Bill would boost generic drug safety in USA, says consumer group


A bill giving generic drug manufacturers in the USA the authority to revise labeling for their products…

GenericsNorth AmericaPoliticsRegulation

PhRMA welcomes US Congressional support for Pediatric Reauthorization ACT


US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has welcomed the bipartisan…

LegalNorth AmericaPharmaceuticalRegulation

Towards a robust global framework for conduct and oversight of clinical trials in EU


The European Medicines Agency has published the final reflection paper on ethical and good clinical practice…


NICE turns down Roche breast cancer drug Avastin, citing too many uncertainties


UK drug watchdog the National Institute for Health and Clinical Excellence (NICE), said this morning…


Halozyme plunges as FDA call for more data on HyQ BLA


USA-based Halozyme Therapeutics saw its shares plummet 24% to $8.56 by close of trading yesterday, after…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQImmunologicalsNorth AmericaRegulation

No proof of added benefit of Sativex, says German IQWiG


In an early benefit assessment under to the German Act on the Reform of the Market for Medicinal Products…

AlmirallEuropeGW PharmaceuticalsNeurologicalPharmaceuticalPricingRegulationSativex

Legislative changes to hamper near-term innovative drugs market in Central Europe


Due to legislative changes implemented during 2011 in most of the Central European (CE) countries, the…

EuropeGenericsMarkets & MarketingPharmaceuticalPricingRegulation

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