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Major changes at US FDA, with new posts and appointments


The world of FDA regulation is changing rapidly and, in an effort to keep current, US Food and Drug Administration…

BiotechnologyGenericsManagementNorth AmericaPharmaceuticalRegulation

Shire’s Lialda now OKed for ulcerative colitis maintenance of remission in the USA


The US Food and Drug Administration has approved Ireland-headquartered specialty drugmaker Shire’s…

Gastro-intestinalsLialdaNorth AmericaPharmaceuticalRegulationShire

Roche to file for approval of pertuzumab, which does well as combo in Ph III breast cancer trial


Swiss drug major Roche (ROG: SIX) says it plans to seek approval of its monoclonal antibody pertuzumab…


European Commission and Australia OK Bristol-Myers Yervoy and Novo Nordisk’s FlexTouch


Following a recent positive recommendation from the European Medicine Agency’s advisory panel, Bristol-Myers…

Bristol-Myers SquibbDiabetesEuropeFlexTouchNovo NordiskOncologyPharmaceuticalRegulationYervoy

Two key validation steps for Livatag achieved by BioAlliance Pharma


French orphan cancer drug developer BioAlliance Pharma (Euronext Paris: BIO) has announced the validation…

BioAlliance PharmaLivatagOncologyPharmaceuticalRegulationResearch

API production in Russia: scarce but slowly developing


Over the past few years a trend toward slow development has been observed on the part of producers of…

EuropeGenericsMarkets & MarketingPharmaceuticalRegulationResearch

New pan-Canadian cancer drug review process gets underway


Cancer patients and clinicians in Canadians are set to benefit from the implementation of the pan-Canadian…

North AmericaOncologyPharmaceuticalPricingRegulation

Transcept Pharma expects further FDA delay for Intermezzo NDA


Following a teleconference with the US Food and Drug Administration, neurosciences company Transcept…

IntermezzoNeurologicalNorth AmericaPharmaceuticalRegulationTranscept Pharmazolpidem

Room for improvement of HTA process to accelerate medicines access


A new report on Health Technology Assessment (HTA) processes published today highlights significant areas…

Asia-PacificBiotechnologyEuropeNorth AmericaPharmaceuticalRegulation

Canada amends market authorization for “extraordinary use new drugs”


The government of Canada has introduced amendments to the Food and Drug Regulations and the Patented…

North AmericaPharmaceuticalRegulation

Eisai to file Zonegran as first-line epilepsy therapy in Europe on good trial results


Based on the positive results of a late-stage clinical trial, Japanese drug major Eisai’s (TYO:…


US FDA consults on companion diagnostics


The US Food and Drug Administration yesterday issued a new draft guidance to facilitate the development…

North AmericaPharmaceuticalRegulation

Lilly CEO warns that Germany’s health reforms are harming innovation


Speaking to the Federation of German Industries Conference in Germany last week, John Lechleiter, chairman,…

Eli LillyEuropePharmaceuticalPoliticsPricingRegulation

Amylin and Lilly to re-file Bydureon with US FDA sooner than expected with new tQT data


Amylin Pharmaceuticals (Nasdaq: AMLN), Eli Lilly (NYSE: LLY) and Alkermes (Nasdaq: ALKS) have announced…

AlkermesAmylinBydureonDiabetesEli LillyPharmaceuticalRegulationResearch

GlaxoSmithKline files for expanded Votrient use in USA and Europe


UK pharma giant GlaxoSmithKline (LSE: GSK) says that it has submitted a variation to the Marketing Authorisation…

EuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationVotrient

US Biotech posts strong second quarter gain, says Burrill


Anyone attending the 2011 BIO International Convention in Washington DC, which concluded last week, would…

BiotechnologyFinancialMergers & AcquisitionsNorth AmericaRegulation

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