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EMA guidelines on pharmacogenetics in evaluating pharmacokinetics of medicines


The European Medicines Agency on Friday published a guideline advising pharmaceutical companies how to…


At last, draft guidance on biosimilars pathway from US FDA


Coming somewhat behind European Union action, the US Food and Drug Administration late yesterday issued…

BiotechnologyGenericsNorth AmericaRegulation

Shire forecasts strong 2012 EPS growth on record 2011 sales; Vyvanse news


Shire (LSE: SHP), the UK’s third-largest drugmaker, posted a pleasing set of financial for full-year…

FinancialNeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

Global peptic ulcer market forecast to reach $1.05 billion by 2018; FDA warns on PPIs


The global peptic ulcer therapeutics market was worth $892.4 million in 2010, and is forecast to grow…

Gastro-intestinalsMarkets & MarketingPharmaceuticalRegulation

Amgen fails to get FDA advisory backing for extended use of Xgeva


The world’s largest independent biotech firm, Amgen (Nasdaq: AMGN), has failed to convince a Food…

AmgenBiotechnologyNorth AmericaOncologyPharmaceuticalRegulationXgeva

GW Pharma’s Sativex cleared in Austria


The UK’s GW Pharmaceuticals’ (AIM: GWP) Sativex (delta-9-tetrahydrocannabinol (THC) and cannabidiol…

AlmirallEuropeGW PharmaceuticalsNeurologicalPharmaceuticalRegulationSativex

Another FDA hurdle for Orexigen obesity drug candidate


It might seem to some that the US Food and Drug Administration has no intentions of approving any new…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearchTakeda Pharmaceuticals

Merck & Co confirms NDA filing for suvorexant in 2012


US drugs giant Merck & Co (NYSE: MRK) yesterday provided an update on the development program for suvorexant,…

Merck & CoNeurologicalNorth AmericaPharmaceuticalRegulationResearchsuvorexant

Reinventing biopharma: Strategies for an evolving marketplace


The biopharmaceutical industry today is facing a multifaceted “value challenge”. It is no longer…

BiotechnologyGlobalMarkets & MarketingPharmaceuticalPricingRegulation

New bipartisan legislation to address US drug shortages


US Representatives John Carney (Democrat, Delaware) and Larry Bucshon (Republican, Indian) last week…

GenericsLegalNorth AmericaPharmaceuticalRegulation

EMA planning fundamental change in pharmacovigilance rules


The European Medicines Agency, together with the European Union member states and the European Commission,…


NICE issues negative guidance for Zytiga


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

EuropeJanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationZytiga

FDA approves combo diabetes drug Jentadueto and Kalydeco


The US Food and Drug Administration) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets,…

Boehringer IngelheimDiabetesEli LillyJentaduetoKalydecolinagliptinNorth AmericaPharmaceuticalRare diseasesRegulationVertex

Two hurdles to jump for SkyePharma, as it changes CEO


On the same day that UK-based SkyePharma (LSE: SKP) announced that Axel Mueller has resigned as chief…

3MEuropeFinancialFlutiformManagementPharmaceuticalRegulationRespiratory and PulmonarySkyepharma

Allos Thera questions CHMP Folotyn decision; posts new data


USA-based Allos Therapeutics, Inc. (Nasdaq: ALTH) says that it has submitted a request to the European…

Allos TherapeuticsEuropeFolotynOncologyPharmaceuticalRegulationResearch

PhRMA transitions management of BRAT framework to CIRS


The Pharmaceutical Research and Manufacturers of America (PhRMA) says it has transferred its Benefit-Risk…

North AmericaPharmaceuticalRegulationResearch

Faster-than-expected FDA approval of Roche’s vismodegib


There was good news for Swiss drug major Roche's (ROG: SIX)subsidiary Genentech yesterday, when it received…

BiotechnologyCurisErivedgeGenentechNorth AmericaOncologyPharmaceuticalRegulationRochevismodegib

Cell Therapeutics updates on Pixuvri


Seattle, USA-based Cell Therapeutics (Nasdaq and MTA: CTIC) says that it has voluntarily withdrawn its…

BiotechnologyCell TherapeuticsNorth AmericaOncologyPixuvriRegulation

Irish pharma sees failures in ESRI report on use of pharmaceuticals


A new report by Ireland’s Economic and Social Research Institute (ESRI) has recommended new ways…


FDA finally approves Bydureon


There was good news on Friday for USA-based Amylin Pharmaceuticals (Nasdaq: AMLN) and Alkermes (Nasdaq:…

AlkermesAmylinBydureonDiabetesEli LillyNorth AmericaPharmaceuticalRegulation

EC and Italian government seek to boost generic medicine use


The European Commission’s formal call last week on Italy to comply with European Union rules on…

EuropeGenericsMarkets & MarketingPatentsPharmaceuticalPoliticsRegulation

FDA OKs Pfizer’s Inlyta and accepts NDA for bosutinib


The US Food and Drug Administration on Friday approved global pharma behemoth Pfizer’s (NYSE: PFE)…

bosutinibInlytaNorth AmericaOncologyPfizerPharmaceuticalRegulation

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