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2151 to 2175 of 2534 results

Bayer’s Xarelto gets backing in Scotland


German drug major Bayer’s (BAY: DE) oral anticoagulant Xarelto (rivaroxaban) has been accepted by…


Rush Bill would make most patent settlement deals in USA unlawful


Last week, US Representative Bobby Rush (Democrat, Illinois) introduced HR 3995, the Protecting Consumer…

GenericsLegalNorth AmericaPharmaceuticalRegulation

NICE views breast cancer drugs from GSK and Roche too expensive


The UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft…


Columbia Labs hands over NDA to Watson


Columbia Laboratories (Nasdaq: CBRX) has transferred the New Drug Application for progesterone vaginal…

Columbia LaboratoriesCrinoneLicensingNorth AmericaPharmaceuticalRegulationReproductiveWatson PharmaceuticalsWomen's Health

FDA wants more info on Menveo; advisory negative on Dacogen


Swiss drug major Novartis (NOVN: VX) said this morning that it has received a Complete Response letter…

Astex PharmaceuticalsDacogenEisaiMenveoNorth AmericaNovartisOncologyPharmaceuticalRegulationVaccines

Watson confirms patent challenge to Bayer’s Beyaz


US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) on Friday confirmed that its subsidiary, Watson…

BayerBeyazGenericsNorth AmericaPatentsRegulationReproductiveWatson Pharmaceuticals

Fitch backs FDA planned guidelines, saying they open the door to biosimilars


Fitch Ratings believes the US Federal Drug and Administration's proposed biosimilar pathway regulations,…

BiotechnologyGenericsHospiraNorth AmericaRegulation

Clinical market in CIS to exceed $940 million euros in 2014


Clinical trials in the Commonwealth of Independent States (CIS) countries have been developing in a positive…

EuropeMarkets & MarketingPharmaceuticalRegulationResearch

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At last, draft guidance on biosimilars pathway from US FDA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

2151 to 2175 of 2534 results

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