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2151 to 2175 of 2534 results

Bayer’s Xarelto gets backing in Scotland

14-02-2012

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

BayerCardio-vascularEuropePharmaceuticalPricingRegulationXarelto

Rush Bill would make most patent settlement deals in USA unlawful

14-02-2012

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

14-02-2012

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

EuropeGlaxoSmithKlineHerceptinOncologyPharmaceuticalPricingRegulationRocheTyverb

Columbia Labs hands over NDA to Watson

13-02-2012

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

13-02-2012

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

13-02-2012

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

12-02-2012

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

12-02-2012

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

12-02-2012

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

BiotechnologyEuropePharmaceuticalRegulationResearch

At last, draft guidance on biosimilars pathway from US FDA

10-02-2012

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

10-02-2012

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

09-02-2012

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

09-02-2012

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

07-02-2012

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

AlmirallEuropeGW PharmaceuticalsNeurologicalPharmaceuticalRegulationSativex

Another FDA hurdle for Orexigen obesity drug candidate

07-02-2012

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

07-02-2012

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

07-02-2012

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

BiotechnologyGlobalMarkets & MarketingPharmaceuticalPricingRegulation

New bipartisan legislation to address US drug shortages

06-02-2012

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

GenericsLegalNorth AmericaPharmaceuticalRegulation

EMA planning fundamental change in pharmacovigilance rules

03-02-2012

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

BiotechnologyEuropePharmaceuticalRegulation

NICE issues negative guidance for Zytiga

02-02-2012

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

01-02-2012

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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