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2125 to 2149 of 2523 results

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Seattle, USA-based Cell Therapeutics (Nasdaq and MTA: CTIC) says that it has voluntarily withdrawn its…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

Germany’s IQWiG finds “hint” of advantage for Novartis’ Gilenya


The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed whether Swiss drug…


EC closes procedural case against Servier


The European Commission said last Friday that it has closed an investigation into Fremch independent…

EuropeGenericsMarkets & MarketingPharmaceuticalRegulationServier

LEO Pharma gets FDA nod for Picato


Independent Danish drugmaker LEO Pharma says that the US Food and Drug Administration has approved its…

DermatologicalsLEO PharmaNorth AmericaPharmaceuticalPicatoRegulation

French government delists certain Ipsen products


French drugmaker Ipsen (Euronext: IPN) announced the French government’s decision to no longer reimburse…

EuropeGingko bilobaIpsenMarkets & MarketingNeurologicalPharmaceuticalRegulation

Department of Justice seeks permanent injunction against Ranbaxy


The US Department of Justice, on behalf of the Food and Drug Administration, has filed a consent decree…

Asia-PacificGenericsLegalNorth AmericaRanbaxy LaboratoriesRegulation

Overview of biologic regulations in India


Currently, all biologics in India, including innovative and copy biologics are approved as new drugs,…


US FDA mixed views on Vytorin and Zetia


US drug giant Merck & Co (NYSE: MRK) yesterday received Food and Drug Administration approval to update…

Cardio-vascularMerck & CoNephrology and HepatologyNorth AmericaPharmaceuticalRegulationVytorinZetia

Expanded use for Merck Serono’s Rebif in EU


Merck Serono, the Switzerland-based division of Germany’s Merck KGaA (MRK: DE), says that that the…

EuropeMerck KGaAMerck SeronoNeurologicalPharmaceuticalRebifRegulation

2125 to 2149 of 2523 results

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Eleven Biotherapeutics

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