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2125 to 2149 of 2523 results

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

Two hurdles to jump for SkyePharma, as it changes CEO

31-01-2012

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

31-01-2012

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

31-01-2012

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

31-01-2012

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

30-01-2012

Seattle, USA-based Cell Therapeutics (Nasdaq and MTA: CTIC) says that it has voluntarily withdrawn its…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

30-01-2012

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

BiotechnologyEuropePharmaceuticalPricingRegulation

FDA finally approves Bydureon

30-01-2012

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

30-01-2012

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

30-01-2012

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

30-01-2012

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

EuropeGilenyaNeurologicalNovartisPharmaceuticalPricingRegulation

EC closes procedural case against Servier

29-01-2012

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

EuropeGenericsMarkets & MarketingPharmaceuticalRegulationServier

LEO Pharma gets FDA nod for Picato

29-01-2012

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

29-01-2012

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

27-01-2012

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

26-01-2012

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

Asia-PacificBiotechnologyGenericsRegulation

US FDA mixed views on Vytorin and Zetia

26-01-2012

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

25-01-2012

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

EuropeMerck KGaAMerck SeronoNeurologicalPharmaceuticalRebifRegulation

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