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US patient share leaders in first-line BRAF-mutation positive malignant melanoma

27-11-2013

According to US oncologists surveyed in the third quarter of 2013 by BioTrends Research, a unit of Decision…

Bristol-Myers SquibbGlaxoSmithKlineMarkets & MarketingMekinistNorth AmericaOncologyPharmaceuticalRocheTafinlarYervoyZelboraf

US FDA clears GlaxoSmithKline’s H5N1 flu vaccine

26-11-2013

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s pandemic Influenza…

GlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

US FDA eases restrictions on GSK diabetes drug Avandia

US FDA eases restrictions on GSK diabetes drug Avandia

26-11-2013

The US Food and Drug Administration yesterday (November 25) lifted some severe limitations on the prescribing…

AvandiaDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

Orexigen to resubmit US NDA for obesity drug Contrave

26-11-2013

Along with presenting new data for its weight loss drug candidate Contrave (naltrexone SR and bupropion…

ContraveMetabolicsNorth AmericaOrexigen TherapeuticsPharmaceuticalRegulationResearchTakeda Pharmaceuticals

“Breakthrough Therapy” status for Portola’s andexanet alfa

25-11-2013

USA-based Portola Pharmaceuticals has been granted “Breakthrough Therapy” designation by the US Food…

andexanet alfaBayerBristol-Myers SquibbCardio-vascularEliquisNorth AmericaPharmaceuticalPortola PharmaceuticalsRegulationResearchXarelto

J&J’s Invokana approved in Europe and Olysio cleared in USA

J&J’s Invokana approved in Europe and Olysio cleared in USA

25-11-2013

It was a good news day for US health care giant Johnson & Johnson, with two of its Janssen subsidiaries…

Anti-viralsDiabetesEuropeInvokanaJanssenJohnson & JohnsonMedivirNorth AmericaOlysioPharmaceuticalRegulation

Drug approvals for Bayer in USA and Japan

Drug approvals for Bayer in USA and Japan

23-11-2013

There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22),…

AmgenAsia-PacificBayerBiotechnologyEyleaNexavarNorth AmericaOncologyOnyx PharmaceuticalsOphthalmicsPharmaceuticalRegeneronRegulation

Cost of medicines covered by employee benefit plans in Canada “will be sustainable”

Cost of medicines covered by employee benefit plans in Canada “will be sustainable”

22-11-2013

One of the most rigorous and detailed forecasts ever conducted for the Canadian private drug plan market…

FinancialHealthcareNorth AmericaPharmaceutical

Drugmakers “poised to cash in on Obamacare’s coverage expansion,” says GlobalData

Drugmakers “poised to cash in on Obamacare’s coverage expansion,” says GlobalData

22-11-2013

Despite the noteworthy criticism that the USA’s Affordable Care Act (ACA) is attracting, pharmaceutical…

HealthcareNorth AmericaPharmaceutical

Sanofi and Regeneron report positive Phase III results with sarilumab in RA

Sanofi and Regeneron report positive Phase III results with sarilumab in RA

22-11-2013

French drug major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals (Nasdaq: REGN) have…

Anti-Arthritics/RheumaticsEuropeNorth AmericaPharmaceuticalRegeneronResearchSanofisarilumabUSA

Pfizer’s Xalkori gains regular FDA approval for NSCLC

Pfizer’s Xalkori gains regular FDA approval for NSCLC

22-11-2013

The US Food and Drug Administration yesterday (November 21) granted pharma behemoth Pfizer’s Xalkori…

North AmericaOncologyPfizerPharmaceuticalRegulationXalkori

FDA calls for more info from Forest and Gedeon Richter on cariprazine

21-11-2013

The US Food and Drug Administration has issued a complete response letter regarding the New Drug Application…

cariprazineForest LaboratoriesGedeon RichterNeurologicalNorth AmericaPharmaceuticalRegulation

Immunologist Yong-Jun Liu named head of research at MedImmune

Immunologist Yong-Jun Liu named head of research at MedImmune

20-11-2013

US-based MedImmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca…

BoardroomImmunologicalsMedImmuneNorth AmericaPharmaceuticalUSA

J&J unit DePuy in $2.5 billion US settlement relating to ASR Hip System

20-11-2013

US health care giant Johnson & Johnson’s subsidiary DePuy Orthopaedics and the Court-appointed committee…

DePuyFinancialJohnson & JohnsonLegalNorth AmericaPharmaceutical

Drug Quality and Security Act passes in US Senate

20-11-2013

After months of discussion in the US Congress, finally HR 3204, the Drug Quality and Security Act, which…

LegalMarkets & MarketingNorth AmericaPharmaceuticalProduction

FDA committee recommends approval for BioMarin's Vimizim

FDA committee recommends approval for BioMarin's Vimizim

20-11-2013

A US Food and Drug Administration panel has voted in favor of approval of Vimizim for the treatment of…

BioMarin PharmaceuticalNorth AmericaPharmaceuticalRare diseasesRegulationUSAVimizim

Horizon Pharma gets US rights for Vimovo from AstraZeneca

Horizon Pharma gets US rights for Vimovo from AstraZeneca

19-11-2013

USA-based Horizon Pharma has entered into an agreement to acquire from Anglo-Swedish drug major AstraZeneca…

Anti-Arthritics/RheumaticsAstraZenecaHorizon PharmaLicensingNorth AmericaPharmaceuticalPozenVimovo

US FDA accepts AstraZeneca’s NDA for naloxegol

US FDA accepts AstraZeneca’s NDA for naloxegol

19-11-2013

The US Food and Drug Administration has accepted the New Drug Application for naloxegol, an investigational…

AstraZenecaGastro-intestinalsnaloxegolNektar TherapeuticsNorth AmericaPharmaceuticalRegulation

Pharma figures high in EU R&D Investment Scoreboard, but led by US firms

19-11-2013

Though not topping the league table, the pharmaceutical industry had a number of drugmakers among the…

EuropeFinancialGlaxoSmithKlineJohnson & JohnsonMerck & CoNorth AmericaNovartisPfizerPharmaceuticalResearchRocheSanofi

AbbVie releases positive Phase III results for oral hepatitis C program

AbbVie releases positive Phase III results for oral hepatitis C program

18-11-2013

US drugmaker AbbVie has released the first Phase III results for the investigational three direct-acting-antiviral…

AbbVieAntibiotics and Infectious diseasesNorth AmericaPharmaceuticalResearchUSA

FDA says PCSK9 inhibitors may not require outcome studies

FDA says PCSK9 inhibitors may not require outcome studies

18-11-2013

The US Food and Drug Administration has said that pharma companies developing PCSK9 inhibitors will not…

Cardio-vascularNorth AmericaPharmaceuticalRegulationUSA

Zafgen’s obesity treatment beloranib demonstrates weight loss in Phase II results

Zafgen’s obesity treatment beloranib demonstrates weight loss in Phase II results

18-11-2013

Privately-owned US biopharmaceutical company Zafgen has announced final efficacy and safety data from…

beloranibMetabolicsNorth AmericaPharmaceuticalResearchUSAZafgen

FTC highlights focus on health care markets competition before Judiciary subcommittee

17-11-2013

The USA’s Federal Trade Commission described its ongoing efforts to protect competition and consumers…

HealthcareLegalMergers & AcquisitionsNorth AmericaPharmaceutical

Positive FDA panel recommendation for Vanda’s tasimelteon

Positive FDA panel recommendation for Vanda’s tasimelteon

15-11-2013

The US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee…

HetliozNorth AmericaOphthalmicsPharmaceuticalRegulationtasimelteonVanda Pharmaceuticals

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