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European neurologists expect Biogen Idec’s Tecfidera to be preferred MS drug

European neurologists expect Biogen Idec’s Tecfidera to be preferred MS drug

16-04-2014

Surveyed neurologists in France, Germany, Italy, Spain and the UK project that 16% of their diagnosed…

AubagioBiogen IdecChemistryCNS DiseasesEuropeGenzymeMajorPharmaceuticalPharmacologyPhysicianResearchSANTecfidera

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

16-04-2014

UK pharma giant GlaxoSmithKline yesterday received the much anticipated approval from the US Food and…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationTanzeumUSA

EMA concludes inquiry into Roche infringement procedure

EMA concludes inquiry into Roche infringement procedure

14-04-2014

The European Medicines Agency says it has concluded its inquiry into alleged non-compliance with pharmacovigilance…

EuropePharmaceuticalRegulationRoche

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

Extended US market exclusivity for BioMarin's rare disease drug Kuvan

14-04-2014

US drugmaker BioMarin Pharmaceutical says that the Food and Drug Administration has granted Kuvan (sapropterin…

BioMarin PharmaceuticalKuvanNorth AmericaPharmaceuticalRare diseasesRegulationUSA

Ukraine pharma trade group APRaD sets out priorities with Vice PM and Customs authority

Ukraine pharma trade group APRaD sets out priorities with Vice PM and Customs authority

14-04-2014

The Ukraine Association of Pharmaceutical Research and Development (APRaD) participated in a meeting…

Eastern EuropePharmaceuticalPoliticsPricingRegulationUkraine

AbbVie achieves response rate of 96% in Phase III trials of hepatitis C treatment

AbbVie achieves response rate of 96% in Phase III trials of hepatitis C treatment

14-04-2014

US drugmaker AbbVie has revealed promising new results from its hepatitis C development program at the…

AbbVieAnti-viralsPharmaceuticalResearchUSA

Impressive data for once-daily sofosbuvir and ledipasvir treatment of HCV genotype 1

12-04-2014

Strong results from three Phase III clinical trials (ION-1, ION-2 and ION-3) evaluating the investigational…

Anti-viralsBiotechnologyGilead SciencesledipasvirResearchsofosbuvirSovaldi

Impax Pharma resubmits NDA for Rytary

Impax Pharma resubmits NDA for Rytary

11-04-2014

Impax Laboratories’ branded products division has resubmitted the New Drug Application for Rytary (carbidopa…

Impax LaboratoriesNeurologicalNorth AmericaPharmaceuticalRegulationRytaryUSA

Pharmacovigilance Risk Assessment Committee April meeting highlights

Pharmacovigilance Risk Assessment Committee April meeting highlights

11-04-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation…

Cardio-vascularEuropeMen's HealthNeurologicalPharmaceuticalRegulationRespiratory and Pulmonary

RAPS Taiwan Chapter becomes first in Asia

11-04-2014

The Regulatory Affairs Professionals Society (RAPS) has announced the establishment of a new chapter…

Asia-PacificMarkets & MarketingPharmaceuticalRegulation

Bristol-Myers’ all-oral daclatasvir and asunaprevir combo shines in Ph III

Bristol-Myers’ all-oral daclatasvir and asunaprevir combo shines in Ph III

10-04-2014

US pharma major Bristol-Myers Squibb has presented new Phase III trial data of its combination therapy…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirPharmaceuticalResearch

Promising results for Merck & Co’s hepatitis C drug combo

Promising results for Merck & Co’s hepatitis C drug combo

10-04-2014

US pharma giant Merck & Co has announced additional data from the ongoing C-WORTHy study, a multi-arm…

Anti-viralsMerck & CoMK-5172PharmaceuticalResearch

Sovaldi effective for retreatment of chronic hepatitis C in patients not cured with prior antiviral therapy

Sovaldi effective for retreatment of chronic hepatitis C in patients not cured with prior antiviral therapy

10-04-2014

US antivirals major Gilead Sciences today announced positive findings from an open-label clinical trial…

Anti-viralsBiotechnologyGilead SciencesResearchSovaldi

GSK’s Tafinlar also no added benefit over vemurafenib, says IQWiG

GSK’s Tafinlar also no added benefit over vemurafenib, says IQWiG

09-04-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

GermanyGlaxoSmithKlineNorthern EuropeOncologyPharmaceuticalPricingRegulationTafinlarvemurafenib

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

09-04-2014

US biopharma firm Halozyme Therapeutics says that the US Food and Drug Administration informed the company…

Halozyme TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationResearchUSA

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