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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

GSK faces bribery allegations in Poland

GSK faces bribery allegations in Poland

14-04-2014

UK pharma major GlaxoSmithKline is facing allegations of bribing doctors in Poland, according to the…

BBCGlaxoSmithKlineGSK regional managerLegalMajorMedicinePharmaceuticalPolandPulmonologyRespiratory and PulmonarySeretideUK

Russia may tighten criteria for the patentability of drugs

Russia may tighten criteria for the patentability of drugs

14-04-2014

The Russian Federal Anti-Monopoly Service is considering tightening the criteria of patentability, in…

Eastern EuropePatentsPharmaceuticalPoliticsRussia

RaQualia and Asahi Kasei Pharma progress their collaboration

RaQualia and Asahi Kasei Pharma progress their collaboration

14-04-2014

RaQualia Pharma says that its ongoing joint research with fellow Japanese drugmaker Asahi Kasei Pharma…

Asahi KaseiJapanLicensingPharmaceuticalRaQualia PharmaResearch

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

Sylvia Mathews Burwell nominated as next US HHS Secretary as Sebelius quits

Sylvia Mathews Burwell nominated as next US HHS Secretary as Sebelius quits

14-04-2014

On Friday in a Rose Garden ceremony, US President Barack Obama announced that Sylvia Mathews Burwell,…

ManagementNorth AmericaPharmaceuticalPoliticsUSA

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

UAE’s Julphar inks five-year deal to market Merck & Co drugs

11-04-2014

United Arab Emirates-based drugmaker Julphar has signed a five-year licensing deal with US pharma giant…

JulpharLicensingMerck & CoPharmaceutical

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

Interview: AstraZeneca’s oncology expert Susan Galbraith on the company’s exciting pipeline

Interview: AstraZeneca’s oncology expert Susan Galbraith on the company’s exciting pipeline

11-04-2014

The full year report from Anglo-Swedish drug major AstraZeneca (LSE: AZN) in February was full of optimism.…

AstraZenecaInterviewsIressaOncologyPharmaceuticalUK

Potential growth trajectories for the US biopharmaceutical sector

Potential growth trajectories for the US biopharmaceutical sector

11-04-2014

The Pharmaceutical Research and Manufacturers of America (PhRMA) yesterday released a report that outlines…

North AmericaPharmaceuticalPoliticsResearchUSA

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

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