Regulation - GlaxoSmithKline

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Prosonix and Mylan in deal for Flixotide and Flovent generics

15-04-2014

Prosonix, a UK-based company which is developing a portfolio of inhaled “Respiratory Medicines by Design,”…

FloventGenericsGlaxoSmithKlineGlobalLicensingMylan LaboratoriesProsonixRespiratory and Pulmonary

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

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

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

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

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

EMA plans targeted discussions on clinical trial data policy

EMA plans targeted discussions on clinical trial data policy

09-04-2014

The European Medicines Agency will launch a final round of targeted consultations with key stakeholders…

EuropePharmaceuticalRegulationResearch

Pharmacyclics seeks additional indication for Imbruvica in USA

Pharmacyclics seeks additional indication for Imbruvica in USA

08-04-2014

USA-based Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug…

BiotechnologyImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmacyclicsRegulationUSA

Teva launches first generic Lovaza in USA

Teva launches first generic Lovaza in USA

08-04-2014

Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval…

Cardio-vascularGenericsGlaxoSmithKlineLovazaMarkets & MarketingRegulationTeva Pharmaceutical IndustriesUSA

US/EU generic industries call for thoughtful changes to speed medicines to patients

US/EU generic industries call for thoughtful changes to speed medicines to patients

08-04-2014

In a joint letter sent to the European Commission and the Office of the US Trade Representative, the…

EuropeGenericsPoliticsRegulationUSA

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