Regulation - Anti-virals, Ukraine

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GSK confirms further misconduct allegations, now in Jordan and Lebanon

17-04-2014

There has been recent publicity on cases of alleged misconduct by UK Pharma giant GlaxoSmithKline employees…

GlaxoSmithKlineJordanMarkets & MarketingPharmaceuticalRegulationRest of the World

EMA says that vials of falsified Herceptin have been identified

EMA says that vials of falsified Herceptin have been identified

16-04-2014

The European Medicines Agency says it has been informed that vials of Swiss drug major Roche’s blockbuster…

EuropeHealthcareHerceptinOncologyPharmaceuticalRegulationRoche

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

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

Ukraine drug imports halted due to VAT confusion

Ukraine drug imports halted due to VAT confusion

15-04-2014

Imports of medicines into Ukraine have completely stopped, due to current confusions regarding the value-added…

Eastern EuropeFinancialMarkets & MarketingPharmaceuticalUkraine

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

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