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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

Negative results for asthma candidate cause Cytos Biotech to look at liquidation

14-04-2014

Swiss drug developer Cytos Biotechnology today revealed that the Phase IIb study of CYT003 in patients…

BiotechnologyFinancialResearchRespiratory and Pulmonary

NeoStem to acquire California Stem Cell, expanding pipeline

14-04-2014

USA-based NeoStem has entered into a definitive agreement to acquire California Stem Cell, an Irvine,…

BiotechnologyCalifornia Stem Cellmelapuldencel-TMergers & AcquisitionsNeoStemOncologyResearch

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

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

Obeticholic acid produces meaningful biochemical and clinical improvements in PBC cirrhosis patients

14-04-2014

Results from an international Phase III study presented at the European Association for the Study of…

Intercept PharmaceuticalsNephrology and Hepatologyobeticholic acidPharmaceuticalResearch

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

Joint initiative aims to expedite clinical research in Brazil

Joint initiative aims to expedite clinical research in Brazil

14-04-2014

Representatives from universities, scientific research institutions and the pharmaceutical industry created…

BrazilCentral EuropeHealthNational Health Surveillance AgencyPharmaceuticalPharmaceutical industryPharmacologyPoliticsResearch

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

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

Immune responses enhanced and sustained when Provenge is given after ADT in prostate cancer

Immune responses enhanced and sustained when Provenge is given after ADT in prostate cancer

12-04-2014

US biotech firm Dendreon has released positive preliminary data from a long-term analysis of the Phase…

BiotechnologyDendreonOncologyProvengeResearch

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

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