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Bio-Techne to acquire China’s PrimeGene

15-04-2014

Techne Corp (d/b/a Bio-Techne) says that its R&D Systems China subsidiary has entered into an agreement…

Bio-TechneBiotechnologyMergers & AcquisitionsPrimeGene Bio-Tech

New report finds upturn in the Swiss biotech sector in 2013

15-04-2014

The Swiss biotech sector saw increases in terms of net sales, capital investments and number of employees,…

BiotechnologyBusiness FinanceBusiness FinanceEnvironmentHelvetiiMarkets & MarketingNorthern EuropeSwitzerland

Dutch biotech Mucosis partners with Chinese firm

Dutch biotech Mucosis partners with Chinese firm

15-04-2014

Dutch biotech company Mucosis has entered into a long-term collaboration and license agreement with China-based…

BiotechnologyChangchunChief executiveChinaDiseaseHuman respiratory syncytial virusLicensingMimopath technologyNetherlandsVaccines

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

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

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

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

Emerging therapies for relapsed/refractory CLL/SLL expected to offer efficacy benefits

Emerging therapies for relapsed/refractory CLL/SLL expected to offer efficacy benefits

11-04-2014

The effect of a therapy on overall survival and progression-free survival are attributes that most influence…

BiotechnologyEuropeGilead SciencesidelalisibImbruvicaJohnson & JohnsonMarkets & MarketingOncologyUSA

Ampio’s Vyrix unit out-licenses certain rights for Zertane to Paladin

10-04-2014

USA-based biotech firm Ampio Pharmaceuticals says its wholly-owned subsidiary Vyrix Pharmaceuticals…

Ampio PharmaceuticalsBiotechnologyEndo Health SolutionsLicensingMen's HealthPaladin LabsVyrix PharmaceuticalsZertane

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

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