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Gilead signs licenses with generic drugmakers for hepatitis C drugs

Gilead signs licenses with generic drugmakers for hepatitis C drugs

15-09-2014

US biotech firm Gilead Sciences today signed non-exclusive licensing agreements with seven India-based…

Anti-viralsBiotechnologyCadila PharmaceuticalsCiplaGenericsGilead SciencesHeteroIndialedipasvirLicensingMylan LaboratoriesPricingRanbaxy LaboratoriessofosbuvirSovaldiStrides Arcolab

FDA accepts Tuzistra XR NDA for full review

FDA accepts Tuzistra XR NDA for full review

15-09-2014

The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription…

LicensingPharmaceuticalRegulationRespiratory and PulmonaryTris PharmaTuzistraUSAVernalis

Akashi gets rights to novel DMD treatment from Tonus

Akashi gets rights to novel DMD treatment from Tonus

15-09-2014

US clinical-stage biopharma firm Akashi Therapeutics has acquired global rights to GsMTx-4, a small molecule…

Akashi TherapeuticsGlobalGsMTx-4LicensingPharmaceuticalRare diseasesTonus Therapeutics

Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

Shire gets priority review for its Vyvanse sNDA in binge eating from FDA

15-09-2014

Ireland-headquartered drugmaker Shire has received acceptance for its filing with priority review for…

AbbVieIrelandNeurologicalPharmaceuticalRegulationShireVyvanse

Alchem International commits to tropane alkaloid APIs to resolve supply gap

15-09-2014

Following the decision by the principal European manufacturers to exit or end market development and…

Alchem InternationalGenericsIndiaMarkets & MarketingProductiontropane alkaloid

Biosimilars market could make vast cost savings - but only if it is sustainable: report

Biosimilars market could make vast cost savings - but only if it is sustainable: report

15-09-2014

Biosimilars stand to represent a major opportunity for cost saving across Europe as long as it becomes…

BiosimilarBiosimilarsDrugsEuropeEuropean Biosimilars GroupMarkets & Marketing

FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

In the second of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

PharmaceuticalPharmacologyRegulationResearchUSA

UK cancer charity partners with Asterias Biotherapies on lung cancer vaccine

UK cancer charity partners with Asterias Biotherapies on lung cancer vaccine

15-09-2014

The charity Cancer Research UK and its commercialization arm Cancer Research Technology (CRT), have reached…

Asterias BiotherapeuticsBiotechnologyBioTimeCancer Research TechnologyLicensingOncologyResearchUKVaccines

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