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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

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