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Tetraphase reports positive oral dosing data in Phase III of eravacycline

Tetraphase reports positive oral dosing data in Phase III of eravacycline

03-09-2014

US pharma company Tetraphase Pharmaceutical has announced positive top-line data from the lead-in portion…

Antibiotics and Infectious diseasesComplicated urinary tract infectionseravacyclineLevofloxacinPharmaceuticalResearchTetraphase PharmaceuticalsUS Food and Drug AdministrationUSA

Ipsen receives priority review for sNDA for Somatuline

Ipsen receives priority review for sNDA for Somatuline

01-09-2014

French drugmaker Ipsen has received priority review for its supplemental New Drug Application from the…

Gastroenteropancreatic neuroendocrine tumorsIpsenOncologyPharmaceuticalRegulationSomatulineUS Food and Drug AdministrationUSA

India's Piramal will divert resources from early-stage research to advanced-stage molecules

India's Piramal will divert resources from early-stage research to advanced-stage molecules

29-08-2014

Indian pharma company Piramal Enterprises has announced its intention to stop early-stage research in…

IndiaMetabolic disordersPharmaceuticalPiramal EnterprisesPiramal HealthcareProductionResearchSwati PiramalUS Food and Drug Administration

Takeda's 10-year study finds no link between pioglitazone and bladder cancer

Takeda's 10-year study finds no link between pioglitazone and bladder cancer

29-08-2014

Japan’s largest drugmaker Takeda has completed the post-marketing commitment and data submissions to…

Bladder cancerEuropean Medicines AgencyJapanOncologyPharmaceuticalPioglitazoneRegulationResearchTakeda PharmaceuticalsUS Food and Drug Administration

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

15-08-2014

There was good news late yesterday for German family-owned pharma major Boehringer Ingelheim, when an…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivatiotropiumUS Food and Drug AdministrationUSA

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

08-08-2014

Canadian RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals revealed yesterday that…

Anti-viralsEbolaMicrobiologyPharmaceuticalRegulationResearchTekmira PharmaceuticalsTKM-EbolaUS Food and Drug AdministrationUSA

US Senators call for immediate release of guidance on biosimilar drugs

US Senators call for immediate release of guidance on biosimilar drugs

06-08-2014

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in…

BiosimilarsGenericsPoliticsRegulationUS Food and Drug AdministrationUSA

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