Drug Development Pharma - January 9, 2014
FDA and European Medicines Agency launch generic drug application inspections initiative
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies. Studies […]
Drug Development Pharma - November 19, 2013
Naloxegol reaches milestone
AstraZeneca has announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol. The investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) has been studied in opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, the most common side effect caused by chronic administration of prescription opioid pain […]
Pharma Business - October 17, 2013
FDA approval of Novo Nordisk’s BLA Novoeight
Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) have approved its Biologics License Application (BLA) for recombinant coagulation factor VIII, Novoeight. The FDA approved Novoeight for use in adults and children with haemophilia A for control and prevention of bleeding, perioperative management and routine prophylaxis to prevent or reduce the frequency […]
Drug Development Pharma - October 9, 2013
Takeda and Lundbeck announce FDA approval of Brintellix
Takeda Pharmaceutical Company and H. Lundbeck A/S jointly have announced that the U.S. Food and Drug Administration (FDA) has approved Brintellix (vortioxetine) for the treatment of adults with major depressive disorder (MDD). “MDD is a multifaceted disorder that encompasses emotional, physical and cognitive symptoms that may make it challenging to treat,” said Michael Thase, M.D., […]
