• The FDA published fee notices by the Generic Drug User Fee Amendments of 2012, establishing fee amounts and due dates for applications pending on Oct. 1, which are considered backlog applications, and for new generic drug submissions received as of Oct. 1. Read More
• Dainippon Sumitomo Pharma Co. Ltd., of Osaka, Japan, and Takeda Pharmaceutical Co. Ltd., also of Osaka, said the European Medicines Agency confirmed the acceptance for review of the marketing application for atypical antipsychotic medication lurasidone, an oral, once-daily drug, for treating schizophrenia. Read More
• Durata Therapeutics Inc., of Morristown, N.J., reached its target enrollment for DISCOVER 2 (Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response), the second global Phase III trial of Durata's lead product candidate, dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria. Read More
• Amarantus BioSciences Inc., of Sunnyvale, Calif., said it received positive behavorial efficacy data for MANF in a neurorestoration 6-hydroxydopamine rat model of Parkinson's disease. Read More
Nearly one in four marketed drugs contains the chemical element fluorine, including household names for vastly different indications such as Lipitor (atorvastatin, Pfizer Inc.), Cipro (ciprofloxacin, Bayer AG) and Prozac (fluoxetine, Eli Lilly and Co.) Read More
Sanofi SA, which reported third-quarter results Thursday, placed its pipeline challenges front and center, noting "business [earnings per share] reflects patent expirations." Read More
The ripe market for an acute kidney injury (AKI) therapy good enough to win FDA approval drew Thrasos Therapeutics Inc. into the game, and $35 million in funding should help the company through Phase II trials with THR-184, its lead compound. Read More
• Daiichi Sankyo Co. Ltd., of Tokyo, said it completed patient enrollment in the Hokusai-VTE Phase III study testing once-daily oral Factor Xa inhibitor edoxaban. Read More
