FDA Pulls Luveris NDA at Company’s Request
The FDA has withdrawn the NDA for injectable fertility drug Luveris at the request of the manufacturer. Source: Drug Industry Daily
KaloBios Announces New Transparency Measures for Drug Prices
Although it has no drugs on the market, KaloBios Pharmaceuticals has announced that it will limit price increases to the rate of inflation or Consumer Price Index, and will do…
AbbVie, Genentech Scoop Up FDA Approval for Leukemia Drug Venclexta
The FDA has given the green light to the chronic lymphocytic leukemia treatment Venclexta, which will be marketed by AbbVie and Roche’s Genentech unit. Source: Drug Industry Daily
Senate Committee Eyes Contempt Proceedings Against Valeant’s Pearson
Two lawmakers are mulling contempt proceedings against outgoing Valeant CEO J. Michael Pearson after he failed to provide a deposition on Friday as part of an investigation into drug pricing.…
FDA: Consider Real-World Usage Early On To Avoid Medication Errors
The FDA is pressing drugmakers to build risk assessments into their drug designs early on to cut down on medication errors. Source: Drug Industry Daily
Schnedar Steps Down From Role in OC, Cosgrove Takes Her Place
Cynthia Schnedar, director of CDER’s Office of Compliance, stepped down from her role on March 18 to take an unspecified private sector job, according to an email from CDER Director…
MHRA Slams Two Indian Drugmakers Over Purported GMP Deficiencies
British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP…
French Regulator Shutters Vaccine Manufacturer Over GMP Deficiencies
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after apparently finding numerous GMP…
WHO Letter Blasts Cadila on Data Integrity Concerns and GMP Issues
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization.…
FDA Bashes Two Indian Drugmakers for Allegedly Flouting Procedures
The FDA has slammed two Indian drugmakers — Emcure Pharmaceuticals and Lupin —for purported GMP violations. Source: Drug GMP Report
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