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Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More
Merck & Co. is suing German biotech and chemical giant Merck KGaA in federal court for alleged trademark infringement as part of a larger battle between the two companies over the rights to the Merck name. Read More
The FDA has issued warning letters to two U.S. dietary supplement makers and a Hong Kong drugmaker — already under import alert in the U.S. — for significant cGMP violations over adulterated products and data integrity issues. Read More
With BioMarin’s Duchenne muscular dystrophy candidate drisapersen failing to garner FDA approval this week, a competitor close on its heels also is facing questions from the agency over whether it offers any benefit. Read More
A clinical trial in France has left six hospitalized with one brain-dead in a “serious accident” that is triggering an inspection and investigation. Read More