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Merck has agreed to pay $830 million to settle claims that it failed to inform investors of the heart risks related to its Vioxx pain medication, which is now discontinued. Read More
The U.S. Supreme Court has refused to hear Johnson & Johnson’s appeal of an unfavorable ruling in a negligent labeling case, a decision that will cost the company $140 million. Read More
The European Commission has blessed the first biosimilar of Amgen’s blockbuster drug Enbrel, clearing the way for Samsung Bioepis to release the biosimilar in select EU countries in the coming weeks. Read More
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