A top U.S. regulator is discrediting research published a year ago that found impurities in dozens of generic heart drugs made overseas, saying the investigators contaminated the samples during their testing.
Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show.
U.S. regulators are mobilizing to shore up confidence in America’s generic-drug supply as alarm grows over the quality of products made in India, and the head of the largest U.S.-based maker of the medicines predicted more trouble lies ahead.
Paulson & Co. executives were sued for alleged conflicts in the handling of intellectual property assets in the bankruptcy of a group of resorts including Miami’s Doral golf course, where Tiger Woods won his 76th PGA Tour event last month.
Watson Pharmaceuticals Inc. may begin immediately marketing a generic version of Takeda Pharmaceutical Inc.’s diabetes drug Actos, a federal judge ruled, handing the U.S. Food and Drug Administration a defeat.