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The FDA compiled 22 case studies of different drugs, vaccines and devices that demonstrated promising results in Phase II studies, but later failed in larger Phase III clinical trials. Read More
Mallinckrodt will pay $100 million to settle FTC charges that the company maintained a U.S. monopoly for the only approved adrenocorticotropic hormone (ACTH) drug, Acthar, by acquiring the rights to a rival therapy, Synacthen. Read More
McKesson has agreed to pay a record civil penalty of $150 million to settle DEA and Justice Department allegations that the drug distributor failed to report suspicious orders of opioids. Read More
The high court will review Bristol-Myers Squibb’s appeal of a California Supreme Court ruling that grants the state’s courts jurisdiction to hear lawsuits filed by non-state residents. Read More
The FDA handed Chinese manufacturer Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. Read More
The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. Read More