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Insys Therapeutics bribed doctors to prescribe its fentanyl spray, the company admitted as part of a $225 million settlement with the U.S. government, the Department of Justice announced. Read More
Drug sponsors should think about loosening up their exclusion criteria—especially when recruiting for later stage trials, the FDA says in new draft guidance document published Thursday. Read More
A panel of experts on Thursday urged the FDA to approve a three-drug cocktail that backers say has produced miraculous results in patients with a particularly nasty form of tuberculosis. Read More
Including patients co-infected with HBV/HCV in an immuno-oncology drug trial has its own complexities because of the “known interaction” between the two viruses during co-infection, Merck said. Read More
In April 2017, the Northern District of Illinois ordered GSK to give $3 million to the widow of Stuart Dolin, an attorney who committed suicide after taking a Paxil generic. Read More
The agency said “there isn’t enough evidence to support the use of stem cells for purposes other than reconstitution of blood formation and the immune system.” Read More
Federal officials on Wednesday filed to intervene in a whistleblower suit alleging that English drugmaker Mallinckrodt used a copay charity as a front for illegal kickbacks. Read More
Attorneys General who have painted the generics industry as an illegal price-fixing cabal should face their state employee health plans and demand they only pay for brand name drugs, the head of the largest generics lobbying group said Wednesday. Read More