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Bayer has agreed to pay $40 million to resolve alleged violations of the False Claims Act (FCA) in connection with three of the company’s drugs, the U.S. Department of Justice (DOJ) said in a statement. Read More
Otsuka Holdings and H. Lundbeck filed another lawsuit in an attempt to stop Viatris (formerly Mylan) from marketing a generic of the injectable version of the antipsychotic drug Abilify Maintena (aripiprazole). Read More
A U.S. District Court in Delaware has decided in favor of United Therapeutics over Liquidia in one of its patent disputes over Tyvaso (treprostinil), a drug used to treat pulmonary arterial hypertension — abnormally high blood pressure in the arteries of the lungs. Read More
A federal judge ruled earlier this week that stem cell therapies are procedures, not drugs, and that the FDA has no jurisdiction over them, blocking the agency’s attempt to regulate the California Stem Cell Treatment Center’s (CSCTC) products. Read More
The FDA conducted 113 pre-abbreviated new drug application (ANDA) meetings in support of the development of generic drug products in fiscal 2021, up from 92 in fiscal 2020. Read More
Florida governor Ron DeSantis (R) is suing the FDA for “unlawfully withheld or unreasonably delayed” approval of a program that would permit the state to import prescription drugs from Canada to save residents a purported $150 million a year. Read More
The FDA has denied a request by Intarcia for a hearing on its New Drug Application (NDA) for the company’s investigational drug-device product ITCA 650 (exenatide) for treatment of type 2 diabetes. Read More
NICE said the clinical trial evidence showed that the transplants are significantly better than antibiotics alone in resolving C. diff infections in the recommended patient population. Read More