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None of the nine pharmacy benefit managers (PBM) ordered in 2022 and 2023 to turn over business practice documents to the FTC have fully complied, FTC Chair Lina M. Khan told a bipartisan group of legislators who wrote in January seeking an update on the inquiry. Read More
Minerva Neurosciences has received a complete response letter (CRL) from the FDA on an NDA for the company’s schizophrenia drug roluperidone. Read More
The problem of potentially illicit, contaminated or low-potency counterfeit drugs coming into the U.S. from other countries is “huge,” but the government doesn’t have a handle on the true numbers, said FDA Commissioner Robert Califf on Wednesday during a Reuters Newsmakers webinar. Read More
This week, critics complain that the Biden administration just doesn’t get Bayh-Dole, the DOJ hands BioMarin a subpoena, another Humira biosimilar snags FDA OK, and Novo Nordisk sticks a deal for molecular glue. Read More
A finalized FDA guidance outlines how drug manufacturers and all registrants of drug establishments should report the “amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution.” Read More
Topical ophthalmic drug developers have asked the FDA for greater clarity on evaluating visible particulate matter, extractables and leachables, and petitioned the agency for more specifics on quality issues, as the comment period closed Monday on a revised guidance for such products. Read More
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting, including four orphan drugs, one biosimilar and two generics. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
In a slowdown for Venatorx Pharmaceuticals, Melinta Therapeutics and the progress of new treatment for adults with complicated urinary tract infections (cUTI), the FDA issued a Complete Response Letter (CRL) for the companies’ NDA for cefepime-taniborbactam. Read More