Archive for February 2024

The U.S. government should have to prove that the claims in False Claims Act (FCA) kickback cases would not have been submitted “but for” kickbacks, says Teva Pharmaceuticals in response its latest to a years-long back-and-forth with the Department of Justice (DOJ). Source: Drug Industry Daily

Medtronic has filed a patent infringement lawsuit against Axonics in two venues and also faces a Class I recall of its Duet system used to drain cerebrospinal fluid. Source: Drug Industry Daily

The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid becoming a burden on manufacturers, according to many of the 28 comments posted. Source: Drug Industry Daily

The FDA has issued warning letters to three eye drop manufacturers as part of ongoing investigations into a multi-state outbreak of more than 80 antibiotic-resistant eye infections that have led to four patient deaths and at least 14 cases of vision loss. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Minerva Neurosciences has received a complete response letter (CRL) from the FDA on an NDA for the company’s schizophrenia drug roluperidone. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Soft tissue markers BioZorb and BioZorb LP pose a potential risk of serious complications said the FDA in a safety communication released Tuesday. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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.” Source: Drug Industry Daily