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President Biden announced on Monday that manufacturers for all ten drugs have agreed to participate in the Inflation Reduction Act (IRA) drug price negotiations — but that negotiations continue as all drugmakers have submitted counter offers. Read More
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). 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
Despite its denial of any wrongdoing, Pfizer has agreed to a settlement payment of $93 million to finally erase 12 years of antitrust litigation with drug distributors involving Lipitor, the pharma giant’s cholesterol drug. Read More
FTC and HHS are jointly seeking more intel on how the practices of two types of pharmaceutical drug middlemen — group purchasing organizations (GPOs) and drug wholesalers — may be contributing to generic drug shortages. Read More
Novo Nordisk achieved settlements that force two clinics to cease selling unapproved versions of the company’s semaglutide products and explain in their marketing materials that unapproved compounded drugs have not been evaluated or approved by the FDA. Read More
When questioned by senators in a hearing Thursday about why Americans pay exponentially more for many brand name drugs than residents of other countries, pharmaceutical company CEOs repeatedly pointed to rebates they must offer to pharmacy benefit managers (PBM) as the real problem, an allegation the committee soundly rejected. Read More
The FTC’s supportive comment comes in response to the Biden Administration’s December call to invoke the Bayh-Dole Act of 1980’s “march-in” rights to control drug pricing. Read More
The Federal Trade Commission (FTC) has waded into the march-in rights fracas, supporting the obscure Bayh-Dole Act as a tool to moderate drug pricing and control patent thickets on drugs developed with federal funding. Read More
Novo Nordisk has agreed to acquire three fill-finish sites in connection with a transaction where Novo Holdings has agreed to acquire Catalent, a contract development and manufacturing company headquartered in New Jersey. Read More