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HHS has stopped shipping Eli Lilly’s COVID-19 antibody cocktail (bamlanivimab/etesevimab) because of the therapy’s lack of effectiveness against new variants of SARS-CoV-2. Read More
Just ahead of its scheduled trial, Johnson and Johnson said it would settle for $263 million with the state of New York over a lawsuit in which the state pointed to the company as one of the key drivers of the opioid crisis. Read More
The House Appropriations Committee proposes to increase funding to the FDA by $257 million for the agency’s nonuser fee funds for fiscal 2022, an increase that falls $86 million short of the amount President Biden requested for the agency. Read More
Pfizer has pushed the pause button on its worldwide distribution of Chantix (varenicline) after elevated levels of the suspected carcinogen, nitrosamine, were found in some batches of the pills. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new drugs for approval at its June 21-24 meeting, including two cancer drugs, two generics and a biosimilar. Read More
A Centers for Disease Control and Prevention (CDC) vaccines expert panel voted 14-0 vote last week to recommend Sanofi’s controversial dengue fever vaccine, Dengvaxia, despite concerns over risks associated with its use. Read More
Two U.S. House committees are broadening their investigation into Emergent BioSolutions’ troubled Bayview, Md., facility, calling on Johnson & Johnson (J&J) and AstraZeneca (AZ) to provide details of their COVID-19 vaccine contracts with the firm. Read More