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HHS previously halted U.S. deliveries of bamlanivimab in late March because the antibody wasn’t effective against certain coronavirus variants. Read More
The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal antibodies and Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib). Read More
The FDA is prioritizing preapproval inspections of generics based on whether the products can alleviate drug shortages, agency officials said at the Drug Information Association (DIA)’s 2021 global annual meeting yesterday. Read More
Real-world medical evidence is increasingly taking its place alongside clinical trial data in decision-making by prescription drug sponsors and the FDA, said participants in a panel discussion yesterday at the Drug Information Association’s 2021 global annual meeting. Read More
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