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Eli Lilly and healthcare company UnitedHealth are working together to conduct a pragmatic study of the American pharma titan’s COVID-19 antibody treatment, bamlanivimab (LY-CoV555), a therapy that received Emergency Use Authorization (EUA) from the FDA nearly a month ago. Read More
PhRMA and BIO have filed lawsuits in an attempt to thwart the Trump administration’s most favored nations policy, a drug pricing measure unpopular with the pharma industry that will soon come into effect, and the litigation is likely to delay the policy’s implementation. Read More
A Vermont-based over the counter (OTC) skincare company Twincraft developed certain “written production and control procedures to include batches formulated with the intent to provide less than 100 percent of the labeled or established amount of active ingredient,” an FDA investigator found during an Aug. 18-25 inspection. Read More
Warnings of international crime targeting the yet-to-be-approved COVID-19 vaccines are getting louder, with the international police agency Interpol last week issuing an Orange Notice, which warns of an “imminent threat to public safety.” Read More
With the FDA’s vaccine advisory committee scheduled to consider Pfizer’s COVID-19 vaccine on Dec. 10, the drugmaker is facing confusion and doubt regarding how many vaccines it can actually deliver once approval comes. Read More
The Biden transition team has asked Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious disease expert, to stay on in the role he has held there since 1984. Read More
The FDA has had trouble finding members for its vaccine advisory committee that will meet on Dec. 10, to consider recommending Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine candidate — surely one of the most important advisory panel meetings in the agency’s history. Read More