We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Under the Operation Warp Speed allocation program, bamlanivimab will be given to patients free of charge via weekly distribution to states and territories. Read More
Combination product agreement meetings — known within the FDA as CPAMs — are a prime way sponsors of such products can gather agency feedback on their applications, the agency said in a final guidance released yesterday. Read More
The U.S. government is exercising its option for an additional 650,000 doses of Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) for $812.5 million, following the drug’s Emergency Use Authorization (EUA) in November for mild-to-moderately ill COVID-19 patients at high risk. Read More
The Commerce Department is requesting comments on the U.S. supply chain for essential medicines and on the wider public health “industrial base” and is providing an unusually short window for responses. Read More
Teva Pharmaceuticals subsidiary Actavis Laboratories infringed upon five patents belonging to Tris Pharma by producing and marketing generic versions of Tris’s Quillivant XR, an extended-release liquid formulation of methylphenidate to treat attention deficit hyperactive disorder (ADHD), a federal court has ruled. Read More
President Trump has scheduled a COVID-19 vaccine summit for Dec. 8 with pharma executives, government leaders, scientific experts and others just days before an FDA advisory panel meets to discuss Emergency Use Authorization (EUA) for Pfizer’s vaccine candidate. Read More
In a watershed moment in the pandemic, the UK became the first Western nation to authorize a COVID-19 vaccine for emergency use, granting Pfizer clearance for its highly effective shot Wednesday, though the move drew immediate criticism from the EU. Read More
The White House called in FDA Commissioner Stephen Hahn for a meeting yesterday to discuss the pace at which the agency is moving to authorize Pfizer’s COVID-19 vaccine. Read More
HHS has elaborated on the government’s decision to do away with the Unapproved Drugs Initiative (UDI), a controversial program launched in 2006 that forced drugmakers to either remove unapproved drugs from the market or earn FDA approval for them by showing safety and efficacy. Read More