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The FDA is working on a report tied to a two-day meeting this week to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts to modernize the drug supply chain in the U.S. It has not set a release date for the report. Read More
A cystic fibrosis (CF) advocacy group has levied a formal complaint with the United Nations (UN), charging that Vertex Pharmaceuticals is violating the world body’s guidelines by unfairly pricing its CF drugs and not ensuring widespread equitable access. Read More
FDA today said it is publishing two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Read More
An FDA Emergency Use Authorization (EUA) could come as soon as this weekend for Pfizer/BioNTech’s COVID-19 vaccine, with the vaccine advisory committee set to meet tomorrow to discuss the agency’s 53-page analysis concluding that the two-dose regimen met its strict EUA requirements. Read More
As accusations fly that the Trump administration passed on securing doses of Pfizer’s highly effective COVID-19 vaccine beyond an initial supply contract, the president signed an executive order Tuesday that intends to prioritize American access to vaccines supported or procured by the government and threatened to invoke emergency legislation, if needed, to bolster supplies. 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
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