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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
Distribution plans for the Pfizer-BioNTech COVID-19 vaccine in the U.S. remain an enormous question mark as an initial roll-out of mass vaccination gets under way in the UK. 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
The COVID-19 pandemic does not appear to be slowing down the rate at which the FDA is approving novel drugs, although there is anecdotal evidence that it is causing the agency to miss some deadlines for approvals under the Prescription Drug User Fee Act (PDUFA). Read More
AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 percent. 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
Beckton Dickinson (BD) has announced that it is investing $1.2 billion over four years toward strengthening its manufacturing capabilities for future pandemic responses and injectable drug and vaccine innovation. Read More