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Azurity Pharmaceuticals downplayed the serious risks and overstated the benefits of its leukemia drug Xatmep (methotrexate) oral solution in the text of a promotional email sent to healthcare professionals, according to a Nov. 24 “untitled letter” from the agency’s Office of Prescription Drug Promotion (OPDP). Read More
The University of Oxford has attempted to clarify the dosing error it and AstraZeneca (AZ) made in a clinical trial assessing COVID-19 vaccine AZD1222, following divergent reports between the two of what exactly transpired. Read More
With FDA emergency authorization seeming very likely for Pfizer’s COVID-19 vaccine within days, all 50 states and U.S. territories have finalized their individual “microplans” for distribution and administration, according to an Operation Warp Speed official. Read More
Yesterday, Pfizer and BioNTech disclosed that information pertaining to their regulatory submission for emergency-use approval of COVID-19 vaccine BNT162b2 was hacked on a European Medicines Agency (EMA) server containing the data. Read More
Both the EU and Japan have forged larger initial supply deals for Pfizer’s COVID-19 vaccine than the U.S. government, which is in the hot seat for declining to order additional vaccine doses, and it appears Pfizer will have to honor its deals with other countries before it can provide more to the U.S., though the government disputes that. Read More
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