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The first doses are expected to arrive by the end of September or possibly later, depending on BioNTech’s production schedules and the progress of vaccinations in Taiwan. Read More
The FDA issued an advisory to drugmakers about the risk of bacterial contamination of non-sterile water-based drug products by Burkholderia cepacian (BCC). Read More
Pfizer and BioNTech executives are meeting with federal health officials this week to emphasize that vaccinated people need COVID-19 booster shots — but the FDA and the Centers for Disease Control and Prevention (CDC) say that’s not what the science shows, at least not yet. Read More
The European Council — which represents the heads of state or the governments of EU members — must also adopt the proposed legislation for it to become law. Read More
The FDA has reached an agreement on draft commitments to the biosimilars industry for the upcoming iteration of the biosimilar user fee program, BsUFA III, which will cover fiscal 2023 through 2027. Read More
President Biden is taking aim at the pharma industry, directing his administration to issue a comprehensive drug pricing plan within 45 days and to implement a Trump-era proposal to import cheaper prescription drugs from Canada. Read More
Fourteen of the world’s largest drug companies spend millions of dollars more on stock buybacks and executive compensation than they do on research and development, a new congressional report has concluded. Read More
Acting FDA Commissioner Janet Woodcock is calling for a wide-ranging federal investigation into her own agency’s actions during the drug approval process with Biogen over its newly approved Alzheimer’s disease drug Aduhelm (aducanumab). Read More