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The city of Philadelphia and the state of Washington have rejected the recent $26 billion national opioid settlement with three major drug distributors and drugmaker Johnson & Johnson (J&J), with Philadelphia filing a lawsuit pushing back. Read More
The FDA has added some clarifications in a final guidance released yesterday for sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on submitting field alert reports (FARs), reminding them that FAR requirements apply to all products under an NDA or ANDA including positron emission tomography drugs, designated medical gases, and combination products containing a drug constituent part. Read More
Janet Woodcock has remained acting commissioner of the FDA since January rather than gaining a nomination for a permanent appointment because of a series of political difficulties, two prominent regulatory attorneys said yesterday in an FDAnews webinar. Read More
The House Energy and Commerce Committee marked up two dozen health and technology bills this week, sending them to the House floor for consideration — including one aimed at bolstering the drug supply chain. Read More
The anti-Aduhelm uproar consuming the Alzheimer’s community is due to a campaign of “extensive misinformation and misunderstanding,” Biogen executives claim. Read More
Three major opioids distributors — McKesson, Cardinal Health and AmerisourceBergen — and drugmaker Johnson & Johnson (J&J) have reached an historic $26 billion settlement agreement with state attorneys general over their role in allegedly fueling the nation’s opioid epidemic. Read More
The FDA has placed a clinical hold on Magenta Therapeutics’ Investigational New Drug (IND) application for its leukemia and myelodysplastic syndrome drug candidate, MGTA-117. Read More