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Eli Lilly plans to pursue accelerated approval of its Alzheimer’s treatment donanemab, using the same fast-track pathway Biogen used for its controversial Alzheimer’s drug Aduhelm. Read More
Two U.S. House committees are broadening their investigation into Emergent BioSolutions’ troubled Bayview, Md., facility, calling on Johnson & Johnson (J&J) and AstraZeneca (AZ) to provide details of their COVID-19 vaccine contracts with the firm. Read More
Incyte needs to complete another clinical trial of its proposed anal cancer treatment retifanlimab before the FDA should consider approving it, an agency advisory committee said Thursday. Read More
Remarks by Acting FDA Commissioner Janet Woodcock about the future of medical research and drug approval resulted in a backlash this week, adding to calls for her resignation from Sen. Joseph Manchin (D-W.V.) and increasing pressure from advocacy groups and federal legislators that she not be made permanent FDA commissioner. Read More
A Centers for Disease Control and Prevention (CDC) expert panel yesterday concluded that there is likely a link between heart inflammation and inoculations with the Pfizer/BioNTech and Moderna COVID-19 vaccines but emphasized that the benefits of the shots greatly outweigh the risks. Read More
Norwich Pharmaceuticals was hit with an FDA Form 483 for several quality deficiencies observed during a March 8 to 16 inspection of its Jamaica, N.Y., facility. Read More
GlaxoSmithKline (GSK) yesterday unveiled plans for what it calls the “New GSK,” including focused investment in the development of vaccines and specialty medicines, which it predicts will make up the largest share of the company’s revenue within five years. Read More
A World Health Organization (WHO) expert panel will consider adding 40 new medications to the WHO’s Essential Medicines List (EML) at its annual conference in Geneva over the next two weeks. Read More