The U.S. Department of Health and Human Services has tapped Sean Keveney for the job of FDA chief counsel, but the recent history of the position muddies the waters when it comes to HHS oversight of FDA legal affairs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, BMS, Elicio, Everest, Kye, Ouro, Sumitomo.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Conduit, Fresenius Kabi, Gilead, Kashiv, MS Pharma, Polpharma, Redwire, Serb, Tango, Y-mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aicuris, Crystal, HMNC, Sana, Urogen, Vertex, Windtree.
Jazz Pharmaceuticals plc is prepped and ready for launch following U.S. FDA accelerated approval of dordaviprone as the first systemic therapy for H3 K27M-mutant diffuse glioma. Branded Modeyso, the orally administered first-in-class imipridone was acquired via Jazz’s acquisition earlier this year of Chimerix Inc. in a deal valued at about $935 million.
Precision medicine is becoming a reality in Asia Pacific as more targeted therapies are being developed that are tailored to individual patients, offering a potential cure for disease. But is Asia Pacific ready to harness this transformation, and if not, what are the hurdles that need to be cleared? A new report by LEK Consulting examines Asia Pacific’s readiness for what it calls the “Precision Era,” and examines four key biopharma markets in Australia, China, Japan and South Korea.
Cancel culture continues at the U.S. Department of Health and Human Services (HHS) as it observes National Immunization Awareness Month with another strike against vaccines. This time, a $500 million strike specifically targets 22 mRNA vaccine R&D programs at the Biomedical Advanced Research and Development Authority (BARDA), marking the beginning of the end of BARDA’s funding for mRNA vaccines.
RSS
