In what shakes out to be the largest follow-on stock offering in biopharma history, Revolution Medicines Inc., an oncology company that was the subject of buyout rumors earlier this year, priced 10.56 million shares to raise $1.5 billion just two days after wowing investors with top-line phase III data of its RAS inhibitor daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma.
New hires and promotions in the biopharma and med-tech industries, including: Adagene, Asgard, Harmony, Inspira, Kashiv, Kivu, Laigo, Panntherapi, Parabilis, Tempest, Valanx, Valo.
The U.S. FDA’s latest draft guidance on gene therapies focuses on nonclinical studies using next-generation sequencing-based methods and bioinformatics to evaluate safety risks associated with off-target editing and loss of genome integrity in human gene-edited products.
Clinical updates for biopharma and med tech, including data readouts and publications: Abbvie, Allogene, Biontech, Caliway, Caliway, Corcept, Duality, Eli Lilly, Genmab, GSK, Ideaya, Impact, Lixte, Ocular, Pharmasens, Revolution, Servier, Spyre, Synox.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Apotex, Beckman Coulter Diagnostics, Daiichi, Kymera, Merck, Prosomnus, Regeneron, Replimune, Roche, Sanofi.
New hires and promotions in the biopharma and med-tech industries, including: Alx Oncology, Dariohealth, Epitopea, Frontier, Geron, Leal, Lineage, Nrx, OS, Palvella, Pelthos, Prothena.
If a recent warning letter is anything to go by, the U.S. FDA could be using the 2013 Drug Supply Chain Security Act as another enforcement tool to shut down unauthorized suppliers by clamping down on the dispensers that purchase their unapproved drug products.
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