After years of battling to retain its hold on Grail Inc., Illumina Inc. finally announced that it will be unwinding the ill-fated acquisition of the multi-cancer early detection test maker. In addition to stiff opposition from activist investor Carl Icahn that cost Illumina’s previous CEO and board chair their positions, European and U.S. regulators have consistently opposed the deal. Read More
Zimvie Inc. will sell its spine business to private equity investor H.I.G. Capital for $375 million, a move that should clean up its balance sheet and allow it to focus on the more profitable dental business. The deal is structured as $315 million in cash plus a promissory note for $60 million with an interest rate of 10%, compounded semi-annually. Read More
Neuroone Medical Technologies Corp. received U.S. FDA 510(k) clearance for its Onerf ablation system which is capable of both recording electrical activity and ablation of nervous tissue. Read More
Both the U.K. MHRA and the U.S. FDA approved their first CRISPR-based gene therapy in 2023. Crispr Therapeutics AG and partner Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) was approved by the MHRA in November and the FDA on Dec. 8. The U.K. approval is for both severe sickle cell disease (SCD) and transfusion-dependent thalassemia (TDT). In the U.S., the approval is for severe SCD, with a PDUFA date for TDT coming up in spring 2024. Read More
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blue Water Biotech, Bone Biologics, Carl Zeiss Meditec, Elutia, Harvard Apparatus Regenerative Technology, Onconetix, Ophthalmic Research Center, Proteomedix, Retrieve Medical, Serf, Stryker, Thubrikar. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioamerica, Masimo, Neuronetics, Tyber Medical, Fuse-AI. Read More
