The speculation as to the status of Michelle Tarver, the acting director of the U.S. FDA’s device center, is officially over despite disclaimers at. The outgoing director, Jeff Shuren, said Tarver “will make a great center director” in remarks during an Oct. 17 public appearance, thus cementing Tarver’s role at FDA.
Nowdiagnostics Inc. established an exclusive agreement with Laboratory Holdings Inc. for distribution of its First To Know syphilis test in the U.S. The test provides results in 15 minutes with as little as a single drop of blood. The test will be available to hospitals and clinicians by the end of 2024 and offered to patients directly through Labcorp Ondemand in 2025.
U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
Insider trading isn’t always about profits. Sometimes it’s avoiding losses. That’s the basis of the U.S. SEC’s complaint against Matthew Groom, an information technology consultant to Spero Therapeutics Inc. Groom agreed Sept. 15 to a $28,000 settlement to resolve the complaint stemming from a trade of Spero shares that enabled him to avoid $13,000 in losses when news of the company’s downsizing and issues with its lead product became public two years ago.
With two complete response letters in the rearview mirror, Abbvie Inc.’s Vyalev (foscarbidopa/foslevodopa) has been approved by the U.S. FDA for treating Parkinson’s disease. The drug is the first subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced disease.
Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.
Nyxoah SA recently raised $27 million after selling three million shares in a bid to shore up its capital base as it prepares to commercialize Genio — its obstructive sleep apnea technology — in the U.S.
Sunbird Bio Inc. closed an additional financing round of $14 million Oct. 16, reeling in new funding from Eli Lilly & Co. and the Singapore Economic Development Board’s investment arm, EDBI Pte Ltd.
The med-tech industry has been keen to see government fill in the so-called valley of death for breakthrough medical devices for some years, and 2024 may be the year it is finally done. Scott Whitaker, president and CEO of the Advanced Medical Technology Association said in an Oct. 16 press briefing that a House bill may pass during the upcoming lame duck session, bringing to a close an effort that has been the better part of a decade in the making.
Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
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