Jun Chen, a tenured associate professor of bioengineering at the Samueli School of Engineering at the University of California Los Angeles (UCLA), leads a team developing a speech-sensing wearable patch. The technology translates the intricate muscle movements of the larynx into discernible speech.
Haemonetics Corp. acquired Vivasure Medical Ltd. for €100 million (US$116 million) cash plus up to an additional €85 million (US$99 million) in contingent payments based on sales and other milestones. The deal continues nearly four years of increasing investment in Vivasure by Haemonetics in support of its latest version of the Perqseal vessel closure device.
Generative AI has largely escaped the U.S. FDA’s regulatory purview up to now, but OpenAI seems poised to create a new source of regulatory angst for the agency. The company unveiled its ChatGPT Health Jan. 7, a large language model that when used professionally could land the company in the FDA’s regulatory crosshairs.
The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.
Debate over Vanda Pharmaceuticals Inc.’s Hetlioz (tasimelteon) for use in jet lag disorder looks to continue after the U.S. FDA rejected the latest supplemental NDA submission, with the agency’s Center for Drug Evaluation and Research concluding the application cannot be approved in its current form.
Takeda Pharmaceuticals Co. Ltd.’s oral tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), met the co-primary endpoints and all ranked secondary endpoints in two pivotal phase III studies in patients with moderate to severe plaque psoriasis.
Having nailed down alignment with the U.S. FDA in December on a phase III trial that will start in the middle of this year, Immuneering Corp. updated the overall survival and safety data from an ongoing phase IIa trial testing atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients (n=34), with more than 13 months median follow-up time.
News of Eli Lilly and Co. purchasing Ventyx Biosciences Inc. for $14 per share arrived after market close Jan. 7, following unconfirmed rumors of the buyout that drove shares up by more than 52% at one point.
The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health, but anyone who was expecting a clear break with the 2019 version of the guidance was almost certainly disappointed.
It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.
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