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Thursday, Nov 30 2023

Full Issue

FDA Clears First-Ever Oral Device To Battle Sleep Apnea

The device is made by Vivos Therapeutics and is designed to help with severe obstructive sleep apnea, and is an alternative to devices made by companies like Philips. Also in the news: Pharmavite LLC; Generation Bio; obesity drugs and BMI; and more.

Vivos Therapeutics said on Wednesday the U.S. health regulator has cleared its oral device for severe obstructive sleep apnea (OSA), leading a massive rally in the company's shares before the bell. The clearance is the first ever for an oral appliance. ... According to Vivos, its treatment is an alternative to therapy devices made by companies such as Philips and ResMed that send pressurized air into a patient's nose and mouth during sleep as well as to surgically placed implants that send electrical signals to the brain. (11/29)

Pharmavite LLC, the maker of Nature Made vitamins, has agreed to acquire women鈥檚 health company Bonafide Health LLC for $425 million. The company, whose ultimate parent is Otsuka Holdings Co., isn鈥檛 disclosing further financial details of its all-cash deal for Bonafide Health. Bonafide Health will continue to operate out of its current headquarters in Harrison, New York, after the purchase and there are no workforce implications to the acquisition. (Sanchez and Tse, 11/30)

Generation Bio, a Cambridge genetic medicines startup, became the latest Massachusetts biotech to slash its payroll, eliminating nearly 70 jobs as part of a move to conserve its cash into 2027. The company, launched by Atlas Venture in 2016 to develop new ways to deliver gene therapies, said Thursday that a 鈥渟trategic reorganization鈥 would reduce its workforce by 40 percent, or 68 jobs. Its shares edged up 3.4 percent to $1.16 on the Nasdaq after its announcement. (Weisman, 11/29)

So much depends on the simple calculation of dividing one鈥檚 weight by the square of their height. According to the FDA, people qualify for prescriptions of Wegovy and Zepbound鈥攖he obesity-drug versions of the diabetes medications Ozempic and Mounjaro鈥攐nly if their BMI is 3o or higher, or 27 or higher with a weight-related health issue such as hypertension. (Tayag, 11/29)

In news about biobanks 鈥

Any changes in your medications or allergies? Check. New health issues since your last visit? Check. And would you like to contribute a blood and DNA sample for a massive research project? That last question is now part of the electronic check-in process for patients at Penn Medicine clinics and hospitals, and it already is yielding promising clues in the study of disease. (Avril, 11/29)

Data from half a million people鈥檚 whole genome sequences are now available to researchers worldwide, as the U.K. Biobank on Thursday debuted the latest addition to what it aims to be the world鈥檚 most comprehensive health data resource. (Joseph, 11/29)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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