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.
Reuters:
US FDA Clears Vivos Therapeutics' Oral Device For Sleep Apnea
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)
Bloomberg:
Nature Made Vitamins Owner Buys Bonafide Health For $425 Million
Pharmavite LLC, the maker of Nature Made vitamins, has agreed to acquire women’s health company Bonafide Health LLC for $425 million. The company, whose ultimate parent is Otsuka Holdings Co., isn’t 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)
The Boston Globe:
Generation Bio Cuts Workforce By 40 Percent
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 “strategic reorganization” 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)
The Atlantic:
Obesity Drugs Are Giving New Life To BMI
So much depends on the simple calculation of dividing one’s weight by the square of their height. According to the FDA, people qualify for prescriptions of Wegovy and Zepbound—the obesity-drug versions of the diabetes medications Ozempic and Mounjaro—only 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 —
Philadelphia Inquirer:
Penn Medicine BioBank Enrolls 260,000, Yields Clues To Heart Disease, Glaucoma, Hearing Loss
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)
Stat:
U.K. Biobank Has 500,000 Peoples' Genome Sequences Available
Data from half a million people’s 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’s most comprehensive health data resource. (Joseph, 11/29)
