Morning Briefing
Summaries of health policy coverage from major news organizations
No Major Concerns Raised By FDA Staff On Grail's Galleri Multicancer Blood Test
MedPage Today: FDA Staff Find No Major Concerns With Galleri Multicancer Early Detection Test
FDA staff members had no major concerns or questions about the safety, accuracy, risks, or benefits of the Galleri multicancer early detection (MCED) blood test ahead of an advisors' meeting that will be held Wednesday. The prescription, qualitative in vitro diagnostic test from Grail is intended to screen for early detection of multiple types of cancer in adults ages 50 and older. (Bassett, 9/21)
Stat: What A Vote On Grail Cancer Detection Test May Mean For The Company, Patients
Shares in Grail, the company developing a blood test aimed at detecting many different types of cancer early, when they can be treated more effectively, surged 33% Monday after the Food and Drug Administration posted documents ahead of an advisory committee meeting that suggest the agency may take a favorable view of the test. (Herper, 9/21)
In other pharma and tech developments —
Healthcare Dive: Mayo Clinic, Thermo Fisher Partner To Create Biomedical Database
Mayo Clinic and Thermo Fisher Scientific have founded Precure, a company focused on creating one of the world’s leading biomedical datasets. The company, which Mayo Clinic unveiled last week, will use molecular data generated from one million biospecimens, clinical information and other resources to create the dataset. (Taylor, 9/21)
Bloomberg: Smart Ring Maker Oura, Backers Seek $2.2 Billion In US IPO
Health and fitness ring-maker Oura Inc. and some of its backers are seeking to raise as much as $2.2 billion in a US initial public offering. The maker of smart rings that track metrics including heart health, activity and sleep plans to market 50 million shares for $40 to $44 each, according to its filing Monday with the US Securities and Exchange Commission. The company will look to sell 13.5 million shares, while shareholders including Forerunner Ventures and Lifeline Ventures will offer 36.5 million. (Patnaik, 9/21)
Stat: Alkermes’ Orexin Agonist Shows Potential To Treat ADHD In Early-Stage Trial
Drugs called orexin agonists have been hailed for their ability to treat rare sleep disorders, but with new data, Alkermes is showing for the first time that the new class of therapies may benefit people with ADHD. (Chen, 9/21)
MedPage Today: Gabapentin Use Rose As Restrictions Fell, Study Shows
Gabapentin use jumped quickly in Michigan after the drug was removed from the state's controlled substance schedule in 2024, a cross-sectional study showed. From 2023 through 2025, gabapentin dispensing in the Michigan Medicaid program ranged from 33 to 43 prescriptions per 1,000 enrollees, while pregabalin dispensing remained consistently lower, reported Juan Hincapie-Castillo, PharmD, MS, PhD, of the University of Pittsburgh, and co-authors. (George, 9/21)
KFF Health News: Insurance Coverage Lags As Cancer Science, Treatment Move Forward
Eighteen months after his initial diagnosis, chemotherapy hadn’t slowed 21-year-old Mason Henderson’s rare brain tumor, which had spread to his spinal fluid. So he left his home in southeastern Texas to spend three weeks in a clinical trial in New York City. But that failed, too, leaving a murky path for Henderson, whose cancer was so rare the World Health Organization had only given it a name in 2021. So early this year, Henderson’s doctors, evaluating his tumor’s deep genetic language, turned to a drug made by Merck and AstraZeneca called Lynparza. (Allen, 9/22)
On GLP-1s —
NewsNation: GLP-1 Manufacturers Novo And Eli Lilly Sued By Patients Over Sudden Vision Loss Risk
Patients are suing the makers of GLP-1 weight-loss drugs over a condition leading to sudden vision loss. They say that the drug manufacturers failed to provide clear information about the possible side effect, while some experts say the evidence linking the two is mixed. (Whiteside, 9/21)
Newsweek: Scientists Find Potential Way To Preserve Muscle During GLP-1 Weight Loss
GLP-1 medications have transformed obesity treatment, helping millions of people lose weight. But they come with a drawback that concerns doctors and users alike: people often lose a significant amount of muscle, or lean mass, alongside body fat. (Gray, 9/21)
Axios: The Dangerous Risks Of Stopping Ozempic And GLP-1s
Stopping Ozempic and other GLP-1 drugs may carry health risks beyond weight regain, according to a growing body of research. Many patients stop GLP-1 treatment because of cost, side effects or other reasons, but emerging research suggests some cardiovascular and metabolic benefits can fade after treatment ends. (Scribner, 9/21)
Chicago Tribune: Illinois Gov. JB Pritzker Reveals 80-Pound Weight Loss
Gov. JB Pritzker disclosed Monday that he was diagnosed with type 2 diabetes two years ago and has since lost 80 pounds using a GLP-1 drug. (Gorner, 9/21)
