Morning Briefing
Summaries of health policy coverage from major news organizations
Study Used To Win FDA Nod For Amgen's Vasculitis Drug Is Under Review
Bloomberg: Amgen’s Tavneos Faces Scrutiny As NEJM Investigates Approval Study
The New England Journal of Medicine is investigating allegations of research misconduct in a key study used to approve Amgen Inc.’s drug Tavneos. The US Food and Drug Administration recently proposed pulling the drug from the market, alleging that the medicine was approved based on manipulated data. European health regulators are also reviewing the drug. (Swetlitz and Langreth, 6/5)
On microplastics and plasma exchange —
Axios: Microplastics In Blood Drop After Plasma Exchange, Circulate Study Reports
A "blood cleansing" treatment gaining popularity in the longevity space appears to reduce microplastics circulating in the bloodstream, according to newly published research. (May, 6/7)
On cancer —
Undark: Promising 'Liquid Biopsies' May Not Be Ready For Primetime
An emerging technology seeks to help revolutionize the world of cancer diagnosis: Multi-cancer early detection tests aim to spot signals for different types of cancer from a single blood draw or other body fluid sample. Also known as a specific type of liquid biopsy, MCED tests look for abnormalities that may indicate cancer, like circulating tumor DNA; some tests can indicate the likely origin of a cancer, while others may merely show that cancer could be present without identifying a probable type or location. A key advantage of MCEDs, supporters say, is their potential to identify cancers at earlier, more treatable stages. As such, they may help save lives. (Cohen, 6/8)
The Wall Street Journal: The Era Of The One-Size-Fits-All Cancer Drug Is Ending
Investors have poured billions into the hunt for the next Keytruda. The latest data carries a sobering message: there may be no single successor to Merck’s mega-blockbuster in cancer. No company is riding that hope harder than Summit Therapeutics. A couple of years ago, the biotech backed by billionaire Bob Duggan published data suggesting its drug, ivonescimab, beat back a form of lung cancer longer than Keytruda did. The stock rocketed, turning a company with no approved product into one worth over $20 billion at its peak, more than Moderna is worth today. Investors began to believe something better than Keytruda had finally arrived. (Wainer, 6/6)
The Wall Street Journal: 20-Somethings Are Getting Double Mastectomies As Cancer Rates Rise In Young Adults
The summer before Sophia Benson started graduate school at New York University, her mom threw her a “boob-voyage” party, a farewell to her natural breasts. When Benson was 18, she learned her father had a BRCA1 gene mutation, as did his sister, who was diagnosed with breast cancer at 33. BRCA1 significantly increases a person’s risk of developing certain cancers, including breast and ovarian. Benson found out at 21 that she had the mutation, too, and underwent a double mastectomy and reconstruction last year. (O'Brien, 6/7)
On weight loss drugs —
CBS News: This Weight-Loss Drug Hasn't Been Approved By The FDA. Doctors Are Prescribing It Anyway.
Retatrutide isn't supposed to be everywhere. Touted as the next generation in the GLP-1 craze, it's an experimental weight-loss drug that is not authorized outside of clinical trials. The Food and Drug Administration hasn't reviewed whether it is safe and effective, which is the legal path for prescription drugs to come to market. And yet retatrutide is for sale all over the internet, a phenomenon with no modern precedent. (Gilbert, Yamaguchi and Geller, 6/8)
MedPage Today: Modest Weight Loss Plus Few GI Upsets With Amylin Injectable
Petrelintide, an investigational long-acting amylin analog, induced significant weight loss with minimal side effects in the global phase II ZUPREME-1 study. By week 28, all five investigational doses of petrelintide yielded significantly greater weight loss compared with placebo when added to a reduced-calorie diet and exercise in people with obesity or overweight. (Monaco, 6/7)
Bloomberg: Boehringer Pitches Muscle-Sparing Obesity Drug In Crowded Field
Boehringer Ingelheim GmbH is pitching its experimental obesity drug as a way to help patients lose fat while preserving muscle, providing a potential edge in the crowded market for weight-loss medicines. Survodutide reduced visceral fat, the harmful type stored deep in the abdomen around organs, by as much as 34% in an analysis within a larger clinical trial, the company said Sunday. Lean mass accounted for no more than 10.8% of the change in total tissue mass at the highest dose, while liver fat fell by more than 60%. (Wind and Kresge, 6/7)
NBC News: The Next Goal For Weight Loss Drugs? Fewer Injections
For millions of people taking weight loss drugs, the next breakthrough may not be more weight loss. It may be fewer injections. Pfizer and Amgen are developing monthly GLP-1 shots — a departure from injections like Wegovy and Zepbound, which are taken weekly. (Lovelace Jr., 6/6)
Bloomberg: Novo Nordisk CEO Looks Beyond Weight Loss To Longevity, Aesthetics
Novo Nordisk A/S Chief Executive Officer Mike Doustdar says the company’s blockbuster obesity drugs could ultimately pull it into increasingly buzzy areas of healthcare, from longevity research to aesthetic medicine. “We have to be obsessed with what our patients want,” Doustdar said Sunday in an interview at the American Diabetes Association conference in New Orleans. (Muller, 6/7)
