FDA Backtracks; Pharmacies Continue With Knockoff Weight Loss Drugs
The Washington Post reports that intense public backlash and a lawsuit led the FDA to reconsider its declaration, made two weeks ago, that the shortage of weight loss drugs Mounjaro and Zepbound is over. The flip allows compounding pharmacies to continue making unbranded copies while the FDA reevaluates its decision.
The Washington Post:
Amid Backlash, FDA Changes Course Over Shortage Of Weight-Loss Drugs
The U.S. Food and Drug Administration, after intense public pressure and a lawsuit, is reconsidering its declaration barely two weeks ago that a shortage of the appetite-suppressing drugs Mounjaro and Zepbound is over, a temporary about-face that will allow pharmacies to keep selling unbranded copies. The extraordinary turn of events has caused confusion for patients who rely on the cheaper, off-brand versions and for the compounding pharmacies that have been allowed to make them as long as the official shortage continued. (Gilbert, 10/19)
Stat and The Examination:
FDA Lawyers Leave To Work For Tobacco, Vaping Firms
Perham Gorji was a career government lawyer, helping to lead the Food and Drug Administration’s battle against tobacco and e-cigarettes. He was there as the agency contemplated a ban on menthol cigarettes, and as vapes of all shapes and sizes flooded the market, hooking a new generation on nicotine. (Kranhold, 10/21)
On CVS and other drugstores —
Modern Healthcare:
CVS Replacing Karen Lynch With David Joyner Surprises Analysts
With Karen Lynch out and David Joyner up at CVS Health, Wall Street analysts expressed mixed sentiments about the company’s decision to promote internally but haven’t changed their long-term outlook on the healthcare giant. Lynch, whom Joyner replaced as president and CEO on Thursday, faced a deluge of challenges during her three-year tenure leading CVS Health. (Berryman, 10/18)
Los Angeles Times:
CVS Workers Strike At 7 SoCal Stores For Better Pay, Healthcare
Workers at seven CVS pharmacies in Southern California have gone on strike for better pay and healthcare and to protest what they say is bad-faith contract bargaining by the company. The walkout, which affected four stores in Los Angeles and three in Orange County, began Friday morning and continued into the weekend. On Saturday outside one of the L.A. stores, strikers urged customers not to cross the picket lines. (Ding, 10/20)
The New York Times:
The Powerful Companies Driving Local Drugstores Out Of Business
The small-town drugstore closed for the last time on a clear and chilly afternoon in February. Jon Jacobs, who owned Yough Valley Pharmacy, hugged his employees goodbye. He cleared the shelves and packed pill bottles into plastic bins. Mr. Jacobs, a 70-year-old pharmacist, had spent more than half his life building his drugstore into a bedrock of Confluence, Pa., a rural community of roughly 1,000 people. Now the town was losing its only health care provider. Obscure but powerful health care middlemen — companies known as pharmacy benefit managers, or P.B.M.s — had destroyed his business. (Abelson and Robbins, 10/19)
The Atlanta Journal-Constitution:
Avoid These Fake Online Pharmacies, DEA Says
Online pharmacies have risen in popularity over the years, especially for some Americans who feel their pharmaceutical needs have not been met by traditional methods. These pharmacies, however, can have hidden dangers. The U.S. Drug Enforcement Administration released a public safety alert at the beginning of the month, warning of an increase seen in pills laced with fentanyl and methamphetamine being sold by online pharmacies as legitimate medications. (Ogunbayo, 10/20)
Also —
The Wall Street Journal:
Activist Starboard Value Takes Stake In Tylenol-Maker Kenvue
Activist investor Starboard Value has a sizable stake in Kenvue, the consumer-products giant that makes Tylenol and Listerine, according to people familiar with the matter. Starboard wants Kenvue, which was spun out of Johnson & Johnson last year and has a market value of over $40 billion, to make changes to boost its share price, the people said. (Thomas, 10/20)
Stat:
Pfizer Results Raise Questions About Gene Therapies For Duchenne
Confounding data from a Pfizer clinical trial has rattled the field of gene therapy for Duchenne muscular dystrophy, raising more questions about the regulatory standard used to approve a treatment from Sarepta Therapeutics, and complicating plans for other companies hoping to develop next-generation products. (Mast and Feuerstein, 10/21)
Stat:
Shingles Treatment Study Led By Surgeon Who Lost Career To Disease
It began with a burning pain in her right eye. At first, Elisabeth Cohen thought she’d gotten something in it. But the next day, as she was pushing her hair back on that side of her head, she noticed a blister near the hairline. She knew immediately what it was: shingles. (Molteni, 10/21)
Reuters:
FDA Approves Astellas' Gastric Cancer Therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's website showed on Friday. The therapy, branded as Vyloy, was approved to be used in combination with a type of chemotherapy for patients with a type of cancer which begins in the gastroesophageal junction, where the esophagus and stomach meet. (Roy, 10/18)
Stat:
Using AI, Images Are Fueling A New Boom In Cell Biology
Compared to molecular techniques to study single cells, images feel a little like “old school biology,” says Anne Carpenter, an artificial intelligence and cell biology researcher at the Broad Institute. Yet images are a gold mine that can yield information as rich as the genome — once you learn how to extract it. (Chen, 10/21)
