FDA Endorses Vaporized Hydrogen Peroxide As Medical Device Sterilizer
Ethylene oxide has long been the go-to for sterilizing medical devices, but the chemical is dangerous and a known carcinogen. Meanwhile, the FDA told several drugmakers that their CAR-T cancer therapy drugs' boxes should carry a warning that the treatment may add to cancer risks.
Stat:
FDA Endorses New Sterilization Method For Medical Devices
The chemical used to sterilize half of all medical devices in the United States is also known to cause cancer. After years of deliberating on alternatives, the Food and Drug Administration this month deemed a safer gas, vaporized hydrogen peroxide, a legitimate way to decontaminate devices. It’s a small step in pushing the medical device industry away from the carcinogenic chemical, called ethylene oxide. (Lawrence, 1/24)
In other cancer news —
NBC News:
FDA Says Cancer Treatment CAR-T Therapy May Increase Risk Of Cancer
The Food and Drug Administration this week told several drugmakers to add a boxed warning — the agency’s strongest safety label — to the prescribing information for a type of cancer treatment called CAR-T therapy, saying the treatment itself may increase a person’s risk of cancer. Carly Kempler, a spokesperson for the FDA, said that, despite the warning, "the overall benefits of these products continue to outweigh their potential risks." (Lovelace Jr., 1/24)
CNBC:
Johnson & Johnson To Settle Talc Baby Powder Probe
Johnson & Johnson has reached a tentative settlement to resolve an investigation by more than 40 states into claims the company misled patients about the safety of its talc baby powder and other talc-based products, the company said in a statement to CNBC on Tuesday. Notably, the settlement does not resolve the tens of thousands of consumer lawsuits, some of which are slated to go to trial this year, alleging that those talc-based products caused cancer. (Constantino, 1/23)
More pharmaceutical news —
Reuters:
Martin Shkreli's Lifetime Drug Industry Ban Upheld
Martin Shkreli, known for once hiking the price of a life-saving drug more than 4,000%, cannot return to the pharmaceutical industry after a federal appeals court on Tuesday upheld his lifetime ban. A three-judge panel of the 2nd U.S. Circuit Court of Appeals in Manhattan said a lower court judge acted properly in imposing the ban and ordering Shkreli to repay $64.6 million because of his antitrust violations. Shkreli, 40, became notorious and gained the sobriquet "Pharma Bro" when, as chief executive of Turing Pharmaceuticals in 2015, he raised the price of the newly-acquired antiparasitic drug Daraprim overnight to $750 per tablet from $17.50. (Stempel, 1/23)
Bloomberg:
Walgreens Said To Explore $4 Billion-Plus Sale Of Shields Health
Walgreens Boots Alliance Inc., the troubled drug-store chain in turnaround mode, is exploring options including a sale of Shields Health Solutions, the specialty pharmacy business it acquired a majority of three years ago, according to people familiar with the matter. The business could be valued at more than $4 billion in a sale, said the people, who asked to not be identified because the details aren’t public. (Davis, Gould, and Nair, 1/23)
Axios:
Many Patients Keep Weight Off After Stopping Anti-Obesity Meds: Study
Most patients on a new class of anti-obesity medications kept at least some of the weight off up to a year after they stopped taking the medication, according to new data from Epic Research. This appears to contradict previous studies that have indicated patients on drugs known as GLP-1 agonists need to stay on them to keep the weight off. (Reed, 1/24)
The Wall Street Journal:
Obesity Drugs Lead To Muscle Loss—Pharma Companies Want To Fix That
Weight-loss medications such as Wegovy and Zepbound are quickly growing in popularity, and for good reason: They are remarkably effective and might help lower other health risks, too. There is a catch, though. A good portion of that weight reduction can come in the form of muscle-mass loss. While losing muscle, and not just fat, is to be expected when you deprive yourself of calories, some experts worry that it could lead to an increased risk of injury, especially for older people. Another concern is that losing muscle could slow down patients’ metabolism, leading to weight regain. And whether people gain a proportionate amount of muscle upon weight regain isn’t totally clear. (Wainer, 1/22)
