OxyContin Maker Purdue Pharma Gets FDA’s OK For Overdose-Reversal Device
The device, called Zurnai, is the latest in a string of approvals for products that use nalmefene, essentially a more powerful version of naloxone, Stat explains. But Stat goes on to say that the news is likely to spark anger on multiple fronts.
Stat:
FDA OK's Purdue Pharma’s New Overdose-Reversal Medication
Purdue Pharma, the company best known for fueling the opioid crisis by misleadingly marketing the infamous painkiller OxyContin, received approval on Wednesday for a new auto-injector device used to reverse opioid overdoses. (Facher, 8/7)
In other pharmaceutical and tech news —
Reuters:
Third Trial Over Zantac Cancer Claims Ends With Hung Jury
The third trial over claims that discontinued heartburn drug Zantac ended in a mistrial on Wednesday when jurors could not agree about whether pharmaceutical company Boehringer Ingelheim was responsible for an Illinois man's cancer. Martin Gross alleged in his lawsuit in state court in Chicago that he developed prostate cancer from a carcinogenic contaminant called NDMA found in the drug. His lawyer, Sean Grimsley, said he would take his case to trial again. (Pierson, 8/7)
AP:
After Baby's Death, Kentucky Parents Sue Infant Formula Maker At Center Of 2022 Crisis
The parents of a Kentucky baby who died last fall after drinking bacteria-tainted infant formula are the latest to sue Abbott Nutrition, the manufacturer at the heart of a 2022 crisis that left millions of Americans scrambling to feed their children. Willow Jade Dellaquila, of Carrollton, Kentucky, was 13 days old when she died on Nov. 5, 2023. She was infected with cronobacter sakazakii, a dangerous germ traced to a can of Similac Total Comfort powdered formula used in the baby’s bottles, records show. (Aleccia, 8/7)
CBS News:
Doctors Optimistic About Results From New Alzheimer's Drug Infusions
On Wednesday, Independence Health System held a press conference at the Westmoreland Hospital in Greensburg to give people who may be diagnosed with or already have Alzheimer's disease new hope and a positive path forward. Between these healthcare systems' Westmoreland and Butler facilities, they have been treating Alzheimer's patients with infusions of two new drugs: lecanemab and donanemab-azbt. (DeRose, 8/7)
CBS News:
AI Technology Could Help Detect Eye Conditions In Children
Smartphones could help identify eye disorders in children. In a new study published in JAMA Network Open, researchers in China examined more than 1,400 facial photographs from nearly 500 children and developed an artificial intelligence model that can accurately detect three common pediatric eye conditions: myopia or nearsightedness, strabismus or "crossed eyes", and ptosis or drooping of the upper eyelid. (Marshall, 8/7)
Stat:
CMS Finalizes Medicare Coverage Rule For Breakthrough Devices
The Centers for Medicare and Medicaid Services has finalized its rule easing reimbursement for medical device makers. Called Transitional Coverage for Emerging Technologies, the program gives device makers with products deemed “breakthrough” technology by the Food and Drug Administration a quicker way to secure Medicare coverage. The agency first introduced the rule last June. (Lawrence, 8/7)
On weight loss drugs —
Reuters:
US Patients Take Wegovy Obesity Drug For Around Six Months, Novo Nordisk Says
U.S. patients are on average staying on Novo Nordisk's Wegovy weight-loss medication for just six months, an executive said on Wednesday, attributing the short time to the low availability of the wildly popular drug. (8/7)
The New York Times:
More People Are Overdosing on Ozempic Alternatives
Three hours after Becky Cheairs injected herself with the first dose of compounded semaglutide, she started to vomit. Crouched over the toilet, reeling from nausea, she thought there was no way she would make it on the R.V. trip from Arkansas to San Antonio she had planned that weekend. She was right: She spent the next day throwing up at least once an hour. Like many others, Ms. Cheairs, 66, had taken the drug to lose weight. But she hadn’t taken the brand-name products Ozempic or Wegovy, which come in pens pre-filled with a specific dose. (Blum, 8/6)
KFF Health News:
How Little Denmark Got Homegrown Giant Novo Nordisk To Lower Ozempic Prices
On May 13, Sen. Bernie Sanders (I-Vt.) published an open letter to Novo Nordisk on the front page of a leading Danish newspaper, urging the hometown company to live up to its altruistic standards by lowering U.S. prices for its blockbuster diabetes and weight loss drugs. What Sanders didn’t realize was that Denmark, a country of 6 million, was enduring its own crisis over how to pay for the Novo Nordisk drugs Ozempic and Wegovy. (Allen, 8/8)