Morning Briefing
Summaries of health policy coverage from major news organizations
FDA: Pharma Firm Used Contaminated IV Bags For Epidural Injectable Drug
In a startling failure of quality control, Amneal Pharmaceuticals relied on contaminated bags for a sterile injectable drug even after identifying the risk and then lowered its standards so that the bags could continue to be used, according to an Aug. 27 warning letter issued by the U.S. Food and Drug Administration. (Silverman, 9/3)
The Pharmaceutical Research and Manufacturers of America, a drugmaker lobbying group, has launched an advertisement campaign that takes aim at the 340B Drug Pricing Program. The campaign鈥檚 message is that nonprofit hospitals鈥 expanded use and abuse of the program lead to significant markups on drug costs for patients, employers and taxpayers, according to a Wednesday news release. The video ad also closes with a call to action for viewers to 鈥渢ell Congress to fix 340B.鈥 (DeSilva, 9/3)
The results of randomized clinical trial show that a single shot of the antibiotic benzathine penicillin G (BPG) is as effective in treating early syphilis as the three-injection regimen used in many patients, researchers reported today in the New England Journal of Medicine. The findings come at a time when the United States and other countries around the world have been experiencing shortages of BPG, which has been the standard treatment for early syphilis since the early 1950s. (Dall, 9/3)
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) announced today that it is awarding $1 million to biotechnology company Zeteo Tech to advance work on a noninvasive diagnostic test that can diagnose lower respiratory tract infections (LRTIs) from exhaled breath. (Dall, 9/3)
On weight loss drugs 鈥
A GLP-1 receptor agonist may help improve metabolic profiles for certain schizophrenia patients on antipsychotics, the randomized HISTORI trial indicated. (Monaco, 9/3)
A team of scientists was crunching Danish health registry data several years ago when it noticed something surprising: Diabetes patients who鈥檇 used Novo Nordisk A/S鈥檚 last-generation diabetes medicine Victoza or similar GLP-1 drugs appeared to be getting dementia at noticeably lower rates than those treating their diabetes another way. Specifically, adults who鈥檇 been taking the injectable for two years had about a 20% lower risk of a dementia diagnosis. 鈥淭hat is in and of itself not proof,鈥 says Martin Holst Lange, the drugmaker鈥檚 chief scientific officer. But 鈥渋t did catch our attention.鈥 (Kresge, 9/4)
麻豆女优 Health News: As Insurers Struggle With GLP-1 Drug Costs, Some Seek To Wean Patients Off
After losing 50 pounds on the injectable weight loss medication Zepbound, Kyra Wensley received a surprising letter from her pharmacy benefit manager in April. Her request for coverage had been denied, the letter said, because she鈥檇 had a body mass index of less than 35 when she started Zepbound. The 25-year-old who lives in New York had been taking Zepbound without incident for months, so she was confused: Why was her BMI, which had been around 32 when she started, becoming an issue only now? (Ducharme, 9/4)