FDA: Pharma Firm Used Contaminated IV Bags For Epidural Injectable Drug
Amneal Pharmaceuticals lowered its standards to be able to continue using the bags even after the problem had been identified, the FDA said in a warning letter sent last week. Other news is on a one-shot early syphilis treatment trial, GLP-1 drugs, and more.
Stat:
FDA Finds Amneal Pharma Used Contaminated IV Bags For Sterile 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)
Modern Healthcare:
PhRMA Launches 340B Program Ad Campaign
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’s message is that nonprofit hospitals’ 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 “tell Congress to fix 340B.” (DeSilva, 9/3)
CIDRAP:
Trial Data Support 1-Dose Antibiotic Treatment For Early Syphilis
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)
CIDRAP:
CARB-X Funds Development Of Novel Diagnostic For Lower Respiratory Tract Infections
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 —
MedPage Today:
Ozempic May Blunt Metabolic Effects Of Antipsychotics
A GLP-1 receptor agonist may help improve metabolic profiles for certain schizophrenia patients on antipsychotics, the randomized HISTORI trial indicated. (Monaco, 9/3)
Bloomberg:
Novo Tests Ozempic Pill As Possible Alzheimer’s, Dementia Drug
A team of scientists was crunching Danish health registry data several years ago when it noticed something surprising: Diabetes patients who’d used Novo Nordisk A/S’s 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’d been taking the injectable for two years had about a 20% lower risk of a dementia diagnosis. “That is in and of itself not proof,” says Martin Holst Lange, the drugmaker’s chief scientific officer. But “it did catch our attention.” (Kresge, 9/4)
KFF 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’d 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)
