Factory That Fills Wegovy Shots Repeatedly Broke Sterility Rules
Reuters reports that a factory involved in producing the blockbuster weight-loss drug has repeatedly breached sterile-safety rules and failed to perform quality checks, as found by FDA inspectors. Meanwhile, obesity drugs weren't added to a list of essential medicines in the WHO's latest update.
Reuters:
Insight: Wegovy Weight-Loss Injection Factory Plagued By Sterile-Safety Failures
The factory that fills the self-injection pens for booming weight-loss drug Wegovy has repeatedly breached U.S. sterile-safety rules in recent years and staff have failed to perform required quality checks, a Reuters review of regulatory documents shows. The breaches at Catalent, the Wegovy pen filler, were found by inspectors from the U.S. Food and Drug Administration who visited the plant in Brussels in October 2021 and August 2022 to check on its compliance with manufacturing regulations, according to detailed FDA reports on the inspections, obtained by Reuters under freedom of information laws. (Fick, 7/27)
Reuters:
Obesity Drugs Don't Make WHO's Essential List, But Ebola, MS Drugs Added
Obesity drugs will not join the World Health Organization's (WHO) latest essential medicines list, but treatments for diseases, including Ebola and multiple sclerosis will, documents published by the U.N. agency showed. The WHO's essential medicines list is a catalogue of the drugs that should be available in all functioning health systems. (Rigby, 7/26)
Reuters:
Exclusive: UK Probes Novo's Ozempic, Weight-Loss Drug Saxenda Over Suicidal, Self-Harming Thoughts
Britain is reviewing a class of drugs used in a diabetes medicine and a weight-loss treatment sold by Novo Nordisk after some patients reported suicidal or self-harming thoughts, two weeks after similar action by the European Union. (Fick, 7/26)
In other pharmaceutical news —
Reuters:
Moderna/Merck Begins Late-Stage Study Of Skin Cancer Vaccine Combination
Moderna and its partner Merck said on Wednesday that they had begun enrolling patients in a late-stage study testing their personalized mRNA-based skin cancer vaccine in combination with the immunotherapy Keytruda. Data from a mid-stage study in 157 patients had shown that the vaccine combination cut the risk of recurrence or death by 44% in patients with melanoma, the most deadly form of skin cancer, when compared with Keytruda alone. (7/26)
Bloomberg:
Private Equity Backers Of Plan B Morning-After Pill Weigh $4 Billion Sale
The private equity owners of Foundation Consumer Healthcare are exploring a potential sale of the company behind popular morning-after pill Plan B One-Step, according to people familiar with the matter. (Davis and Tse, 7/26)
Bay Area News Group:
Dietary Supplement Company Balance Of Nature To Pay $1.1 Million Over Misleading Advertising
A dietary supplement company agreed to pay a $1.1 million settlement after a group of California district attorneys — including several in the Bay Area — challenged the company’s claims that its freeze-dried capsules could cure diabetes, lupus and numerous other ailments. Evig LLC — which does business as Balance of Nature — agreed to the settlement after the California Food, Drug and Medical Device Task Force filed a civil lawsuit against the company, claiming that its advertising campaigns across California “were not supported by competent and reliable scientific evidence,” according to a news release by the Santa Clara County District Attorney’s Office. (Rodgers, 7/26)
Stat:
FDA Inspection Underscores Problem At Major Drug Compounder
One of the largest compound pharmacy operations in the U.S. recently recalled a slew of injectable medicines used by hospitals over concerns about possible side effects and a newly released regulatory report underscores the extent of the problem. (Silverman, 7/26)
The Boston Globe:
The Once-Hot Market For Biotech Jobs And Lab Space Has Cooled. What Now?
When Crystal Shih Byers left her job at Novartis in 2020, she was excited to make the leap into a smaller startup. Byers had spent almost nine years at Novartis, most recently helping lead a group that worked on gene therapy. But pharmaceutical companies are large and complex, and she craved more immediate impact. “I was looking for a place where I could be in the room,” she says. She wanted more autonomy, and to feel like her work would reach patients sooner. (Miller, 7/26)
