Inspection Finds Contamination At Major Pharmaceutical Plant In Indiana

Stat: Major U.S. Drug Manufacturing Plant Did Not Properly Investigate Cat Hair, Pests, And Other Problems, FDA Finds
Cat hair, pests, bacteria, and equipment failures. These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company’s acquisition of Catalent, one of the largest contract manufacturers serving the pharmaceutical industry. A copy of a Food and Drug Administration inspection report was obtained by STAT. The plant — located in Bloomington, Indiana, and one of three that Novo acquired late last year — conducts a variety of tasks, from filling vials and syringes with medicines to labeling and packaging. (Silverman and Chen, 8/21)

Newsweek: Ozempic Linked To Reduced Cancer Risk
People with obesity who take weight loss and diabetes drugs like Ozempic and Mounjaro could face a lower risk of cancer compared to those with obesity who do not. Looking at 14 cancers, of which 13 were associated with obesity, scientists discovered people taking glucagon-like peptide-1 receptor agonists (GLP-1RAs)—the official name for the class of drugs—had a small reduction in risk of any of the cancers. (Millington, 8/21)

Stat: FDA Agrees To Speed Review For An Ultra-Rare Disease Drug
The Food and Drug Administration has agreed to decide by late next month whether to approve an ultra-rare disease drug developed by Stealth BioTherapeutics, a significant step after the company claimed it may have to close its doors if an agency endorsement is not made in coming weeks. (Silverman, 8/21)

Stat: Ionis Drug For Hereditary Angioedema Approved By FDA 
Ionis Pharmaceuticals won approval from the Food and Drug Administration on Thursday for a drug that prevents painful swelling attacks triggered by a rare genetic condition. The therapy, Dawnzera, was approved for hereditary angioedema (HAE) after a pair of late-stage trials found that it significantly reduced the rate of swelling attacks, including among patients who switched from taking therapies already on the market to Ionis’ drug. (Wosen, 8/21)

In health care industry news —

Modern Healthcare: Court Approves Blue Cross’ $2.8B Antitrust Deal With Providers
A federal judge has approved the Blue Cross Blue Shield Association’s $2.8 billion agreement with numerous healthcare providers to settle antitrust allegations and reform the operations of its 33 member companies. Judge R. David Proctor, of the U.S. District Court for the Northern District of Alabama-Southern Division, approved the settlement Tuesday. The $2.8 billion will be distributed among as many as 3.3 million hospitals, physicians and other healthcare providers, Proctor wrote in the final order. (Tepper, 8/21)

The Boston Globe: Former Mass General Surgeon, A Pioneer In Gender Reassignment, Faces Lawsuits
Surgeon Curtis Cetrulo became a leading light of a cutting-edge program at Massachusetts General Hospital soon after it opened in 2018, crafting penises for transgender men — and helping plant a flag in Boston amid intensifying national competition for such procedures. By then, Cetrulo was already well known in plastic surgery circles. He had led a Mass. General team two years earlier that completed the country’s first successful transplant of a penis, involving a 64-year-old man who had lost his penis to cancer. (Kowalczyk, 8/21)

Modern Healthcare: Where Food Is Medicine Programs Are Heading
Some call it food is medicine. Others say food as medicine. Either way, the efforts to keep people healthier through better nutrition are garnering more attention as need and interest from healthcare leaders grows. Health and Human Services Department Secretary Robert F. Kennedy Jr., who has targeted processed foods and food additives, has called out food-is-medicine programs as a way to improve health and mental health. (DeSilva, 8/20)