FDA Reports Quality Lapses At Indiana Drug Factory That Novo Is Buying
The facility in Bloomington, Indiana, belonged to contract drugmaker Catalent. FDA inspectors found issues including a "pest" on the manufacturing line. Novo is buying Catalent to boost Wegovy production. Also: A report says FDA oversight of foreign firms making U.S. market drugs is weak.
Reuters:
US FDA Finds Control Lapses At Catalent Plant Being Sold To Novo
U.S. drug regulators in November found quality control lapses at the Bloomington, Indiana factory of contract drug manufacturer Catalent, including discovery of a "pest" on the manufacturing line, according to an inspection report. Novo Holdings, the parent company of Novo Nordisk, on Monday announced it was buying Catalent in a $16.5 billion deal that included its Bloomington plant, which it plans to sell to Novo Nordisk to help it produce its popular weight-loss drug Wegovy. (Wingrove, 2/7)
In related news about plant inspections —
CIDRAP:
New Report Highlights Weak FDA Oversight Of Foreign Firms Making Medications For US Market
The US Food and Drug Administration (FDA) continues to struggle in overseeing more than 4,800 foreign drug manufacturers supplying medications for the US market, although it has taken action to improve its drug-safety oversight, the Government Accountability Office (GAO) told the House of Representatives' Subcommittee on Oversight and Investigations yesterday. "We have identified long-standing weaknesses in FDA's ability to oversee this manufacturing, an issue highlighted in our High-Risk Series since 2009," Mary Denigen-Macauley, PhD, director of GAO's healthcare team, testified. As of 2022, 58% of makers of drugs bound for the US market were located overseas, the GAO noted. (Van Beusekom, 2/7)
In other pharmaceutical industry news —
Minnesota Public Radio:
Eli Lilly Settlement Caps Insulin Prices For Minnesotans
A settlement between the state of Minnesota and drugmaker Eli Lilly will give Minnesotans access to insulin for $35 a month, at least for the next five years. Minnesota Attorney General Keith Ellison announced the settlement Wednesday morning. (Cox, 2/7)
ABC News:
Weight Loss Drugs Linked To Lower Likelihood Of Depression And Anxiety Diagnoses: Study
Most weight loss drugs were linked to a lower likelihood of depression and anxiety diagnoses, according to research published by Epic Research. The researchers looked at over three million diabetic patients and nearly one million non-diabetic patients taking GLP-1 medications ... in the study that was published Tuesday. ... Diabetic patients taking Semaglutide were 45% less likely to be diagnosed with depression and 44% less likely to be diagnosed with anxiety, according to the study. (Hoffman and Benadjaoud, 2/8)
Modern Healthcare:
GE HealthCare Bets AI Investments Will Pay Off In 2024
GE HealthCare is looking to stake its claim as radiology emerges as a key area poised to benefit from artificial intelligence. The medical device company was spun off from parent GE in January 2023. In the year since, it has rolled out products, made multiple AI-focused acquisitions and invested in research and development to try and take the lead on AI-enabled radiology care. (Turner, 2/7)
Stat:
Industry Veterans Launch New Biotech VC With $310M
Three biotech VC veterans, including one of the co-founders of radiopharma success story RayzeBio, are launching a new investment fund called Scion Life Sciences. Scion was started by former Apple Tree Partners colleagues Sam Hall and Aaron Kantoff, along with Tadd Wessel, managing partner of the health care private equity firm Petrichor. They raised $310 million for its first fund, blowing past their original $250 million target. (DeAngelis, 2/7)
Reuters:
Cigarette Giant BAT Makes Move On US Heated Tobacco Market
British American Tobacco submitted an application to make certain health claims about its Glo Hyper Pro device in the United States in December, its first clear move to bring the alternative smoking product to the key market. BAT had applied to market the product in the U.S. in 2021. But since then it has been unclear whether it planned to market the product in the United States. (2/8)
KFF Health News:
FDA's Plan To Ban Hair Relaxer Chemical Called Too Little, Too Late
In April, a dozen years after a federal agency classified formaldehyde a human carcinogen, the Food and Drug Administration is tentatively scheduled to unveil a proposal to consider banning the chemical in hair-straightening products. The move comes at a time of rising alarm among researchers over the health effects of hair straighteners, products widely used by and heavily marketed to Black women. But advocates and scientists say the proposed regulation would do far too little, in addition to being far too late. (Cohen, 2/8)
