FDA Blasts Drugmaker In India For ‘Cascade Of Failures’
The agency visited the Intas Pharmaceuticals plant in Gujarat, India, in November. The company was cited for problems with data integrity, accuracy, procedures designed to prevent microbiological contamination, and much more — including the discovery of a truck full of shredded documents. In other pharmaceutical and biotech news: Wegovy, epilepsy, solid tumor cancer treatment, and more.
FDA Cites Indian Drugmaker For Numerous Quality Control Problems
In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses. (Silverman, 1/19)
Pallone Pushes NIH And FDA To Disclose Steps Being Taken To Ensure Clinical Trial Results Are Reported
A Democratic lawmaker is demanding to know what steps the Food and Drug Administration and the National Institutes of Health are taking to ensure that results of clinical trials funded by the government are reported to a federal database. (Silverman and Wilkerson, 1/19)
Will The EU Give Vouchers To Pharma To Develop Needed Antibiotics?
Amid rising concern over antibiotic resistance, a battle is brewing in Europe over a proposal to offer vouchers to companies as an incentive to develop new treatments. The controversial idea has already raised objections from more than a dozen members of the European Union. (Silverman, 1/19)
For The Second Time, A Big Drugmaker Offers Warranty On A Medicine
In a bid to blunt competition and address rising drug costs, Sanofi is offering a warranty that will cover the cost for any hospital if a specific medicine fails to work, marking only the second time a major pharmaceutical company has taken such a step. (Silverman, 1/19)
What Happens When You Stop Taking Wegovy Or Ozempic? Many People Regain The Weight.
Wegovy, or semaglutide, is part of a class of drugs called GLP-1 agonists. They mimic a hormone that helps reduce food intake and cuts appetite. In clinical trials, Wegovy was shown to reduce body weight by around 15%. (Lovelace Jr., Lynch and Thompson, 1/19)
New Tech Targets Epileptic Seizures With Lasers, Robots And Precision Surgery
About three million people in the United States have epilepsy, including about a million who can't rely on medication to control their seizures. For years, those patients had very limited options. Surgery can be effective, but also risky, and many patients were not considered to be candidates for surgery. (Hamilton, Scott, Lu and Spitzer, 1/20)
Some Biotechs Bet That Mesothelin Is Key To Tackling Solid Tumors
Scientists working to produce immunotherapies for solid tumor cancers have spent decades searching for biological targets that can help them distinguish between healthy cells and cancerous ones. Finding such biomarkers is critical to developing treatments that can kill the cancer without also killing the patient. (Chen, 1/20)