Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Blasts Drugmaker In India For 'Cascade Of Failures'
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)
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)
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)
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)
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)
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)
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)
