STAT+: Pharmalittle: We’re reading about Lilly plant problems, FDA reorganization plans, and more
The FDA uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by the agency.
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because now the time has come to dive back in to the usual routine of online meetings, calls, and deadlines. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or three of stimulation. Our choice today is peppermint mocha. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits to help you get started on your journey today. We hope your excursion is rewarding and interesting. And of course, do stay in touch. …
The U.S. Food and Drug Administration recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by the agency, Reuters reports. The FDA inspection in July at a Lilly plant in Branchburg, N.J., detected eight separate deficiencies. These included problems in tracking manufacturing processes and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment, according to an inspection report. Lilly said in a statement that the company had asked the FDA to allow for “additional flexibility” to manufacture migraine treatment Emgality on a different production line if needed in the future.
The European Medicines Agency this week will consider wider use of Novo Nordisk’s weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks, Reuters notes. An approval could help the company better argue its case for making the drug available via public sector health systems in Europe. The possible new use of Wegovy, based on a drug trial known as SELECT, will be assessed during the monthly meeting of an EMA assessment panel. Many European countries have kept a restrictive stance when it comes to health system coverage of drugs that are primarily for weight loss, with some, including Germany, even ruling out such payments by law.
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