Rise and shine, another busy day is on the way. We can tell because the official mascots got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy parade of vehicles passing nearby on their way to who knows what? As for us, we are firing up the trusty coffee kettle to brew another cup of stimulation. Our choice today is roasted coconut. Please feel free to join us. Meanwhile, the time has come to get cracking. So here is the latest laundry list of interesting items for you to peruse. We hope you have a smashing day and, of course, do keep in touch. Best of luck, everyone. …
U.S. Food and Drug Administration Commissioner Marty Makary says the agency does not plan to put a “black box” warning on Covid vaccines, despite a recent report that regulators were preparing to add a new caution to the immunizations, Bloomberg News says. CNN reported Friday that the FDA was preparing to change the safety information related to the shots to include its strongest level of warning. But on Monday, in an interview with Bloomberg TV, Makary said that “we have no plans to put that on the Covid vaccine.” He added that some agency officials had recommended putting a boxed warning on the shots, but some scientists and agency leaders, including the top vaccine regulator Vinay Prasad, did not think it was necessary because of the changing risks.
A U.S. judicial panel plans to centralize a growing number of lawsuits against Novo Nordisk and Eli Lilly alleging patients lost some or all of their eyesight while taking the companies’ blockbuster weight loss drugs before a judge in Pennsylvania, Reuters notes. The U.S. Judicial Panel on Multidistrict Litigation, which manages complex federal litigation, agreed with the plaintiffs that the cases should be centralized in their own multi-district litigation in Philadelphia federal court rather than added to the existing mass litigation in the same court over gastrointestinal side effects of the drugs. The lawsuits in the new MDL allege the drugs, including Novo Nordisk’s Ozempic, Wegovy, and Saxenda, and Eli Lilly’s Trulicity, can trigger non-arteritic anterior ischemic optic neuropathy, a condition that occurs when blood flow to the optic nerve is blocked or reduced, which can lead to blindness.
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