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By Ed Silverman Nov. 18, 2022
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall our treasured signal to daydream about weekend plans. Our agenda is in the proof-of-concept phase, but we hope to promenade with the official mascot, hang with Mrs. Pharmalot, catch up on our reading, and nap extensively. And what about you? Those of you on this side of the pond may want to prepare for an upcoming celebration, although we hear turkeys are pricey, so perhaps pivoting to some other fowl — cornish hen, anyone? — may be worth considering. The annual holiday season is also nearing so this may be an opportunity to sharpen your bargain-hunting skills. Or you may want to take stock of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
Pharmaceutical companies could be made to disclose prices and deals for products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord, Reuters reports. A draft version of the accord, which is being negotiated by the health agency’s 194 member countries, calls for it to be compulsory for companies to reveal the terms of any public procurement contracts. The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world.
The first therapy that delays the onset of type 1 diabetes received approval from the U.S. Food and Drug Administration, CNN tells us. The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield and is from ProventionBio and Sanofi, is given through intravenous infusion. The treatment comes as a 14-day course of infusions that each last 30 to 60 minutes. As of 2019, about 1.9 million people have type 1 diabetes in the U.S., according to the American Diabetes Association, including 244,000 children and adolescents. Type 1 affects 8% of everyone with diabetes.
Diabetic patients will now have easier access to insulin after the FDA approved an Eli Lilly biosimilar as interchangeable with the biologic drug, Bloomberg News notes. Rezvoglar, which the agency previously approved in December 2021, can now be swapped out as a substitute for Lantus, which is sold by Sanofi, at the pharmacy counter without prior authorization from a certified medical prescriber. The Lilly drug is the second interchangeable insulin product approved by the FDA and is part of agency efforts to offer and ease access to lower-cost treatments for patients.
A FDA official says that most warning letters issued for manufacturing issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools, according to Regulatory Focus. The agency issued 62 warning letters and 23 import alerts related to drugs, excluding compound-related actions. The number of warning letters prompted by onsite inspections rose dramatically: 42, or 68%, of the warning letters followed onsite inspections, while 16, or 26%, resulted from inspecting samples and four, or 6.5%, resulted from records requests. But the agency still faces a backlog.
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Pharmalot Columnist, Senior Writer
Ed covers the pharmaceutical industry.
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