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 still shaping up but looks to be exceedingly modest. We expect to catch up on our reading, promenade with the official mascots, and take a few naps. We also hope to hold still another listening party, where the rotation will likely include this, this, this, this and this. And what about you? Once again, we will note that apple orchards and pumpkin patches are beckoning, but supplies may be dwindling. This is also a fine time to stock up for the winter, so chop those logs, caulk those drafty corners, and search for snazzy sweaters. If this is all too much for you, though, you can sit at home and dream about days to come. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
The U.S. Food and Drug Administration announced the first nine recipients of the Commissioner’s National Priority Review vouchers, a program offering an expedited drug review to companies with products that align with the agency’s national health priorities, STAT says. The agency announced the program in June, touting perks such as a one-to-two month drug review timeline and enhanced communications with FDA review staff, as opposed to the 10-to-12 months most companies wait. The criteria for eligible companies was somewhat vague, though the agency referenced addressing unmet health needs, beefing up domestic manufacturing, and delivering more innovative cures as potential qualifications for the program.
The Trump administration struck a deal with EMD Serono to lower drug prices — part of a larger push from the administration to expand coverage and improve affordability for fertility services, STAT tells us. The administration plan has several components, including the drugmaker pledging to lower drug prices, new benefits rules to encourage employers to offer in vitro fertilization coverage outside of health insurance, and a U.S. Food and Drug Administration priority review voucher for another fertility drug not currently available in the U.S. EMD Serono is the third drugmaker to strike a deal with the president, after announcements from Pfizer and AstraZeneca in recent weeks. EMD Serono has pledged to offer direct-to-consumer sales of its IVF therapies and to participate in the TrumpRx purchasing platform in 2026.
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STAT Pharma: The science and business of new drug development
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