STAT+: Pharmalittle: We’re reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more
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, so far, is very low-key. We hope to catch up on our reading, promenade with the official mascots, and take a few naps. We may also manicure the Pharmalot grounds. And of course, we hope to hold still another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The choices are endless this time of year. In particular, the great outdoors are beckoning — trails can be hiked, streets can be walked, country roads can be driven. If this fails, there is always the great indoors. You could cook a fabulous meal, shop for something that looks spiffy, or binge watch on the telly. Or you could be totally zen and do absolutely nothing. Well, whatever you prefer, have a grand time. But be safe. Enjoy, and see you soon…
A U.S. Food and Drug Administration advisory panel recommended updating this fall’s Covid shots to target the XFG variant, a fast-growing strain nicknamed “stratus,” NBC News tells us. The recommendation — from the FDA’s Vaccines and Related Biological Products Advisory Committee — is meant to help vaccine makers prepare shots for the fall and winter, when Covid infections typically rise. The meeting was the agency’s first since FDA Commissioner Marty Makary resigned. His resignation did not play a role; the meeting was already on the calendar before he resigned. Makary drew criticism last year after the agency imposed stricter requirements on who could get Covid shots.
Pfizer and China’s Innovent Biologics agreed to a global licensing and collaboration deal worth up to $10.5 billion to develop 12 early-stage cancer medicines, as global drugmakers race to tap China’s booming biotech pipeline, Reuters says. The deal also includes a $650 million upfront payment to Innovent and up to $9.85 billion in potential development, regulatory and commercial milestone payments. The value of such deals in the greater China region rose nearly tenfold from 2021 to an unprecedented $137.7 billion last year. The partnership spans a portfolio of antibody-drug conjugates with novel differentiated payloads and multi-specific antibodies, comprising eight Innovent-originated early-stage assets and four Pfizer-proposed discovery programs.
The World Health Organization identified drugs from Regeneron Pharmaceutical, Mapp Bio, and Gilead Sciences that should be fast-tracked through clinical testing to respond to the current Ebola outbreak, Pharmaphorum notes. The WHO’s independent experts have said Regeneron’s maftivimab, Mapp’s MBP134, and Gilead’s remdesivir should be studied in patients infected with the Bundibugyo form of Ebola currently infecting more than 1,000 people in the Democratic Republic of the Congo, with cases also reported in neighbouring Uganda. At last count, the Bundibugyo outbreak had led to 10 confirmed deaths, with another 223 suspected, although the WHO has said it could be much larger as the virus is thought to have circulated undetected for some time.
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المصدر: STAT News
