Hello, everyone, and how are you today? We are just fine, thank you, despite the steady rain drenching the sleepy Pharmalot campus. Our spirits remain sunny thanks, in part, to sage advice from the Morning Mayor: “Every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will indulge in a few more cups of stimulation — our choice today is blueberry cobbler — and continue our quest for items of interest. Speaking of which, here are some tidbits. Hope your day is simply smashing, and do drop us a line when interesting developments pop up in your vicinity. …
A bidding war has broken into the open for Metsera, which focuses on developing drugs to treat obesity, as Novo Nordisk made an offer a month after Pfizer announced plans to purchase the company, STAT says. The Novo offer, what it called “an unsolicited proposal,” reflects the pressure pharmaceutical companies are under to gain an edge in the white-hot obesity market. It also seems to have gained traction with Metsera. After Novo announced its move, which Pfizer called “reckless and unprecedented,” Metsera issued a statement saying it considered the Novo offer “superior.” Under the terms of its deal with Pfizer, that notice now means Pfizer has four business days to renegotiate the terms of its offer, according to Metsera. Pfizer, however, disagreed. In its own statement, Pfizer argued Novo’s action was “an attempt by a company with a dominant market position to suppress competition in violation of law by taking over an emerging American challenger.”
The Trump administration announced a draft framework that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable and accessible for patients, STAT writes. The framework will shorten the path for the U.S. Food and Drug Administration to approve biosimilars, or copycat versions of biologic drugs, by lowering the clinical standards companies need to meet before bringing the drugs to market. That will cut the cost of developing biosimilars and the time needed to approve them, according to FDA Commissioner Marty Makary, who added that the agency plans to release its final guidance on biosimilars in three to six months. The FDA is also working to make more biosimilars interchangeable with brand-name drugs at the pharmacy counter — and to shorten approval times in other ways as well. The proposed policy is the latest in an aggressive push from the administration to lower drug prices.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
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