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Good morning, we’ve bought extra information at present about Vinay Prasad — let’s get into it.
Vinay Prasad makes his debut at FDA
Sooner or later after he was named the director of the FDA’s Heart for Biologics Analysis and Analysis, Vinay Prasad confirmed up at headquarters yesterday and struck a humble, self-deprecating, and even earnest tone, in accordance with a recording obtained by STAT’s Lizzy Lawrence.
That tone sounded at odds together with his on-line firebrand persona. However, in his remarks, Prasad emphasised his dedication to proof, his admiration for company staff, and his want to serve the American public.
“My tutorial analysis self-discipline is epidemiology, evidence-based medication,” he mentioned. “I applaud what you do. I’ve realized lots from studying your papers during the last 20 years.”
How involved ought to biotech be about Prasad?
Whereas the tone of Prasad’s remarks on the FDA was calm, the response on Wall Avenue to information of his appointment, as mentioned in yesterday’s publication, was something however. Biotech shares plunged.
How a lot ought to the trade actually be involved, although?
He’ll little question be harder regulator of gene therapies than his predecessor Peter Marks, my colleague Adam Feuerstein writes. However in the long term, requiring stringent trials and robust proof will result in higher medicine that profit each sufferers and firms, on this view.
It’s in all probability additionally unlikely Prasad will be so strict that corporations abandon the sector, provided that FDA Commissioner Marty Makary selected him, and Makary has been advocating for streamlining and accelerating opinions of rare-disease medicine, Adam writes.
Choose offers blow to compounding pharmacies
Compounding pharmacies suffered one other blow yesterday, as a federal decide sided with the FDA over its choice final yr to take away Eli Lilly’s GLP-1 drug tirzepatide (branded as Mounjaro and Zepbound) from its scarcity listing.
When GLP-1 medicine have been in scarcity the final two years, hordes of compounders started making cheaper copies, however when the FDA eliminated tirzepatide from its scarcity listing on the finish of final yr, that meant compounders might now not maintain making copies. A compounding commerce group sued the FDA, arguing that the branded drug was in reality nonetheless in scarcity, however the decide has now in the end dominated in opposition to the group.
The identical decide final month additionally rejected a bid by the identical commerce group to permit compounders to proceed making copies of Novo Nordisk’s semaglutide (branded as Ozempic and Wegovy). That case remains to be enjoying out, although, because the decide hasn’t but issued a closing ruling.
Learn extra from STAT’s Ed Silverman.
These developments have left many sufferers who rely on compounded medicine in a near-impossible scenario. The telehealth corporations and pharmacies that supply compounded merchandise at the moment are pursuing probably dangerous methods like mixing in components or encouraging sufferers to stockpile. On the identical time, many sufferers nonetheless can’t afford the branded therapies. Learn extra on instances like this right here.
Extra reads
- RFK Jr. needs People’ well being information to review autism. It’s not that straightforward to get them, STAT
- Watch: Contained in the world of web peptides, STAT
- The value of remission: a reporter’s private story with Revlimid, ProPublica
