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Good morning, folks! Biotech had a bit of a rough day yesterday because, get this, Vinay Prasad got picked to lead the FDA’s biologics center. Yeah, not the best news, huh? Stick around, though, because I’ve got a little surprise for you at the end of this newsletter.
So, this FDA critic, Vinay Prasad, is all set to take the reins at the center overseeing vaccines and biologics. He’s known for being pretty vocal about his criticisms of mainstream medicine, especially during the whole Covid chaos. He’s not afraid to call out the FDA for being too cozy with big pharma and not really hitting the mark on safety and effectiveness. Want to know more? Read on.
Now, Prasad has been throwing shade at the FDA for using surrogate endpoints and fast-tracking approvals. He’s not a fan of decisions like giving the green light to Biogen’s Alzheimer’s drug or Sapreta’s gene therapy. And get this, his views clash with what FDA Commissioner Marty Makary has been saying about speeding up the drug review process. Investors were not thrilled with the Prasad news, and the XBI took a hit, dropping over 6%. Ouch.
Moving on to Novo Nordisk, they’re seeing some light at the end of the tunnel. Shares went up by 5% as execs are hopeful for a sales boost for the obesity drug Wegovy later this year. Even though Novo had to lower its sales and profit predictions for 2025, the outlook isn’t all gloom and doom. The competition is tough, with Eli Lilly’s Zepbound making waves in the obesity drug market. Novo is blaming compounded GLP-1 drugs for the revised forecast, but things might be looking up as the FDA is cracking down on compounding pharmacies.
Oh, and guess what? Two Flatiron Health vets started a new firm called Inductive Bio. They’re working on an AI tool to help biotechs predict the toxicity of small molecule drugs. Sounds pretty cool, right? The company raised $25 million in funding, so they must be onto something good.
In other news, Marea Therapeutics is making waves with their new drug that slashes remnant cholesterol levels in half. This could be a game-changer in treating cardiovascular disease. The drug targets a protein that plays a role in producing remnant cholesterol, and even though there were some bumps in the road during development, things are looking up now.
And hey, did you catch the Met Gala this year? Our eagle-eyed colleagues spotted some outfits that looked strangely familiar, like they were inspired by pharmaceutical company logos. Check out the comparisons, they’re pretty spot on.
Alrighty, that’s a wrap for today. Stay tuned for more juicy biotech news coming your way soon! Bye for now.
