A harsh FDA critic will lead vaccine, biologics regulation

Vinay Prasad, an academic and fierce critic of the medical mainstream, has been chosen to be the next director of the FDA center that oversees vaccines and biologics. He replaces longtime director Peter Marks, who was forced out of the agency in March by health secretary RFK Jr.

He's perhaps most widely known for his online presence criticizing Covid-era policies around vaccines and masks for children. But he's also accused the FDA more broadly of being too cozy with the pharma industry and falling short on safety and efficacy standards. Read more.

And for a deeper look at what he's said about various topics, ranging from vaccines to gene therapies to the FDA itself, we've combed through Prasad's papers, social media posts, and Substack and gathered some of his comments here.

Notably, he's been critical of the FDA's use of surrogate endpoints and accelerated approval, and has bashed the agency's decisions to approve products like Biogen's Alzheimer's drug aducanumab and Sapreta's gene therapy for Duchenne muscular dystrophy. Prasad's stance seems to conflict with recent comments by FDA Commissioner Marty Makary, who said he wants to speed up the drug review process.

Investors were not happy with the Prasad news, leading the XBI to fall over 6% yesterday. Shares of gene and cell therapy companies were particularly hard hit, with some plunging nearly 30%.

vTFET-biotech-stocks-falls-on-vinay-prasad-news

pharma

Novo cuts financial outlook but sees sales rebounding later this year

From my colleague Andrew Joseph: Shares of Novo Nordisk were up some 5% early this morning as company executives forecast improved sales of the obesity drug Wegovy later this year.

The stock boost for Novo, whose value has slid by a third over the past six months, came even as the Danish company lowered its sales and profit guidance for 2025. Sales are now expected to grow in the range of 13-21% at constant exchange rates, down from 16-24%, while profit should grow from 16%-24%, revised from 19-27%. Some investors had been anticipating the guidance cuts.

While Novo’s Wegovy has been facing fierce competition from Eli Lilly’s Zepbound, with the latter obesity drug increasingly winning market share in the U.S., Novo blamed its downwardly revised forecast on the availability of compounded GLP-1 drugs. Lars Fruergaard Jørgensen, Novo’s CEO, said on a call with reporters that compounders have captured up to a third of the U.S. obesity market.

But semaglutide (the key ingredient in Wegovy and Ozempic) is no longer considered by the FDA to be in shortage, so compounding pharmacies will no longer be legally allowed to make their versions of the drugs. Novo executives pointed to this as one reason Wegovy sales should increase in the second half of the year. They also cited the continuing global expansion of the drug (which is now available in roughly 25 countries), their agreements with telehealth companies to provide the drug, a pact with CVS Caremark to prioritize Wegovy on its formularies, and new indications for Wegovy’s label.

Jørgensen, asked about the loss of investors’ trust in recent months, said the company was taking the issue seriously and had a strategy to increase prescriptions in the U.S. “We do not appreciate when investors are not pleased,” he said. “It is really about making sure that we execute on our plans.”

venture

New AI tool aims to forecast small molecule toxicity

Two veterans from the health tech company Flatiron Health have launched a new firm called Inductive Bio, which is developing an AI tool to help biotechs forecast the toxicity of small molecule drugs.

Inductive raised $25 million in a Series A financing round, my colleague Allison DeAngelis learned exclusively. The round was led by Obvious Ventures and also included Andreessen Horowitz, Lux Capital, and several data scientists.

Predicting the way that small molecules are absorbed and metabolized is a finicky science that's ripe for AI transformation, but it hasn’t yet been the focus of many AI efforts since small molecules are very difficult to model with computers.

cardiovascular

Marea drug could offer new way to lower heart risks

Marea Therapeutics said this morning that its experimental drug cut what's known as “remnant cholesterol” in half in a mid-stage study. The results pave the way for further trials and could lead to a new way of treating cardiovascular disease.

Remnant cholesterol is distinct from LDL (bad) or HDL (good) cholesterol, and elevated levels are associated with a higher risk of serious heart complications even in patients prescribed standard cholesterol-lowering medicines, according to Ethan Weiss, Marea’s co-founder and chief scientific officer.

The drug blocks a target called ANGPTL4, a protein found in fat tissue that plays a role in the production of remnant cholesterol. The target and drug have been around for decades, but development was stymied by a safety study in mice.

fashion break

Seeing pharma everywhere

The first week of May means it's Met Gala week. Loyal readers may recall that last year we found uncanny resemblances between some of the outfits and some of the distinct logos of the drug companies in our midst. (Scroll to the bottom of this page to jog your memory.)

There were some amazing outfits for this year's Met Gala, which featured the theme “Superfine: Tailoring Black Style,” and I'm hoping to keep this going as an annual tradition, as long as my editor allows me to continue doing this.

My colleagues Brittany Trang and Allison DeAngelis, who seem to have a special talent (or maybe curse) for seeing logos of pharmaceutical companies wherever they look, spotted some more resemblances this year. Take a look:

Mindy Kaling