Today we talk about an advance in an experimental mRNA vaccine for HIV, dive deep on Vinay Prasad’s sudden FDA departure, and more.

The need-to-know this morning

• Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.
• Biogen, Argenx, Sanofi, and Bristol Myers Squibb reported second-quarter earnings. 
• AbbVie and Apellis Pharma reported earnings, too. 

Inside the undoing of Vinay Prasad at the FDA

Vinay Prasad’s short-lived but polarizing run as head of the FDA’s biologics division ended just 84 days in, after his aggressive push to tighten oversight on gene therapies and Covid-19 vaccines drew heat from all sides — Trump allies, RFK Jr. loyalists, Democrats, and Duchenne patient advocates.

His decision-making on Sarepta Therapeutics’ gene therapy— which he viewed as backed by staff and rooted in safety concerns — fueled political pressure that only mounted after far-right influencer Laura Loomer launched a campaign highlighting his progressive leanings and past anti-Trump comments. A powerful and extremely online regulator ran out of friends when it mattered most.

Continue to STAT+ to read the full story…

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Hello! Today, we talk about a cool experimental enzyme therapy, observe more patent maneuvers over Eylea, and see an ‘underdog’ startup get a huge seed round to target a common kidney disease.

The need-to-know this morning

• Soleno Therapeutics pre-announced $31-33 million in Vykat XR sales for the second quarter — beating consensus expectations by a wide margin. The drug was approved in late March to treat Prader-Willi syndrome, a rare genetic disease that causes an insatiable desire to eat. Soleno is also raising $200 million in a follow-on stock sale.
• AbbVie is paying $700 million upfront to acquire licensing rights to a “trispecific antibody” treatment for cancer developed by Ichnos Global Innovation. The drug, called ISB 2001, targets CD38 and BCMA protein receptors on tumor cells and the CD3 receptor on T cells. A Phase 1 study in multiple myeloma is underway.

Brawl over Eylea gets biosimilar industry’s attention

A high-stakes legal fight between Regeneron and Amgen over the blockbuster eye drug Eylea is putting the U.S. patent system under a microscope — and is being closely watched by biosimilar makers.

Continue to STAT+ to read the full story…

AbbVie said Monday that it would pay up to $2.1 billion to acquire Capstan Therapeutics, a startup developing CAR-T therapies for autoimmune conditions, fibrosis, and cancer. 

AbbVie will pay up to $2.1 billion in cash when the deal closes, according to a press release. The companies did not give further details about the financial terms or a timeline for completing the acquisition. 

Capstan launched in 2022 and has raised around $340 million from OrbiMed, Vida Ventures, RA Capital, Polaris Partners, and the venture teams at Pfizer, Bayer, Eli Lilly and Company, and Bristol Myers Squibb. It was last valued at around $500 million, according to Pitchbook. 

Continue to STAT+ to read the full story…

Health and Human Services Secretary Robert F. Kennedy Jr. recently revealed on a health influencer podcast that he received unproven stem cells at a clinic in Antigua for his throat condition, spasmodic dysphonia. He also suggested that he wants to give the public much broader access to such unproven therapies, which would be extremely risky.

This revelation confirms what I had suspected for months about Kennedy. It also raises new concerns about a possible upcoming wave of reckless cell therapy deregulation from this administration.

Continue to STAT+ to read the full story…

The report found that 96% of the Part D plans and 88% of the Medicare Advantage drug plans agreed to cover at least one of the 10 available copycat drugs on their 2025 formularies. And some did not cover the brand-name version. This was a big jump in coverage from 2024, when only 64% of the Part D plans and 52% of the Medicare Advantage drug plans covered at least one biosimilar version of Humira.

Overall, 99% of enrollees in Part D Plans and 90% in Medicare Advantage drug plans had access to at least one Humira biosimilar in 2025. However, some plans are still restricting access to the biosimilars this year, which precludes usage. Specifically, 10% of Medicare Advantage drug plans and 1% of Part D plans cover only the brand-name medication.

Continue to STAT+ to read the full story…

The meeting was with a startup created by Flatiron Health veterans Josh Haimson and Ben Birnbaum. The duo had built the first team at Flatiron focused on machine learning, and, a few years after pharmaceutical giant Roche snapped up the company for $1.9 billion, they launched their own company.

Their new venture, Inductive Bio, has created an artificial intelligence tool that biotechs can use to design and model different versions of a small-molecule drug, sussing out what variation might cause drug toxicity or be metabolized too quickly. 

Continue to STAT+ to read the full story…

customers six years ago, but did not report any profits from those sales on its 2019 tax returns because all of the income was supposedly earned offshore, according to an investigation by the Democratic staff of the Senate Finance Committee.

As a result, the company was able to avoid paying billions of dollars in federal income taxes and, in fact, also did not report any taxable income in the U.S. for 2018 and 2020. To accomplish this, Pfizer used what was described as an “egregious tax gimmick” called “round-tripping,” a tax avoidance scheme that involves making sales to U.S. customers, but treating the profits as foreign income for tax purposes.

Often, round-tripping refers to offshoring manufacturing to a foreign subsidiary located in another country or jurisdiction with lower tax rates. The list includes Puerto Rico and Ireland, where Pfizer has various operations. Another tactic is to shift intellectual property rights to such havens or engage in transfer pricing, which involves a company selling itself products at artificially high prices.

Continue to STAT+ to read the full story…

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning. Let’s get straight into the news today.

Read the rest…

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning. The MAHA movement is influencing not only the federal government, but also state legislatures across the U.S. We discuss all that and the key biotech news today.

Read the rest…

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

When it comes to delivering shareholder value through M&A, Ron Renaud is a biotech investor’s best friend. Over the last 10 years, all three of the companies he has helmed were sold to Big Pharma for a combined $16 billion. 

With that track record — and the financial windfall it brings — no one would have begrudged Renaud, 55, had he desired to spend more time with his Cape Cod fishing buddies. But he can’t quit biotech. Weeks after overseeing the close of Cerevel Therapeutics’s $8.7 billion acquisition by AbbVie, Renaud is back as CEO of Kailera Therapeutics, a newly formed company with a pipeline of weight loss drug candidates.

Continue to STAT+ to read the full story…