To make the time fly, we are firing up the trusted coffee kettle and brewing another cup of stimulation. Our choice today is honey almond crunch. Can you guess what gives it the crunch? Meanwhile, the time has come to get cracking. Here are a few items of interest to help you get started. We hope you have a lovely day, and do keep in touch. Feedback, tips, and suggestions are always welcome. …

The U.S. Food and Drug Administration is launching a program to reward companies with accelerated drug review and speedy agency feedback, if their actions align with the agency’s national health priorities, STAT tells us. Those priorities include addressing unmet public health needs or health crises, beefing up domestic production of drugs, and delivering more innovative cures. The new priority review relies on a carrot instead of a stick. Rather than the typical review time of 10-12 months, recipients of the “Commissioner’s National Priority Voucher” are entitled to a review within one to two months after a final drug application is submitted. A “limited” number of companies will receive the vouchers this year. Some may also earn an accelerated approval, in which the FDA sends a drug to market based on an endpoint predicting clinical benefit. Chosen companies will also be subject to a different regulatory process. An application will be reviewed not by scientists in a specific FDA center, but by a “multidisciplinary team” of physicians and scientists across the agency. 

Dozens of companies have pledged to build  more manufacturing facilities in the U.S. since President Trump took office, but generic drugmakers are not among them – and they have no plans to change that anytime soon, The Wall Street Journal notes. Generic drug companies – which supply about 90% of the medications taken by Americans – say further domestic investment is too risky in such a low-margin and unpredictable business, unless the government helps to steady the sector. Drugmakers want more clarity from the Trump administration on the potential pharmaceutical tariffs, which some companies warn could lead them to close U.S. plants altogether. More U.S. investment by brand-name drugmakers, however, will not address issues such as curbing shortages of drugs or supplying essential medicines, which largely involve generic drugs that are made overseas, according to supply-chain experts. Instead it will spur production of expensive medicines already made in America such as cell therapies or biologic cancer drugs, which make up more than 80% of the country’s drug expenditure.

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On that note, we have assembled a menu of tidbits to help you get started. Meanwhile, we have also fired up the coffee kettle for another cup of stimulation. Our choice today is Mexican cinnamon. We hope your day is simply smashing and, as always, do keep in touch if something saucy arises …

Sarepta Therapeutics is halting shipments of its Duchenne muscular dystrophy gene therapy for patients who can no longer walk, following the death of a second person who received the treatment, STAT writes. The company disclosed the first patient death — a 16-year-old boy — in March. Both occurred from acute liver failure, a side effect that has been seen with other gene therapies. Sarepta said both patients were non-ambulatory, meaning their disease had progressed to the point they relied on a wheelchair. Most children with Duchenne lose the ability to walk by adolescence. The company is now working with experts to come up with an enhanced immunosuppressive regimen that could make the therapy, called Elevidys, safer for non-ambulatory patients. Sarepta also said it was pausing dosing in an ongoing clinical trial of Elevidys, called Envision, that is focused on older ambulatory and non-ambulatory patients. 

Sens. Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced a bill that would ban pharmaceutical manufacturers from using direct-to-consumer advertising, including social media, to promote their products, The Wall Street Journal writes. The bill would prohibit any promotional communications targeting consumers, including through television, radio, print, digital platforms, and social media. It will apply to all prescription drug advertisements. The bill comes after repeated calls from Department of Health and Human Services Secretary Robert F. Kennedy Jr. to end prescription drug advertising. Kennedy said while running for president that he would issue an executive order kicking pharmaceutical commercials off television, arguing that Americans take too many prescription medicines and suggesting that industry spending was influencing news coverage of the drug industry. Sanders and King each voted against Kennedy’s confirmation, but are critics of prescription drug ads. King in February introduced a bill to prohibit pharmaceutical advertising to consumers in the first three years after a medicine’s approval, following other efforts in past years.

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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.

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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.

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Means, an M.D. and author who runs a holistic wellness blog and co-founded the health tech company Levels, is the sister of Calley Means, an adviser to Health Secretary Robert F. Kennedy Jr. Both Meanses have become key influencers in the MAHA world, with Casey lending her medical training and knowledge to the cause. 

Trump’s original nominee to the post of surgeon general was Janette Nesheiwat, a medical doctor and Fox News contributor. The White House withdrew her nomination a day before Nesheiwat was scheduled to appear before a key Senate committee. She came under fire in recent weeks for previous comments she’d made online in support of the Covid vaccine and masking during the pandemic. CBS News also reported that Nesheiwat received her medical degree from a school in the Caribbean, not, as she claimed, the University of Arkansas School of Medicine.

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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. 

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The hulking factories are tucked away off the roads around the village of Ringaskiddy — operated by the likes of Pfizer, Johnson & Johnson, and BioMarin, whose plant featured signs last week touting a new facility “coming Q1 2027.”

The nearby town of Carrigtwohill crows that it’s grown “+400% over the past 20 years,” a surge driven by sites run by AbbVie and Gilead. 

And down in Kinsale, an Eli Lilly campus rises up out of the Irish countryside, a hub that recently underwent an $800 million expansion to meet the surging demand for the company’s obesity and diabetes drugs. Placards along the edge of the property celebrate Lilly’s sponsorship of the upcoming Kinsale 10-mile road race. 

“It’s absolutely everything to this area,” Jack White, a member of the County Cork council, told STAT, referring to the presence of pharma manufacturing here. 

President Trump is less fond of the industry’s operations in Ireland. As he seeks to impose tariffs on goods worldwide, part of a bid to bring companies back to the U.S. and generate jobs, he has specifically called out pharma manufacturing in this country and pledged to announce new levies on drugmakers. In his view, the U.S. trade imbalance with Ireland — one largely driven by pharmaceutical exports — is a particular injustice. As a result, the industry is now caught in his crosshairs, anxiously awaiting details from the administration.

“All of a sudden Ireland has our pharmaceutical companies, this beautiful island of five million people has got the entire U.S. pharmaceutical industry in its grasp,” Trump said in a March meeting with Irish Prime Minister Micheál Martin marking St. Patrick’s Day. “I’d like to see the United States not have been so stupid for so many years, not just with Ireland, with everybody.”

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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.

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So, too, is the vast, unexplored drug-hunting territory of chemical space, waiting to be illuminated by data’s light.

Every AI model trained for biology only can see what’s illuminated by the data points it is trained on. AlphaFold succeeded in predicting protein structures because the 200,000 or so known protein structures in the Protein Data Bank covered enough of the limited ways amino acids can combine that the model was able to understand what almost the entire protein structure space looked like. But ask the PDB for only the structures where proteins are hugging other proteins or — even rarer — interacting with drug-like molecules, and there’s nowhere near enough illumination for AI biology models to understand what the topography of those plains look like, much less make useful predictions for drug discovery.

Life sciences data company Apheris on Thursday announced an effort to boost the capabilities of protein AI models by uniting several pharmaceutical companies’ proprietary data. Apheris’ consortium of pharma companies is partnering with OpenFold3 — Columbia professor Mohammed AlQuraishi’s open-source dupe of AlphaFold3 — to train the model on AbbVie and Johnson & Johnson’s vast stores of structural data. The collaboration will focus on structures relevant to drug discovery, such as small molecule-protein and antibody-antigen interactions. 

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After all, the neurons could use all the help they can get, would you not agree? Meanwhile, here are a few items of interest for you to digest as you embark on your own journey today, which we hope is meaningful and satisfying. On that note, time to hustle. Best of luck, and do keep in touch. …

Prominent outside scientists who help the U.S. National Institutes of Health evaluate its internal research programs are being abruptly removed, according to five advisers whose positions were terminated and a recording of an internal meeting obtained by STAT. The motivations behind the removals from the agency boards of scientific counselors remain unclear. But among those being terminated are non-U.S. citizens, women, scientists from underrepresented racial and ethnic groups, and individuals whose research focus or other work touches on areas the new administration considers taboo, such as diversity and equity. The removals come amid a broader attempt by the Trump administration to align health agencies with the president’s views on DEI, gender, immigration, and other issues, by terminating grants mentioning words like “diversity” or focused on environmental justice, while explicitly targeting such employees for removal.

GSK has teamed up with two research organizations in the U.K. to explore a possible link between its shingles vaccine Shingrix and a reduced risk of dementia, Pharmaphorum says. The tantalizing hypothesis — drawn from observational and retrospective studies — is that vaccination against shingles can help protect against dementia in the following years. To test it prospectively, GSK will work with the UK Dementia Research Institute and Health Data Research UK to use de-identified, population-level electronic health data from the National Health Service to look at the impact of shingles vaccination on dementia risk. Their study will look at real-world data from around 1.4 million people aged 65 and 66 at the time that the U.K. expanded its shingles national immunization program in 2023. Research has already shown that vaccines against shingles potentially reduce the risk of dementia, but past studies only identified associations, not causality.

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