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First came the new teaser for Nathan Fielder’s documentary on Elizabeth Holmes. Now come the memes. Bring it on.
FDA names permanent heads of drug and biologics centers
For the past few months, key centers at the FDA have been led by acting officials. The agency said yesterday it will now make them permanent. Michael Davis will be director of the Center for Drug Evaluation and Research, and Karim Mikhail will be director of the Center for Biologics Evaluation and Research.
Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is ginseng peach, a favorite from our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips and criticism. …
In a pair of late-stage trials, an AstraZeneca drug reduced the dangerous flare-ups that worsen COPD, positioning it as a potential new option for the vast number of patients with the debilitating lung condition, STAT explains. According to data released Tuesday, the results also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that the injectable drug could reap billions in annual sales if approved, both in COPD and in other conditions including asthma.
The Trump administration permanently filled four key leadership roles at the U.S. Food and Drug Administration on Tuesday, after nominating Heidi Overton to lead the agency late last month, STAT says. Three of the officials are serving in an acting capacity, and will take the same roles permanently. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products.
WASHINGTON — The Trump administration permanently filled four key leadership roles at the Food and Drug Administration on Tuesday, after it nominated Heidi Overton to lead the agency late last month.
Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products.
The fourth appointee, Jared Seehafer, will serve as the FDA’s first deputy commissioner for technology and artificial intelligence. He joined the FDA as an adviser in 2025 after founding a life science software company and working in investment advising in biotech, according to his LinkedIn. Under the Trump administration, the agency has pushed its staff to use AI to speed up its review processes.
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Today, we delve into how an FDA approval paradoxically complicated access to Revolution Medicines’ new pancreatic cancer drug for some patients, see standout mid-stage results for Roivant’s pulmonary hypertension drug, and more.
Hope you had a lovely long weekend! Estoy trabajando en este Readout de la Biblioteca Vasconcelos en la CDMX.
Good morning, everyone, and welcome to another working week. We hope the weekend respite — longer than usual thanks to a holiday on this side of the pond — was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cup of stimulation. Our choice today is butter pecan. Feel free to join us. Remember, no prescription is required. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals, and we hope you conquer the world. And, of course, do keep in touch. …
An experimental Novartis drug for a rare neuromuscular condition failed to improve muscle function in a pivotal study, its second major trial collapse in a matter of days,STAT writes. The two study flops will likely stoke concerns about its pipeline and acquisition strategy as it navigates a major patent cliff, though the company did see a victory with a multiple sclerosis drug last week. The stock was down by as much as 10% in early trading in Switzerland. The Phase 3 HARBOR trial was testing the drug del-desiran in a condition called myotonic dystrophy type 1, known as DM1, which causes progressive muscle stiffness and weakness.
Novo Nordisk stopped two trials of a drug that aims to tame inflammation as a way to improve cardiovascular health, another blow for the approach, STAT notes. The company said it had halted the HERMES and ATHENA trials of its drug, ziltivekimab, after a data monitoring committee found they were unlikely to succeed. Novo informed trial investigators on Friday. The move follows the earlier failure of the drug in the ZEUS trial, which showed that the medicine, despite lowering markers of inflammation, did not reduce the risk of major clinical complications, including deaths and heart attacks.
In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday.
Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma.
In the trials, tozo reduced COPD exacerbations — any sudden worsening of the disease requiring medical care, whether a severe cough or breathlessness — by about 30% across all patients over a year, according to data presented at the European Respiratory Society’s annual conference in Barcelona and published in the New England Journal of Medicine. That finding makes tozo competitive with other COPD treatments that have reached patients in recent years, but notably, the tozo trials included participants not eligible for the other new drugs. The benefits seen in those patients could give AstraZeneca a large segment of the market to itself.
RFK Jr. adviser Calley Means and Kennedy’s son Finn attended the Enhanced Games, the pro-doping athletic competition and biohacking extravaganza that took place over the weekend in Las Vegas, according to The Washington Post. Send news tips and personal bests to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
Ripple effects
For weeks, Republicans have been preoccupied with an immigration funding bill that they’re pushing through Congress, without support from Democrats. I’ve not been writing about that bill because it doesn’t include health care policies. But it’s now becoming relevant to health care, albeit indirectly.
Early last week, Republicans were expected to pass that budget reconciliation bill without much friction. By the end of the week, Senate Republicans adjourned for a week-long recess without voting on it due to an impasse over a new $1.8 billion settlement fund for Trump’s allies. They’d also butted heads with the president over his demands for $1 billion for a White House complex and ballroom.
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Hi! Hope you had a nice extended weekend.
Today: Eli Lilly’s gene-editing data seems promising for high cholesterol, an AI drug discovery CEO dispelled some AI drug discovery hype, and the new interim FDA chief is so far well received.
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have clear blue skies and chilly breezes greeting us today. Who could ask for anything more? Actually, we could — it is time to reheat the coffee kettle for another cup of stimulation. Our choice today is strawberry creme, a pantry favorite. Please feel free to join us. Remember, no prescription is required and no rebates are involved. And now, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please do keep in touch. We have adjusted our settings to accept postcards and telegrams. …
Eli Lilly reported that a high dose of its gene-editing therapy reduced cholesterol levels by 62% in participants in a Phase 1 clinical trial, an early but encouraging test of whether a one-time treatment may one day help people seeking to lower their LDL, or “bad,” cholesterol, STAT writes. Lilly acquired the therapy in its $1 billion buyout of Verve Therapeutics last year. There were no treatment-related serious adverse events in the study, a notable finding given that Verve had to shelve its first candidate over safety concerns. Lilly now plans to begin a Phase 2 trial in an unspecified number of patients and will likely need to then run Phase 3 trials in thousands of patients for the treatment to earn approval.
Eli Lilly agreed to buy three early- and mid-stage vaccine developers in deals that could cost up to nearly $4 billion, STAT notes. The drugmaker, which is rich with cash from its booming GLP-1 business, in recent months has picked up companies working on cancer, autoimmune diseases, and sleep disorders, all for under $10 billion each. The new acquisitions — Curevo, LimmaTech Biologics, and Vaccine Company — will give Lilly a much larger footprint in infectious diseases, an area that has not recently been a priority for the company. Lilly framed the move as one that fit with a broader focus on preventing serious health problems.
Eli Lilly said Tuesday it would buy three early- and mid-stage vaccine developers, a boost for the field.
The deals — which together could cost up to nearly $4 billion — are the latest acquisitions from Lilly, a company rich with cash from its booming GLP-1 business. In recent months, it’s picked up companies working on cancer, autoimmune diseases, and sleep disorders, all for under $10 billion each.
The companies being bought are Curevo, LimmaTech Biologics, and Vaccine Company.
WASHINGTON — People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top food official in 2025.
They knew Kyle Diamantas worked at Jones Day representing food, beverage, and tobacco-industry clients. They saw the picture of him and Donald Trump Jr. holding giant, dead wild turkeys after a hunt. He had no experience in public health, in medicine or science, or in government.
The credentials didn’t scream qualified. And Diamantas was stepping into a center rocked by DOGE layoffs and a defiant resignation by former leader Jim Jones.
Sen. John Cornyn: How many patents do you [have?] AbbVie CEO Richard Gonzalez: … A hundred and thirty-six patents. Cornyn: A hundred and thirty-six patents on one drug? Gonzalez: But, well, remember, Humira is like nine different drugs, or 10 different drugs. So — Cornyn: I thought you said to Sen. [Debbie] Stabenow it was the same molecule. Gonzalez: It is the same molecule, but it treats different conditions. And if you look at that patent portfolio — Cornyn: So you use the same molecule to treat different conditions and you can get a patent on that treatment? Gonzalez: Certainly.
The above exchange comes from a 2019 congressional hearing. Sen. John Cornyn, a Republican from Texas, was asking AbbVie’s CEO, Richard Gonzalez, to explain to the Senate Committee on Finance how his company had amassed so many patents on this single drug called Humira. Gonzalez, who was no stranger to controversy, chose to respond by likening it to multiple drugs. After AbbVie had received the first regulatory approval for Humira to treat rheumatoid arthritis, a condition that causes inflammation of the joints, it thought the drug might also work on inflammatory bowel disease. In fact, AbbVie would eventually test, obtain patents for, and get FDA approval of the drug for several inflammation-related conditions. For Gonzalez, the 136 patents AbbVie had accumulated up until that point were justified. They were “innovations they had created,” he said. This would mean another 18 years of patent protection beyond the expiry of Humira’s original patent in 2016.
Eli Lilly said Monday that a high dose of its gene-editing therapy reduced cholesterol levels by 62% in participants in a clinical trial, an early but encouraging test of whether a one-time treatment may one day help people seeking to lower their LDL, or “bad,” cholesterol.
Lilly acquired the therapy, VERVE-102, in its $1 billion buyout of Verve Therapeutics last year. Executives tout it as a potential treatment to broadly prevent heart disease, the world’s leading killer, as many patients struggle to stay on existing, more conventional medicines for reducing cholesterol levels.
There were no treatment-related serious adverse events in the Phase 1 study — a notable finding, given that Verve had to shelve its first candidate due to safety concerns.
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Merck’s bet on an antibody-drug conjugate developed in China has paid off in a major Phase 3 lung cancer study, where sacituzumab tirumotecan paired with Keytruda sharply outperformed Keytruda alone in a subset of lung cancer patients.
Also, the NIH is down another leader, and Sam Altman-backed longevity startup Retro Biosciences raises more funds.
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is unusually busy thanks to a lengthy to-do list that must be tackled before we walk one of the no-longer-so-short people down the aisle. What else? Hard to keep track, but once the chaos subsides, we hope to settle in for another listening party, where the rotation will likely include this, this, this, this and this. And what about you? Spring is in the air, so perhaps this is time to hike a trail, stroll through a park, or take a long drive to nowhere. You could also plan a summer getaway (book now before those fuel costs rise again) or clear out the perennial clutter. If all this is too much or the weather fails to cooperate, you could simply go into zen mode and plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you on Tuesday, since there is a long weekend due to a holiday on this side of the pond. …
Biogen and Denali Therapeutics said Thursday that their experimental therapy for Parkinson’s disease failed to slow the degenerative brain disorder in a randomized trial, dealing a substantial blow to a scientific approach that stoked excitement among advocates and academics, STAT explains. In the study, 648 adults with Parkinson’s were randomized to receive either a placebo or a pill targeting a protein called LRRK2. In 2004, researchers discovered that mutations in the LRRK2 gene can cause a rare, inherited form of Parkinson’s. And in 2018, another group of scientists showed that blocking the protein might actually benefit all patients with the disease. The results are a significant setback to the latter idea.
Earlier this month, Genentech offered countless academics and other researchers up to $125,000 in grants to generate papers about several topics that read like key talking points for a trip to Capitol Hill,STAT reports. The company is seeking “rigorous, independent” work that focuses on the potential consequences of U.S. pricing policies on future innovation, the idea that pharmaceutical discovery is a strategic national asset, and the risks surrounding R&D, according to a request for proposals that came with a June 30 deadline for submissions. Such overtures are hardly new, but this particular solicitation appears notable partly because the company is being very direct about seeking research that is designed to address specific points, rather than solicit topics that may — or may not — dovetail with corporate goals.
The Food and Drug Administration on Friday rejected — again — an experimental treatment for advanced skin cancer developed by Replimune Group.
Replimune’s treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency.
The drug was initially rejected in July, just two months after Vinay Prasad was appointed the FDA’s head of biologics. As an academic oncologist, Prasad criticized regulators for approving drugs with limited data, and the Replimune decision was viewed as a possible sign of the stricter stance he might take at the agency.
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CAR-T therapies are continuing to gain traction in autoimmune disease, with a notable new case.
Also, the FDA has withdrawn approval of GSK’s leucovorin for a rare brain disorder tied to autism, closing out an unusual episode shaped in part by political pressure.
After a courtroom defeat, Trump administration health officials have revised the governing documents for a key federal vaccine panel to broaden its membership, increase its focus on potential harms of vaccines, and empower allies of health secretary Robert F. Kennedy Jr.
The new charter for the committee that advises the Centers for Disease Control and Prevention on vaccine use appears aimed at trying to evade the type of legal challenge that has left the currently appointed body in limbo. In addition, the document puts greater emphasis on the role of the Advisory Committee on Immunization Practices in studying injuries possibly linked to vaccination — though the committee has always paid close attention to any emerging evidence that called into question the safety of individual vaccines.
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