Please feel free to join us. Remember, no prescription is required. 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. …

Vinay Prasad had a problem. Several, actually, STAT tells us. His staff at the U.S. Food and Drug Administration kept leaking to the press. He was under attack by President Trump’s allies after moving to pull a gene therapy off the market. Democrats  were unhappy with his Covid vaccine restrictions and anti-vaccine advocates were lambasting him for approving the shots at all. He sent off an email to his team on Saturday evening, attempting to control the backlash. The agency’s recent crackdown on the gene therapy product was driven by a scientific consensus, he said. Not just him. “The motivation is solely what we think is in the public interest— the accurate judgment of benefits and risks,” Prasad wrote. By Tuesday, he was out of a job. His tenure as director of the FDA Center for Biologics Evaluation and Research lasted just 84 days. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary opposed dismissing Prasad, but were overruled by President Trump, according to POLITICO. Meanwhile, George Tidmarsh, the FDA’s top drug regulator, was named acting director of the FDA’s Center for Biologics Evaluation and Research, STAT notes.

Eli Lilly’s blockbuster diabetes drug Mounjaro matched the ability of an older treatment to prevent major heart complications in a large trial, results that show the medication has cardiovascular benefits on top of helping lower blood sugar and weight, STAT says. Type 2 diabetes patients taking Mounjaro experienced an 8% lower risk of cardiovascular-related death, heart attack, or stroke compared to people taking Trulicity. The data mean the drug met the study goal of showing “non-inferiority” — that is, Mounjaro did not perform worse than Trulicity, but Mounjaro was not proven to be better than Trulicity. Some doctors had hoped Mounjaro would outperform Trulicity. In a survey conducted by TD Cowen analysts, doctors assigned Moujaro a 60% chance of superiority. The demonstration of non-inferiority confirms the widely held belief that Mounjaro does benefit the heart. Doctors are likely to continue prescribing the drug at the same rate, given it is already shown to be highly effective in lowering blood sugar and reducing weight.

Continue to STAT+ to read the full story…

To make the time fly, we are firing up the trusted coffee kettle and brewing another cup of stimulation. Our choice today is crème brulée, a tasty treat. Now, though, the time has come to get cracking. So 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. …

President Trump said he was likely to impose tariffs on pharmaceuticals as soon as the end of the month, suggesting that those import taxes could hit alongside broad “reciprocal” rates set for implementation on Aug. 1, Bloomberg News informs us. “Probably at the end of the month, and we’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we’re going to make it a very high tariff,” he said. Still, any tariffs could immediately impact drugmakers like Eli Lilly, Merck, and Pfizer that produce drugs overseas and risk driving up costs for U.S. consumers. At a Cabinet meeting earlier this month, Trump said he expected pharmaceutical tariffs to grow as high as 200% after giving companies a year to bring manufacturing back to the U.S. Trump has already announced investigations under Section 232 of the Trade Expansion Act of 1962 on drugs, arguing a flood of foreign imports was threatening national security.

A divided U.S. appeals court panel upheld West Virginia’s ban on medication abortion, ruling that the law does not conflict with the ability of the U.S. Food and Drug Administration to regulate the drug, The Hill explains. The U.S. Court of Appeals for the 4th Circuit dismissed mifepristone manufacturer GenBioPro’s effort to strike down West Virginia’s near-total abortion ban in a 2-1 decision. The court ruled FDA approval of mifepristone did not preempt West Virginia’s law. GenBioPro produces a majority of the mifepristone sold in the United States and has held FDA approval for generic mifepristone since 2019. GenBioPro argued that FDA authority to impose regulations on the prescription and distribution of mifepristone superseded state efforts to restrict access to medications. A lower court ruled against the company, which then appealed the decision. The ruling marks the first time a federal appeals court has said states can restrict the use of mifepristone. Twenty-eight states restrict access to medication abortions, according to the reproductive health nonprofit Guttmacher Institute. 

Continue to STAT+ to read the full story…

So join us as we hoist the ever-present cup of stimulation — our choice today is maple bourbon — and attack the fast-growing to-do list. Have a grand day, everyone, and do stay in touch. …

A court battle between two of the nation’s largest biotechs — Regeneron Pharmaceuticals and Amgen — is testing the legal limits of how far drugmakers can go in using patents to thwart competition, STAT writes. The case is being closely watched by companies that sell biosimilar medicines amid concerns that the U.S. patent system is being gamed in ways that critics say can maintain high prices for medicines. The saga began early last year when Regeneron filed a lawsuit accusing Amgen of infringing a key patent on its best-selling Eylea injectable drug, which is used to combat such eye diseases as wet age-related macular degeneration, among other ailments. The treatment, with a list price of nearly $1,900 a shot, is at the heart of a multibillion-dollar product line. At the time, Amgen was one of several companies that hoped to sell a biosimilar version, but Amgen’s approach set it apart from the others — and paved its way to the marketplace earlier than Regeneron had hoped.

The U.S. Food and Drug Administration will start publishing the rejection letters that companies until now have mostly kept hidden from investors and the public, Bloomberg News reports. “We had a long set of meetings with our lawyers to determine that we can do this,” FDA Commissioner Marty Makary said in an interview with Bloomberg Television’s Wall Street Week. The agency has historically left it up to drugmakers to disclose when and why their medicines are not approved. But companies often give incomplete or misleading accounts of their interactions with regulators, and that can make an application’s deficiencies seem more minor than they really are, Makary said in the interview airing Friday. “There’s an opportunity for companies to spin the results,” he said. “Now, the decision letters will be public for shareholders and the public to see.” Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.

Continue to STAT+ to read the full story…

To make the time fly, we are firing up the trusted coffee kettle and brewing another cup of stimulation. Our choice today is strawberry creme, which occupies a prominent spot in our pantry. But now, 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. …

Spain is investigating Novo Nordisk over concerns it may be illegally advertising its weight loss drugs Ozempic and Wegovy, EuroNews tells us. It is the latest in a string of inquiries into the company, with authorities in at least two other European countries accusing Novo Nordisk of unlawfully promoting its medications in recent years. Health officials worry drugmakers are seeking to boost already sky-high demand, possibly in violation of a European Union ban on consumer advertising for drugs that can only be obtained via prescription. The latest kerfuffle involves a campaign Novo Nordisk launched in Spain this month to raise public awareness about the health risks of obesity. The company also launched a website — which has since been taken down — on obesity’s health risks that cited endorsements from key scientific societies, recommended questions for people to ask their doctors, and offered weight loss tips. The tips included a healthy diet, exercise and sleep, and did not explicitly mention any medicines, but the Spanish health ministry said the campaign could serve as “covert advertising” for Novo Nordisk drugs.

AstraZeneca chief executive officer Pascal Soriot would like to move the drugmaker’s stock market listing to the U.S., The Times of London reports. Soriot has spoken privately of his preference to move the listing on a number of occasions and has even discussed moving AstraZeneca’s domicile. But he is likely to face resistance from parts of the board should he push for such a move, as well as the U.K. government, which is not believed to have been informed. Soriot, who has led AstraZeneca since 2012, has spoken publicly of his concerns about how Europe has fallen behind the U.S. and China, the company’s two largest markets, in innovating new medicines. He is known to be deeply frustrated with the U.K.’s operating environment, particularly restrictions on the approval of new medicines by the National Institute for Health and Care Excellence and the pricing of medicines under a National Health Service sales rebate scheme. Any attempt to move the listing would be highly controversial and a significant blow to the London stock market and the U.K. life sciences sector, which the Labor government set as a priority in its industrial strategy.

Continue to STAT+ to read the full story…

After all, the world keeps spinning no matter what the thermometer says. Hope you have a successful day and conquer the world. And of course, do keep in touch. …

Novo Nordisk’s top executives ignored internal warnings that the company was not sufficiently prepared for the launch of its weight loss drug Wegovy, leaving the drugmaker in a more vulnerable position when rival Eli Lilly entered the market, Reuters reports. Novo has enjoyed $46 billion in net profits since 2021, when Wegovy became the first highly effective obesity treatment approved in the U.S. But Lilly’s Zepbound therapy outstripped Wegovy in weekly new prescriptions this year as Novo struggles to convince investors it can remain competitive amid the weight loss drug boom. Novo is reorganizing its leadership team following the surprise ouster of chief executive office Lars Fruergaard Jorgensen. Other key executives already stepped down, including U.S. chief Doug Langa, who had insisted on a commercial launch soon after Wegovy’s U.S. approval. In heated internal discussions, sales and marketing executives urged Langa to first secure more supply and health insurance coverage, without which many patients could not afford Wegovy’s monthly cost of up to $1,300. Lilly was not expected to enter the market for at least two years and Novo could have been better prepared, according to former employees.

The House Judiciary Committee has subpoenaed a former Pfizer executive who is considered central to its investigation into an allegation that clinical testing related to the development of the company’s Covid-19 vaccine was purposefully delayed until after the 2020 presidential election, CNN reports. The demand for documents and a deposition from Philip Dormitzer comes after the committee says he failed to comply with requests to appear voluntarily and turn over records. Dormitzer is a key figure in the legislative probe. The committee has alleged it had information that the former Pfizer executive, after he left for a job with GSK, told his colleagues that Pfizer had delayed announcing its Covid vaccine was effective until after the election. The Wall Street Journal had reported that GSK brought those claims to federal prosecutors in Manhattan. But Dormitzer disputed that there had been any delay in seeking approval for the vaccine.

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…

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.

Continue to STAT+ to read the full story…

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.

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…