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. …

Is George Tidmarsh, the U.S. Food and Drug Administration’s top drug regulator, trying to exact revenge on a prominent Wall Street investor after a run-in with him six years ago? STAT asks. This is the question biotech investors were wagging about all Monday after Tidmarsh used his personal LinkedIn page to raise questions about the safety of voclosporin, a rather obscure drug the FDA approved in 2021 to treat patients with lupus nephritis, a type of autoimmune disease that damages the kidneys. Voclosporin has “significant toxicity,” Tidmarsh wrote in his LinkedIn post, adding that the drug “has not been shown to provide a direct clinical benefit for patients.” Aurinia Pharmaceuticals is the Canadian drugmaker that sells voclosporin under the brand name Lupkynis. Its stock price sank 16% on the Tidmarsh comments. It is highly unusual, if not unheard of, for a top FDA official to use a personal social media account to criticize a specific drug, particularly without providing evidence to back up such a claim. 

The Pharmaceutical Research & Manufacturers of America plans to launch a new website in January to help patients buy prescription drugs directly from manufacturers, bypassing pharmacy benefit managers and other middlemen, Reuters says. The website, to be called AmericasMedicines.com, will allow drugmakers to list medicines available for direct purchase and connect patients with programs that offer lower prices and fewer barriers to access. The move is part of a broader push by the industry to simplify how Americans get their medicines and reduce out-of-pocket costs following mounting pressure from the Trump administration. President Trump has urged pharmaceutical companies to bring down U.S. drug prices, and in July sent letters to 17 major drugmakers demanding they slash U.S. prescription drug prices to match those paid in other developed nations. The White House has also floated the idea of a government-run website, possibly named TrumpRx, to help Americans shop for cheaper medicines.

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Pharmalot, where the rotation may include this, this, this, this and this. And what about you? This is a lovely time of year to enjoy just about anything involving the great outdoors, weather permitting. So perhaps you can stock up on apples and pumpkins, or traipse through gnarly woods in search of hidden streams and existential moments. Or if you find yourself indoors, there are books and moving picture shows to absorb. The choices are seemingly endless, yes? Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

President Trump threatened pharmaceutical companies with a 100% tariff unless they build manufacturing plants in the U.S., STAT notes. The tariff would begin on Oct. 1 and could affect all “branded or patented” drugs, the president said in a social media post. Companies could avoid it by building manufacturing facilities in the U.S., Trump said, defining “building” as “‘breaking ground’ and/or ‘under construction.’” The post comes days before a deadline he set for drug companies to lower their prices. The Trump administration made lowering drug prices through a so-called most-favored nation policy, in which the U.S. is charged the same prices other countries pay, a top priority. The administration opened a probe into the national security rationale for tariffs on drug companies, known as a Section 232 investigation. The results, expected in the coming months, could offer the president a pathway to levy tariffs on the pharmaceutical industry. Drug companies are in the middle of months-long talks with the administration about lowering their prices in the U.S., but no deals have been publicly announced.

Several global drugmakers have announced large U.S. investments in recent months in response to pressure from President Trump, although it is not clear from public disclosures how far those projects have progressed, Bloomberg News adds. For instance, Merck, Novo Nordisk, and Eli Lilly are among the companies that have started U.S. building since 2023, with construction sites in Delaware, North Carolina, and Texas. The projects are aimed at anchoring supply chains inside U.S. borders and supporting blockbuster medicines. AbbVie has said it will begin expanding its Illinois facilities this fall. The new duties could hit about $220 billion of U.S. pharmaceutical imports and lift the average tariff rate by 3.3 percentage points, Bloomberg Intelligence economists estimate. Still, substantial uncertainty remains, including whether countries or regions that have struck trade deals with the U.S. will avoid the new levy. For example, the European Union’s trade agreement from late July specified that tariffs on medicines would be 15%, and it is unclear if that arrangement cancels out the latest levy.

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Our choice today is maple bourbon, a double shot for the needy neurons. Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck and do keep in touch …

The U.S. Food and Drug Administration has warned Hims & Hers, a major telehealth purveyor of widely popular obesity drugs, to stop “false or misleading” marketing, according to The New York Times. The letter was one of about 100 warning letters sent to drug advertisers last week. The agency commissioner, Marty Makary, said on Tuesday that the letters were being sent to traditional pharmaceutical companies as well as to online pharmacies. The letter to Hims & Hers warned the company to halt the use of marketing language that falsely implies that one of its products is approved by the FDA. The agency has not yet publicly released the letter. Hims & Hers has capitalized on a huge demand for weight loss drugs like Novo Nordisk’s Wegovy, offering low-cost, compounded versions. In the past few years, telemedicine companies like Hims & Hers have emerged as an aggressive new type of drug advertiser. The agency said the Hims & Hers website made claims that were “false or misleading,” making the product “misbranded.”

AstraZeneca has paused a planned $270 million investment in its Cambridge, U.K., research site, the latest drugmaker to retreat from the country, Reuters reports. The decision about the investment, which had been set to create 1,000 jobs, means none of the planned funding — originally announced in March 2024 — is currently proceeding. In January, the company scrapped plans to invest $612 million in its vaccine manufacturing plant in northern England, citing a cut in U.K. government support. The move comes after Merck last week blamed the challenging U.K. business environment for its decision to abandon a new research center in London. The news, which will deliver a blow to Prime Minister Keir Starmer’s government and its efforts to draw investment into the U.K.’s stagnant economy, was announced just days before U.S. President Trump arrives for a state visit. In July, AstraZeneca said it would spend $50 billion to expand manufacturing and research capabilities in the U.S. by 2030 — one of many announcements by pharmaceutical companies reacting to Trump’s tariff policy.

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So far, the rotation will include this, this, this, this and this. And what about you? Summer may be nearing an end but time still remains to enjoy the great outdoors. If weather does not permit, perhaps this is an opportunity to get a head start and winterize your castle. You could also lounge about and stream a moving picture or two. Or catch up with someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

U.S. Food and Drug Administration leaders are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield agency decisions from public scrutiny, KFF Health News tells us. The agency “would like to get away” from assembling panels of experts to examine and vote on individual drugs, because “I don’t think they’re needed,” said George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research. He relayed the message Tuesday at a meeting of health care product makers and Wednesday to an FDA advocacy group. In addition to being redundant, Tidmarsh said advisory meetings on specific drugs were “a tremendous amount of work for the company and for the FDA. We want to use that work and our time to focus on the big questions.” Tidmarsh said committees would still be consulted on general issues like how to regulate different classes of drugs. But meetings on specific drugs were mainly useful, he said, because they allowed the public to see how the FDA worked.

Novo Nordisk’s new chief executive officer Maziar Mike Doustdar is calling workers back to the office as the Ozempic maker struggles to catch up with Eli Lilly in the hyper-competitive obesity market, Bloomberg News says. Office-based employees will need to come in five days a week starting Jan. 1. The move comes a day after Doustdar announced the drugmaker, which is headquartered in Denmark, would slash its workforce by 11%. Novo did not previously have a global policy on working from home, a common perk for Danish employees. The company had prized work-life balance, with employees in its home market frequently taking much of the month of July off and leaving the office by 4 p.m. to see to personal obligations. Before this week’s layoffs announcement, Doustdar also fired newly hired employees who had not yet started their jobs — some within days of when they were scheduled to begin — cut bonuses, and began a hiring freeze. Doustdar has called for a “performance culture” to catch up with Lilly, which has taken the lead in the U.S. obesity market.

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Our choice today is salted caramel, which offers a whiff of the Jersey shore. Sounds appetizing, yes? As always, we invite you to join us. Meanwhile, here is the latest menu of tidbits to help you get started on your journey. We hope that your day is simply smashing and that you conquer the world. And of course, do keep in touch. We appreciate suggestions, criticism, and juicy tips. …

AbbVie agreed to pay up to $1.2 billion to buy Gilgamesh Pharmaceuticals’ investigational psychedelic drug to treat major depression, a sign that pharmaceutical companies are warming up to the burgeoning field, STAT writes. The move builds on AbbVie’s growing focus on neuroscience. Last year, it also acquired Cerevel Therapeutics for $9 billion, but after the deal closed, the schizophrenia drug at the center of the acquisition failed to show benefits in key trials. A growing number of biotech companies have emerged to study psychedelics for psychiatric disorders, but the field suffered a major setback last year when regulators rejected a Lykos Therapeutics MDMA candidate for post-traumatic stress disorder. Companies are now hoping the Trump administration will be supportive of psychedelics after U.S. Health and Human Services Secretary Robert F. Kennedy Jr. vowed to end the “aggressive suppression of psychedelics.” 

The European Commission granted marketing authorization for Gilead Sciences’ twice-yearly injection for preventing HIV infection, Reuters notes. The drug, known as lenacapavir, will be sold in Europe under the brand name Yeytuo. It was approved in June by regulators in the U.S., where it is marketed as Yeztugo. The EC approval applies to the European Union’s 27 member states, as well as Norway, Iceland, and Liechtenstein. Before the drug can be made available to patients, Gilead will need to establish pricing and reimbursement terms with health systems in each country. In the U.S., the list price is over $28,000 a year, prompting some insurers to postpone coverage. Meanwhile, Gilead said it also filed for regulatory review with authorities in Australia, Brazil, Canada, South Africa, and Switzerland and is preparing filings in Argentina, Mexico, and Peru. The company intends to pursue submissions to regulatory authorities in low- and middle-income countries, including priority registrations covering 18 countries that represent 70% of the HIV burden of 120 countries named in voluntary licensing agreements.

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Have a wonderful day and do drop us a line when you hear something juicy. …

Insmed received U.S. Food and Drug Administration clearance for the first treatment for a chronic lung disease, opening the biotech up to what could be a multibillion-dollar product, STAT writes. The company will sell the daily pill, brensocatib, under the brand name Brinsupri for bronchiectasis. The approval comes after the treatment succeeded in one of last year’s most closely watched Phase 3 trials. Insmed, which will sell the drug at an annual list price of $88,000, estimates the drug can deliver peak sales of $5 billion, making it a growth driver that could help propel it into becoming a major biotech. The company has also filed for the drug to be approved in Europe and the U.K. and plans to file in Japan. Bronchiectasis affects about 350,000 to 500,000 adults in the U.S., according to the American Lung Association. 

A clutch of Western drugmakers are looking to boost sales of their most innovative and expensive medicines in China, the world’s second-largest pharmaceuticals market, by trying to get their treatments included in Beijing’s new catalog for commercial health insurance, Bloomberg News explains. Eli Lilly, Pfizer, and Novo Nordisk are among those who have applied for a place in the catalog, according to documents released by the National Health Security Administration. The idea of the list, incorporating innovative drugs that are far too expensive to be covered by the state insurance program but recommended for reimbursement by private health insurers, was first touted this year. With state-backed insurance unable to afford their treatments, drugmakers until now had to choose between offering steep discounts in exchange for a spot on the national drug reimbursement list, or limit themselves to a much smaller private market. The commercial catalog, which could allow these drugs to be reimbursed at a smaller discount, will open a new door for multinational companies to expand sales.

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We also plan to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? As always, summer is moving by quickly, so perhaps this is an opportunity to enjoy the great outdoors. Beaches, lakes, and mountain trails are perennials, yes? You could also tend to your garden, visit the local library (your tax dollars at work), or perhaps take time to experiment with a recipe or two. Or you could simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The Trump administration has been talking to drugmakers about ways to raise prices of medicines in Europe and elsewhere in order to cut drug costs in the United States, Reuters reports, citing a White House official and three pharmaceutical industry sources. U.S. officials told drug companies it would support their international negotiations with governments if they adopt “most favored nation” pricing under which U.S. drug costs match the lower rates offered to other wealthy countries. The Trump administration has asked some companies for ideas on raising prices abroad and has held multiple meetings over several months aimed at lowering U.S. prices without triggering cuts to research and development spending drugmakers insist would result. The previously unreported discussions reflect the challenges Trump faces to achieve that goal, and are the backdrop to the letters he sent last week to 17 major drugmakers, urging them to cut U.S. prices to match those paid overseas.

The U.S. Food and Drug Administration announced a program to make it easier for drug companies to set up manufacturing facilities in the U.S. and reduce the country’s reliance on imported medicines, Pharmaphorum notes. The regulator revealed FDA PreCheck, a two-phase approach to getting approval for new production sites. The first promises to provide quicker responses from the agency on start-up tasks like facility design, construction, and pre-production. The second phase is based on a pledge by the FDA to “streamline” the chemistry, manufacturing, and controls section of new facility applications with the help of “pre-application meetings and early feedback.” The move ties in with President Trump’s ongoing campaign to drive medicines manufacturing to the U.S. from overseas, a push that has already resulted in big investment commitments from a string of companies, including AstraZeneca, AbbVie, Roche, Novartis, Eli Lilly, and Johnson & Johnson. The FDA plans to hold a public meeting on September 30 to discuss the new program.

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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.

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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. 

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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.

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