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.

Continue to STAT+ to read the full story…

Pharmalot and the rotation will likely include this, this, this, this and this. And what about you? Once again, we maintain there is no better time to enjoy the great outdoors. And as seasonal festivities approach, you could start searching for the great pumpkin or, if you are particularly ambitious and visit the correct locales, you could hunt down your own turkey. For those inclined to hang around Gotham, there are always museums and moving picture shows to take in. Or you could hide indoors with a good book. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

CVS Health is naming longtime executive David Joyner as its new chief, succeeding Karen Lynch at the helm of the struggling health care giant, The Wall Street Journal writes. Joyner has been president of CVS Caremark, the company’s pharmacy benefit manager, as well as an executive vice president of CVS. He is set to take over as president and chief executive on Friday. CVS is making the changes after repeatedly cutting its forecasts for this year’s financial performance, moves that led to a 19% decline in its share price this year, a push for changes by a major hedge fund, and a board review of strategy that included the option of breaking up the company. Joyner will face a difficult task. Not only must he turn around CVS’s Aetna health insurance business, but he must also contend with U.S. Federal Trade Commission scrutiny of pharmacy benefit giants including Caremark. CVS also faces longstanding challenges in the retail pharmacy business. 

Donald Trump has backed off his ambitious plans to slash U.S. drug prices and repeal the Affordable Care Act, leaving something of a vacuum in his health policy agenda. One former Trump White House official says the policy ideas are there — but enacting them could take messy fights, STAT tells us. The official, Joe Grogan, said Republicans will need to repeal or revisit President Biden’s signature drug pricing law and expanded Affordable Care Act subsidies, should Trump take office. Trump had previously proposed tying U.S. drug prices to a basket of payments made by similarly wealthy countries, but has retreated from that approach. Grogan said this is because Biden’s plan to let Medicare negotiate drug prices directly with pharmaceutical companies, passed in the Inflation Reduction Act, changed the landscape. As the provisions go into effect, this has raised premiums, which Grogan forecasted could cause a “death spiral” in Medicare Part D, the program’s prescription drug benefit.

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So grab that cup of stimulation and get started. Our flavor today is tiramisu, for those tracking our habits. Now, though, the time has come to get busy. So please grab your own cup and dig in to the items of interest assembled below. We hope you have a wonderful day, and please do keep in touch. …

A major California health insurer is set to offer one of the world’s top-selling drugs for free in a bid to show the medicine can reach Americans affordably without going through the middlemen that typically control its flow, The Los Angeles Times says. Blue Shield of California struck an unusual deal to buy a lower-cost version of Humira directly from a manufacturer, bypassing the giant pharmacy benefit managers that normally determine which maker’s drug will go to tens of millions of Americans. AbbVie’s Humira has been a prime example of how drug prices can stay high even after drugmakers lose patent protection. Sales of Humira, at one point the world’s top-selling drug, were $14 billion last year even after low-cost versions hit the market. Blue Shield of California currently spends more than $100 million a year on Humira, more than any other drug. The new lower prices and lack of fees for middlemen should result in a savings of $20 million over three years, executives said, adding that the figure might be a low estimate.

In response to increased criticism of its pricing, Gilead Sciences has reached voluntary licensing deals with companies to make generic versions of its twice-yearly HIV medicine, lenacapavir, in 120 mostly low- and lower-middle-income countries, STAT reports. The move comes after a pair of late-stage clinical trials found the injectable medicine was highly effective in preventing HIV, paving the way for the company to seek regulatory approval for pre-exposure prophylaxis, or PrEP. The results generated considerable excitement since a daily pill is nearly 100% effective but compliance is spotty and there is a stigma attached to regularly taking a drug for HIV. But its impact on addressing an epidemic that, as of 2022, still led to more than 1 million new infections each year is uncertain. And the reason is pricing. Lenacapavir is already approved for treating HIV but has a hefty price tag of $42,250. So patient advocates have been urging the company to reach a licensing deal but also lower its price. The criticism was heightened after a recent analysis found that the medicine could be made for as little as $26 to $40 a year. As a result, Gilead is hoping its licensing plan will appease critics.  

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We are doing our best to maintain sunny spirits, though, because once again, we recall some helpful wisdom from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is orange cream, for those tracking our habits. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

Express Scripts, which is one of the largest pharmacy benefit managers in the U.S., filed a lawsuit demanding that a recent Federal Trade Commission report accusing the industry middlemen of raising drug prices should be vacated, STAT tells us. In scathing language, the company argued the report was “seventy-four pages of unsupported innuendo leveled … under a false and defamatory headline.” The lawsuit also alleged the FTC “followed prejudice and politics, not evidence or sound economics, and wrongly concluded that PBMs inflate drug costs and harm independent pharmacies.” FTC Chair Lina Khan was also accused of “anti-PBM bias.”

Antimicrobial-resistant bacterial infections directly caused more than 1 million deaths worldwide annually from 1990 to 2021, and that number is projected to increase by almost 70% over the next 25 years, MedPage Today writes, citing an analysis in The Lancet. In 2021, 1.14 million deaths that were attributable to bacterial antimicrobial resistance occurred across the globe, slightly higher than the 1.06 million AMR-attributable deaths in 1990. Bacterial AMR was also associated with an estimated 4.71 million deaths in 2021, about the same as in 1990. By 2050, the researchers forecast that an estimated 1.91 million AMR-attributable deaths and 8.22 million AMR-associated deaths could occur every year worldwide. From 2025 to 2050, a cumulative 39.1 million deaths attributable to AMR could occur.

Continue to STAT+ to read the full story…

With any luck, we will also find time for another listening party, where the rotation is likely to include this, this, this, this and this. And what about you? Summer is rapidly nearing an end, but there is still time to enjoy the great outdoors. Remember, beaches, lakes, and hiking trails are beckoning. This may also be an opportunity to sample new eateries or catch up on your reading, or perhaps, simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you on Tuesday, since this is a holiday weekend on this side of the pond. …

Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment, STAT writes. Researchers combined data on nearly 4,000 patients across four trials who had heart failure with reduced ejection fraction (or HFpEF) and found that 5.4% of those treated with Wegovy experienced cardiovascular-related death or heart failure events, compared with 7.5% of those who received placebo. This translated to a 31% risk reduction. On heart failure events, defined as hospitalizations or urgent care visits, Wegovy cut the risk by 41%. On cardiovascular-related deaths, it reduced the rate by 18%, but this result was not statistically significant.

Meanwhile, Wegovy demonstrated still another benefit to patients in a study that found, compared to placebo, the medicine cut the chances of dying from Covid-19 by roughly a third, STAT notes. Given that obesity is a major risk factor for severe Covid outcomes, it perhaps seems obvious that a medicine that helps people lose weight also helps protect them from the worst tolls of a SARS-CoV-2 infection. But researchers say it might not be as straightforward as that. “All of that just means somebody is in a better state when they get hit by a medical disaster like a severe Covid infection,” said Benjamin Scirica, a cardiovascular medicine specialist at Brigham and Women’s Hospital in Boston, who presented the data Friday at the European Society of Cardiology’s annual meeting in London.

Continue to STAT+ to read the full story…

So grab that cup of stimulation and get started. Our flavor today is pumpkin spice, for those tracking our habits. Now, though, the time has come to get busy. So please grab your own cup and dig in to the items of interest assembled below. We hope you have a wonderful day, and please do keep in touch. …

Delaware’s highest court agreed to hear an appeal by GSK and other drugmakers seeking to end more than 70,000 lawsuits claiming discontinued heartburn drug Zantac caused cancer, Reuters writes. GSK, Pfizer, Sanofi, and Boehringer Ingelheim are asking the court to overturn an order by a lower court judge allowing plaintiffs in the lawsuits to offer expert testimony on the alleged cancer link, which the companies argue is not supported by sound scientific methods. Without that testimony, the lawsuits cannot go forward. The drugmakers won a significant victory in 2022, when a federal judge in Florida rejected the plaintiffs’ expert witnesses in about 50,000 cases on the grounds that they did not use reliable scientific methods. Some of the Florida cases are being appealed, and the vast majority of the remaining cases are in Delaware.

Neurocrine Biosciences reported that the lowest dose of an experimental pill for schizophrenia reduced psychosis reported by patients in a mid-stage study, but higher doses of the drug also tested were ineffective, STAT informs us. The company said the study results supported advancing the medicine into Phase 3 studies next year. Investors viewed the mixed data with more concern, sending Neurocrine stock down 18% in early trading. The drug belongs to an emerging class of neuropsychiatric medicines that target muscarinic receptors in the brain. This type of drug has garnered a lot of attention due to the acquisitions of Karuna Therapeutics ($14 billion) and Cerevel Therapeutics ($8.7 billion) by Bristol Myers Squibb and AbbVie, respectively.

Continue to STAT+ to read the full story…

Meanwhile, here are a few items of interest to get you started on your journey, which we hope will be meaningful and productive. Best of luck, and do keep in touch. …

Eli Lilly will start providing low-dose vials of its obesity drug Zepbound through its direct-to-consumer platform, a move that will likely ease supply constraints and draw more patients to the company’s online portal, STAT writes. Lilly is also selling the vials at a discount to the currently available injectable pens, which carry a list price of $1,060 for a month’s supply. Under the new offering, which is meant for patients paying on their own without insurance, 2.5-milligram vials will cost $399 for one month’s supply, and 5-milligram vials will cost $549, roughly the equivalent of the average monthly payment for a used car. Dosages of Zepbound pens go up to 10 and 15 milligrams, but Lilly is only offering low-dose vials for now and will evaluate the possibility of selling high-dose vials later.

Cigna plans to remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement in 2025, and recommend less-pricey biosimilar versions of the medicine instead, Reuters tells us. Going forward, Boehringer Ingelheim’s Cyltezo, Simlandi from Teva Pharmaceuticals and Alvotech, and an unbranded version of Hyrimoz from Sandoz will be covered on some lists that are managed by its pharmacy benefits unit Express Scripts. This is the second major U.S. pharmacy benefits manager to stop recommending coverage of Humira, following similar action by CVS Health’s Caremark unit in April. That move led more patients to switch to biosimilar versions of Humira in three weeks than had in the prior 15 months.

Continue to STAT+ to read the full story…

We also hope to hold another listening party, where the rotation will likely feature this, this, this, and this. And what about you? This is a grand time to enjoy the great outdoors. Beaches and lakes are beckoning. City streets want to be strolled. And woods are inviting the adventurous for long mysterious walks. Take your pick. Or you could simply hide indoors and binge-watch something on the telly. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

A U.S. court tossed a U.S. Chamber of Commerce lawsuit challenging the Medicare Drug Price Negotiation Program established through the Inflation Reduction Act, with a judge finding that several plaintiffs in the suit lacked standing, STAT reports. U.S. District Judge Michael Newman for the Southern District of Ohio found that the Chamber’s argument it could sue on behalf of its members through associational standing was incorrect. The plaintiffs argued they could sue on behalf of pharmaceutical companies that are members of the organization — in this case, AbbVie and its subsidiary Pharmacyclics. Pharmacyclics is based in California, and AbbVie operates in Illinois, California, Massachusetts, and Washington, D.C., but the suit was filed with a local Chamber chapter in Dayton, Ohio.

California lawmakers are making a last-minute push before adjourning to restrain pharmacy benefit managers against the background of a national effort to rein in prescription drug prices, Bloomberg Law writes. Proponents of the bill, led by pharmacists, argue SB 966 would help place needed safeguards on the middlemen who negotiate with drug manufacturers and manage prescription benefits for employers. The bill would require PBMs to be licensed. Supporters say the companies have undermined competition and are financially squeezing smaller pharmacies. The effort comes as lawmakers in 41 states have filed more than 170 related bills this year to regulate PBMs.

Continue to STAT+ to read the full story…

We are doing our best to maintain sunny spirits, though, because once again, we recall some helpful wisdom from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is maple bourbon. Remember, a prescription is not required. So no need to fret over whether rebates are being passed along. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

Four pharmaceutical companies involved in the negotiations over prices for Medicare do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026, Reuters writes. Executives from Bristol Myers Squibb, Johnson & Johnson, AbbVie, and AstraZeneca, which have 5 of the 10 drugs chosen for the first wave of negotiations, described their views on quarterly conference calls. “I think the drugmakers were frightened (these prices) would be a big deal. But now, the ones who have reported or commented have actually said it seems to be OK and in line with expectations,” UBS analyst Trung Huynh.

The U.K.’s cost-effectiveness watchdog blocked the National Health Service from providing an innovative treatment for a form of advanced breast cancer, blaming AstraZeneca and Daiichi Sankyo for being “unwilling” to offer their Enhertu drug at a low enough price, The Financial Times tells us. Helen Knight, director of medicines evaluation at the National Institute for Health and Care Excellence, said cost was to blame for the decision, the first breast cancer treatment NICE rejected in six years. If a drug is not recommended by NICE, it cannot be made available on the NHS. The decision also shows the challenge for stretched health care systems to fund complex, novel medicines.

Continue to STAT+ to read the full story…

So grab that cup of stimulation and get started. Our flavor today is coconut rum, for those tracking our habits. Now, though, the time has come to get busy. So please grab your own cup and dig in to the items of interest assembled below. We hope you have a wonderful day, and please do keep in touch. …

Roche reported positive early data from another of the obesity drug candidates that it picked up through an acquisition late last year, bolstering the case it could become a player in the competitive weight loss medicine field, STAT says. The company said its once-daily pill, called CT-996, led to a placebo-adjusted average weight loss of 6.1% after four weeks in patients with obesity who did not have diabetes. The reported figures came from an initial analysis of a Phase 1 trial. Roche said patients who took its experimental pill reported side effects similar to those on related drugs, namely mild to moderate gastrointestinal issues.

Around the world, patients suddenly cannot find enough of the insulins made by companies they have long relied on to do so, STAT explains. In the U.S., a Novo Nordisk decision to discontinue a product has left patients with fewer options. At the same time, patients are encountering shortages of other products from Novo and Eli Lilly. For months, pharmacies have been running out of vials of certain insulins that patients use to fill the pumps they wear on their body. Supply issues have also spread to the U.K. and South Africa. The reasons for the shortages are complex, but the diabetes community fears one factor driving the phenomenon: Insulin manufacturers may be less interested in making it.

Continue to STAT+ to read the full story…