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…

What is upon us right now, however, is our ever-growing to-do list. Sound familiar? So here are some items of interest. Have a great day, everyone. …

Moderna plans to cut its annual spending on research and development by 23%, or $1.1 billion, between 2024 and 2027 in a concession to investors who have viewed the company’s outlays following its pandemic-era windfall as profligate, STAT writes. In a press release issued ahead of an investor meeting today, the company also said it plans to break even by 2028, when it expects it will reach annual sales of $6 billion. Moderna shares have fallen 29% so far this year and are down more than 82% from their highs during the pandemic — when its ability to rapidly develop a Covid-19 vaccine stood as a proof-of-concept for its technology and left it flush with revenue. Now Moderna, which still has a market capitalization of $30 billion, faces the challenge of moving forward quickly on its many research products.

Shares in Roche dropped to a two-month low on Thursday after an experimental weight-loss pill that carries high market hopes was linked to an elevated rate of temporary side effects in its initial test phase on humans, Reuters points out. The stock was trading 3.5% down in morning trading, after the company presented details on the trial with its once-daily pill CT-996 late on Wednesday. A brief summary in July of the study’s promising results had boosted its share price. According to a presentation at the European Association for the Study of Diabetes in Madrid, all 25 trial participants experienced mild or moderate side effects, including those that only received an ineffective placebo. Side effects were mostly gastrointestinal, like those associated with similar drugs.

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The BIOSECURE Act would prohibit many biotech and pharmaceutical companies from conducting certain research and development activities, including the manufacturing of drugs through named Chinese companies. On Monday, an updated version of the bill passed the House of Representatives with strong bipartisan support. Notably, a number of representatives with expertise in health care and the life sciences ultimately voted against the legislation. The Senate is expected to take up a slightly different version later this year.

BIOSECURE proponents argue that allowing the Chinese Communist Party access to U.S. patient information is a national security concern, as is the overreliance on China for drug development. They aren’t wrong. Protecting that information and being able to make our own medicines should be a national priority.

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The U.S. Food and Drug Administration has scolded AbbVie for making false and misleading claims in a TV ad about a migraine pill that features Serena Williams, the third time this year the agency has taken a major pharmaceutical company to task for its marketing.

The agency is upset with Abbvie for a couple of reasons. First, the TV spot suggests that the medication, which is called Ubrelvy, will “provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated,” according to an Aug. 29 letter that was posted on Wednesday on the FDA website.

Moreover, the regulator also chastised the company for using a “celebrity athlete,” which is problematic in this instance because the ad “amplifies the misleading representations and suggestions made and increases the potential for audiences to find the misleading promotional communication more believable due to the perceived credibility of the source.”

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On Sunday, a small biotech company called Summit Therapeutics won a remarkable victory, saying its experimental drug outperformed Merck’s Keytruda, the world’s best-selling drug, in non-small cell lung cancer, the disease that represents Keytruda’s biggest market.

By itself, Summit’s victory would be a dramatic story, although not an unheard of one in the unpredictable world of biotechnology. But it’s just the start. Because at the center of it is one of the industry’s most iconoclastic figures: Robert “Bob” Duggan, who became a billionaire after he bought up shares of another biotech company, Pharmacyclics, that was on the brink of failure, developed a breakthrough cancer drug, and sold the company to AbbVie for $21 billion.

Duggan, 80, is a living rebuke to a pharmaceutical industry self-image that is increasingly crafted in Cambridge, Mass. and San Francisco. Before Pharmacyclics, he had no drug industry experience, having worked in cookie stores and then surgical robots. He lacks a college degree, and is a practicing scientologist who told STAT in an interview that he reads the works of Scientology founder L. Ron Hubbard every day and who has in the past said he’d given the church more than $360 million. He speaks in long, dramatic arcs, often spelling out words, referencing their roots, or giving itemized lists.

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…

LONDON — Novo Nordisk made worldwide headlines last year when a study demonstrated that Wegovy, its powerful and exceedingly popular weight loss medicine, helped reduce the risk of cardiovascular emergencies like heart attacks. 

Researchers on Friday unveiled results demonstrating another benefit that the drug offered to patients in that study: Compared to placebo, it cut the chances of dying from Covid-19 by roughly a third. 

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. Some studies have indicated that the drug, also known as semaglutide, bolsters the immune system, tamps down inflammation, and strengthens other organs, including the liver and kidneys, in ways that scientists are only beginning to tease out. 

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.

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WASHINGTON — The day drugmakers dreaded has finally arrived. 

Medicare officials on Thursday unveiled the results of the program’s first 10 drug price negotiations, despite the industry’s two-decade, multimillion-dollar lobbying campaign and barrage of lawsuits to stop them. 

The drugs that received negotiated prices are Bristol Myers Squibb’s blood thinner Eliquis, Boehringer Ingelheim’s diabetes drug Jardiance, Johnson & Johnson’s blood thinner Xarelto, Merck’s diabetes drug Januvia, AstraZeneca’s diabetes drug Farxiga, Novartis’ heart failure treatment Entresto, Amgen’s rheumatoid arthritis drug Enbrel, J&J and AbbVie’s blood cancer treatment Imbruvica, J&J’s anti-inflammatory medicine Stelara, and Novo Nordisk insulins that go by names including Fiasp and NovoLog. 

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