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.

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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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Gavin Newsom to support food makers’ nightmare scenario — a first-in-the-nation law banning certain food additives in the state, which was signed into law last year.

Wagner is best known for his co-ownership of Magnolia Pictures alongside his longtime business partner Mark Cuban. But now, he told STAT in an extended interview, he’s dedicating himself to fighting food makers and their industrial creations, ultra-processed foods.

“I want people angry,” said Wagner, who is worth an estimated $1.9 billion. “This is an indictment of the food companies that have tainted our food supply, and now we wake up 50, 60 years later with a nation that is unhealthy.”

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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.

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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 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.

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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.

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that MBX Biosciences hired Salomon Azoulay as chief medical officer. Previously, he worked at Sumitovant Biopharma, where he was chief medical officer and head of research and development.

But all work and no play makes for a dull chief medical officer.

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We may also hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This may be an opportunity to enjoy the great outdoors if the heat is not a deterrent. After all, lakes and oceans are often happy antidotes to the humidity. If you prefer, you could rummage about your local library for a fun read, visit a museum, or take in a moving picture show — remember those? Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Novo Nordisk’s Ozempic was linked to lower rates of dementia and other mental problems in a study that raises expectations about its potential ancillary benefits, The Telegraph writes. Researchers analyzed 130,000 U.S. diabetes patients, including about 20,000 taking semaglutide, known by the brand name Ozempic for diabetes, or Wegovy for weight loss. They compared the injections with three other common diabetes drugs and the impact on 22 different neurological and psychiatric conditions. The risk of developing dementia was 48% lower in those taking Ozempic than those on sitagliptin, 37% lower than those on glipizide, and 9% lower than those on empagliflozin.

Smaller pharmacy benefit managers may be having more than a moment as some health insurers and employers show the major players the door, according to Modern Healthcare. Insurance companies and employers fed up with commonplace industry practices are ditching PBMs owned by CVS Health, Cigna Group, and UnitedHealth Group, and instead are inking contracts with smaller competitors pushing transparent business models. The changes occur amid increased scrutiny of the largest pharmacy benefit managers over concerns their business practices and a lack of transparency are driving up the cost of medicines.

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So we will make an effort to nudge it in a better direction by brewing a few cups of stimulation. Our choice today is strawberry creme. Please feel free to join us. Meanwhile, here are a few items of interest for you to peruse. We hope you have a smashing day and conquer the world. And as always, do keep in touch. We appreciate feedbacks and tips. …

Eli Lilly will acquire Morphic Holding for $3.2 billion in cash and gain access to an experimental drug for different types of inflammatory bowel diseases, STAT notes. Morphic’s lead drug is an oral treatment that is being evaluated in Phase 2 studies in ulcerative colitis and Crohn’s disease. Morphic is developing a portfolio of oral integrin therapies for treating serious chronic diseases, including fibrosis, autoimmune, cardiovascular and metabolic diseases and cancer. Last year, the U.S. Food and Drug Administration approved Lilly’s Omvoh for treating adults with moderate-to-severe active ulcerative colitis.

AbbVie paid health care providers roughly $145.7 million last year to promote its drugs, according to a STAT analysis of newly released government data. The massive sum spent by the company, which makes the blockbuster Humira anti-inflammatory drug, is the most a pharmaceutical company has doled out on marketing to doctors since such data became available in 2017. The figure includes compensation for consulting and other services like speaking fees, lodging and travel for doctors, and meals, as well as a small number of payments made directly to hospitals.

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