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…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

So grab that cup of stimulation and get started. Our flavor today is mocha hazelnut, 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. …

For the second time, the U.S. Food and Drug Administration has declined to approve an AbbVie therapy for patients with Parkinson’s disease due to problems at a third-party manufacturer, Reuters writes. The company maintained that the agency had not identified issues with the therapy’s safety or efficacy and did not request additional trials. The therapy is a version of carbidopa-levodopa, the standard of care for the disease. It is administered subcutaneously, or under the skin, through an infusion pump in order to improve patients’ motor functions. If approved, analysts estimate $619.67 million in sales for ABBV-951 in 2026, according to LSEG data.

U.S. Sen. Jacky Rosen (D-Nev.) wants the U.S. Department of Health and Human Services to investigate why a low-cost generic cancer drug is not widely available to patients, The Hill reports. In a letter sent to the agency, Rosen questioned why Medicare patients pay $3,000 a month for abiraterone, a generic oral drug used as part of prostate cancer treatment, when a version that costs $171 is also on the market. The drug is sold by CivicaScript, a nonprofit that works with manufacturers to develop a drug and then partners with insurers, pharmacies, and pharmacy benefit managers to sell it to patients at a fraction of the price it would cost otherwise.

Continue to STAT+ to read the full story…

Today, we’re sipping a hot cup of caffeinated black, while mulling the rise and fall and, apparently (!), rise again of Luckin Coffee, a chain whose cashless kiosks and discount lattes were once seen as China’s answer to Starbucks, before allegations emerged of widespread accounting fraud. This Bloomberg story has the best quote I’ve read all week, from a former executive (who was not accused of wrongdoing): “Obviously, it was wrong and unlawful to fabricate data. But you still have to acknowledge the great design that was its business model.” Anyway, here’s some news:

The FDA has questions about Eli Lilly’s experimental Alzheimer’s drug, STAT tells us. Documents released in advance of Monday’s advisory committee hearing show regulators are mulling whether donanemab, which slowed cognitive decline in a large study, should be limited to a subset of patients with a key biomarker, called tau, used to screen patients for Lilly’s trial. They also want to know if the drug’s benefits justify the risk of severe brain swelling and bleeds seen in the study.

The FDA took the rare step of publicly explaining why it rejected a drug, Endpoints relays. The agency put out a notice about the application to approve Vanda Pharmaceuticals’ sleep disorder drug Hetlioz as an insomnia medication, saying the company “does not provide substantial evidence of effectiveness” and didn’t show the drug was safe. It asked for a new “well-controlled” trial. Vanda is currently suing the FDA, while facing pressure to accept a takeover bid from Cycle Pharmaceuticals.

Continue to STAT+ to read the full story…

After all, the world continues to spin, although it remains a bit wobbly where we are after losing a Pharmalot ancestor, which explains our recent disappearance. To cope, we are brewing a cup of stimulation. Our choice today is hot buttery rum. As always, you are invited to join us. We hope your day is productive and meaningful. Either way, do keep in touch. …

Almost a dozen pharmaceutical companies have lost sensitive customer data due to a supply chain cyberattack that trickled down from Cencora, TechRadar writes. In late February, the wholesaler — previously known as AmerisourceBergen — disclosed a data breach incident with few details. But 11 drug companies have now submitted almost identical breach notification letters to the California Attorney General’s office claiming a data breach as a result of the Cencora incident. Among them is Novartis, GSK, Bayer, AbbVie, Regeneron Pharmaceuticals, Genentech, Incyte, Sumitomo Pharma America, and Acadia Pharmaceuticals.

A last-ditch effort by World Health Organization member states failed to finish negotiations on a pandemic accord ahead of the World Health Assembly meeting this week, The New York Times reports. The key articles in the draft text that remained unresolved included the thorny formula for global sharing of vaccines and medicines during international health emergencies. Among the most contentious issues in the draft treaty is a section called Pathogen Access and Benefits Sharing, under which countries would be required to swiftly share genetic sequences and samples of emerging pathogens. These data are crucial for rapid development of diagnostic tests, vaccines, and treatments.

Continue to STAT+ to read the full story…

While you ponder the sobering possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is maple bourbon. Remember that no prescription is required and so rebates do not have to be calculated. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. …

Fake studies have flooded publishers of top scientific journals, leading to thousands of retractions and millions of dollars in lost revenue, The Wall Street Journal says. The biggest hit has come to Wiley, which is closing 19 journals, some of which were infected by large-scale research fraud. The sources of the fake science are “paper mills” — businesses or individuals that, for a price, will list a scientist as an author of a wholly or partially fabricated paper. The mill submits the work, generally avoiding the most prestigious journals in favor of publications such as one-off special editions that might not undergo as thorough a review and where there is a better chance of getting bogus work published.

A U.S. lawmaker is accusing Amgen of “putting profits before patients” over its decision to continue marketing a high dose of a pricey cancer treatment instead of a lower dose that is less expensive and not as toxic to patients, STAT reports. At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and which won conditional regulatory approval three years ago. At the time, the Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval.

Continue to STAT+ to read the full story…