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…

The massive sum spent by AbbVie, the maker of the mega blockbuster anti-inflammatory drug Humira, is the most a pharmaceutical company has spent 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.

The payments, made public by the Centers for Medicare and Medicaid Services, provide an insight into AbbVie’s marketing in the immediate aftermath of the company losing its monopoly on Humira, which dominated the company’s balance sheets for the better part of the last two decades. The payments show that the company is being far more aggressive in targeting doctors than competitors of comparable size.

Continue to STAT+ to read the full story…

The agency sent a civil investigative demand requiring Teva to provide information related to the patents listed in the so-called Orange Book, which is maintained by the Food and Drug Administration. The move comes after the FTC late last year began warning Teva and several other companies that they should remove hundreds of “improperly or inaccurately” listed patents or face further action.

The FTC has argued Teva and these other companies listed patents in the Orange Book without properly claiming certain key information, such as a drug substance or method for using a drug. Industry critics say the tactic makes it harder for generic companies to sell lower-cost alternatives to Americans and has been blamed by several congressional lawmakers for keeping prices high.

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Vallabh and her husband, Eric Minikel, scientists at the Broad Institute, have been racing to develop a treatment for prion disease, a rare form of neurodegeneration that killed her mother at age 51 and would, if left untreated, likely kill Vallabh as well. It’s an insidious disease. Although it can have several causes, in her case, a single genetic misspelling will lead neurons to produce misfolded versions of otherwise workaday proteins called prions. These mutant prions jump cell to cell, like viruses, misfolding other prions they touch and forming toxic, neuron-killing chains.

So why not use CRISPR to repair or remove the mutant gene?

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…

Patent and Trademark Office has proposed a new rule designed to stem the use of so-called patent thickets, which are wielded by pharmaceutical companies to delay the arrival of lower-cost generic medicines in the marketplace.

Essentially, thickets are collections of numerous patents that add only incremental changes to a drug and, therefore, produce little to no additional benefit to patients. Yet they extend precious monopolies for brand-name drugmakers and, consequently, are blamed for contributing to ongoing high drug costs for countless Americans.

To assemble a thicket, drug companies rely on a critical tool with a wonky name — a terminal disclaimer — which is the subject of the proposed rule. In short, a terminal disclaimer is a stipulation made by a drug company to the PTO that a continuation or follow-on patent — essentially, a minor patent that makes few substantive changes to a medicine — will expire at the same time as the original patent.

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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…