We are also readying another listening party with Mrs. Pharmalot (the rotation will include this, this and this) and will stop to observe some ancient rituals (sufganiyot, anyone?). And what about you? Holidays are nearing, but there is still time to squeeze in a visit to a nearby temple of consumption. You could also plan a much-needed getaway. Or work on your list of resolutions for the next year — if so, we wish you much luck. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon….

AbbVie is leaving several major industry groups representing its interests in Washington, D.C., STAT reports. The company is leaving the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, the two prominent pharmaceutical trade associations, according to the groups. AbbVie is also leaving the Business Roundtable, a group comprising the chief executives of the largest U.S. companies. The decision comes as regulators begin to implement the drug-pricing provisions of the Inflation Reduction Act that drugmakers spent millions in lobbying to defeat.

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Pharmalot (this will be first up). And what about you? There are some holidays just around the bend, so this may be an opportunity to open those catalogs or visit the nearest temple of consumption. You know what they say — act now, before prices rise still further. There is still time, of course, to plan a holiday getaway. Or you could hit the pause button and take stock of life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, STAT tells us. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, the Centers for Medicare and Medicaid Services administrator, said at the Milken Institute Future of Health Summit when asked about how the agency will approach the drug. “We will look at it as new data comes.” Last April, Medicare finalized a coverage policy in which it would only pay for Aduhelm if patients were enrolled in a clinical trial.

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Our choice today is the ever-flavorful pumpkin spice. And you? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits. Hope you conquer the world, and do keep us in mind when you see something fascinating. …

Emergent BioSolutions, which makes Narcan, a nasal-spray form of naloxone, said the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray, The Wall Street Journal writes. The company said the priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of rivals that announced a planned foray into the market. The FDA has encouraged companies to apply for approval for over-the-counter versions of overdose-reversal medications to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.

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The holiday season is beckoning, so this may be a fine time to plan a getaway or a get-together. You could also splurge on gift giving before prices rise still further. This may also be an opportunity to turn on the telly and catch up on your binge watching. Or you might want to plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

After finding success investing in the more obviously lucrative corners of American medicine — like surgery centers and dermatology practices — private equity firms have moved aggressively into the industry’s more hidden niches: They are pouring billions into the business of clinical drug trials, Kaiser Health News writes. And a fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. To date, 11 of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies.

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Sir Pharmalot himself suggested we make a mention of where turkey futures stand this morning, in case anyone is trying to score a last-minute turkey at bargain prices. Instead, we’re more focused on gaming out our oven strategy for the big meal, with a particular priority on the pecan pie we’re on tap for. We are, after all, a former winner of STAT’s pie contest, so we have a reputation to uphold. A few more pieces of wisdom as we head into the holiday: Warm up appropriately for both your turkey trots and turkey feasts — we don’t want any injuries out there. Salads absolutely have a place on the Thanksgiving table (you need something bright and acidic to cut through everything else that’s rich and fatty; cranberry sauce should not have to shoulder that responsibility alone). And finally, no matter how full you get, there’s always room for dessert — and yes, for an extra helping of gratitude. Enjoy the holiday.

The U.S. Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder, STAT writes. The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company. Hemgenix will cost $3.5 million, making it the most expensive drug approved to date. The approval of Hemgenix provides physicians with a new, potentially curative treatment option for patients with severe hemophilia B, a rare bleeding disorder caused by a genetic mutation that prevents the body from producing sufficient quantities of a clotting protein called Factor IX.

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Meanwhile, as we hunt for still another, here is the latest laundry list of interesting items to help you on your journey today. We do hope you have a meaningful and productive experience. And as always, we invite you to keep in touch. After all, our work is more interesting when you pass along insights, tips, and secrets. …

UnitedHealth Group’s pharmacy benefits manager, OptumRx, will keep AbbVie’s Humira alongside up to three biosimilar medicines next year, Bloomberg News writes. The decision is a partial win for AbbVie, since its rheumatoid arthritis treatment has generated almost $200 billion in sales in nearly two decades. Several competing biosimilar versions are set to debut in the U.S. in 2023, giving prescription drug plans a chance to pit different suppliers against one another for discounts. Optum Rx, which is the third-largest U.S. pharmacy benefit manager and managed $112 billion in drug spending last year, will place biosimilars on its formulary in the same position as Humira.

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Good morning, everyone, and how are you today? We are doing just fine, thank you, as we settle in to a busy routine at the latest big STAT event. However, we are exerting additional energy in search of an acceptable cup of stimulation. We will keep you posted on our progress. Meanwhile, we have still found time to assemble the latest list of interesting items for you to peruse. As always, we hope you have a meaningful and productive day. And of course, please keep in touch. We treasure secret dossiers and other delicious tidbits. …

Walmart has agreed to pay $3.1 billion to settle opioid-crisis lawsuits brought by several U.S. states and municipalities, adding to a landmark settlement with rival pharmacy chains, The Wall Street Journal writes. The agreement, which will require significant improvements in how Walmart pharmacies handle opioids, resolves a collection of lawsuits brought by states, cities, and Native American tribes. Earlier this month, CVS Health and Walgreens Boots Alliance agreed to pay roughly $5 billion apiece to settle the lawsuits. The companies did not admit wrongdoing. Each state, local government, and tribe will need to decide whether to participate in the settlement.

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