Meanwhile, do keep us in mind if you hear anything saucy. Our in-basket has been outfitted to accept postcards and telegrams. Have a smashing day. …

Eli Lilly says that all doses of its new Mounjaro diabetes drug are now available after social-media enthusiasm about weight-loss benefits sparked a two-month-long shortage, Bloomberg News tells us. The drug was approved in the U.S. last May to help people with type 2 diabetes control their blood sugar levels. Mounjaro is part of a group of diabetes treatments known as GLP-1s that have shown outsize potential for weight loss. Some of the drugs, including Mounjaro, are being recommended by doctors for weight loss even though they have not been explicitly approved as an obesity treatment in a common practice known as off-label prescribing.

Continue to STAT+ to read the full story…

Although gray skies are hovering over the Pharmalot campus, our spirits remain sunny because, as the Morning Mayor taught us, “Every brand new day should be unwrapped like a precious gift.” And so, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is salted caramel mocha. 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. …

Pharmaceutical executives are ready to make deals, The Wall Street Journal says. Executives at Pfizer, Merck, and Novartis are looking for promising drugs to add to their pipelines and replenish sales as top-selling products lose patent protection in the coming years. Meanwhile, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. The acquisitions could help the companies add new sales to aging line-ups and suggest this year could be a busy one for industry dealmaking. The $88 billion in total deal value last year, involving 75 biopharma tie-ups of at least $100 million, was the lowest since 2017, according to Ernst & Young.

Continue to STAT+ to read the full story…

Our choice today is Jack Daniels (yes, this is a real thing) in honor of our 16th anniversary since Pharmalot debuted. We would like to take a moment to thank you for tuning in all these years and, moreover, lift our cup to recognize those of you who provide feedback, suggestions, criticism, and tips. Now, though, time to get cracking once again. We hope your day is productive and meaningful. And of course, do stay in touch. …

After mobilizing to quickly develop and manufacture a Covid-19 vaccine, Johnson & Johnson has vastly scaled back efforts to produce the shots as it faces slumping demand, The Wall Street Journal reports. In recent months, J&J terminated manufacturing agreements with companies that helped produce the shot, such as Catalent and Sanofi. Meanwhile, a partnership with Merck to help make the shots, forged at the urging of the U.S. government, has not lived up to expectations. The companies are now engaged in arbitration. Merck made J&J vaccines at only one plant, but did not make commercial doses at another plant involved a more complex part of the manufacturing process.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…