The rotation will likely include this, this, this and this. And what about you? Once again, this is a wonderful time to enjoy the great outdoors — beaches, woods, and lakes are beckoning. Or you could putter about your castle — a little spring cleaning is a good thing. And if mom is around, remember to say hi. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The U.S. Senate health committee passed a package of bills aimed at speeding generic drug competition and reining in pharmacy benefit managers, but it failed to pass an ambitious reform despite strong bipartisan support, STAT explains. The committee passed, 18 to 3, a bill that would ban pharmacy benefit managers from using spread pricing. The bill would also require that pharmacy benefit managers disclose rebates, fees, and other payments they receive and pass them on to the insurers for whom they negotiate the concessions. Lawmakers did not vote on a bill that would ban pharmacy benefit managers from charging administrative fees based on a percentage of a drug’s list price.

Pfizer chief executive officer Albert Bourla indicated that pharmaceutical companies will likely take legal action against Medicare drug price negotiations, CNBC tells us. Bourla referred to a provision in the Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. Bourla called the plan “negotiation with a gun to your head.” The first negotiations start in September and new prices will go into effect in 2026. He said the most “certain way” to stop negotiations would be to call on Congress to introduce legislation that will revise the plan, but noted he is “not optimistic” about that happening.

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Pharmalot — the rotation will include this, this and this. And what about you? Given the spate of tumultuous news these past few days, perhaps spending time by calming ocean waters or in the solitude of a woodsy area is in order. Or you could zone out and binge-watch something fanciful on the telly. Or perhaps this is an opportunity to plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Genentech said an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and currently president at Stanford University, did not find evidence of fraud or intentional wrongdoing, STAT reports. But the review also points to another previously undisclosed case of scientific misconduct by a post-doctoral researcher in Tessier-Lavigne’s lab. The findings come after the university newspaper reported former Genentech employees claimed an internal review uncovered falsified data and that the neuroscientist tried to keep that information quiet.

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As always, we are quaffing some cups of stimulation — roasted coconut is our choice du jour — and assembling some tidbits for your pleasure. So, time to get cracking. Hope you have a smashing day, and do stay in touch. We always enjoy your tips and insights. …

A U.S. Food and Drug Administration advisory panel concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients, STAT reports. The panel voted 9-0 that the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 5-3 vote (with one abstention) the panel concluded the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval. The mixed votes suggest the FDA will likely grant accelerated approval, which would allow Biogen to market the drug while it collects additional data to confirm its benefit.

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Our choice today is mocha marshmallow. No prescription is required, so no rebates must be paid or tracked. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. Postcards and telegrams are welcomed. …

The Biden administration will fine drugmakers that hiked prices faster than the inflation rate on 27 medicines administered in physician offices, STAT notes. Pfizer had the most drugs on the list of any manufacturer, with five. AbbVie’s blockbuster rheumatoid arthritis drug, Humira, is on the list. Gilead Sciences, Endo International, Leadiant Biosciences, and Kamada had two drugs each. The fines are some of the first major changes to the U.S. drug pricing landscape since the Inflation Reduction Act became law. But White House officials said they intend to delay actual invoices for the price hikes until 2025.

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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.

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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.

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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.

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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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