In making its case, the Pharmaceutical Accountability Foundation argued AbbVie allegedly overcharged the Dutch health care system by up to $1.2 billion by “abusing” its position in the marketplace and keeping prices high. The company sold approximately $2.3 billion worth of Humira in the Netherlands between 2004 and 2018, when its patents provided a monopoly.

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Humira has been the world’s best-selling medicine since it arrived on the market in 2002. Now, it is finally getting competition with the release of Amgen’s biosimilar drug, Amjevita. Humira’s main patent expired in 2016, but a byzantine patent saga has kept other drugmakers from offering their own version of the monoclonal antibody used to treat conditions such as rheumatoid arthritis and Crohn’s disease.

In this video, STAT senior writer and Pharmalot columnist Ed Silverman breaks down the convoluted world of pharmacy benefit managers, formularies, and a legal maneuver called “patent thicketing” that controls how much patients pay for this beneficial treatment.

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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So to give it a nudge in a useful direction, we are firing up the coffee kettle to brew another cup of stimulation. Our choice today is maple bourbon. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits to help you start your journey. We hope your day is productive and meaningful. And of course, do keep in touch. We are searching for new pen pals …

Now that its blockbuster immune-disease therapy Humira is facing lower-priced competition, AbbVie is turning to a pair of next-generation successors to replenish the billions of dollars in sales that will be lost, The Wall Street Journal writes. The company is also betting on four drug approvals by the end of next year. In addition, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. AbbVie is counting most on persuading doctors that two newer immune drugs, Skyrizi and Rinvoq, are more effective than Humira and can pass peak Humira sales in four years.

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Underscoring the opaque and confusing nature of pharmaceutical pricing, Amgen announced long-awaited discounts for its biosimilar version of Humira — the world’s best-selling medicine — and the numbers suggest the biggest winners may be health insurers and others in the supply chain, but not patients.

Here’s why: The drug company will offer its medication, called Amjevita, at two different discounts — 5% and 55% — off the roughly $80,000 wholesale, or list, price. The maneuver reflects the behind-the-scenes negotiations that occur between pharmaceutical companies and the pharmacy benefit managers, or PBMs, that create formularies, or lists of medicines for which insurance coverage is provided.

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For years, Humira dominated the market for treating rheumatoid arthritis and other autoimmune disorders. In the process, it became the best-selling medicine in the world and generated billions of dollars in annual sales for AbbVie, which extended its monopoly time and again by filing dozens of patents that made it harder for would-be rivals to launch lower-cost biosimilar versions.

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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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