AbbVie is acquiring Landos Biopharma, whose lead drug is a small molecule that takes a novel approach to treating ulcerative colitis. Preliminary proof-of-concept data from a Phase 2 study are expected later this year.

Editor’s note: A recording of the event is embedded below.

Several biosimilar versions of Humira, which for years has been the world’s best-selling medicine, entered the U.S. market over the past year. What has that meant for insurance coverage and the way drugmakers are marketing these medicines? Join leading experts to discuss the impact on the industry and patients.

Sponsor introduction

• Thomas Newcomer, vice president and head of U.S. market access, Samsung Bioepis (sponsor)

Featured speakers

• Chris M. Brown, president, McAteer
• Michael Gonzales, independent health care consultant, Michael Gonzales, LLC; former national and regional account director, AbbVie
• Fran Gregory, MBA, PharmD, vice president of emerging therapies, Cardinal Health
• Ed Silverman, Pharmalot columnist, senior writer, STAT (moderator)

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So let us be optimistic and convince ourselves we can nudge it in a better direction with a cup of stimulation. Our choice today is cinnamon vanilla, which we recently procured. Please feel free to join us. Meanwhile, here are a few tidbits to help you get started. We hope you have a smashing day and conquer the world…

A drug that has been used for decades to treat allergic asthma and hives significantly reduced the risk of life-threatening reactions in children with severe food allergies who were exposed to trace amounts of peanuts, cashews, milk and eggs, The New York Times writes, citing newly published research. The drug, Xolair, has already been approved by the U.S. Food and Drug Administration for adults and children over age 1 with food allergies. This is the first treatment that drastically cuts the risk of serious reactions — like anaphylaxis, a life-threatening allergic reaction that causes the body to go into shock — after accidental exposures to various food allergens.

Colorado is pioneering a new way for states to crack down on prescription drug costs, STAT reports. In a first-in-the-nation move, a state board voted to create a payment limit for a widely prescribed Amgen drug used to treat arthritis, a step that may usher in a new era in which state governments take more aggressive action to control the cost of prescription medicines. The drug, called Enbrel, costs insurers an average of $46,772 per patient per year, according to 2022 data from the state’s all-payer claims database. The state board evaluated two other drugs so far, but Enbrel was the first the board deemed unaffordable for Colorado patients.

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that KaliVir Immunotherapeutics hired James Burke as chief medical officer. Previously, he worked at CG Oncology, where he was also chief medical officer.

But all work and no play can make for a dull chief medical officer.

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Hello! Today, we discuss how the FDA is holding firm in how it handles non-compliant trial sponsors and investigators, how PhRMA is rebuilding its ranks, and offer up a fabulous podcast.

The need-to-know this morning

• Advisers to the European Medicines Agency recommended the approval of Qalsody, a treatment for ALS from Biogen.

What do CEOs owe the world?

Did Humira break the system? And can you CRISPR a fetus? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.

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Meanwhile, do keep us in mind if you hear anything interesting. We continue to accept — at absolutely no charge to you — postcards and telegrams. And of course, we hope you have a smashing day. …

AbbVie announced that chief executive officer Richard Gonzalez, who has managed its ascent since being spun off from Abbott Laboratories in 2013, will step down in July, STAT notes. Gonzalez previously said he would depart when AbbVie had a plan in place to move on from its best-selling drug, Humira, which is now facing competition from cheaper biosimilars. He will be replaced by chief operating officer Robert Michael, who, like Gonzalez, is a longtime AbbVie executive. Worth noting: Gonzalez, 70, who will become executive chairman of the board of directors, should be a sobering reminder to pharmaceutical industry critics of the resilience of a chief executive officer’s reputation.

Three conservative-led states — Idaho, Kansas and Missouri — lost their bid to intervene in a battle between the Biden administration and conservative physicians over the abortion pill mifepristone, Bloomberg Law writes. The U.S. Supreme Court decision comes ahead of March 26 oral arguments in the case and marks a victory for the Biden administration in defending U.S. Food and Drug Administration safety decisions on the drug that previously were struck down by an appeals court. The state intervention motion was tailored to maintain the litigation should the Supreme Court find that the conservative physicians lacked standing to sue the FDA over its decisions on the pill.

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Gonzalez had previously said he would depart when AbbVie had a plan in place to move on from its best-selling drug, Humira, which is now facing competition from cheaper biosimilars.

He will be replaced by Chief Operating Officer Robert Michael, who, like Gonzalez, is a longtime AbbVie executive. Gonzalez, 70, will become executive chairman of the board of directors.

Gonzalez should be a sobering reminder to the drug industry’s critics of how resilient a CEO’s reputation can be. Because while he has been a subject of nearly constant criticism for AbbVie’s handling of Humira and the patents protecting it, investors are likely to remember him fondly.

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As a result, the researchers contend the patents may be unfairly used to preclude competition from companies that may want to market lower-cost generic products. They also suggest antitrust regulators may want to widen a probe into improperly filed patents for asthma inhalers and epinephrine injectors to include drug-and-device combination products for combating diabetes.

A total of 188 patents were examined for 10 combination products that include a delivery device and a medicine known as a GLP-1. Among the products reviewed was Eli Lilly’s Mounjaro and Novo Nordisk’s Ozempic. Patents for another Novo Nordisk treatment, Wegovy, were also reviewed since it contains the same key ingredient as Ozempic, even though it is approved only for weight loss.

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Pharmalot, and the rotation will likely include this, this, this, and this. And what about you? This is a fine time to enjoy the great indoors. So why not tidy up around your castle? When done, you could park yourself in front of the telly and watch a few moving picture shows. Of if you’re feeling old fashioned, you could pull out the Scrabble board. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

U.S. Senate health committee chair Bernie Sanders has taken a step toward subpoenaing the chief executive officers at Johnson & Johnson and Merck related to an investigation into high drug prices in the U.S., STAT writes. The step is highly unusual, since the health committee has not issued a subpoena in more than 40 years. Sanders (I-Vt.) invited the J&J and Merck executives, along with Bristol Myers Squibb chief executive officer Chris Boerner, to testify at a Jan. 25 hearing. But only Boerner agreed, and only if at least one other chief executive participated. Instead, Sanders will hold a committee vote on whether to issue the subpoenas and authorize a probe into drug costs on Jan. 31.

But Johnson & Johnson is accusing Sanders of retaliating against the company and others that sued the Biden administration to stop a program to negotiate how much Medicare pays for high-cost drugs, Bloomberg Law reports. The allegation appears in a letter that was written one week before Sanders announced the Senate health committee would vote on whether it would use subpoenas to force J&J and Merck CEOs to testify on U.S. drug prices. The committee’s actions raise “significant concerns that the hearing is intended as retribution” against companies suing the Biden administration over the Medicare negotiation program, the letter says.

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In a series of letters sent on Thursday, Sen. Amy Klobuchar (D-Minn.) demanded the companies explain why they have, so far, not responded to warnings issued two months ago by the Federal Trade Commission to remove more than 100 patents from the registry. The agency threatened the drug companies with litigation if they failed to comply.

The FTC had challenged a total of 10 companies over listings for patents on such medicines as asthma inhalers and epinephrine auto-injectors as part of an effort to mitigate actions that thwart competition. Among the companies to which the agency sent warnings are AbbVie, AstraZeneca, Mylan Specialty, Boehringer Ingelheim, and subsidiaries of GSK and Teva Pharmaceutical.

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