WASHINGTON — Two Republican lawmakers who introduced legislation to water down the Inflation Reduction Act’s Medicare drug price negotiation program managed to find themselves a Democratic co-sponsor — even though every single Democrat in Congress in 2022 voted for the legislation.

They found their perfect candidate in Rep. Don Davis, a Democrat representing a North Carolina district that includes parts of the state’s Research Triangle. He came to Washington in 2023, so didn’t vote on the original law. He received donations in 2023 from the political action committees for Gilead, Astellas, Genentech, Bayer, Pfizer, Novo Nordisk, GSK, Bristol Myers Squibb, BIO, Amgen, Boehringer Ingelheim, Merck, AbbVie, and Eli Lilly.

“We must support the development of critical, life-sustaining medical treatments and cures,” Davis said in a written statement, and a spokesperson declined to elaborate. He is joined on the bill by Rep. Greg Murphy (R-N.C.) and Brett Guthrie (R-Ky.), the Energy and Commerce health subcommittee chairman.

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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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Testosterone is essential for bone health in men. It helps maintain bone density and improve bone microarchitecture, preventing fractures. So treating older men with hypogonadism — a condition that causes low testosterone levels — with the hormone should decrease their likelihood of getting fractures, right?

Surprisingly not, according to a study published Wednesday in the New England Journal of Medicine. The research was conducted on 5,204 men between the ages of 45 and 80 with hypogonadism. Half received a low-dose testosterone gel daily, while the other half was given a placebo. The trial is part of a larger ongoing study sponsored by AbbVie, the maker of AndroGel, a testosterone gel.

Ahead of the trial, researchers estimated that the testosterone group would have a 30% lower risk of fracture than the placebo group, according to the paper’s authors, led by Peter Snyder, the medical director of Penn Pituitary Center. Instead, three years into the study, the cumulative incidence of fractures was 3.8% in the testosterone group, compared to 2.8% in the placebo group. 

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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 SpliceBio hired Aniz Girach as chief medical officer. Previously, he was chief medical officer at ProQR Therapeutics.

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

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We will draw on a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Remember, a prescription is not required. So no need to mess with rebates. Our choice today is crème brûlée. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

Starting April 1, CVS Health will no longer offer AbbVie’s Humira to patients in its commercial prescription plans and, instead, will direct them to biosimilar versions of the anti-inflammatory drug that became available last year, Bloomberg News writes. CVS’s Caremark unit is the first major pharmacy benefit manager to announce such a shift. The move is a blow for AbbVie, which managed to keep Humira on PBM lists of covered drugs even when plans added lower-cost biosimilars. CVS’s Cordavis unit will also start selling a version of Humira with AbbVie in the second quarter, though it will not be preferred on CVS commercial drug plans.

The U.S. Food and Drug Administration is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking medications known as GLP-1 receptor agonists, which are approved to treat diabetes or weight loss, CNN reports. These include Ozempic, Rybelsus, Wegovy, Saxenda, Victoza, Mounjaro, and Zepbound. The FDA is “evaluating the need for regulatory action” after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, or hair loss; aspiration, or accidentally breathing in things like food or liquid; and suicidal ideation in people using these medications.

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To ring the register, a pharmaceutical company may create a patent thicket, which involves filing dozens of patents that, in some cases, add little value to their medicines but extend precious monopolies. And one crucial, but little-known tool for making this happen is something called a terminal disclaimer.

In short, a terminal disclaimer is a stipulation provided to the U.S. Patent & Trademark Office that a continuation or follow-on patent – essentially, a minor patent that makes few substantive changes to a medicine – will expire at the same time as the original patent filed by a pharmaceutical company. By doing so, a drugmaker can circumvent prohibitions on awarding more than one patent for an invention.

As a result, a drug company can quickly add a number of patents that can be used to protect its medicines from would-be rivals. How so? As patents pile up, companies that want to sell generic or biosimilar versions of these medicines find themselves fighting longer and more expensive patent infringement lawsuits that are designed to delay their plans.

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We trust you have your own busy agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is gingerbread — and attack the fast-growing to-do list. We hope you have a smashing day and, of course, do stay in touch. Our settings are adjusted to accept postcards and telegrams. …

Activist investor Carl Icahn plans to oust directors at Illumina, laying the groundwork for a second board challenge at the gene-sequencing company months after shareholders elected one of his director candidates, Reuters writes. Icahn disclosed his plans without offering details in a letter to other shareholders less than 24 hours after Illumina said it will divest blood test maker Grail. In Monday’s letter, Icahn blamed the Grail acquisition, which has faced regulatory challenges since 2021, for a 75% drop in Illumina’s share price that he says wiped away $55 billion in value for shareholders. The stock was up more than 2% at $130.39 on Monday.

As more data emerge that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms. A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss, STAT tells us. In mice experiments, scientists found that the treatments, known as GLP-1-based drugs, acted through the brain to reduce inflammation throughout the body. This was over a short period of time before the mice lost weight, according to the study, published Monday in Cell Metabolism.

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This year’s selection is so deservingly obvious that I won’t fabricate suspense by starting with an honor roll of runners-up. More on those high-achieving folks later. Let’s get right to the main course: David Ricks of Eli Lilly is the runaway, rock star, who-else-could-it-be Best Biopharma CEO of 2023.

What an incredible year it’s been for Ricks and the Lilly executive team who helped him achieve so much. My colleague Matt Herper wrote earlier this year about the “dynamic duo” of Ricks and Chief Scientific Officer Dan Skovronsky.

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