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.

Continue to STAT+ to read the full story…

By some measures, private equity investment lagged in 2023, a year marked by growing distress and high-profile downfalls among private equity-backed health care companies.

Even so, three sectors still managed to see strong deal flow and prices: med spa, cardiology, and clinical trial sites, according to a new PitchBook report analyzing private equity investments in health care services in 2023. Each of the three niches continue to generate buzz among investors, even as other areas fizzle.

It’s not that those three industries are perfect fits for private equity, it’s that the more obvious areas like autism therapists and physician practices are struggling with high interest rates and regulatory scrutiny, said Rebecca Springer, PitchBook’s lead health care analyst.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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. 

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…