STAT

STAT+: Biden’s SOTU highlights pharma’s biggest political problem: It is terrifyingly, awfully alone

If you’re a drug company executive, you probably feel like you got up on the wrong side of bed.

On Thursday night, President Biden proposed expanding one of his most popular policies: the Medicare price negotiation process that was put in place as part of the Inflation Reduction Act. “Americans pay more for prescription drugs than anywhere else,” Biden said. “It’s wrong and I’m ending it.”

Obviously, the drug industry is not going to be happy about new price limitations in the U.S., the biggest market for pharmaceuticals. But, even more than that, Biden’s move emphasizes a painful reality: That pharmaceutical companies remain one of the biggest political targets in the country — despite their key role in addressing the Covid-19 pandemic and their development of wildly effective new weight loss drugs.

Continue to STAT+ to read the full story…

1 year 3 months ago

Biotech, Matt's Take, biotechnology, drug prices, Joe Biden, Pharmaceuticals, STAT+

STAT

STAT+: Up and down the ladder: The latest comings and goings

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.

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.

Continue to STAT+ to read the full story…

1 year 3 months ago

Pharma, Pharmalot, biotechnology, life sciences, Pharmaceuticals, STAT+

STAT

STAT+: Pharmalittle: We’re reading about a CEO change at AbbVie, a long-acting HIV drug, and more

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is strawberry creme — and get started. To help you along, we have assembled another menu of tidbits for you to peruse.

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.

Continue to STAT+ to read the full story…

1 year 3 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: AbbVie CEO Gonzalez to step down after a decade fiercely defending its top seller, Humira

AbbVie announced Tuesday that CEO Richard Gonzalez, who has managed the company’s ascent since it was spun off from the device maker Abbott Laboratories in 2013, will step down in July.

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…

1 year 3 months ago

Biotech, Pharma, AbbVie, biotechnology, patents, Pharmaceuticals, STAT+

STAT

STAT+: Lasers, cardiology, clinical trials: 2023’s top private equity targets

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.

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…

1 year 4 months ago

Business, Health, Insurance, cardiovascular disease, Clinical Trials, finance, Hospitals, physicians, policy, private equity, STAT+

STAT

STAT+: The lone Democrat willing to weaken Medicare’s power to negotiate drug prices

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

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…

1 year 4 months ago

Politics, CMS, Congress, drug prices, Medicare, STAT+, White House

STAT

STAT+: Diabetes treatments have improperly listed patents that should be removed, analysis finds

More than half of the injector-pen patents for several widely used diabetes treatments — including Ozempic and Mounjaro — do not mention several important characteristics that should otherwise prevent them from being listed in a key federal registry, according to a new analysis.

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…

1 year 4 months ago

Pharma, Pharmalot, biotechnology, Obesity, patents, STAT+

STAT

STAT+: Pharmalittle: We’re reading about Sanders targeting pharma CEOs, insider trading, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Given the forecast, our agenda is modest. We expect to catch up on our reading, take a few naps, and promenade with the official mascots as often as possible. We also plan another listening party with Mrs.

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…

1 year 4 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Klobuchar urges drugmakers to remove patents FTC calls improper and inaccurate

Amid a push to crack down on patent abuse by the pharmaceutical industry, a key U.S. lawmaker is urging six large drug companies to remove dozens of patents that were identified by regulators as improperly or inaccurately listed with a federal registry.

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…

1 year 4 months ago

Pharma, Pharmalot, patents, Pharmaceuticals, STAT+

STAT

STAT+: Testosterone didn’t lower fracture risk in a surprising new study. Researchers have theories about why

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?

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…

1 year 4 months ago

Health, Research, STAT+

Pages