The results add to growing evidence that molecular aging, a process by which our cells accrue damage and dysfunction over time, doesn’t progress in a linear fashion — nor only forward.

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The drug, known as Pemgarda and marketed by the biotech Invivyd, is the first such drug to become available since the agency pulled AstraZeneca’s Evusheld off the market in January 2023. New Omicron variants had rendered Evusheld ineffective.

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A summary of the proposed rules were read out by board president Sherif Zaafran, who summarized the proposed rules at a regularly scheduled meeting. He said they were not intended to “regulate or prohibit abortion” but to help define legal exemptions whereby abortion is permitted to save the life or major bodily function of the mother.

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Driving the momentum? Economics 101.

Biotechs rely on borrowing capital, which is a more tenuous task when interest rates are high. But interest rates have most likely peaked, with Federal Reserve officials signaling earlier this week they expected to make three cuts this year. For public biotechnology startups that have been battered by the market in recent years, this is a very good thing, Rod Nathan, portfolio manager and partner of J. Goldman & Co., said on a panel at STAT’s Breakthrough Summit East in New York on Thursday.

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The object of their furor wasn’t just the government. It was also Steward Health Care, the medical conglomerate that made Malta the first stop in its aggressive bid to expand internationally, even as its chain of hospitals in Massachusetts teeters on the verge of bankruptcy.

The €400 million figure is the amount Malta’s opposition party claims the government paid an affiliate of Steward and another company over an eight-year period to provide medical care to its citizens and transform three dilapidated state-owned hospitals into world-class institutions.

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Medicare previously wasn’t reimbursing for Wegovy, since the federal payer is legally barred from covering weight loss drugs. But the Food and Drug Administration this month approved Wegovy for preventing heart problems in people with obesity and heart disease, leading many to suspect that Medicare would start covering the drug for this usage.

Makers of obesity drugs have been hoping that showing additional benefits beyond weight loss would induce more insurers to cover them. Medicare’s guidance, first reported Thursday, moves in that direction, but experts point out that the private insurers that administer Medicare’s prescription drug benefit — called Part D — can still choose to not include Wegovy on their formularies, especially if they think it would be too costly.

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And here is our regular feature in which we highlight a different person each week. This time around, we note that GRO Biosciences hired Tracey Lodie as chief development officer. Previously, she worked at Quell Therapeutics, where she was chief scientific officer.

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

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Some Medicare members could get help paying for the popular new weight loss drug Wegovy — as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes, The Wall Street Journal reports. Medicare Part D drug-benefit plans may cover weight loss drugs if approved for an additional use that is considered medically accepted under federal law. The new guidance cracks open Medicare reimbursement of the popular obesity drugs, potentially paving the way for thousands of new people getting prescriptions and for billions of dollars in additional spending on them. It could also add to the pressure on commercial health plans to cover the drugs.

Germany’s public health insurance scheme can cover certain patients with a risk of heart disease or strokes to take the weight loss Wegovy drug, a big boost for Novo Nordisk’s efforts to convince governments of its wider medical benefits, Reuters says. The European Medicines Agency has been reviewing wider use of Wegovy to include reducing the risk of strokes and heart attacks, adding to the previously approved use to tackle obesity. Guidance posted online by health agency G-BA said that regulation banning Germany’s health insurance system from paying for weight loss drugs would not apply in the case of other approved uses of the weekly injection.

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Hi, it’s Meghana. Today, Illumina finally finds an advocate in the EU, a CRISPRed pig kidney is transplanted into a living human, and more.

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“We used to say, well, you may spend five years in the research phase, another five in development. Now I see a project that takes one year of research, from an idea to studies,” said Mikael Dolsten, chief scientific officer and president of Pfizer research and development. “Time is life. You care about patients. And when the distance to run is long, it holds back the energy and the inspiration.”

Key to that success are transformative new technologies like messenger RNA, which powered vaccines developed by Pfizer with its partner BioNTech.

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The rise of ride-sharing companies like Uber and Lyft represents a striking example of a new, and arguably better, business model that managed to overcome the barriers of tradition, payment, and regulation. Many health care device makers have employed similar strategies to great effect, overcoming barriers by creating sufficient market demand to limit inevitable pushback. On the one hand, this may be an efficient workaround to a cumbersome regulatory process that some believe stifles innovation. On the other hand, it may put patients at risk with new treatments or devices being adopted with enthusiasm outpacing credible evidence.

Uber’s origin story is well known. When it sought to enter various markets around the U.S., it encountered enormous barriers, including the entrenched taxicab companies, customer behavior, and existing (and potentially obsolete) laws or regulations. Rather than attempting an expensive and prolonged campaign aimed at local, state, and national legislators and courts, Uber chose to enter the market and deal with the consequences later. In New York City, for example, it quickly achieved a large share of the consumer transport business. Its market dominance was so profound that it drove down the cost of taxi medallions from $1.3 million in 2014 to $250,000 in 2016. In a version of the famous maxim, “Ask for forgiveness, not permission,” Uber’s initial foray into markets skirted close to the edge of regulatory and legal proscriptions. Notwithstanding many critiques for its corporate culture and limited driver benefits, the loyalty Uber built among its customers helped buffer the company from significant regulatory backlash.

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That’s what attendees at the Breakthrough Summit East in New York had on their hands Thursday, as four participants presented their work in this year’s STAT Madness competition — an annual March Madness bracket-style battle to find the best innovation in science and medicine.

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“It’s the fastest-growing sport in America because you could be any shape, size, age,” Cullity said. “There’s an 82-year-old who kicks my butt.”

There’s virtually nothing that could keep her away from the court — except maybe her own injury history. Cullity tore her anterior cruciate ligament three times while playing basketball in high school and lacrosse in college, injuries she’s intent on avoiding with training tailored to her past and future.

That’s why she and her organization have partnered with a hospital’s sports performance center to design fitness programs for Eleven-0’s members, who can also participate in research.

“You feel like you’re getting what the Patriots next door get every day,” she said on a recent Friday afternoon.

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We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Recorded live from from the STAT Breakthrough Summit East in New York City, we discuss some event highlights, including words from CRISPR pioneer Feng Zhang and Regeneron Pharmaceuticals head scientist George Yancopoulos. We also discuss the latest news in the life sciences, including a twist in the GLP-1 story, the cost of gene therapy, and, of course, pie.

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But even as she expressed enthusiasm for the new drugs’ potential, Volkow criticized pharmaceutical companies for neglecting a moral imperative to develop new addiction treatments — but acknowledged that the health system more broadly doesn’t incentivize drug companies to treat the U.S. drug crisis with urgency.

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The remarks from Nora Volkow, the longtime director of the National Institute on Drug Abuse, serve as a cautionary note amid widespread enthusiasm about ibogaine, a naturally occurring substance that drug companies and researchers have increasingly cast as a potential paradigm-shifting addiction treatment.

But its potential cardiac side effects could stand in the way of receiving approval from the Food and Drug Administration, Volkow said.

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After 35 years as head scientist at Regeneron Pharmaceuticals, Yancopoulos has led the development of 12 approved medicines, turning a once-fledgling company into the $100 billion global drugmaker it is today. And you can trace a straight line back to the childhood fascination with science he fostered growing up in Woodside, Queens.

“My high school science project was about regenerating neurons, and ‘Regeneron’ is a contraction of ‘regenerating neurons,’” Yancopoulos said at the STAT Summit East on Thursday. “In some ways I’m still working on my high school science project.”

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Experts pointed to lab-developed tests, or LDTs, as one important element that could help make this connection during a panel at the STAT Breakthrough Summit East in New York on Thursday. These tests, which are performed by certified labs using clinical samples, are playing an increasingly important role in shaping health care decisions — and they have the potential to identify genetic diseases.

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But now, a decade later, Editas is seen as lagging behind its peers. CRISPR Therapeutics, in partnership with Vertex Pharmaceuticals, won the race to get the first CRISPR-based medicine across the finish line. Intellia Therapeutics was the first to show that CRISPR editing could be performed inside the body. Editas, meanwhile, has seen a revolving door among its executives.

So what happened?

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A systematic review by the Peterson Health Technology Institute found, though, that digital tools used to manage diabetes with the help of finger-stick blood glucose readings don’t result in clinically meaningful improvements over standard care. As a result, they don’t reduce health care spending — they drive it up.

“Most of the solutions in this category do not deliver clinical benefits that justify their cost,” Caroline Pearson, executive director of the institute, told STAT. Despite finding that some populations may benefit, the report concludes that current evidence doesn’t support broader adoption for most products.

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