To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.

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The CDC said Missouri health officials didn’t learn that the health worker had symptoms until after the individual had recovered, too late to run a diagnostic test.

“CDC is in close communication with the state of Missouri in its ongoing investigation into the positive H5N1 case there, including regarding the identification of an additional symptomatic close contact,” a spokesperson for the agency told STAT via email. “The finding does not change CDC’s assessment that the risk to the public remains low.”

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Starting in fall 2025, people who want to order the vaccine to give it to themselves or their children at home will be able to do so. 

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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 Latiga Biotherapeutics hired Neil Singla as chief medical officer. Previously, he worked at Lotus Clinical Research, which he founded and where he was, most recently, chief scientific officer.

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

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The glucose route has been ineffective, says William Lowry, a biologist at the University of California, Los Angeles. 

He has an idea why. A new study that Lowry and his team published in Science Advances on Friday suggests that cancer cells readily consume multiple food sources, and their ability to metabolize at least two of these nutrients must be blocked to have an effect. That work, done in mice, might help scientists open a new way to treat cancer by targeting its metabolism.

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The drug, known chemically as arimoclomol and now marketed as Miplyffa, was one of three that companies put in clinical trials around a decade ago, after parents of children with the disease pushed scientists and companies to focus on the condition and helped steer their efforts. 

Those trials largely failed or yielded mixed results. Niemann Pick, or NPC, is slow-moving and can have a different constellation of symptoms in different patients, including motor deficits, cognitive deficits, seizures and difficulty hearing and swallowing — making it hard to show that a drug is having an impact after a year, particularly if that impact is modest. 

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Starting Jan. 1, 2025, Amazon employees will no longer have access to Progyny’s services. Instead, Amazon will use Maven as its fertility benefits vendor, the person said. Amazon already had a relationship with Maven for virtual “family-building care.” The person asked not to be identified because Amazon is still communicating the change to its workers.

On Wednesday, Progyny disclosed to investors that a “significant client” had decided to end its agreement with the company. Progyny did not name the client, but said the client had 670,000 members and represented 13% of Progyny’s revenue in 2023. The company said the client accounted for a “smaller percentage” of its profits.

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The administrative complaint accused CVS Caremark, Cigna’s Express Scripts, and UnitedHealth’s OptumRx of creating a “perverse” system of rebates that favored insulin that was sold at higher list prices in order to “line their pockets” at the expense of patients, who were forced to pay more for the medication.

“Millions of Americans with diabetes need insulin to survive, yet for many of these vulnerable patients, their insulin drug costs have skyrocketed over the past decade thanks in part to powerful pharmacy benefit managers and their greed,” said Rahul Rao, deputy director of the FTC’s Bureau of Competition, in a statement.

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Segan was chief medical officer at Olympus from 2020 to 2023. Olympus is a leading distributor of endoscopes and the recipient of FDA warning letters claiming the company did not adequately address product defects — including instances where endoscope caps fell into patients’ bodies.

“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey Shuren, head of FDA’s medical devices center, at the time. 

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(Important info: If you’re already a subscriber to HCI, get a friend to sign up at this link with the referral code provided in Monday’s newsletter and be entered to win a $100 bookshop.org gift certificate!)

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A Phase 2a trial tested monlunabant, a pill that inhibits CB1 receptors that Novo got through its acquisition of Inversago Pharma last year. Those on the lowest dose of 10 mg lost on average 6.4% of their weight at 16 weeks, compared with 0.6% in the placebo group, Novo said Friday. The study also tested higher doses of 20 mg and 50 mg, but Novo said “limited additional weight loss” was seen at these higher doses and did not disclose specific data.

The most common side effects were gastrointestinal, with most instances being mild to moderate and dose dependent, similar to what’s been seen with the class of GLP-1 obesity drugs on the market. 

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In August, H+H announced a drastic reduction in appointment times for new patients in both adult primary care and pediatrics, cutting them from 40 minutes to just 20. For context, industry standard is typically 30 to 40 minutes for outpatient visits, and 40 minutes for specialists based on the complexity and age of the patient. This cut is not just an inconvenience; it’s a crisis in the making.

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U.S. Sen. Bill Cassidy (La.), a key Republican senator with seats on the health and finance committees, introduced a bill to let some small biotechs avoid Medicare price negotiations, STAT reports. The Inflation Reduction Act, one of President Biden’s signature legislative achievements, allows Medicare to negotiate prices after pills have been on the market for nine years, while biologics are protected for 13 years. The differential is supposed to account for the extra time that it typically takes to develop biologics, which are more complicated than small-molecule medicines. The IRA exempts some small biotechs from Medicare negotiation. However, that exemption expires after 2028, and it only applies to drugs that were on the market in 2021. His bill would exempt “research and development-intensive small biotech manufacturers” after the current exemption expires.

A price battle has broken out in the hot market for weight loss drugs, The Wall Street Journal says. Eli Lilly and Novo Nordisk, which sell the popular injections, are each dangling discounts to gain an edge and to induce health plans to pay up. The concessions are slashing as much as half off the price tags of the $1,000-plus-a-month medicines. For people who pay out of pocket, Lilly recently introduced vials of its drug Zepbound that cost as little as $399 a month. Price concessions are a new, major development in the burgeoning market for weight loss drugs, after high prices and limited supplies led many health plans to refuse coverage and prompted some patients to turn to lower-priced but unapproved custom-made versions. The moves could prod more health plans to begin paying for the medicines. That would help some workers who are clamoring for the drugs — but unable to afford them without health insurance — to finally be able to fill prescriptions.

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Good morning! Today, we see Ginkgo pivot into AI, becoming yet another contender in a crowded market. Also, we see more documents destroyed at an Indian drug manufacturing plant, and offer up a fabulous podcast.

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The new guidance will affect nearly 6,000 universities and other institutions with projects funded by HHS, which have until 2026 to comply. The goal is to help institutions “handle these allegations efficiently and fairly and assure those people that are making allegations know the process we’re going to follow,” Sheila Garrity, director of the HHS Office of Research Integrity (ORI), told STAT.

Among the noteworthy updates to the final rules are clarifying both the process to appeal a decision made by the ORI and how institutions can deem certain instances the result of an “honest mistake.” 

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His 5:2 diet — two days of limited eating (600 calories or less) and five unrestricted days — became widely popular.

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At the time, there was no organization truly led by people most impacted by diabetes that was free from pharmaceutical industry influence and really fighting for what patients need most. Now, nearly 12 years later, after supporting the growth of a global movement (#insulin4all) and building a multi-country organization from scratch, I am stepping aside. But first, I want to share what I have learned from taking on Big Pharma and, in many cases, winning.

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The biotech this week announced a new artificial intelligence model for use in biological research, as well as a data service academic researchers and companies can use to develop their own models. The announcement comes as a growing number of biotechs, big tech companies, and academics apply neural networks and machine learning to biology, promising that the same basic technology that powers ChatGPT can also help design new therapies and speed the pace of fundamental research.

Ginkgo executives say the new efforts provide an opportunity where it can clearly compete. But experts and analysts aren’t so sure. Ginkgo faces competition for both of the new services it’s now offering and it’s not clear how much — if any — advantage the struggling company offers.

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The Inflation Reduction Act, one of President Biden’s signature legislative achievements, allows Medicare to negotiate prices after pills have been on the market for nine years, while biologics are protected for 13 years. The differential is supposed to account for the extra time that it typically takes to develop biologics, which are more complicated than small-molecule medicines. 

The IRA exempts some small biotechs from Medicare negotiation. However, that exemption expires after 2028, and it only applies to drugs that were on the market in 2021. 

Continue to STAT+ to read the full story…