lunes, 31 de agosto de 2026

The unintended consequences of the Lindsay Clancy case How fear of liability could affect psychiatric care of mothers

https://www.statnews.com/2026/08/28/lindsay-clancy-postpartum-psychosis-reproductive-psychiatrists-liability/ By Renee Sorrentino and Susan Hatters FriedmanAug. 28, 2026 Sorrentino is a forensic psychiatrist in Boston. She is president-elect of the American Academy of Psychiatry and the Law. Friedman is a forensic and reproductive psychiatrist at Case Western Reserve University. She is past president of the American Academy of Psychiatry and the Law.

Juul gets OK to sell updated vaping device with age-gating technology In recent years, company has paid roughly $3 billion to settle lawsuits over teen use of its products

https://www.statnews.com/2026/08/28/juul-fda-clearance-updated-ecigarette-age-gating-technology/ By Associated PressAug. 28, 2026

FDA approves Protagonist and Takeda’s drug for rare blood cancer Mimrylo, a weekly injection, is a new kind of treatment for polycythemia vera By Adam FeuersteinAug. 30, 2026 Senior Writer, Biotech

https://www.statnews.com/2026/08/30/fda-approves-mimrylo-takeda-protagonist-treatment-for-polycythemia-vera/

EASD 2026 Abstract 97 Global estimates of past, present and future type 1 diabetes incidence, prevalence and mortality: the DIAMOND-T1D model

2.7 million That’s how many more people around the world will be living with type 1 diabetes by 2049. In the U.S., that means an increase of more than half a million cases, topping out at 2,055,235. The global estimate, presented Friday at the annual meeting of the European Association for the Study of Diabetes in Milan, reflects a 29% jump from 9.4 million in 2025 to 12.1 million near the mid-century mark. New cases per year, projected to grow by 14%, are rising more sharply in low-income countries, but absolute numbers remain higher in high-income countries. The researchers say those differences likely stem from a combination of genetics, environmental triggers, and higher case-detection rates in high-income countries. https://drive.google.com/file/d/1Zip9nGloBl1t3_APTfx5EJ-VirDGVxOp/view?_hsenc=p2ANqtz-_Vkq1hC9Ul3zaH7gZZp6ZP-K4d9BIet4LLpYcpjmYvLTJ9fCycfSxmfjRjm86UjWYdgLmy_BwijGD4dYr_Dunfo5D3Rw&_hsmi=435905713

Alnylam defends heart disease drugs after failure of AstraZeneca’s Wainua Biotech argues that it medicines maintain their value, and that a key trial has a better design

https://www.statnews.com/2026/08/30/alnylam-attr-astrazeneca-wainua-attruby-heart-disease/ By Andrew JosephAug. 30, 2026 Europe Correspondent Can a pregnancy hormone steer a cardiovascular treatment? The pregnancy hormone relaxin has long been studied as a potential avenue for a cardiovascular treatment because it can cause blood vessels to widen and relax. One snag has been that high doses of relaxin-related drugs have come with safety issues. AstraZeneca thinks it may have an advantage with its oral relaxin agonist AZD5462. The drug provides a lower dose than older injectable and intravenous formulations, and has now shown hints that it could be an effective medicine, according to midstage trial results presented over the weekend at the European Society of Cardiology’s annual conference. The Phase 2 LUMINARA study tested different doses of AZD5462 in patients with different kinds of heart failure, one known as HFrEF and another as HFpEF, which are distinguished based on how well the heart can still pump blood. The aim of the study was to help investigators figure out what a potential Phase 3 study, which would test clinical outcomes, should look like. Overall, based on a measure of cardiac function, investigators found the drug showed promise, particularly in patients with HFrEF. One nagging issue: A lower dose led to more dramatic effects. “We see positive signals, particularly in rEF patients, on some of the cardiac function metrics that clue us into, would it be effective as a heart failure therapy?” AstraZeneca’s Mina Makar told STAT. “And so we think it has the right combination of efficacy and safety, and now we need to make some decisions as to if we progress it and how we progress it.” For now, AstraZeneca hasn’t detailed any Phase 3 development plans.

We’re reading about drug pricing deals, a new cancer therapy approval, and more Meanwhile, BioNTech has terminated a Phase 2 trial for its colon cancer vaccine

https://www.statnews.com/pharmalot/2026/08/31/drug-pricing-deals-polycythemia-vera-mimrylo-pharmalittle-newsletter/ By Jason MastAug. 31, 2026 General Assignment Reporter

A Novartis drug cut inflammation. Can it improve heart outcomes? The drug, pacibekitug, targets IL-6, a common inflammatory driver By Andrew JosephAug. 29, 2026 Europe Correspondent

https://www.statnews.com/2026/08/29/novartis-pacibekitug-inflammation-il6-tourmaline-heart-disease/?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz--H7l184vsuRf3xjj77PtzXOzKgOvfz7YmHF21zNAxCsoXPNhrCrlCzFB6GmBDZa0t0rREj0gFvkuqZcwBUrOixNivK7w&_hsmi=436067550&utm_content=436067550&utm_source=hs_email Novartis inflammation drug clears an early hurdle A newly acquired Novartis drug notably reduced inflammation in a midstage study — but whether that will translate into fewer heart attacks and strokes is still an open question, STAT’s Andrew Joseph writes. Pacibekitug, an antibody targeting the inflammatory protein IL-6, was the centerpiece of Novartis’ $1.4 billion acquisition of Tourmaline Bio last year. It lowered levels of hsCRP, a cardiovascular risk marker, by 76% to 89% after 180 days, compared with a 7% increase among patients on placebo, accordingly to newly released data. But the results come with a caveat: Novo Nordisk’s rival IL-6 drug recently failed a pivotal cardiovascular trial despite similarly lowering inflammation. To determine whether this particular pathway actually improves outcomes, Novartis says it is planning a Phase 3 cardiovascular outcomes program. The drugmakers hasn’t yet disclosed which patients it will target.