viernes, 31 de octubre de 2025

A Bite, a Bill, and a Bureaucratic Chill in Winning Halloween Haikus By KFF Health News Staff Illustrations by Oona Zenda October 31, 2025

https://kffhealthnews.org/news/article/halloween-haiku-contest-seventh-annual-2025-winners/

Morning Briefing: Today's News Summaries Friday, Oct 31 2025 9:09 AM ++++ ++++

Morning Briefing: Today's News Summaries Friday, Oct 31 2025 9:09 AM Many States — But Not All — Step Up To Help SNAP Beneficiaries Amid Deadline https://kffhealthnews.org/morning-breakout/many-states-but-not-all-step-up-to-help-snap-beneficiaries-amid-deadline/ Kennedy Softens Warning On Tylenol; Study Ties Covid In Pregnancy, Autism https://kffhealthnews.org/morning-breakout/kennedy-softens-warning-on-tylenol-study-ties-covid-in-pregnancy-autism/ HHS Drafts Plan To Effectively End Trans Care For Youths Nationwide https://kffhealthnews.org/morning-breakout/hhs-drafts-plan-to-effectively-end-trans-care-for-youths-nationwide/ FDA's Block Of Mifepristone Access Is Unlawful, Federal Judge Rules https://kffhealthnews.org/morning-breakout/fdas-block-of-mifepristone-access-is-unlawful-federal-judge-rules/ Insurers Blame Hospitals' Use Of AI, 'Aggressive' Coding For Price Spikes https://kffhealthnews.org/morning-breakout/insurers-blame-hospitals-use-of-ai-aggressive-coding-for-price-spikes/ Telltale Signs Of Bird Flu Infection Aren't Always Evident, Review Finds https://kffhealthnews.org/morning-breakout/telltale-signs-of-bird-flu-infection-arent-always-evident-review-finds/ Longer Looks: Interesting Reads You Might Have Missed https://kffhealthnews.org/morning-breakout/longer-looks-interesting-reads-you-might-have-missed-239/ Viewpoints: Our Leaders Failed Us By Cutting Medicare Telehealth Coverage; Will Help For Chronic Pain Go Next? https://kffhealthnews.org/morning-breakout/viewpoints-our-leaders-failed-us-by-cutting-medicare-telehealth-coverage-will-help-for-chronic-pain-go-next/

Better Treatments Buoy Multiple-Myeloma Patients, Bound by Research Cuts and Racial Disparities By Melba Newsome October 31, 2025

https://kffhealthnews.org/news/article/multiple-myeloma-patients-treatment-research-cuts-racial-disparities/

California’s New Allergen-Disclosure Law: A Sign of Things to Come? October 31, 2025 By Charles D. Snow —

https://www.thefdalawblog.com/2025/10/californias-new-allergen-disclosure-law-a-sign-of-things-to-come/?utm_source=rss&utm_medium=rss&utm_campaign=californias-new-allergen-disclosure-law-a-sign-of-things-to-come

Health care workers under 65 must be vaccinated against Covid Recent discussions about Covid vaccines have overlooked this important group

https://www.statnews.com/2025/10/30/covid-vaccine-health-care-workers-under-65/

Biden’s law sets Trump up for success in negotiating cheaper Medicare drug prices Ozempic and some costly cancer drugs face Medicare’s drug price negotiation program this year

https://www.statnews.com/2025/10/30/trump-biden-medicare-drug-price-negotiations/

Trump cuts have decimated the federal addiction and mental health agency Amid overdose and suicide crises, SAMHSA has lost more than half its staff

https://www.statnews.com/2025/10/30/samhsa-grant-cuts-staff-reductions-impact-analyzed/

FDA criticism of MDMA-assisted therapy is an opportunity for psychedelic medicine The FDA is asking psychedelic medicine to meet the same scientific standards as any other drug

https://www.statnews.com/2025/10/30/fda-crl-lykos-mdma-therapy-reset-psychedelic-medicine/

How Moderna, the company that helped save the world, unraveled After missteps and misfortune, the biotech confronts a precarious future By Jason MastOct. 30, 2025

https://www.statnews.com/2025/10/30/moderna-rise-fall-biotech-analysis-from-pandemic-rise-to-mrna-crash/

Novo Nordisk makes offer for obesity-focused Metsera, aiming to outbid Pfizer The rival proposals reflect how competitive and crucial the obesity market has become for pharma companies

https://www.statnews.com/2025/10/30/novo-nordisk-metsera-pfizer-acquisition-offer-bidding-war/

Senate hearing for Casey Means, Trump’s surgeon general pick, is postponed after she goes into labor The news came hours before the wellness influencer was set to appear virtually with the committee

https://www.statnews.com/2025/10/30/casey-means-surgeon-general-senate-hearing-postponed-labor/

Biopharma’s agentic AI moment

Biopharma’s agentic AI moment Owkin — an AI company focused on unraveling the complexity of biology and advancing new diagnostics and therapies — partnered with STAT Brand Studio on a Pulse Check report to survey more than 200 executives and researchers in the U.S. and Europe about agentic AI. The report examines how leaders perceive this emerging technology, from its potential to streamline discovery and research to the strategic priorities, adoption strategies, budgets, and barriers that shape its role in biopharma. https://www.statnews.com/biopharmas-agentic-ai-moment/

Eli Lilly’s weight loss and diabetes drug tops Keytruda as world’s best-selling medicine The therapy, marketed as Zepbound and Mounjaro, took the crown from Merck at a striking pace

https://www.statnews.com/2025/10/30/eli-lilly-zepbound-mounjaro-bestselling-obesity-drug/

Cigna stock nosedives on news that ending PBM rebates will lower that segment’s profit Express Scripts will become rebate-free for many commercial health plans starting in 2027

https://www.statnews.com/2025/10/30/drug-rebates-cigna-pbm-industry-shakeup/

BridgeBio’s great week and Moderna’s unraveling

https://www.statnews.com/2025/10/30/readout-loud-podcast-bridgebio-moderna-vaccines-biotech-metsera/

Proposed changes in Medicare coverage threaten access to procedures used to treat pain Administrative contractors don’t want to cover peripheral nerve block procedures for chronic pain

https://www.statnews.com/2025/10/31/medicare-coverage-peripheral-nerve-block-procedures/

A $20 over-the-counter drug in Europe requires a prescription and $800 in the U.S. It’s just one way pharma erodes Americans’ trust

https://www.statnews.com/2025/10/31/why-miebo-costs-40-times-more-than-its-european-version/

Insurers say they’ll deploy more AI to combat ‘aggressive’ coding by hospitals Payers blame providers’ use of automated AI tools for some of their shrinking profits

https://www.statnews.com/2025/10/31/health-insurer-ai-fights-hospital-ai-coding-billing/

Health care takes center stage in this year’s elections, a sign of midterm strategies to come Democrats are tying health care to affordability issues, while Republicans try to leverage Trump’s recent announcements

https://www.statnews.com/2025/10/31/governors-races-health-care-politics-midterm-testing-grounds/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_icAdD2K-gk0-xh9nTz7UQGxeME9JULWy-x15a_CPAIVx8Ry2AVksy1mMrMgzSsHFHdPfq5NL8Qw1Cp3m4ZeI1xNy9AA&_hsmi=387732612&utm_content=387732612&utm_source=hs_email Health care takes center stage for midterm elections The results of next week’s governors’ races could have major implications on the parties’ midterm approaches to federal health policy. In Virginia and New Jersey’s gubernatorial races, new lines of attack are opening up, with both Democrats and Republicans refining their central message to highlight their perceived strengths. Democrats want to link health issues with economic ones, seizing on voter frustrations around rising costs and cuts to health programs. Republicans, meanwhile, are touting Trump’s deals to lower drug prices. If you’re a regular Morning Rounds reader, you don’t need me to tell you that American health care is undergoing a transformational shift, especially after the passage of Republicans’ One Big Beautiful Bill, which is set to slash Medicaid funding by nearly $1 trillion over the next decade. Elections are a great way to track how Americans are feeling about it all. Read more from STAT’s Daniel Payne.

Under Vinay Prasad, employees at a key FDA center fear speaking out, look for the exits Prasad is contending with slumping morale as senior leaders quit CBER By Lizzy LawrenceOct. 31, 2025

https://www.statnews.com/2025/10/31/vinay-prasad-fda-cber-management-issues-insiders-say/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_y8k5S3IjVh03QuCMdQhjP-h--yYZBPryAPOnZga3ALOHof4jClTFaa9o33_RTQFEAZWOtOQYMwqNWUQ4ZpZmHIExR7g&_hsmi=387732612&utm_content=387732612&utm_source=hs_email Vinay Prasad’s tumultuous tenure at the Food and Drug Administration has entered a new, even rockier era: a slow-boiling feud with his staff that could lead to the exodus of dozens of scientists who regulate the nation’s vaccines, biological products, and blood supply. Insiders say Prasad, as director and chief medical and scientific officer for the Center for Biologics Evaluation and Research, has cultivated a work environment rife with mistrust and paranoia since returning from his brief departure. They say Prasad has fired key leaders without explanation and struggled to communicate with staff. They also say his vision for the center, other than applying additional scrutiny to vaccines, is unclear. Another fantastic story from STAT’s Lizzy Lawrence, who interviewed more than 15 current and former FDA staff, contractors, and regulatory experts about Prasad’s rocky tenure. Read on for why his second stint at the CBER has been even more chaotic than his first.

jueves, 30 de octubre de 2025

Viewpoints: Open Enrollment Is Extra Painful This Year; New Covid Vaccine Recommendations Miss A Vital Group

https://kffhealthnews.org/morning-breakout/viewpoints-open-enrollment-is-extra-painful-this-year-new-covid-vaccine-recommendations-miss-a-vital-group/

Research Roundup: The Latest Science, Discoveries, And Breakthroughs

https://kffhealthnews.org/morning-breakout/research-roundup-the-latest-science-discoveries-and-breakthroughs-44/

Alaska Supreme Court Rethinks Rules On Who Can Perform Abortions

Alaska Supreme Court Rethinks Rules On Who Can Perform Abortions Last year, a superior court judge struck down a law that required abortions to be performed only by a doctor licensed by the state medical board, the Anchorage Daily News reported. Other states making news: Ohio, Maine, Florida, Missouri, and California. https://kffhealthnews.org/morning-breakout/alaska-supreme-court-rethinks-rules-on-who-can-perform-abortions/

Study Links Health Issues Later In Life With Using Cannabis Before Age 15

Study Links Health Issues Later In Life With Using Cannabis Before Age 15 Researchers found ties between both physical and mental health issues with early cannabis use. Other health and wellness news is on Character.AI, anti-fall technology in assisted living, the benefits of flavanol-rich foods, and food allergy reminders ahead of Halloween. https://kffhealthnews.org/morning-breakout/study-links-health-issues-later-in-life-with-using-cannabis-before-age-15/

Viral Infections Drastically Raise Risk Of Heart Disease And Stroke: Study

Viral Infections Drastically Raise Risk Of Heart Disease And Stroke: Study Researchers have zeroed in on inflammation sparked by covid, flu, and shingles as one component that explains why some people face an elevated risk of cardiovascular disease after infection. Plus, a look at how air travel fuels disease spread. https://kffhealthnews.org/morning-breakout/viral-infections-drastically-raise-risk-of-heart-disease-and-stroke-study/

Judge Quashes DOJ Effort To Acquire Private Patient Information

Judge Quashes DOJ Effort To Acquire Private Patient Information Judge Jamal N. Whitehead of Federal District Court in the Western District of Washington ruled the Trump administration overstepped its authority when it sought data from a trans health provider. “When a federal agency issues a subpoena ... to intimidate and coerce providers into abandoning lawful medical care, it exceeds its legitimate authority and abuses the judicial process,” he said. https://kffhealthnews.org/morning-breakout/judge-quashes-doj-effort-to-acquire-private-patient-information/

To Cut Drug Costs, FDA Paves Way For Easier Approval Of Copycat Biologics

To Cut Drug Costs, FDA Paves Way For Easier Approval Of Copycat Biologics The draft framework announced Wednesday lowers the standards that companies need to meet to bring the drugs to market. Also, states try to lower drug prices by regulating PBMs; how the immigration crackdown is affecting elder care; and more. https://kffhealthnews.org/morning-breakout/to-cut-drug-costs-fda-paves-way-for-easier-approval-of-copycat-biologics/

Healthcare.gov Unveils Updated Prices; Customers Could Pay Double Next Year

Healthcare.gov Unveils Updated Prices; Customers Could Pay Double Next Year Newly posted prices on the federal marketplace show an average premium increase of 26%, but the actual increase will be closer to 114% unless Congress extends Obamacare tax credits, which are at the heart of the ongoing government shutdown. Meanwhile, military families say their refrigerators will be empty after food aid funding runs dry Saturday. https://kffhealthnews.org/morning-breakout/healthcare-gov-unveils-updated-prices-customers-could-pay-double-next-year/

Refugees Will Be Among the First To Lose Food Stamps Under Federal Changes By Renuka Rayasam October 30, 2025

https://kffhealthnews.org/news/article/refugees-snap-benefits-food-aid-trump-law/

The Quiet Collapse of America’s Reproductive Health Safety Net By Céline Gounder October 30, 2025

https://kffhealthnews.org/news/article/title-x-family-planning-hhs-opa-trump-cuts-reproductive-health-maine/

RFK, Jr.’s bungled science on thimerosal and vaccines Josh Bloom | October 28, 2025 ++++++´+

https://geneticliteracyproject.org/2025/10/28/rfk-jr-s-bungled-science-on-thimerosal-and-vaccines/?mc_cid=3c96341fc5&mc_eid=b73600b7ac The fake Tylenol-causes-autism scare has revived an ancient debate: When should you treat a fever? https://geneticliteracyproject.org/2025/10/28/the-fake-tylenol-causes-autism-scare-has-revived-an-ancient-debate-when-should-you-treat-a-fever/?mc_cid=3c96341fc5&mc_eid=b73600b7ac ‘She started having orgasms for the first time in years’: More and more women are embracing testosterone’s sex and energy jolt https://geneticliteracyproject.org/2025/10/28/she-started-having-orgasms-for-the-first-time-in-years-more-and-more-women-are-embracing-testosterones-sex-and-energy-jolt/?mc_cid=3c96341fc5&mc_eid=b73600b7ac Vaccines, raw milk, fluoride, Tylenol: MAHA right-wing alliance floods state houses with hundreds of science-rejectionist bills https://geneticliteracyproject.org/2025/10/28/vaccines-raw-milk-fluoride-tylenol-maha-right-wing-alliance-floods-state-houses-with-hundreds-of-science-rejectionist-bills/?mc_cid=3c96341fc5&mc_eid=b73600b7ac Republican states win case striking down rule protecting transgender health care rights https://geneticliteracyproject.org/2025/10/27/republican-states-win-case-striking-down-rule-protecting-transgender-health-care-rights/?mc_cid=3c96341fc5&mc_eid=b73600b7ac Should we use CRISPR gene editing to remake humanity? https://geneticliteracyproject.org/2025/10/27/should-we-use-crispr-gene-editing-to-remake-humanity/?mc_cid=3c96341fc5&mc_eid=b73600b7ac A new therapy has been developed that promoters claim can remove microplastics from the body. Is it safe? Does it work? A new therapy has been developed that promoters claim can remove microplastics from the body. Is it safe? Does it work? Daniel Gilbert, Shannon Osaka | Washington Post | October 27, 2025 https://geneticliteracyproject.org/2025/10/27/a-new-therapy-has-been-developed-that-promoters-claim-can-remove-microplastics-from-the-body-is-it-safe-does-it-work/?mc_cid=3c96341fc5&mc_eid=b73600b7ac

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Draft Guidance for Industry October 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product-updated-recommendations?utm_medium=email&utm_source=govdelivery FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs?utm_medium=email&utm_source=govdelivery FDA Issues Draft Guidance to Industry, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies” Today, FDA released a draft guidance for industry “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” This draft guidance describes updated scientific considerations regarding a comparative clinical study with efficacy endpoints (comparative efficacy study or CES) intended to support a demonstration of biosimilarity. Since publication of the Scientific Considerations Guidance in April 2015, FDA has gained significant experience in evaluating analytical differences between proposed biosimilar products and reference products and understanding their impact on clinical performance. As experience with the development and approval of biosimilars has grown, there has been increasing recognition that CES are not as sensitive as modern analytical technologies for detecting differences between products. Accordingly, FDA’s scientific approach to when a CES may be needed to support a demonstration of biosimilarity is evolving. The draft guidance provides an overview of important scientific considerations for determining when a CES may inform a demonstration of biosimilarity. FDA is issuing this draft guidance to seek public comment through the accompanying docket (Docket No. FDA-2011-D-0605). Visit Regulations.gov for instructions on how to comment. This draft guidance describes scientific considerations that support a streamlined approach to demonstrating biosimilarity, which should reduce the time and cost of biosimilar development and help increase access to medications for American patients.

The 2025 report of the Lancet Countdown on health and climate change +...

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01919-1/abstract The 2025 report of the Lancet Countdown on health and climate change provides the most comprehensive assessment to date of the connections between climate change and health, including new metrics which record deaths from extreme heat and wildfire smoke, the coverage of urban blue spaces (rivers, lakes, and coastlines), health adaptation funding, and individual engagement with health and climate change.

Our global food system is increasingly under strain. What needs to be done? Ian Proudfoot, Isabelle Allen | World Economic Forum | October 30, 2025 +++++

https://geneticliteracyproject.org/2025/10/30/our-global-food-system-is-increasingly-under-strain-what-needs-to-be-done/ How will climate change affect the flowers of the future? Annelie Berner | MIT Technology Review | October 30, 2025 https://geneticliteracyproject.org/2025/10/30/how-will-climate-change-affect-the-flowers-of-the-future/ The social roots of sustainable eating Emily Halnon | University of Georgia | October 30, 2025 https://geneticliteracyproject.org/2025/10/30/the-social-roots-of-sustainable-eating/ How AI can improve food safety and nutrition Sedat Arslan | Academia | October 29, 2025 https://geneticliteracyproject.org/2025/10/29/how-ai-can-improve-food-safety-and-nutrition/ As China doubles down rejecting U.S. exports of soybeans, food security takes central focus in next 5-year agricultural plan South China Morning Post | October 29, 2025 https://geneticliteracyproject.org/2025/10/29/as-china-doubles-down-rejecting-u-s-exports-of-soybeans-food-security-takes-central-focus-in-next-5-year-agricultural-plan/

Collecting DNA from hundreds of thousands of detainees, Trump administration immensely expands immigration enforcement Caitlin Dickerson | New York Times | October 29, 2025

https://geneticliteracyproject.org/2025/10/29/collecting-dna-from-hundreds-of-thousands-of-detainees-trump-administration-immensely-expands-immigration-enforcement/

Is AI the solution to combating soaring cases of scientific publishing fraud? Nina Notman | Chemistry World | October 29, 2025

https://geneticliteracyproject.org/2025/10/29/is-ai-the-solution-to-combating-soaring-cases-of-scientific-publishing-fraud/

Viewpoint: The biggest winners of RFK, Jr.’s junk science push Laura Ungar, Michelle Smith | AP | October 30, 2025

https://geneticliteracyproject.org/2025/10/30/viewpoint-the-biggest-winners-of-rfk-jr-s-junk-science-push/

‘‘It could determine the future of the world’: Putin morphs from ethical opponent of gene editing humans to support for creating CRISPR-edited soldiers “without fear, without compassion, without regret or even pain.” It could happen soon Stepan Kravchenko | Bloomberg | October 30, 2025

https://geneticliteracyproject.org/2025/10/30/it-could-determine-the-future-of-the-world-putin-morphs-from-ethical-opponent-of-gene-editing-humans-to-support-for-creating-crispr-edited-soldiers-without-fear-w/ Resurrecting Neanderthals: The scientific challenge and ethical debate Kristina Killgrove | Live Science | October 30, 2025 https://geneticliteracyproject.org/2025/10/30/resurrecting-neanderthals-the-scientific-challenge-and-ethical-debate/

GLP podcast: ‘Health freedom’—a human right or MAHA propaganda tool? Cameron English, Liza Lockwood | October 30, 2025

https://geneticliteracyproject.org/2025/10/30/glp-podcast-health-freedom-a-human-right-or-maha-propaganda-tool/

Digital Health Advisory Committee Meeting

November 6, 2025: Digital Health Advisory Committee Meeting Announcement November 6, 2025

https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-2025-digital-health-advisory-committee-meeting-announcement-11062025?utm_medium=email&utm_source=govdelivery Meeting Materials and Due Date Reminders: Digital Health Advisory Committee Meeting On November 6, 2025, the Digital Health Advisory Committee will discuss and make recommendations on the topic of generative artificial intelligence-enabled digital mental health medical devices. The Committee will discuss the benefits, risks to health, and risk mitigations that might be considered for these new digital mental health devices, including premarket evidence and post-market monitoring considerations. The meeting is open to the public. Registration is not required to attend. The FDA has now made available the following meeting materials: Agenda for the November 6, 2025 Digital Health Advisory Committee Meeting https://www.fda.gov/media/189389/download?attachment=&utm_medium=email&utm_source=govdelivery Roster for the November 6, 2025 Digital Health Advisory Committee Meeting https://www.fda.gov/media/189390/download?attachment=&utm_medium=email&utm_source=govdelivery Executive Summary for the November 6, 2025 Digital Health Advisory Committee Meeting https://www.fda.gov/media/189391/download?attachment=&utm_medium=email&utm_source=govdelivery FDA Discussion Questions for the November 6, 2025 Digital Health Advisory Committee Meeting https://www.fda.gov/media/189392/download?attachment=&utm_medium=email&utm_source=govdelivery Meeting date and time: November 6, 2025, from 9:00 a.m. to 6:00 p.m. Eastern Time Location: The advisory committee meeting will be held virtually. The meeting will be heard, viewed, captioned, and recorded for through an online teleconferencing and/or video conferencing platform.

miércoles, 29 de octubre de 2025

‘AI psychosis’ discussions ignore a bigger problem with chatbots People rely on chatbots because of the scarcity of physical and mental health care

https://www.statnews.com/2025/10/29/ai-psychosis-mental-health-chatbots/

Will Optum Real really end the payer vs provider AI wars? You’re reading the web edition of STAT’s AI Prognosis newsletter

https://www.statnews.com/2025/10/29/will-optum-real-really-end-the-payer-vs-provider-ai-wars-ai-prognosis-newsletter/

Doctors need to ask patients about chatbots It should be a standard part of the intake process across specialties

https://www.statnews.com/2025/10/29/chatbots-doctors-guide-medical-appointments-questions/

Miriam Merad’s 20-year quest to understand one cell is starting to rewrite the rules of cancer immunotherapy Macrophages may also play a role in aging and autoimmune disorders By Angus ChenOct. 28, 2025

https://www.statnews.com/2025/10/28/miriam-merad-macrophages-immune-system-cancer/

A ‘devil’s choice’ on vaccines and pandemic preparedness Seth Berkley, former CEO of Gavi, the Vaccine Alliance, discusses his new book, what went right and wrong with Covid, and more

https://www.statnews.com/2025/10/29/seth-berkley-interview-covid-vaccines-fair-doses/

What do Rollerblades and Ozempic have in common? What happens when brand-name drugs are at risk of ‘genericide’

https://www.statnews.com/2025/10/29/ozempic-from-trademark-to-weight-loss-generic-term-status-report/

Scientists had to change more than 700 grant titles to receive NIH funding. Health disparities researchers fear what’s next Wording changes can alter projects and the questions scientists address By Anil OzaOct. 29, 2025

https://www.statnews.com/2025/10/29/nih-banned-words-analysis-grant-title-changes/

Medicare Beneficiaries Are Not Luddites Author: Drew Altman Published: Oct 29, 2025

https://www.kff.org/from-drew-altman/medicare-beneficiaries-are-not-luddites/ In a new column, President and CEO Dr. Drew Altman discusses new KFF survey data that shows that a surprising share of older adults with Medicare are using health tech regularly, and a solid majority support many of CMS’ goals to make it more widely available. But there are also big income gaps in the use of health tech, and concerns about AI, privacy, and other barriers to rapid and more widespread adoption. “Apparently… a lot of Medicare beneficiaries—but not all beneficiaries equally—are ready for more health tech, and have become tech savvy to survive,” Altman writes.

So Your Insurance Dropped Your Doctor. Now What? By Bram Sable-Smith Illustrations by Oona Zenda October 29, 2025

https://kffhealthnews.org/news/article/health-care-helpline-hospital-insurance-network-contract-disputes-what-to-do/

Viewpoints: US Health Care Is Failing Patients With Mental Illnesses; A Migraine Isn’t Merely A Headache

https://kffhealthnews.org/morning-breakout/viewpoints-us-health-care-is-failing-patients-with-mental-illnesses-a-migraine-isnt-merely-a-headache/

Germany To Put $1B Toward Holocaust Survivors’ Home Care In 2026

Germany To Put $1B Toward Holocaust Survivors’ Home Care In 2026 Data show that survivors are dealing with more complicated health needs and increased disability as the average age of survivors rises. Other news from around the globe is on Chinese scientists, "fertility tourism," heat deaths, and more. https://kffhealthnews.org/morning-breakout/germany-to-put-1b-toward-holocaust-survivors-home-care-in-2026/

Prison Phone Rates Going Up; Critics Predict ‘Huge Implications’ On Health

Prison Phone Rates Going Up; Critics Predict ‘Huge Implications’ On Health The FCC voted Tuesday to dramatically raise the price limits that jails and prisons can charge. The calls, which are usually paid for by family members and friends outside of prison, have been shown to provide many mental and public health benefits, such as promoting relationships with children and reducing recidivism. https://kffhealthnews.org/morning-breakout/prison-phone-rates-going-up-critics-predict-huge-implications-on-health/

Health Experts Warn Medicare Staffing Shortage Will Impact Open Enrollment

Health Experts Warn Medicare Staffing Shortage Will Impact Open Enrollment CMS has been urged to boost staffing in order to ensure that benefits get delivered and communicated well during Medicare's open enrollment period. Other news is on the appointment of the director of Medicaid and CHIP, Bausch Health's exit from the 340B program, and more. https://kffhealthnews.org/morning-breakout/health-experts-warn-medicare-staffing-shortage-will-impact-open-enrollment/

HHS Fires Top Official, A Vaccine Critic Who Says Coup To Oust RFK Jr. Is Afoot

HHS Fires Top Official, A Vaccine Critic Who Says Coup To Oust RFK Jr. Is Afoot Senior adviser Steven J. Hatfill was accused of misrepresenting his role and “not coordinating policy-making with leadership.” When he declined a request to resign, chief of staff Matt Buckham fired him. Plus, a lower-dose covid shot is available for seniors and others at risk for severe infection. https://kffhealthnews.org/morning-breakout/hhs-fires-top-official-a-vaccine-critic-who-says-coup-to-oust-rfk-jr-is-afoot/

Trump Admin Clawing Back Authority Over States’ Medical Debt Protections

The Consumer Financial Protection Bureau contends federal law invalidates state laws that prevent patients' medical debts from being reported to credit bureaus. Separately, male veterans who have breast cancer will find it harder to get health care coverage. Plus, Texas sues the maker of Tylenol. https://kffhealthnews.org/morning-breakout/trump-admin-clawing-back-authority-over-states-medical-debt-protections/

Judge Bans White House From Firing Federal Workers During Shutdown

https://kffhealthnews.org/morning-breakout/judge-bans-white-house-from-firing-federal-workers-during-shutdown/ On Tuesday, U.S. District Judge Susan Illston of San Francisco blocked the firings, stating that the labor unions would likely win their claims that the cuts were arbitrary and politically motivated.

Doctor Tripped Up by $64K Bill for Ankle Surgery and Hospital Stay By Julie Appleby October 29, 2025

https://kffhealthnews.org/news/article/doctor-ankle-surgery-hospital-stay-surprise-bill-of-the-month-october-2025/

Innate immunity regulation of brain health: a webinar from The Lancet Group and Cell Press Thursday, 20/11/2025 · 10:00 Atlantic Time (Canada) (GMT -4:00)

https://www.bigmarker.com/lancet-webinars/innate-immunity-regulation-of-brain-health-a-webinar-from-the-lancet-group-and-cell-press?utm_bmcr_source=hubspot_update_feature_laneur&_hsenc=p2ANqtz-93e6HNyrhvVIM1se-xAyrpClWVEy06UNPUOTOCqaE8Az3iweWd84ksvhM8ZUY0IEXv8BhdcW7AXH2ayRLIBzFYK2SfBQ&_hsmi=387249641

You’ve Got Mail, and Twice the Time to Respond! Two Device Companies Find Themselves with 30 Business Days to Respond to FDA’s Warning Letters October 27, 2025 By Anne K. Walsh & Julie Kim & Esther Petrikovsky —

https://www.thefdalawblog.com/2025/10/youve-got-mail-and-twice-the-time-to-respond-two-device-companies-find-themselves-with-30-business-days-to-respond-to-fdas-warning-letters/?utm_source=rss&utm_medium=rss&utm_campaign=youve-got-mail-and-twice-the-time-to-respond-two-device-companies-find-themselves-with-30-business-days-to-respond-to-fdas-warning-letters

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Draft Guidance for Industry October 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product-updated-recommendations

martes, 28 de octubre de 2025

Viewpoints: Annual Open Enrollment Is About Making More Money; New Meds Make Dementia Less Scary

https://kffhealthnews.org/morning-breakout/viewpoints-annual-open-enrollment-is-about-making-more-money-new-meds-make-dementia-less-scary/

Texas Doctor Gives Up License After Being Sued For Providing Gender Care +++

https://kffhealthnews.org/morning-breakout/texas-doctor-gives-up-license-after-being-sued-for-providing-gender-care/ Pediatrician May Lau has decided to move her practice from Dallas to Oregon after being sued last year by Texas Attorney General Ken Paxton and accused of prescribing testosterone to at least 21 patients, which she denies. More news is from Virginia, California, New Mexico, Maryland, Arizona, South Carolina, Massachusetts, Utah, and Florida. BJC Health Failed To Alert School District About Shooter, Lawsuit Claims The family of Jean Kuczka, a teacher slain in the 2022 shooting at CVPA in St. Louis, has filed a wrongful death suit against BJC Health, alleging that it failed to make the school aware of the threat after the shooter told multiple BJC mental health providers that he planned to “shoot up my old high school” in the two months before the attack. https://kffhealthnews.org/morning-breakout/bjc-health-failed-to-alert-school-district-about-shooter-lawsuit-claims/ Young People In Corn Belt Are Getting Significantly More Cancer Since 2015 An analysis by The Washington Post found that in the past decade, cancer rates in the six states with the highest corn production are rising more rapidly than in the country as a whole. People aged 15-49 living there have shown a 5% increase in overall cancer rates, with kidney and skin cancer soaring to 35%-65% higher than the national average. https://kffhealthnews.org/morning-breakout/young-people-in-corn-belt-are-getting-significantly-more-cancer-since-2015/

Obamacare Premiums Will Climb 30% On Average Next Year +++

https://kffhealthnews.org/morning-breakout/obamacare-premiums-will-climb-30-on-average-next-year/ The news of premium spikes arrives during the prolonged federal government shutdown, which was prompted in part by a fight over the extension of Obamacare subsidies. Higher premiums and a loss of subsidies could mean skyrocketing health care costs for millions. More coverage is on SNAP, WIC, and other impacts of the shutdown. NIH Installation Of Vance Pal To Lead Environmental Health Sciences Panned https://kffhealthnews.org/morning-breakout/nih-installation-of-vance-pal-to-lead-environmental-health-sciences-panned/ Some fear the elevation of Kyle Walsh to a director's role — a promotion that didn't abide by standard procedures — will pave the way for future political appointments. Plus, President Trump issues an all-caps missive about Tylenol, touts his "perfect" MRI findings, and more. California Ponies Up $140 Million To Preserve Planned Parenthood Clinics The Golden State is tapping local funds to ensure the organization can maintain reproductive health services after the federal government cut funding. Plus, as Wyoming moves to prevent regulation of crisis pregnancy centers that counsel against abortion, some centers across the states expand medical services. https://kffhealthnews.org/morning-breakout/california-ponies-up-140-million-to-preserve-planned-parenthood-clinics/

Medicare Advantage Enrollees Have Access to About Half of the Physicians Available to Traditional Medicare Beneficiaries Authors: Matthew Rae, Jeannie Fuglesten Biniek, Tricia Neuman, and Karen Pollitz Published: Oct 27, 2025

https://www.kff.org/medicare/medicare-advantage-enrollees-have-access-to-about-half-of-the-physicians-available-to-traditional-medicare-beneficiaries/ Medicare Advantage enrollees were in a plan that included just under half (48%) of all physicians available to traditional Medicare beneficiaries in their area in 2022, on average. The limitations of provider networks illustrate one of the key tradeoffs for beneficiaries in choosing Medicare Advantage for their coverage.

Will Trump’s Announcement Expand Access to IVF? Authors: Alina Salganicoff, Brittni Frederiksen, and Usha Ranji Published: Oct 27, 2025

https://www.kff.org/womens-health-policy/will-trumps-announcement-expand-access-to-ivf/ The White House announcement focused on reducing the cost of some IVF drugs and clarifying options for employers to offer standalone fertility benefits for their employees and their dependents. This policy watch examines some key takeaways about the Trump IVF plan.

8 Things to Watch for the 2026 ACA Open Enrollment Period Authors: Rayna Wallace, Jared Ortaliza, Matt McGough, Cynthia Cox, Emma Wager, Michelle Long, and Kaye Pestaina Published: Oct 28, 2025

https://www.kff.org/affordable-care-act/8-things-to-watch-for-the-2026-aca-open-enrollment-period/ The ACA Marketplace Open Enrollment season begins November 1, and with it comes looming changes to the enhanced premium tax credits, increases in out-of-pocket premiums, and changes to Marketplace enrollment and eligibility rules. Here are eight things to know about the 2026 Open Enrollment period.

As Sports Betting Explodes, States Try To Set Limits To Stop Gambling Addiction By Karen Brown, New England Public Media October 27, 2025

https://kffhealthnews.org/news/article/sports-betting-state-regulation-gambling-addiciton-massachusetts/

Doctors Muffled as Florida Moves To End Decades of Childhood Vaccination Mandates By Arthur Allen October 27, 2025

https://kffhealthnews.org/news/article/florida-vaccine-mandates-ladapo-pediatricians-flu-measles-disease/

A Listener's DIY Project Helps Others Deal With High Medical Bills Season 14, Episode 2 October 28, 2025

https://kffhealthnews.org/news/podcast/arm-and-a-leg-diy-project-help-with-high-medical-bills/

Many Fear Federal Loan Caps Will Deter Aspiring Doctors and Worsen MD Shortage By Bernard J. Wolfson October 28, 2025

https://kffhealthnews.org/news/article/medical-school-federal-loan-caps-doctor-shortage-trump-law/

Viewpoints: Fast-Tracking Leucovorin Sets Unsettling Precedent; Debt Pushes Med Students Away From Primary Care

https://kffhealthnews.org/morning-breakout/viewpoints-fast-tracking-leucovorin-sets-unsettling-precedent-debt-pushes-med-students-away-from-primary-care/

GLP-1 Drugs Have Rapidly Lowered American Obesity Rates, Survey Shows

https://kffhealthnews.org/morning-breakout/glp-1-drugs-have-rapidly-lowered-american-obesity-rates-survey-shows/ According to the Gallup National Health and Well-Being Index, the U.S. obesity rate fell from 39.9% in 2022 to 37% in 2025. Plus: Women may need less exercise than men to improve heart health.

Stillbirths In US Occur Far More Often Than Previously Reported, Study Finds

https://kffhealthnews.org/morning-breakout/stillbirths-in-us-occur-far-more-often-than-previously-reported-study-finds/ Researchers found that between 2016 and 2022, there was one stillbirth for every 147 births, The Washington Post reported. Worse yet, a significant number of them happened without warning in pregnancies that did not show any previously identified risks.

Cigna Will Scrub Drug Rebate Models From Some Plans Starting In 2027

https://kffhealthnews.org/morning-breakout/cigna-will-scrub-drug-rebate-models-from-some-plans-starting-in-2027/ As Bloomberg explains, pharmaceutical companies pay the rebates in order to get favorable placement on pharmacy benefit managers’ lists of covered drugs, a practice some have likened to kickbacks. All of Cigna's Evernorth customers will have access to upfront discounts starting in 2028.

Mental Health Grants For Schools Must Be Restored, Judge Rules

https://kffhealthnews.org/morning-breakout/mental-health-grants-for-schools-must-be-restored-judge-rules/ The Trump administration had canceled the grants, claiming they were not awarded based on merit. The judge said the states made a case for real harm from the cuts to the grants meant to help with a shortage of mental health workers in schools. Also, more than 1 million people show suicidal intent each week while talking to chatbots.

As States Prep To Sue Over Food Aid, Some In GOP Seek Separate SNAP Vote

https://kffhealthnews.org/morning-breakout/as-states-prep-to-sue-over-food-aid-some-in-gop-seek-separate-snap-vote/ Democrat-led states are petitioning for the government to tap an emergency fund to keep food aid flowing amid the shutdown — after the Trump administration said it would not do that. Meanwhile, a Texas grocer has a plan to help families in need; Connecticut issues emergency relief; and more.

In Pivot, Federal Workers’ Union Calls For Immediate End To Shutdown

https://kffhealthnews.org/morning-breakout/in-pivot-federal-workers-union-calls-for-immediate-end-to-shutdown/ The president of the American Federation of Government Employees suggested that negotiations over Democrats' health care demands should continue only after the government is reopened. Separately, news outlets cover the Obamacare price hikes headed for residents in New Jersey, Illinois, Arizona, and Colorado.

A Ticking Clock: How States Are Preparing for a Last-Minute Obamacare Deal By Amanda Seitz and Julie Appleby October 28, 2025

https://kffhealthnews.org/news/article/obamacare-states-prepare-for-last-minute-aca-deal/

Where Are the Oncologists? Global Workforce Crisis Deepens Cristina Ferrario Medscape Europe October 28, 2025

https://www.medscape.com/viewarticle/where-are-oncologists-global-workforce-crisis-deepens-2025a1000tcs

Onshoring Drug Manufacturing: Insights from FDA’s PreCheck Initiative and Public Meeting October 28, 2025 By Mark I. Schwartz & Julie Kim —

https://www.thefdalawblog.com/2025/10/onshoring-drug-manufacturing-insights-from-fdas-precheck-initiative-and-public-meeting/?utm_source=rss&utm_medium=rss&utm_campaign=onshoring-drug-manufacturing-insights-from-fdas-precheck-initiative-and-public-meeting

lunes, 27 de octubre de 2025

mRNA Covid vaccines rejected as dangerous by RFK, Jr. shown to spark an immune response that could aid cancer survival Michael Le Page | New Scientist | October 24, 2025

https://geneticliteracyproject.org/2025/10/24/mrna-covid-vaccines-rejected-as-dangerous-by-rfk-jr-shown-to-spark-an-immune-response-that-could-aid-cancer-survival/

A new therapy has been developed that promoters claim can remove microplastics from the body. Is it safe? Does it work? Daniel Gilbert, Shannon Osaka | Washington Post | October 27, 2025

https://geneticliteracyproject.org/2025/10/27/a-new-therapy-has-been-developed-that-promoters-claim-can-remove-microplastics-from-the-body-is-it-safe-does-it-work/

Republican states win case striking down rule protecting transgender health care rights Joe Reberkenny | Washington Blade | October 27, 2025

https://geneticliteracyproject.org/2025/10/27/republican-states-win-case-striking-down-rule-protecting-transgender-health-care-rights/

The EU passes landmark legislation to curb plastic nurdles threatening ocean ecosystems. It’s not enough. Genetically engineered bacteria could help Henry Miller, Kathleen Hefferon | October 24, 2025

https://geneticliteracyproject.org/2025/10/24/genetically-engineered-plastic-eating-bacteria-could-clean-up-our-oceans/

Viewpoint: Beyond Plastics: Here’s how ‘dark money’ funds activist environmental causes and keeps money flowing to tort lawyers David Zaruk | October 27, 2025

https://geneticliteracyproject.org/2025/10/27/viewpoint-beyond-plastics-heres-how-dark-money-funds-activist-environmental-causes-and-keeps-money-flowing-to-tort-lawyers/

Is new insurance company downcoding long overdue or a travesty? STAT readers weigh in Keep those letters coming!

https://www.statnews.com/2025/10/25/stat-letters-editor-downcoding-health-profits/

How much should healthy medical research volunteers get paid? Two experts discuss how to properly compensate people for sacrificing their time — and bodies

https://www.statnews.com/2025/10/25/dysentery-human-challenge-study-medical-research-pay/

Novartis to buy RNA-focused Avidity in $12 billion deal It is the latest in a run of acquisitions for the Swiss pharma company

https://www.statnews.com/2025/10/26/novartis-acquire-avidity-rna-neuromuscular-diseases/

Generic drugmakers seek to thwart a Connecticut law that would cap rising prices The law, which goes into effect in January, prohibits drugmakers from raising prices above the inflation rate

https://www.statnews.com/pharmalot/2025/10/27/generic-makers-connecticut-law-prices-inflation/

CAR-T therapies from Cabaletta, Bristol Myers Squibb induce remissions in patients with autoimmune disorders Small trials post encouraging data in severe inflammatory muscle disease

https://www.statnews.com/2025/10/27/cabaletta-bristol-myers-cart-autoimmune/

BridgeBio study data on drug for rare form of muscular dystrophy could set up approval Treatment is for one subtype of limb-girdle muscular dystrophy

https://www.statnews.com/2025/10/27/bridgebio-limb-girdle-muscular-dystrophy/

For heart health, physical activity favors women Women reduced their risk more than men in a large study, but men were more susceptible to coronary heart disease

https://www.statnews.com/2025/10/27/cardiac-health-study-exercise-provides-greater-benefit-women/

Blue Cross plans to target doctors for overcharging. Physicians are furious Doctors say the program fails to recognize that patients don’t fit neatly into categories

https://www.statnews.com/2025/10/27/blue-cross-algorithm-for-health-care-costs-infuriates-doctors/

Hope and ‘no regrets’: How pancreatic cancer surgeon Dr. Michael Zinner faced a pancreatic cancer diagnosis ‘I’m looking for options, and a plan. And the opportunity for hope’

https://www.statnews.com/2025/10/27/how-a-cancer-surgeon-faced-cancer-diagnosis/

Families like mine depend on their local pharmacy for medicine — and for survival Pharmacy closures are a public health emergency in slow motion

https://www.statnews.com/2025/10/27/pharmacy-desert-walgreens-closes-rite-aid-rural-insulin/

Chinese biotech industry shows no signs of slowing as threat of U.S. restrictions loom Deal-making between drugmakers in the two countries remains robust

https://www.statnews.com/2025/10/27/china-biotech-drugmakers-partnerships/

All of a sudden, dementia treatment is becoming very exciting Biomarker-based therapeutics are changing everything for patients — and for physicians

https://www.statnews.com/2025/10/27/dementia-stigma-biomarker-based-therapeutics-treatment/

For Intellia Therapeutics, CRISPR drug’s safety concern is an existential threat It is difficult to imagine a viable future for the biotech company following pause in trials

https://www.statnews.com/2025/10/27/intellia-therapeutics-crispr-impact/

When SNAP benefits run out, ‘people can die,’ say health experts Even temporary food insecurity poses real risks, particularly for people with chronic disease

https://www.statnews.com/2025/10/27/snap-benefits-cut-off-nov-1-government-shutdown/

Intellia pauses two late-stage CRISPR gene-editing trials after emergence of safety concern Treated patient is hospitalized with liver damage, a known risk of therapy

https://www.statnews.com/2025/10/27/intellia-gene-editing-trial-pause/?utm_campaign=daily_recap&utm_medium=email&_hsenc=p2ANqtz-_CAc2dIjB0vDZnktLVYdUHttI29FxjK1qqzZMcnuEpGZ_-bsTIyd6RNBLeKaMlj3Y848eJ4k4xqbYjm5nxiQp2dnHjXg&_hsmi=387101212&utm_content=387101212&utm_source=hs_email

domingo, 26 de octubre de 2025

A Devastating Dx at 23 Sparks a Doctor’s Medical Calling Sarah Yahr Tucker October 24, 2025

https://www.medscape.com/viewarticle/devastating-dx-23-sparks-doctors-medical-calling-2025a1000rq3

What the AI Bubble Is Doing to Healthcare Eric Spitznagel October 24, 2025

https://www.medscape.com/viewarticle/what-ai-bubble-doing-healthcare-2025a1000t0h

Where the Line Is: The Ethical Limits of Physician Investing Donavyn Coffey October 24, 2025

https://www.medscape.com/viewarticle/where-line-ethical-limits-physician-investing-2025a1000t09

WHO: 1 in 3 EU Doctors and Nurses Face Depression or Anxiety Fabio Turone October 24, 2025

https://www.medscape.com/viewarticle/who-1-3-eu-doctors-and-nurses-face-depression-or-anxiety-2025a1000t0r

It’s a Bird! It’s a Plane! It’s a Chemtrail? New Conspiracy Theory Takes Wing at Kennedy’s HHS By Stephanie Armour October 16, 2025

https://kffhealthnews.org/news/article/chemtrails-conspiracy-fringe-theory-maha-kennedy-hhs/ The ideas that airplane vapors are toxic to people and that there are ongoing efforts to intentionally change the climate have long made the social media rounds. Now, they have found advocates at the Department of Health and Human Services. HHS Secretary Robert F. Kennedy Jr. is planning to investigate climate and weather control and is expected to create a task force that will recommend possible federal action, according to a former agency official, an internal agency memo obtained by KFF Health News, and a consultant who helped with the memo. Under President Donald Trump, unscientific ideas have unusual power to take hold and shape public health policy.

U.S. Foreign Aid Freeze & Dissolution of USAID: Timeline of Events Oct 24, 2025 +... (x)

https://www.kff.org/ This timeline provides a detailed overview of actions, including counter-actions, related to the administration’s efforts to freeze all U.S. foreign aid and dissolve the U.S. Agency for International Development (USAID).

Reporters Cover the Shutdown and the Use of AI in Health Care October 25, 2025

https://kffhealthnews.org/news/article/on-the-air-this-week-october-25-2025-shutdown-ai/

State Prescription Drug Affordability Boards: When Cost Takes Precedence Over Patient Health Tony Coelho | October 26, 2025

https://www.healthaffairs.org/sponsored-content/national-minority-quality-forum/state-prescription-drug-affordability-boards-when-cost-takes-precedence-over-patient-health?utm_campaign=6508038-Health%20Affairs%20Sunday%20Update%202025&utm_medium=email&_hsenc=p2ANqtz-9yZF1Gr-Y9BqH0Ac74w1ke-T7JrSLuXS6lfgr77rEEF6tW21-dVzBX0vXwKcA-pwOItLEEtfOyG_q8p1yi0fXqHfGcPA&_hsmi=386777002&utm_content=386777002&utm_source=hs_email

Health Benefits In 2025: Family Premiums Rise 6 Percent, Large Employers Increase Coverage Of GLP-1s For Weight Loss Gary Claxton, Matthew Rae, Anthony Damico, Aubrey Winger, and Emma Wager

https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2025.01106

Podcast: The Different Costs — and Sites — of Care for Commercial Insurers w/ Matthew Maughan Rob Lott October 21, 2025

https://www.healthaffairs.org/do/10.1377/hp20251020.556500/full/?utm_campaign=podcast&utm_medium=email&_hsenc=p2ANqtz-9aj7F6Xq6YVWnRVGiJBq-03ZeFlnwBEf7IC_O_HQubUfP0WyFR7yZMdI_E2UmGn3R7wOC9C65bz_vcP31RBqvJRPw9nQ&_hsmi=386777002&utm_content=ahp&utm_source=hasu

Podcast: Pharmaceutical Tariffs Explained: The Will-They-Won’t-They Story of 2025 Jeff Byers Stacie B. Dusetzina David Simon October 24, 2025

https://www.healthaffairs.org/do/10.1377/hp20251023.953071/full/?utm_campaign=podcast&utm_medium=email&_hsenc=p2ANqtz-8XaohoToUUZQSSFrzhSEdO9pxz2Y_OmXtl1U7p6PZs8vVsG7u6GVuuzg_68-bA52xI18FWKItuIBt8LluNX4Hfk8BcHA&_hsmi=386777002&utm_content=hatw&utm_source=hasu

Tobacco Treatment As A Profit Center Edward Anselm October 24, 2025

https://www.healthaffairs.org/content/forefront/tobacco-treatment-profit-center

Solving The Challenges Of Employee Health Benefits: The North Carolina State Health Plan Story Brad Briner Brian J. Miller Thomas Friedman Emma Turner October 23, 2025

https://www.healthaffairs.org/content/forefront/solving-challenges-employee-health-benefits-north-carolina-state-health-plan-story

To Better Inform Hospital Payment Cap Policies, Pursue Better Data: A Response To Allison Et Al. Roslyn Murray Andrew M. Ryan Erin C. Fuse Brown Christopher M. Whaley October 22, 2025

https://www.healthaffairs.org/content/forefront/better-inform-hospital-payment-cap-policies-pursue-better-data-response-allison-et-al

Medicaid Cuts Threaten Pregnancy And Postpartum Coverage, Access To Care, And Health Annaliese Johnson Zoe D’Angelo Susan Kennedy October 20, 2025

https://www.healthaffairs.org/content/forefront/medicaid-cuts-threaten-pregnancy-and-postpartum-coverage-access-care-and-health

What Might Happen If MA Shifted Certain Drugs From Part B To Part D? R. Brett McQueen October 21, 2025

https://www.healthaffairs.org/content/forefront/might-happen-if-ma-shifted-certain-drugs-part-b-part-d?utm_campaign=forefront&utm_medium=email&_hsenc=p2ANqtz--EPR5kM84WgdISFRK_TRpqmQyiFu9mBeFG_5piQCak5catxeNC0yru4WflrThQ7aSxeTkWaN2D2f2eOangUBOKCmpunQ&_hsmi=386777002&utm_source=hasu

The Jury Is Still Out On ICHRAs Jason Levitis Claire O’Brien Rachael Totz October 22, 2025

https://www.healthaffairs.org/content/forefront/jury-still-out-ichras

Reforming Hospital Price Transparency Enforcement: Closing Loopholes And Empowering Patients Harrison Koos October 22, 2025

https://www.healthaffairs.org/content/forefront/reforming-hospital-price-transparency-enforcement-closing-loopholes-and-empowering

Medicare’s WISeR Model And The Challenge Of Low-Value Care Elizabeth Fowler October 23, 2025

https://www.healthaffairs.org/content/forefront/medicare-s-wiser-model-and-challenge-low-value-care

FDA Vaccine Suspensions: Outliers Or The New Normal? Richard Hughes IV William Walters October 21, 2025

https://www.healthaffairs.org/content/forefront/fda-vaccine-suspensions-outliers-new-normal

sábado, 25 de octubre de 2025

Vaccine rejectionist activists got Idaho to ban shot mandates. They’re now targeting the rest of the country Audrey Dutton | ProPublica | October 23, 2025

https://geneticliteracyproject.org/2025/10/23/vaccine-rejectionist-activists-got-idaho-to-ban-shot-mandates-theyre-now-targeting-the-rest-of-the-country/

RFK, Jr. and his vaccine-skeptical acolytes at the CDC are recommending that we split childhood vaccines to allegedly prevent autism. That’s a scientifically dangerous idea Jay Varma | Psychology Today | October 24, 2025

https://geneticliteracyproject.org/2025/10/24/rfk-jr-and-his-vaccine-skeptical-acolytes-at-the-cdc-are-recommending-that-we-split-childhood-vaccines-to-allegedly-prevent-autism-thats-a-scientifically-dangerous-idea/

mRNA Covid vaccines rejected as dangerous by RFK, Jr. shown to spark an immune response that could aid cancer survival Michael Le Page | New Scientist | October 24, 2025

https://geneticliteracyproject.org/2025/10/24/mrna-covid-vaccines-rejected-as-dangerous-by-rfk-jr-shown-to-spark-an-immune-response-that-could-aid-cancer-survival/

KFF/Washington Post Poll Looks at Parents’ Trust in Children’s Health Content on Social Media, And Unfounded Claims About Abortion Pill Safety Follow FDA Approval of Generic Version Irving Washington , Hagere Yilma , and Joel Luther

https://www.kff.org/health-information-trust/parents-trust-in-childrens-health-content-on-social-media-and-unfounded-claims-about-abortion-pill-safety/?utm_campaign=22234741-KFF-Information-Trust&utm_medium=email&_hsenc=p2ANqtz-_aM8eOKVFztadDG79Flc51yrCV7yLvQji-5vaeig-b0ourSDFwC3GRwly2mj-TvPly8WLXjKNs1e22IAWUnztyx5uf6w&_hsmi=386549812&utm_content=386549812&utm_source=hs_email This volume highlights the latest release from the KFF/The Washington Post Survey of Parents, which finds that most parents report seeing children’s health content on social media, but many are unsure how to evaluate the trustworthiness of advice shared by health and wellness influencers. It also reviews misleading claims about the safety of medication abortion following the approval of a generic version of the abortion pill mifepristone, and it explores reports that federal officials are considering adding autism to the list of conditions covered by the Vaccine Injury Compensation Program. Lastly, it examines the use of AI chatbots by patients seeking to interpret lab results.

Despite a tough year, Moderna forges ahead with cancer therapies The company presented early but promising data at the ESMO conference

https://www.statnews.com/2025/10/23/moderna-cancer-pipeline-esmo-interview-kyle-holen/

Tear down the wall between neurology and psychiatry The way medicine separates the mind from the brain is deeply flawed

https://www.statnews.com/2025/10/23/neurology-psychiatry-artificial-separation-brain-mind/

How to tease out what’s causation and what’s just correlation The acetaminophen-autism debate highlights the challenge of studying cause and effect

https://www.statnews.com/2025/10/23/causation-correlation-tylenol-autism-research/

Time is running out for Anavex and its treatment for Alzheimer’s disease Here’a a look at the realistic scenarios, all of them negative outcomes for the company

https://www.statnews.com/2025/10/23/anavex-alzheimers-drug-chmp/

Algorithms used to determine Medicaid eligibility for home care vary widely among states New report seeks to ‘demystify the tech’ used to deny coverage for elderly and disabled people

https://www.statnews.com/2025/10/24/advocate-investigates-algorithms-determine-medicaid-at-home-care/

FDA delivers split decision on GSK’s blood cancer drug Blenrep, approving its use in some cases The drug was pulled from the market in 2022 after concerns about efficacy

https://www.statnews.com/2025/10/23/fda-approves-blenrep-gsk-drug-multiple-myeloma/

Startups push the FDA and biotech booms in North Carolina

https://www.statnews.com/2025/10/23/fda-startups-biotech-north-carolina-readout-loud-podcast/

Trump’s IVF deal spurs hopes — and adjustments — across fertility sector Firms are optimistic more employers will offer standalone benefits

https://www.statnews.com/2025/10/23/trump-ivf-proposal-fertility-benefit-firms-maven-carrot-react/?utm_campaign=daily_recap&utm_medium=email&_hsenc=p2ANqtz-_dvePLH4YVE-E0ZbbbVie9uEE-bwp6y_exIt8SQx0Eu1KCKB5f-8whgCFii2Gfo0EPeeZAbnA9TiVG0fwILFfR7UV8fA&_hsmi=386617681&utm_content=386617681&utm_source=hs_email

Medical Debt, Financial Risk Factors, and Deferred Care among Low-Wage Workers

https://academic.oup.com/healthaffairsscholar/advance-article/doi/10.1093/haschl/qxaf196/8297018?rss=1&login=false

Will Expanding Catastrophic Coverage Eligibility Increase Marketplace Premium Affordability in 2026?

https://academic.oup.com/healthaffairsscholar/advance-article/doi/10.1093/haschl/qxaf202/8299843?rss=1&login=false

Understanding Biopharmaceutical Investment Decision Making: How Does CBO’s Model Compare to Investor Insights?

https://academic.oup.com/healthaffairsscholar/advance-article/doi/10.1093/haschl/qxaf200/8299842?rss=1&login=false

The Jury Is Still Out On ICHRAs Jason Levitis Claire O’Brien Rachael Totz

https://www.healthaffairs.org/content/forefront/jury-still-out-ichras

Annual Family Premiums For Employer Coverage Neared $27,000 In 2025, New Survey Shows Health Affairs October 22, 2025

https://www.healthaffairs.org/content/forefront/annual-family-premiums-employer-coverage-rise-6-2025-nearing-27-000-workers-paying-6

Solving The Challenges Of Employee Health Benefits: The North Carolina State Health Plan Story Brad Briner Brian J. Miller Thomas Friedman Emma Turner October 23, 2025

https://www.healthaffairs.org/content/forefront/solving-challenges-employee-health-benefits-north-carolina-state-health-plan-story

Medicare’s WISeR Model And The Challenge Of Low-Value Care Elizabeth Fowler October 23, 2025

https://www.healthaffairs.org/content/forefront/medicare-s-wiser-model-and-challenge-low-value-care

Tobacco Treatment As A Profit Center Edward Anselm

https://www.healthaffairs.org/content/forefront/tobacco-treatment-profit-center

viernes, 24 de octubre de 2025

TrumpRx and a most favored nation policy won’t lower prices for patients A better approach would be to fix the broken system around generics and biosimilars

https://www.statnews.com/2025/10/24/trumprx-most-favored-nation-drug-prices-generics-biosimilars/

Trump’s $150-per-month GLP-1 plan won’t reach people like me The weight-loss drugs have helped me manage life in long-term recovery — but their cost has driven me to the gray market

https://www.statnews.com/2025/10/24/glp-1s-weight-loss-addiction-cost/

Advocacy groups form a buyer’s club to obtain generic versions of pricey Vertex cystic fibrosis drug ‘Patient power can change what billion-dollar corporations refuse to,’ one advocate said

https://www.statnews.com/pharmalot/2025/10/23/advocates-buyers-club-generic-vertex-cystic-fibrosis-drug/

At a gathering of biopharma executives, a moment of wonder — and also of worry Industry confronts an era of innovation in the shadow of concerns about public trust, pricing

https://www.statnews.com/2025/10/24/pharma-biotech-innovation-stat-summit/

How the first nine drug companies won priority review vouchers from Marty Makary’s FDA Some applied, others were surprised to win

https://www.statnews.com/2025/10/24/how-pharmaceutical-companies-won-fda-priority-review-vouchers/

Can ‘food noise’ be measured? Telehealth giant Ro rolls out a new scale for obesity care The goal is to assess which treatments quiet incessant thoughts, though some experts are skeptical

https://www.statnews.com/2025/10/24/ro-telehealth-unveils-new-food-noise-scale/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8Ff7eGX8YNJjIvVGzBqARLzEXZuJXj_QOibcod-WxRnZz9h_GDfvd4dqFVor2xZK7LyVpslJnOLt_BzbgZZBPDoHXjXA&_hsmi=386652518&utm_content=386652518&utm_source=hs_email

ACA Premium Payments Would More than Double on Average If Enhanced Tax Credits Expire

ACA Premium Payments Would More than Double on Average If Enhanced Tax Credits Expire How much more could people who buy their insurance from the ACA Marketplaces pay if the enhanced premium tax credits expire at the end of the year? KFF’s Cynthia Cox walks through three real-life examples of how the expiration of the enhanced premium tax credits would affect a family of four, a young working person, and a couple near retirement age. https://www.youtube.com/shorts/Czn5QuvmISo

The Semi-Sad Prospects for Controlling Employer Health Care Costs Author: Drew Altman Published: Oct 22, 2025

https://www.kff.org/from-drew-altman/the-semi-sad-prospects-for-controlling-employer-health-care-costs/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-_DqLVD2eZfG88YtHKW7rIAwq04m7Cl6d0Qci9zUp6KvE8TIB3es_uCkpCK7wpqq1OUgyZ8hyy_pTZ5R_0wYCyU9qGDPw&_hsmi=386723832&utm_content=386723832&utm_source=hs_email In a commentary on KFF's 27th Employer Health Benefits Survey, President and CEO Dr. Drew Altman discusses the obstacles employers face trying to control their health care costs, and the reasons why they’ve never been meaningful supporters of government cost-containment efforts. He predicts that premium increases expected next year could lead to a new wave of higher deductibles and other forms of cost sharing for the 155 million Americans who rely on employer coverage.

KFF Health Tracking Poll: Public Use and Trust in Health Care Apps and Websites Authors: Grace Sparks, Julian Montalvo III, Alex Montero, Mardet Mulugeta, Ashley Kirzinger, Lunna Lopes, and Liz Hamel Published: Oct 24, 2025

https://www.kff.org/public-opinion/kff-health-tracking-poll-public-use-and-trust-in-health-care-apps-and-websites/

Viewpoints: Unaffordable GLP-1s Push Patients Into A Risky Gray Market; TrumpRx Is Pricey Political Theater

https://kffhealthnews.org/morning-breakout/viewpoints-unaffordable-glp-1s-push-patients-into-a-risky-gray-market-trumprx-is-pricey-political-theater/

Longer Looks: Interesting Reads You Might Have Missed

https://kffhealthnews.org/morning-breakout/longer-looks-interesting-reads-you-might-have-missed-238/

Furloughed CMS Employees To Return Temporarily For Open Enrollment

https://kffhealthnews.org/morning-breakout/furloughed-cms-employees-to-return-temporarily-for-open-enrollment/ Employees have been furloughed since the government shut down three weeks ago. Meanwhile, federal workers have begun missing paychecks, and Democrats blocked a bill that would have allowed some workers to be paid.

Federal Judge Overturns Protections For Transgender Health Care

https://kffhealthnews.org/morning-breakout/federal-judge-overturns-protections-for-transgender-health-care/ The Biden-era rule, which barred discrimination against sexual orientation and gender identity in certain health programs and activities, was struck down Wednesday by Judge Louis Guirola Jr. of the U.S. District Court for the Southern District of Mississippi.

Howard University Hospital In D.C. Could Be Teetering On Edge Of Closure

https://kffhealthnews.org/morning-breakout/howard-university-hospital-in-d-c-could-be-teetering-on-edge-of-closure The hospital is a lifeline for patients who are heavily reliant on Medicare and Medicaid, The Wall Street Journal reported. But after major cuts in federal funding, “This is a very vulnerable hospital,” said Dr. Andrea Hayes Dixon, senior VP of health affairs at Howard University College of Medicine.

Launch Prices For Some Medications Outpace Inflation, Review Finds

https://kffhealthnews.org/morning-breakout/launch-prices-for-some-medications-outpace-inflation-review-finds/ The cost when new drugs hit the market are up 51% after discounts, Stat reports. Other pharmaceuticals in the news include generic Trikafta, Enbrel, Blenrep, and more.

NYC Wipes Out $135M In Medical Debt, Easing Burden For 75,000 Residents

https://kffhealthnews.org/morning-breakout/nyc-wipes-out-135m-in-medical-debt-easing-burden-for-75000-residents/ Residents who qualify for this one-time debt relief program will be notified by Undue Medical Debt. Separately, Maryland Gov. Wes Moore decries FEMA's decision to withhold disaster aid.

A Miracle’: Girl, 12, Who Was Gravely Hurt In Minn. Shooting Leaves Hospital

https://kffhealthnews.org/morning-breakout/a-miracle-girl-12-who-was-gravely-hurt-in-minn-shooting-leaves-hospital/ Sophia Forchas, who was shot in the head, was the most seriously wounded child among those who survived the Aug. 27 attack at the Church of the Annunciation in Minneapolis, AP reported. Surgeons removed the left half of her skull. On Thursday, she was greeted with cheers after being taken around town in a limousine.

Listen: Amid Shutdown Stalemate, Families Brace for SNAP Cuts and Paycheck Limbo By Julie Rovner October 24, 2025

https://kffhealthnews.org/news/article/wamu-health-hub-shutdown-stalemate-snap-benefits-paychecks-october-22-2025/

GOP Talking Point Holds ACA Is Haunted by ‘Phantom’ Enrollees, but the Devil’s in the Data By Victoria Knight October 24, 2025

https://kffhealthnews.org/news/article/aca-marketplace-subsidies-tax-credits-insurance-federal-government-shutdown-fraud/

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments October 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-selecting-developing-or-modifying-fit-purpose-clinical-outcome?utm_medium=email&utm_source=govdelivery FDA Issues Final Guidance on Patient-Focused Drug Development The U.S. Food and Drug Administration issued a final guidance “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders.” This guidance (Guidance 3) is the third in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. The purpose of this guidance is to help sponsors identify or develop fit-for-purpose Clinical Outcome Assessment measures of patients’ health that are appropriate for use in a medical product development program.

jueves, 23 de octubre de 2025

Explaining Individual Coverage Health Reimbursement Arrangements (ICHRAs) Published: Oct 22, 2025

https://www.kff.org/private-insurance/explaining-individual-coverage-health-reimbursement-arrangements-ichras/ This policy explainer describes what Individual Coverage Health Reimbursement Arrangements (ICHRAs) are and how do they differ from typical employer-sponsored health care plans.

Annual Family Premiums for Employer Coverage Rise 6% in 2025, Nearing $27,000, with Workers Paying $6,850 Toward Premiums Out of Their Paychecks More of the Largest Firms Cover GLP-1s for Weight Loss, and Use Is Higher Than Expected; Some May Be Limiting Coverage Published: Oct 22, 2025

https://www.kff.org/affordable-care-act/annual-family-premiums-for-employer-coverage-rise-6-in-2025-nearing-27000-with-workers-paying-6850-toward-premiums-out-of-their-paychecks/

The Semi-Sad Prospects for Controlling Employer Health Care Costs Author: Drew Altman Published: Oct 22, 2025

https://www.kff.org/from-drew-altman/the-semi-sad-prospects-for-controlling-employer-health-care-costs/ In a commentary on KFF’s 27th employer health benefits survey, President and CEO Dr. Drew Altman discusses the obstacles employers face trying to control their health care costs, and the reasons why they’ve never been meaningful supporters of government cost-containment efforts. He predicts that premium increases expected next year could lead to a new wave of higher deductibles and other forms of cost sharing for the 155 million Americans who rely on employer coverage. Read the column here.

Perspectives from Employers on the Costs and Issues Associated with Covering GLP-1 Agonists for Weight Loss Published: Oct 22, 2025

https://www.kff.org/health-costs/perspectives-from-employers-on-the-costs-and-issues-associated-with-covering-glp-1-agonists-for-weight-loss/ While more large employers are covering GLP-1 drugs for weight loss, KFF's conversations with employers highlight concerns about the cost of these medications. Many of these employers have considered scaling back coverage of GLP-1 agonists for weight loss, or in some cases, employers are adding or strengthening coverage requirements.

KFF/The Washington Post Survey of Parents: Exposure to and Trust in Children’s Health-Related Information Online

These findings from a KFF/Washington Post survey reveal how parents encounter information related to children's health on social media, including trust in content they see online and whether they have specific, trusted influencers when it comes to information about children's health. https://www.kff.org/public-opinion/kff-the-washington-post-survey-of-parents-exposure-to-and-trust-in-childrens-health-related-information-online/

KFF/Washington Post Poll Looks at Parents’ Trust in Children’s Health Content on Social Media, And Unfounded Claims About Abortion Pill Safety Follow FDA Approval of Generic Version Irving Washington , Hagere Yilma , and Joel Luther

https://www.kff.org/health-information-trust/parents-trust-in-childrens-health-content-on-social-media-and-unfounded-claims-about-abortion-pill-safety/ This volume shares findings from the KFF/The Washington Post Survey of Parents about exposure to and trust in children’s health content on social media, along with misleading claims following the approval of a generic version of mifepristone, reports of autism possibly being added to the Vaccine Injury Compensation Program, and patients using AI chatbots to interpret lab results.

2025 Employer Health Benefits Survey Published: Oct 22, 2025

https://www.kff.org/health-costs/2025-employer-health-benefits-survey/

Viewpoints: There Are Pitfalls To Pharma-Funded Research; Is American Health Care On The Verge Of Collapse?

https://kffhealthnews.org/morning-breakout/viewpoints-there-are-pitfalls-to-pharma-funded-research-is-american-health-care-on-the-verge-of-collapse/

Research Roundup: The Latest Science, Discoveries, And Breakthroughs

https://kffhealthnews.org/morning-breakout/research-roundup-the-latest-science-discoveries-and-breakthroughs-43/

Study: Gum Disease Might Be Linked To Poor Heart And Brain Health

https://kffhealthnews.org/morning-breakout/study-gum-disease-might-be-linked-to-poor-heart-and-brain-health/ In two studies released Wednesday, both published in Neurology Open Access, researchers found associations between gum disease and damage to the brain's white matter, as well as inflammation that can lead to atherosclerosis. Add cavities to the mix, and the risk of stroke increases by 86%.

WVa Medical Cannabis Program Has Raked In $34 Million But Has Spent $0

https://kffhealthnews.org/morning-breakout/wva-medical-cannabis-program-has-raked-in-34-million-but-has-spent-0/ West Virginia officials say the money will remain unspent until federal law, which classifies cannabis as an illegal drug, changes. Other news from around the nation comes out of North Carolina, Maryland, and California. Also: the fight to influence paid family leave policy.

FDA Redacts Names Of Drugs From Reports On Contaminated Factories

https://kffhealthnews.org/morning-breakout/fda-redacts-names-of-drugs-from-reports-on-contaminated-factories/ ProPublica reports that, according to the FDA, releasing the names of the drugs in inspection reports on foreign facilities would violate federal law protecting confidential commercial information. Experts worry that removing this data renders the reports useless for keeping Americans safe.

Bird Flu Infections Surging In Poultry And Cattle; Measles Outbreaks Swelling

https://kffhealthnews.org/morning-breakout/bird-flu-infections-surging-in-poultry-and-cattle-measles-outbreaks-swelling/ With no clear picture of the scope of the U.S. bird flu surge — federal agencies have stopped communicating during the shutdown — state health officials are left to fend for themselves to cope with outbreaks. Meanwhile, Utah, Arizona, and South Carolina are measles hot spots.

OB-GYN Group Urges Members To Support Contraception, Fight Misinfo

https://kffhealthnews.org/morning-breakout/ob-gyn-group-urges-members-to-support-contraception-fight-misinfo/ An official at the American College of Obstetricians and Gynecologists has stressed the importance of helping "patients get access to the evidence-based care they need and deserve." Also: Nurses are going on strike at Tenet Health hospitals in California; a look at the maternity care deserts in Minnesota; and more.

Deportees Recount Horrors Of Hours Spent In ICE’s Full-Body Restraints

https://kffhealthnews.org/morning-breakout/deportees-recount-horrors-of-hours-spent-in-ices-full-body-restraints/ The use of the WRAP — also called “the burrito” or “the bag” — has been criticized as inhumane by deportees and their advocates. Federal lawsuits liken incorrect usage of the device to punishment and even torture, AP reports. Plus, pregnant people decry the care they receive at detention facilities.

Trump Might Replace ACA, Oz Says; 25 States Will Halt SNAP Amid Shutdown

https://kffhealthnews.org/morning-breakout/trump-might-replace-aca-oz-says-25-states-will-halt-snap-amid-shutdown/ CMS Administrator Mehmet Oz told NBC News’ “Meet the Press” on Wednesday that President Donald Trump "has a plan" to redo Obamacare, which is at the heart of the federal shutdown. Oz didn't offer specifics but said, "There’s all kinds of ideas.” Meanwhile, dozens of states say they don't have enough funding to run the Supplemental Nutrition Assistance Program after Nov. 1.

When a Hearing Aid Isn’t Enough By Paula Span October 23, 2025

https://kffhealthnews.org/news/article/hearing-aids-cochlear-implants-medicaid-eligibility-cnc-azbio-surgery/

Officials Show Little Proof That New Tech Will Help Medicaid Enrollees Meet Work Rules By Rae Ellen Bichell and Sam Whitehead October 23, 2025

https://kffhealthnews.org/news/article/medicaid-eligibility-tool-pilot-test-work-requirements-ai-louisiana-arizona-georgia/

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments October 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-selecting-developing-or-modifying-fit-purpose-clinical-outcome

Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers October 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers-0

miércoles, 22 de octubre de 2025

Viewpoints: FDA’s Approval Of Generic Mifepristone Causes Confusion; ERs Can’t Handle Medicaid, ACA Cuts

https://kffhealthnews.org/morning-breakout/viewpoints-fdas-approval-of-generic-mifepristone-causes-confusion-ers-cant-handle-medicaid-aca-cuts/

Gilead To Keep States’ HIV Drug Prices Steady After Earlier Saying They’d Rise +++

https://kffhealthnews.org/morning-breakout/gilead-to-keep-states-hiv-drug-prices-steady-after-earlier-saying-theyd-rise/ The agreement provides relief to federally funded programs that provide free or low-cost drugs to around 110,000 low-income people nationwide. Other news is on the side effects of antidepressants; the cause of auditory hallucinations in schizophrenia; ivermectin as a cancer treatment; and more. Private Equity Firms Blackstone, TPG To Buy Hologic For $13 Billion https://kffhealthnews.org/morning-breakout/private-equity-firms-blackstone-tpg-to-buy-hologic-for-13-billion/ Hologic — which makes mammography systems, breast imaging technology, and biopsy equipment — will go private in the deal. Other health industry news is on home infusion, death rates at U.S. dialysis centers, the shuttering of obstetric services at an Ohio hospital, and more. Hundreds Of Disability Advocates Urge NC Legislature To Repeal Medicaid Cuts https://kffhealthnews.org/morning-breakout/hundreds-of-disability-advocates-urge-nc-legislature-to-repeal-medicaid-cuts/ The state's Department of Health and Human Services slashed reimbursement for Medicaid-covered services on Oct. 1, North Carolina Health News reported. Other health news is from Mississippi, Minnesota, New Jersey, California, and Montana. Plus: A nationwide shrimp recall widens.

Amid Shutdown, Health Care Lobbyists Tiptoe Around Topics To Pursue Wins

https://kffhealthnews.org/morning-breakout/amid-shutdown-health-care-lobbyists-tiptoe-around-topics-to-pursue-wins/ Health care advocates tread a delicate line when it comes to discussions about politically charged ACA subsidies, but they see opportunities to sway lawmakers on bipartisan issues such as telehealth. Meanwhile, moderate Republicans lean on House leadership to address expiring ACA subsidies.

ICE Detainees Claim They’re Served Low-Quality Meals, Are Left Hungry

https://kffhealthnews.org/morning-breakout/ice-detainees-claim-theyre-served-low-quality-meals-are-left-hungry/ USA Today reports on food quality at a Louisiana ICE hub, where detainees say they are subject to a diet of processed foods that are often expired and never fully sate their hunger. A Guardian report highlights ICE detention conditions of perpetual twilight under fluorescent lights.

White House Warns Of Repercussions For Using Artificial Food Dyes

https://kffhealthnews.org/morning-breakout/white-house-warns-of-repercussions-for-using-artificial-food-dyes/ At a health industry conference on Tuesday, White House adviser Calley Means announced that regulations might be imposed on food companies that don't switch away from synthetics. Also: The soda industry pits MAGA against MAHA; experts weigh in on the seed oil scandal; and more.

Despite the Hoopla, Vaccines Should Be in Reach This Cough-and-Cold Season By Michelle Andrews October 22, 2025

https://kffhealthnews.org/news/article/fall-vaccine-guide-explainer-schedule-covid-flu-rsv/

A New Car vs. Health Insurance? Average Family Job-Based Coverage Hits $27K By Phil Galewitz October 22, 2025

https://kffhealthnews.org/news/article/workplace-health-insurance-premiums-family-plans-kff-survey/

The U.S. experiment with profit-driven health care has failed The corporate takeover of health care has destroyed America’s health

https://www.statnews.com/2025/10/21/health-care-system-profit-failed/

Corporate support cannot make up for threats to the NIH budget Pharmaceutical money comes with strings

https://www.statnews.com/2025/10/22/nih-budget-cuts-pharmaceutical-industry-research/

European oncology experts roll out guidance for use of large language models in clinical care Leading professional organization stresses both opportunities and risks

https://www.statnews.com/2025/10/22/new-esmo-guidance-ai-use-in-oncology/

The cost of health insurance for a family jumps to $27,000 Prescription drugs and chronic diseases are contributing to the higher price

https://www.statnews.com/2025/10/22/health-insurance-premiums-up-6-percent-kff-reports/

Would you contract dysentery for $7,300? A conversation about paying healthy medical research volunteers what they’re worth

https://www.statnews.com/2025/10/22/healthy-medical-research-study-pay/

CVS Caremark tells AIDS activists Gilead needs to lower the price of its new HIV drug to get on formularies Email obtained by STAT sheds unusually direct light on the perspectives of country’s largest PBM

https://www.statnews.com/pharmalot/2025/10/22/cvs-caremark-pbm-aids-price-hiv-formularies/

Companies tout a novel payment model for obesity drugs, other medications in drive to lower costs The approach, which allows employers to subsidize costs outside insurance, draws skeptics too

https://www.statnews.com/2025/10/22/startups-mix-lower-insurance-premiums-with-subsidized-cash-drug-purchases/

NEJM and public health group are launching rival to CDC’s MMWR publication After 73 years, many public health experts are losing trust in the ‘voice of the CDC’

https://www.statnews.com/2025/10/21/cdc-mmwr-alternative-new-report-announced-by-nejm-cidrap/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8TzOAGu3H47HuLElCIODEt3SIuxCnvDwRAq-Y9H7ZiRRNz32d-5N3LpCETphrxFO0viuMHnmrEaiwvetJ80kG12WYAbg&_hsmi=386279086&utm_content=386279086&utm_source=hs_email

Individualized Therapies on the RISE November 20, 2025 — 9:30AM–5:00PM

https://healthpolicy.duke.edu/events/individualized-therapies-rise?utm_medium=email&utm_source=govdelivery Registration is now open to attend the FDA Rare Disease Innovation Hub’s November 20th Rare Disease Innovation, Science, and Exploration (RISE) Workshop on individualized therapies. Register here. This public workshop will examine the emerging science and regulatory environment for individualized medicine programs, including nonclinical data recommendations, clinical assessments, regulatory submission structure, and additional information necessary to support the development, evaluation, and potential commercialization of these treatments. The workshop will also provide opportunities for members of the rare disease community, including researchers, sponsors, patients, patient advocates, and regulators, to share their experiences with individualized medicine approaches. The goal of this workshop is to enhance understanding of regulatory considerations for individualized treatments and to inform future policy around individualized treatments.

Bring Out Your Meds! Bring Out Your Meds! October 22, 2025 By Larry K. Houck —

https://www.thefdalawblog.com/2025/10/bring-out-your-meds-bring-out-your-meds-3/?utm_source=rss&utm_medium=rss&utm_campaign=bring-out-your-meds-bring-out-your-meds-3

Quality and Regulatory Predictability: Shaping USP Standards December 11, 2025

https://www.fda.gov/drugs/news-events-human-drugs/quality-and-regulatory-predictability-shaping-usp-standards-12112025?utm_medium=email&utm_source=govdelivery By hosting this workshop, the Association for Accessible Medicines (AAM), FDA, and United States Pharmacopeia (USP) aim to increase stakeholder awareness of, and participation in, the USP standards development process, ultimately contributing to product quality and regulatory predictability throughout the drug development, approval, and product lifecycle. Public quality standards are universally recognized as essential tools that support the design, manufacture, testing, and regulation of drug substances and products. USP standards play a critical role in helping ensure the quality and safety of medicines marketed in the United States and worldwide. This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs. Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate—via public comment—in the development of future standards.

FDA Provides Update to Health Care Professionals About Risk of Inadvertent Intrathecal (Spinal) Administration of Tranexamic Acid Injection

https://www.fda.gov/drugs/drug-safety-and-availability/fda-provides-update-health-care-professionals-about-risk-inadvertent-intrathecal-spinal?utm_medium=email&utm_source=govdelivery FDA Provides Update to Health Care Professionals About Risk of Inadvertent Intrathecal (Spinal) Administration of Tranexamic Acid Injection FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are not to be administered intrathecally (into the spine) or as an epidural injection. FDA is taking this action after having identified and evaluated medication error cases of inadvertent neuraxial (intrathecal or epidural) administration of tranexamic acid. In these cases, tranexamic acid was erroneously administered neuraxially instead of the intended local anesthetic (e.g., bupivacaine, lidocaine, mepivacaine, and ropivacaine), which resulted in serious patient outcomes, including prolonged hospitalization and death. Medical practice-level and facility-level human factors (e.g., storing tranexamic acid injection close to local anesthetics and failing to verify the product before administration) contributed to the medication errors. Tranexamic acid injection is indicated for short-term use (2 to 8 days) in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Health care professionals should only administer tranexamic acid injection by the intravenous route. Tranexamic acid injection is supplied in single-dose ampules and single-dose vials containing 1,000 mg tranexamic acid in 10 mL and is marketed both under the proprietary name, Cyklokapron, and as a generic drug. Tranexamic acid is also supplied in sodium chloride injection in single-dose bags containing 1,000 mg of tranexamic acid in 100 mL solution for intravenous use. FDA is requiring the following changes to the prescribing information for tranexamic acid injection: Add a Boxed Warning to communicate the risk of medication errors involving inadvertent neuraxial administration of tranexamic acid injection Add a statement to indicate that tranexamic acid injection is contraindicated as a neuraxial injection Update the Dosage and Administration section to clarify that tranexamic acid injection is only to be administered intravenously and to provide instructions for preparing and administering the diluted solution Additionally, FDA is recommending that the container labels for tranexamic acid injection prominently display the product name and intravenous route of administration.

Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program

https://www.fda.gov/drugs/pharmaceutical-quality-resources/chemistry-manufacturing-and-controls-development-and-readiness-pilot-cdrp-program?utm_medium=email&utm_source=govdelivery FDA accepting requests to participate in CMC Development and Readiness Program FDA is now accepting requests from drug sponsors to participate in the fourth year of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. This pilot program, described in the FDA Prescription Drug User Fee Act (PDUFA) VII Commitment Letter for fiscal years (FYs) 2023 through 2027, facilitates CMC readiness for selected Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research-regulated products with accelerated clinical development timelines. For drug and biological product sponsors participating in the pilot, FDA will provide product-specific CMC advice during product development, including two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions, based on CMC readiness and defined milestones. The increased communication between FDA review staff and drug sponsors is intended to ensure a mutual understanding of approaches to completing CMC activities to ensure CMC readiness for a marketing application. https://www.federalregister.gov/documents/2025/08/28/2025-16513/chemistry-manufacturing-and-controls-development-and-readiness-pilot-program-program-announcement?utm_medium=email&utm_source=govdelivery

martes, 21 de octubre de 2025

Study: Polio vaccination efforts must not wane

https://www.news-medical.net/news/20251021/Study-Polio-vaccination-efforts-must-not-wane.aspx

Decline in vitamin D levels observed during the Covid-19 pandemic

https://www.news-medical.net/news/20251021/Decline-in-vitamin-D-levels-observed-during-the-Covid-19-pandemic.aspx

Editorial Resilience at the core: transforming primary health care in Latin America and the Caribbean The Lancet Regional Health – Americas + +... +++

The cost of inaction to strengthen the resilience of primary health care in Latin America and the Caribbean: a modelling study https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(25)00258-3/fulltext?dgcid=hubspot_update_feature_updatealerts_lanam&utm_campaign=update-lanam&utm_medium=email&_hsenc=p2ANqtz--UvGjPwt0zfP78jEO3-psEaO-ifaD2q944x7UcTN2VelgNvj-J97dTQ4c33-RYKODwR99T8PUWW-pkJl1pUAkWkPyIGQ&_hsmi=385887207&utm_content=385656380&utm_source=hs_email Editorial Resilience at the core: transforming primary health care in Latin America and the Caribbean The Lancet Regional Health – Americas https://www.thelancet.com/journals/lanam/issue/vol50nonull/PIIS2667-193X(25)X0009-0 Gender, equity, and resilient primary health care in Latin America and the Caribbean: aligned and synergistic goals https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(25)00270-4/fulltext?dgcid=hubspot_update_feature_updatealerts_lanam&utm_campaign=update-lanam&utm_medium=email&_hsenc=p2ANqtz-_D1O4F4jkXPEkaghic41NnWurX7iKSDn2j0od6SX4OOBaQV1B0Vu_rob5l33MpHOCpXA_2bWVURfEFbmzJRDkO8nnBkQ&_hsmi=385887207&utm_content=385656380&utm_source=hs_email No time to wait: resilience as a cornerstone for primary health care across Latin America and the Caribbean, a World Bank-PAHO Lancet Regional Health Americas Commission https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(25)00250-9/fulltext?dgcid=hubspot_update_feature_updatealerts_lanam&utm_campaign=update-lanam&utm_medium=email&_hsenc=p2ANqtz-8NMYe6BVmohQEOWcZaYmDw7_IoJQsFahzQ-YRn6pSWQZLmTLSBThb_XIvpTQLim5d2fMhBxq0v3Oqo08qMRNQedbT_JA&_hsmi=385887207&utm_content=385656380&utm_source=hs_email The Lancet Regional Health Americas in conversation with Ernesto Bascolo, Marcia Castro and Cristian Herrera on their Resilience in Primary Health Care Commission October 10, 2025 • The Lancet Group https://thelancetamericas.buzzsprout.com/2517409/episodes/17962368-ernesto-bascolo-marcia-castro-and-cristian-herrera-on-their-resilience-in-primary-health-care-commission?utm_campaign=update-lanam&utm_medium=email&_hsenc=p2ANqtz-8nWzVlU1nVsryxUTAQu17AvQDADcohp8B9gzPmCfl5po-2AYyoweFyxFR5qh-v8dXgVwvYUr1uRua4eecRX5MhApmhqw&_hsmi=385887207&utm_content=385656380&utm_source=hs_email