Fifth Circuit Invalidates Two More Provisions Of No Surprises Act Rule Katie KeithandEllie DeGarmo September 1, 2026

https://www.healthaffairs.org/content/forefront/fifth-circuit-invalidates-two-more-provisions-no-surprises-act-rule The Trump administration might use the court’s decision to justify additional regulatory changes to the QPA methodology. Another question is whether the decision will prompt Congress to revisit the NSA, especially as its costs rise.

Analyzing The Federal Trade Commission’s Pharmacy Benefit Manager Settlements Michael A. CarrierandRachel Sachs September 2, 2026

https://www.healthaffairs.org/content/forefront/analyzing-federal-trade-commission-s-pharmacy-benefit-manager-settlements Despite the FTC’s promises, its settlements with PBMs will not be fully effective at accomplishing their stated goals. One concern of note: The settlements neglect the recent development of PBMs marketing their own drugs.

Dental Insurance Has The Wrong Maximum Habib Benzian September 1, 2026

https://www.healthaffairs.org/content/forefront/dental-insurance-has-wrong-maximum CMS should let states insure adult dental care differently.

New SAMHSA Requirements Threaten Opioid Use Disorder Treatment And Overdose Prevention Maureen Stewart,Alisa B. Busch,Sage R. Feltus,Sharon Reif,Traci C. Green,andRichard G. Frank September 1, 2026

https://www.healthaffairs.org/content/forefront/undermining-recovery-new-samhsa-requirements-threaten-opioid-use-disorder-treatment-and The health care system must engage people in treatment, provide them with care that is likely to set them on a path to recovery, and ensure that they have continued support. New federal agency requirements threaten those efforts.

Designing Bilateral Medicare-Medicaid Risk Contracts In The New ACO LEAD Model Eric T. Roberts,Kenton J. Johnston,Karen E. Joynt Maddox,Rachel M. Werner,Allison M. Nishi,andJosé F. Figueroa September 2, 2026

https://www.healthaffairs.org/content/forefront/designing-bilateral-medicare-medicaid-risk-contracts-new-aco-lead-model CMS and state Medicaid agencies should consider several factors related to the ACO LEAD (ACO Long-Term Enhanced Design) model’s proposed test of integrated Medicare-Medicaid ACOs.

340B Could Inflate Spending In The CMS Bridge Program By More Than A Billion Dollars Stacie B. Dusetzina,Sayeh Nikpay,andBrian Reid August 27, 2026

https://www.healthaffairs.org/content/forefront/340b-could-inflate-spending-cms-bridge-program-more-than-billion-dollars The existence of duplicative discounts in the Bridge Program likely represents an unintended consequence of its design that could inflate the price tag of the coverage expansion without any corresponding benefit.

AI Can Lower Costs, But Only If Properly Applied Ken Terry August 27, 2026

https://www.healthaffairs.org/content/forefront/ai-can-lower-costs-but-only-if-properly-applied A response to “Why AI Will Accelerate Health Care Inflation” and “Health Care Inflation Means Quality-Adjusted Price Growth, And Artificial Intelligence Can Reduce It.”

From Children To Adults: The Government’s Expanding Attack On Gender-Affirming Care Richard Hughes IV,Eric J. Neiman,Jennifer M. Nelson Carney,andJulia Rioux Thayer September 3, 2026

https://www.healthaffairs.org/content/forefront/children-adults-government-s-expanding-attack-gender-affirming-care The distinction between prohibiting gender-affirming care for minors and restricting gender-affirming care for adults is no longer holding.

Public Charge Restrictions For Immigrants And Their Families: No Rules, No Accountability Leighton Ku September 3, 2026

https://www.healthaffairs.org/content/forefront/public-charge-restrictions-immigrants-and-their-families-no-rules-no-accountability The final “public charge” rule broadens the range of benefits used in determining public charge status, allows officials to consider benefits used by family members, and eliminates regulatory guardrails regarding the public charge determination and appeal rights.

The National Hepatitis C Plan Needs A Correctional-Care Standard Y. Tony Yang September 4, 2026

https://www.healthaffairs.org/content/forefront/national-hepatitis-c-plan-needs-correctional-care-standard Access to medication is not the same as delivery of a cure. Without defined delivery obligations, federal funds risk financing treatment courses rather than completed cures.

Subscription Drug Pricing: The Evidence Behind It Comes From Two States, And They Disagree. Zizi ElsisiandAnirban Basu September 4, 2026

https://www.healthaffairs.org/content/forefront/subscription-drug-pricing-evidence-behind-comes-two-states-and-they-disagree If CMS is to write a template for other states, or if Congress is to buy this design at national scale, it is important to understand why these policies may fail to deliver expected outcomes.

Health Services Professionals Endorse Omitting Some Research Information Under Limited Circumstances: Survey Authors: Alan S. Gerber, Mackenzie Lockhart, Eric M. Patashnik, and Harold A. Pollack

https://www.healthaffairs.org/doi/10.1377/hlthaff.2025.01440 In an era of polarization, misinformation, and declining public trust in experts, effective public communication about health research is essential for disseminating evidence and maintaining the credibility of the research enterprise. Yet when communicating research findings to general audiences, experts face dilemmas about whether to omit information to avoid public confusion, to prevent the stigmatization of marginalized constituencies, or to keep information from being weaponized against vulnerable groups. Drawing on a national survey of health services professionals conducted in April and May 2025, we found that respondents generally rejected omissions serving self-protective or politically strategic ends but accepted omissions aimed at preventing public confusion or harm to marginalized groups. There is meaningful variation in support for these justifications by ideology, education, and workplace. In weighted regressions, conservatives, PhD holders, and those working outside academia in government or other nonuniversity settings were less likely to endorse omissions as justified compared with liberals and moderates, non-PhDs, and university-based researchers. These findings reveal both common ground and meaningful division in how professionals view transparency, underscoring the need for research on actual communication behavior and guidance to help experts navigate these dilemmas.

UC Riverside receives grant to evaluate California’s traditional health care practices benefit

https://www.news-medical.net/news/20260904/UC-Riverside-receives-grant-to-evaluate-Californiae28099s-traditional-health-care-practices-benefit.aspx A $1.25 million grant to UC Riverside from the California Department of Health Care Services (DHCS) will support a statewide evaluation of California's traditional health care practices (THCP) benefit.

Business of Medicine News (+...)

Business of Medicine News Pharmacies Call for Tougher Response to Increasing Crime An NPA survey found most pharmacies faced shoplifting, break-ins, or abuse last year, and almost a third did not report incidents to police. Medscape News UK, September 04, 2026 https://www.medscape.com/index/list_13469_0

Parkinson’s disease imposes €22.8 billion economic burden across Europe

https://www.news-medical.net/news/20260827/Parkinsone28099s-disease-imposes-e282ac228-billion-economic-burden-across-Europe.aspx?utm_source=news_medical_newsletter&utm_medium=email&utm_campaign=parkinson_s_disease_newsletter_2_september_2026 The annual societal cost of Parkinson's disease across Europe reached €22.8 billion in 2019, equivalent to €28.8 billion at 2025 prices, a new study published today in Movement Disorders has shown. As the number of people living with Parkinson's disease continues to grow, researchers warn that health and social care systems are likely to face increasing pressure.

ART-conceived children show reassuring long-term health outcomes

https://www.news-medical.net/news/20260904/ART-conceived-children-show-reassuring-long-term-health-outcomes.aspx The birth of Louise Brown in 1978, the world's first baby conceived through assisted reproductive technology (ART), was a major breakthrough that reshaped the field of reproductive medicine. Today, over 10 million children worldwide have been born through ART procedures, and experts estimate that around one in every 12 babies in Europe and one in every 20 in the USA are conceived artificially. As these numbers continue to rise, so does our responsibility to understand the impact on the long-term health of children born using these techniques.

How Plant Biosensors, IoT, and AI Are Advancing Precision Agriculture

https://www.news-medical.net/life-sciences/How-Plant-Biosensors-IoT-and-AI-Are-Advancing-Precision-Agriculture.aspx Plant-wearable biosensors, IoT connectivity, and AI are shifting precision agriculture from reactive crop management to continuous, data-driven decision-making. Despite challenges related to sensor reliability, interoperability, and large-scale deployment, these technologies are laying the foundation for smarter irrigation, earlier disease detection, and more sustainable farming. Against the backdrop of ever-increasing climate instability and recent reports that predict a 70% global food demand increase by 2050, reviews assessing the state of modern agriculture emphasize that the most pressing need in the field is the development of transformative crop monitoring systems capable of detecting physiological stress before visible symptoms occur, thereby supporting earlier and more targeted interventions.

FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative?utm_medium=email&utm_source=govdelivery On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.

FDA Grants Accelerated Approval to a New Breast Cancer Treatment

https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them. FDA granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, based on an FDA-authorized test. ESR1 mutations are acquired resistance mutations that a tumor may develop during treatment with an aromatase inhibitor, a type of endocrine therapy that is a common front-line treatment for locally advanced or metastatic breast cancer. At the diagnosis of HR-positive metastatic breast cancer, fewer than 5 percent of patients will have this tumor mutation. After disease progression on an aromatase inhibitor, nearly 40 percent of patients will have this tumor mutation. “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment. We owe them every weapon in our arsenal.” said Acting FDA Commissioner Kyle Diamantas, J.D. “Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.” The accelerated approval program allows for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on surrogate or intermediate endpoints. In this case, accelerated approval of Etcamah was granted based on how long patients lived without their disease worsening, measured from the point when the resistance mutation was first detected in the blood. Since it is not yet confirmed whether intervening at this point, rather than at the time of confirmed disease progression, translates into a clinically meaningful benefit, the FDA has required confirmatory studies to verify and describe clinical benefit. “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval,” said Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence. “This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing. But additional evidence is needed to confirm clinical benefit.” ctDNA is made up of tiny pieces of tumor DNA released into the blood, which can allow for earlier molecular detection of resistance mutations. To ensure precise patient matching, the FDA also authorized the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with camizestrant. Efficacy was evaluated in a clinical trial to assess switching to Etcamah, an oral tablet, in combination with a CDK4/6 inhibitor versus continuing an aromatase inhibitor in combination with a CDK4/6 inhibitor. Estimated median progression-free survival was 16 months in the Etcamah and CDK4/6 inhibitor arm and 9.2 months in the aromatase inhibitor and CDK4/6 inhibitor arm. The prescribing information includes a boxed warning for the risk of irregular heart rhythm when Etcamah is taken together with certain other medications, as well as warnings and precautions for an abnormally slow heart rate and potential harm to an unborn baby. Full prescribing information for Etcamah will be posted on Drugs@FDA.

Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates Guidance for Industry September 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policies-compounding-certain-starter-parenteral-nutrition-drug-products-neonates?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube. The FDA became aware of the potential supply gap after children’s hospitals raised concerns about continued access to neonatal starter parenteral nutrition. The concerns were based on the discontinuation of certain standardized neonatal starter PN products made by two outsourcing facilities that are permanently shutting down. “The FDA is committed to deploying every regulatory tool available to prevent critical supply chain gaps from threatening patient care,” said Acting FDA Commissioner Kyle Diamantas, J.D. “We are working closely with healthcare providers and industry partners to help ensure that vulnerable populations continue to have access to the care they need.” In response, the FDA assessed the situation and identified ways to help prevent a disruption in supply. As part of that effort, the agency is issuing an immediately-in-effect guidance, Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates, describing the agency’s temporary regulatory and enforcement priorities regarding certain compounded starter parenteral nutrition drug products. The guidance is intended to help address potential supply gaps and support hospitals in continuing to access critical nutrition drug products while longer-term solutions are identified. “Starter parenteral nutrition is especially important for premature and critically ill newborns who need nutrition soon after birth,” said Michael Davis, M.D., Ph.D., Acting Center Director of FDA’s Center for Drug Evaluation and Research. “These temporary policies are intended to help hospitals maintain access to this life-saving nutrition during this transition.” The guidance describes regulatory and enforcement priorities for certain state-licensed pharmacies, federal facilities and outsourcing facilities that compound specified parenteral drugs under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. The FDA will continue to monitor current and expected supply needs and assess if additional action is needed as the situation develops.

Editorial p867 Reimagining maternal cardiovascular health The Lancet (+...)

Editorial p867 Reimagining maternal cardiovascular health The Lancet https://www.thelancet.com/journals/lancet/issue/vol408no10558/PIIS0140-6736(26)X2033-5

Closing the preparedness gap: moving beyond emergency response to sustain the medical countermeasure ecosystem (+...)

https://www.thelancet.com/journals/lancet/onlinefirst

The 2025 small island developing states report of the Lancet Countdown on health and climate change: building resilience in the face of rising heat

The 2025 small island developing states report of the Lancet Countdown on health and climate change: building resilience in the face of rising heat Georgiana M Gordon-Strachan, PhDa Send email to georgiana.gordonstrachan@uwi.edu ∙ Stephanie Y Parker, MSca ∙ Heather C Harewood, MDc ∙ Kimalie F Parchment, BSca ∙ David C Smith, PhDb ∙ Pablo Mendez-Lazaro, PhDe,f ∙ et al. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00106-3/fulltext?dgcid=raven_jbs_etoc_feature_langlo

The impact of the women’s medical education ban in Afghanistan on service coverage and maternal and neonatal mortality: a modelling study

The impact of the women’s medical education ban in Afghanistan on service coverage and maternal and neonatal mortality: a modelling study Shatha Elnakib, PhDa,b Send email to selnaki1@jhu.edu ∙ Timothy Roberton, DrPHc,d ∙ Husnia Sadat, MPHd ∙ Supriya Madhavan, PhDd ∙ Hadia Samaha, MAf ∙ Mohammad Mahdi Frough, MAe ∙ et al. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00135-X/fulltext?dgcid=raven_jbs_etoc_feature_langlo

Small island developing states on the frontline The Lancet Global Health + +...

Small island developing states on the frontline The Lancet Global Health https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00253-6/fulltext?dgcid=raven_jbs_etoc_email Sep 2026 Volume 14Number 9 https://www.thelancet.com/journals/langlo/issue/vol14no9/PIIS2214-109X(26)X2007-1

Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products September 10, 2026

https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-modernizing-bioequivalence-approaches-topical-transdermal?utm_medium=email&utm_source=govdelivery Virtual Workshop Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products Thursday, September 10, 2026, 8:30 a.m. to 12:40 p.m. (EDT) Join via Adobe Connect: Advancing Generic Drug Development 2026: Modernizing Bioequivalence Approaches This virtual event is FREE! Are you developing a topical or transdermal generic drug product? Join this half-day virtual workshop to hear FDA experts discuss current regulatory recommendations, emerging bioequivalence approaches, and research that is helping streamline generic drug development and review. Attendees can ask questions and learn from case examples showing how GDUFA-funded research has informed guidance revisions and ANDA assessments. The workshop will also address characterization-based approaches, modeling and simulation, in vitro permeation testing (IVPT) method development, and recommendations for topical and transdermal delivery systems. https://events-na12.adobeconnect.com/content/connect/c1/1315899612/en/events/event/shared/5118822171/event_registration.html?_charset_=utf-8&sco-id=7126601038&utm_medium=email&utm_source=govdelivery Topics Current recommendations, implementation challenges, and alternative bioequivalence approaches for topical products. Case examples showing how GDUFA-funded research has informed guidance revisions, reduced submission deficiencies, and supported ANDA assessments. How empirical and in silico research supports product-specific guidances and characterization-based bioequivalence approaches, including robust IVPT method development. Recommendations and implementation strategies for topical and transdermal delivery systems, including how to determine when in vivo studies such as sensitization studies are appropriate Audience Scientists, researchers, current and prospective generic drug applicants, regulatory affairs professionals, and others who work on or have an interest in the development of topical and transdermal generic drug products.

Ionis wins FDA approval for first drug for Alexander disease, a rare and deadly neurological disorder Alexander disease is extraordinarily rare, so Ionis took an unusual approach to testing its drug

https://www.statnews.com/2026/09/03/ionis-fda-approval-zanvastro-alexander-disease/ By Jonathan WosenSept. 3, 2026 West Coast Biotech & Life Sciences Reporter

The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the fear remains The paperwork was never really the problem with clozapine

https://www.statnews.com/2026/09/04/clozapine-children-schizophrenia-neutrophil-fda-monitoring/ By Nitin GogtaySept. 4, 2026 Gogtay is a psychiatrist, physician-scientist, and author of “The Vanishing Children: A Psychiatrist’s Journey to Unravel the Mysteries of Childhood Psychosis.”

Recipients of gene-edited pig kidneys successfully receive human organs Pair of cases mark a milestone for eGenesis in effort to advance xenografts

https://www.statnews.com/2026/09/03/recipients-of-gene-edited-pig-kidneys-receive-human-organs/ By Eric BoodmanSept. 3, 2026 General Assignment Reporter

‘Tactical athletes’ get new guidance for cardiovascular fitness Military, emergency response, and public safety personnel face increased risk — and responsibility for others

https://www.statnews.com/2026/09/03/tactical-athlete-health-risks-new-cardiovascular-guidelines-police-firefighters/ By Elizabeth CooneySept. 3, 2026 Cardiovascular Disease Reporter

Make infectious disease data boring again The CDC’s fight with Pennsylvania over what counts as a measles death is high drama — and deeply disturbing

https://www.statnews.com/2026/09/04/pennsylvania-measles-deaths-data-cdc-director-rfk-jr/ By Debra Houry and Demetre DaskalakisSept. 4, 2026 Houry is the former CDC chief medical officer. Daskalakis is the former director of the CDC’s National Center for Immunization and Respiratory Diseases.

Lindsay Clancy case exposes dangers of fragmented U.S. health system, experts say Clancy’s defense attorney has blamed the clinicians who treated her for failing in their duties

https://www.statnews.com/2026/09/04/lindsay-clancy-health-care-silos-postpartum-care-failures/ By Tara BannowSept. 4, 2026 Hospitals and Insurance Reporter

Medscape State of the Medical Profession Index Report 2026: A Broken System? Tony Stasiek

https://www.medscape.com/p11/medscape-state-medical-profession-index-report-2026-broken-2026a1000tf8

Tending to Personal Finances: Medscape Hospitalist Wealth & Debt Report 2024 Jon McKenna | September 6, 2024 |

https://www.medscape.com/slideshow/2024-hospitalist-wealth-debt-6017589

Steady and Strategic: Medscape Hospitalist Wealth & Debt Report 2026 Tony Stasiek

https://www.medscape.com/p11/steady-and-strategic-medscape-hospitalist-wealth-debt-report-2026a1000tgd?src=

The Digital Health Revolution Has a People Problem Nelly Abulata, MD, PhD, MBA; Osama ES Elhassan, PhD

https://www.medscape.com/viewarticle/digital-health-revolution-has-people-problem-2026a1000wwv

5 Things Doctors Should Know About Medical AI Regulation Steph Weber September 04, 2026

https://www.medscape.com/viewarticle/5-things-doctors-should-know-about-medical-ai-regulation-2026a1000wxy

Offline: How to save WHO Richard Horton + +...

Offline: How to save WHO Richard Horton https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01805-2/fulltext?dgcid=raven_jbs_etoc_feature_lancet Sep 05, 2026 Volume 408Number 10558p867-968, e4-e9 https://www.thelancet.com/journals/lancet/issue/vol408no10558/PIIS0140-6736(26)X2033-5

Advancing Real-World Evidence Program

https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program?utm_medium=email&utm_source=govdelivery#:~:text=As%20announced%20in%20the%20Federal%2cnew%20indications%20of%20approved%20medical The deadline for the eighth submission cycle of the U.S. Food and Drug Administration’s Advancing Real-World Evidence (RWE) Program is September 30, 2026. Of note, FDA has also updated the frequently asked questions section of the Advancing RWE Program website.   For selected product sponsors, the Advancing RWE Program provides the opportunity to meet with FDA staff in CDER, CBER, and OCE, before protocol development or study initiation, to discuss the use of RWE in medical product development. The Advancing RWE Program is an optional pathway for sponsors submitting RWE proposals; established procedures to engage the agency will continue to be available. For more information on the program, visit the Advancing Real-World Evidence Program webpage. Advancing Real-World Evidence Program Frequently Asked Questions https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program-frequently-asked-questions?utm_medium=email&utm_source=govdelivery

HPM Presenting at IQVIA Annual Controlled Substances & State Regulatory Conference (Sept. 16-18) September 4, 2026

https://www.thefdalawblog.com/2026/09/hpm-presenting-at-iqvia-annual-controlled-substances-state-regulatory-conference-sept-16-18/?utm_source=rss&utm_medium=rss&utm_campaign=hpm-presenting-at-iqvia-annual-controlled-substances-state-regulatory-conference-sept-16-18 Hyman, Phelps & McNamara, P.C.’s Karla Palmer and Andrew Hull will be speaking again at IQVIA’s 28th Annual Controlled Substance & State Regulatory Conference in Scottsdale, AZ (Sept. 16-18). As part of a stacked agenda that runs the gamut on controlled substances issues, Ms. Palmer will speak on compliance considerations for compounders, and Mr. Hull will present on how registrants can mitigate risk and preserve reputation during a DEA investigation. Mr. Hull will also be presenting a course with retired DEA Chief Administrative Law Judge John J. Mulrooney, II, a partner at Belanger Rae & Mulrooney, on protecting your rights in DEA administrative actions.

Alcohol-linked cancer deaths doubled over three decades in America

https://www.news-medical.net/news/20260902/Alcohol-linked-cancer-deaths-doubled-over-three-decades-in-America.aspx Alcohol-attributable cancer deaths in the U.S. doubled between 1990 and 2023, a new study found. The study also revealed that alcohol-linked cancer deaths are not limited to older adults or liver cancer. Among adults ages 20 to 54, colorectal cancer was the leading alcohol-attributable cancer death in men, while breast cancer ranked first in women. The study also showed a growing burden from colorectal, esophageal, pancreatic and other cancers.

Immigrants face longer ICU stays after stroke in Canada

Among people who have a stroke in Canada, immigrants were admitted to the intensive care unit (ICU) at similar rates as long-term residents or people who were born in Canada, but they were more likely to have longer stays in the ICU, according to a study published September 2, 2026, in Neurology®, the medical journal of the American Academy of Neurology. https://www.news-medical.net/news/20260902/Immigrants-face-longer-ICU-stays-after-stroke-in-Canada.aspx

Innovation vs. regulation? AI is revolutionizing biotechnology—but raising unintended risks and ethical concerns Chelsea Francek | September 2, 2026

https://geneticliteracyproject.org/2026/09/02/innovation-vs-regulation-ai-is-revolutionizing-biotechnology-but-raising-unintended-risks-and-ethical-concerns/ The recent announcement of novel, viable viruses created by artificial intelligence (AI) was celebrated as a major advance in the fight against antibiotic resistance. But it also raised urgent concerns about regulation.

Fact vs misinformation: An official EU guide to GMOs and gene-edited foods European Parliament | September 1, 2026

https://geneticliteracyproject.org/2026/09/01/fact-vs-misinformation-an-official-eu-guide-to-gmos-and-gene-edited-foods/ The rules governing new gene editing techniques for plants – called “new genomic techniques” (NGTs) – are being changed at EU level. Gene-edited plants will be divided into two categories, depending on the type and number of edits involved. Those with few genetic changes that could have occurred through conventional breeding techniques will be considered conventional plants, while the rest will have to follow the same strict rules as GMOs.

Viewpoint: Realpolitik environmentalism is on the horizon David Zaruk | September 3, 2026

https://geneticliteracyproject.org/2026/09/03/viewpoint-realpolitik-environmentalism-is-on-the-horizon/ When was the last time you heard someone call themselves an “environmentalist”? A decade ago, self-professed environmentalists would proudly claim to all in earshot that they cared for the environment, that they lived sustainably and answered to a higher calling as agents of change to make Mother Earth whole again. These martyrs for the cause identified themselves by their green choices and eagerly displayed their badges and totems. The implication, a decade ago, was that the rest of us were heathens, polluters and peasants.

Science Literacy Project Daily Digest Science Controversies in the Media ++++ ++++

Science Literacy Project Daily Digest Science Controversies in the Media How climate change could impact food safety Popular Mechanics https://geneticliteracyproject.org/2026/09/03/how-climate-change-could-impact-food-safety/ Climate change isn’t just fueling stronger storms and longer droughts — it’s also making the food on your plate riskier, as Popular Mechanics’ Darren Orf reports. A new review from researchers at Ethiopia’s Public Health Institute and Dambi Dollo University, published in the study in One Health Outlook, found that rising temperatures, shifting rainfall, and extreme weather are accelerating the spread of foodborne pathogens worldwide. Do-it-yourself, anti-aging wonder drug deception: No evidence yet metformin works Nautilus https://geneticliteracyproject.org/2026/09/03/do-it-yourself-anti-aging-wonder-drug-deception-no-evidence-yet-metformin-works/ Biohackers have long touted metformin, a cheap diabetes drug, as a secret weapon against aging. But a new review finds the evidence doesn’t yet back the hype, as Nautilus’s Jake Currie reports. Viewpoint: If Trump has his way, nitrogen oxide-polluting AI data centers will be exempt from air pollution rules The Guardian https://geneticliteracyproject.org/2026/09/03/viewpoint-if-trump-has-his-way-nitrogen-oxide-polluting-ai-data-centers-will-be-exempt-from-air-pollution-rules/ The Trump administration is moving to end public notification of air pollution from AI data centers, as Guardian reporter Tom Perkins reports. A proposed EPA rule would make it optional, rather than required, for developers to disclose how much nitrogen oxide, carbon monoxide, and other pollutants their generators and turbines will release under so-called “minor source” Clean Air Act permits. Death of a Chinese girl in a gene-editing trial raises concerns about China’s rush to become a biomedical superpower Science https://geneticliteracyproject.org/2026/09/03/death-of-a-chinese-girl-in-a-gene-editing-trial-raises-concerns-about-chinas-rush-to-become-a-biomedical-superpower/ Six-year-old “Mei” had Snijders Blok-Campeau syndrome, a disorder diagnosed in just 237 people worldwide, marked by developmental delays and simple speech. In March 2025, doctors at Shanghai’s Xinhua Hospital infused trillions of viruses carrying an experimental base-editing therapy into her spinal fluid to correct the mutation. Seven days later she died of a severe immune reaction — a death never made public, as Science and Retraction Watch reveal in a joint investigation by Brendan Borrell. Deadly ‘faith healing’ exemption: Idaho remains the only state shielding parents from prosecution for replacing medical care with prayer or spirits—even if their child dies Audrey Dutton | ProPublica https://geneticliteracyproject.org/2026/09/02/deadly-faith-healing-exemption-idaho-remains-the-only-state-shielding-parents-from-prosecution-for-replacing-medical-care-with-prayer-or-spirits-even-if-their-child-dies/ In Idaho, parents who say their faith prohibits lifesaving medical care for their children can’t be charged with child neglect or manslaughter. Supporters of this protection over the years have included lawmakers who voiced support for “traditional” Idaho values. Viewpoint: With Trump’s declining mental health and an incapacitated Mitch McConnell unlikely to return to the Senate, America’s gerontocracy needs a Public Physician The Atlantic https://geneticliteracyproject.org/2026/09/02/viewpoint-with-trumps-declining-mental-health-and-an-incapacitated-mitch-mcconnell-unlikely-to-return-to-the-senate-americas-gerontocracy-needs-a-public-physician/ Senator Mitch McConnell, 84, hasn’t spoken publicly since an ambulance took him from his Washington home on June 14th, 2026. In The Atlantic, geriatrician Rachael Bedard argues his opaque absence exposes a real gap in American government: no independent body checks whether aging officials are still fit to serve. Viewpoint: RFK Jr. and other vaccine denialists blame vaccines for a surge in severe autism. The surge is a myth—and here’s why Quillette https://geneticliteracyproject.org/2026/09/02/viewpoint-rfk-jr-and-other-vaccine-denialists-blame-vaccines-for-a-surge-in-severe-autism-the-surge-is-a-myth-and-heres-why/ Donald Trump and Robert F. Kennedy Jr. keep pointing to what they call an explosion of severe autism cases as proof that vaccines are poisoning American children, but the epidemiology doesn’t support the claim, as epidemiologist Geoffrey C. Kabat argues in Quillette. Trump has claimed that “large amounts of vaccine, large amounts of like vats of vaccine are currently pumped into your child’s body,” insisting rates were far lower when children received fewer shots. Kabat’s rebuttal: what has actually ballooned is the diagnosis, not the disorder. Can cloud seeding ease the deepening drought across the American West? New York Times https://geneticliteracyproject.org/2026/09/02/can-cloud-seeding-ease-the-deepening-drought-across-the-american-west/ A 26-foot tower resembling a football goalpost in Moab, Utah, pulses electrical charges into clouds — and its maker says that boosted snowfall in the La Sal Mountains 15 percent last winter, as Scott Dance reports for The New York Times. The claim, from Rain Enhancement Technologies, reflects a bigger Western bet: drought-stricken states, utilities and ski resorts are pouring millions into cloud seeding for more rain and snow.

Zero: That is the official American measles death toll for 2026. Here is what RFK Jr.’s CDC leaves out. Henry Miller | September 3, 2026

https://geneticliteracyproject.org/2026/09/03/zero-that-is-the-official-american-measles-death-toll-for-2026-here-is-what-rfk-jr-s-cdc-leaves-out/ The Centers for Disease Control’s weekly measles report is supposed to be a scientific record, not an opportunity to score political points. But this is the Trump administration, where everything, sadly, including science and health policy, appears to be driven by self-interest, personal grievances, and ideological litmus tests. Why should the current uproar over two measles-related deaths in Pennsylvania last month be any different?

Med Students’ Secret Weapon? Sleep Kelly K. James

https://www.medscape.com/viewarticle/med-students-secret-weapon-sleep-2026a1000wnl Every doctor knows that medical school and residency are incredibly demanding. “From a medical student standpoint, not only is there classwork during the day but so much at night to prep for — what you’ve learned and what you’re going to learn,” said Eric J. Olson, MD, p rofessor of medicine at the Mayo Clinic Alix School of Medicine in Rochester, Minnesota, and a pulmonologist and sleep medicine specialist.

Rheumatologists Seek Changes to Looming Medicaid Work Rules Kerry Dooley Young

https://www.medscape.com/viewarticle/rheumatologists-seek-changes-looming-medicaid-work-rules-2026a1000wnr A new Medicaid rule could unfairly cost people with rheumatologic diseases their access to healthcare, while also creating unnecessary administrative burdens for clinicians, medical groups said. At issue are standards for judging medical exemptions set in an interim final rule that the Centers for Medicare & Medicaid Services (CMS) published in June.

Steady and Strategic: Medscape Hospitalist Wealth & Debt Report 2026 Tony Stasiek

https://www.medscape.com/p11/steady-and-strategic-medscape-hospitalist-wealth-debt-report-2026a1000tgd Since we last checked in with hospitalists in the 2024 Medscape Hospitalist Wealth & Debt Report, their financial picture has remained relatively consistent. Call it an offshoot of hospitalists' "balanced lifestyle," says Lawrence B. Keller, CFP, founder of Physician Financial Services in Melville, New York. "Hospitalists know that, for the most part, they are not going to be earning what a surgeon or a proceduralist is going to earn," says Keller, whose firm has nearly 5000 physician clients across the United States. "So they're very much attuned to their financial planning, their finances, and their financial goals -- probably more than some other specialists."

I was a doula before I was an OB-GYN. I wish the two professions understood each other more At a difficult birth, the doula in me understood the disappointment. The doctor in me understood the urgency

https://www.statnews.com/2026/09/03/doula-turned-ob-gyn-birth-plan-disappointment-urgency/ By Debra EluobajuSept. 3, 2026 Eluobaju is a maternal-fetal medicine fellow at Weill Cornell Medicine.

FDA pilot offers generative AI medical devices a path to patients before they are authorized TEMPO program offers regulators hands-on experience with cutting edge tech in real-world settings

https://www.statnews.com/2026/09/03/tempo-fda-pilor-generative-ai-medical-device-regulation/ By Mario AguilarSept. 3, 2026 Health Tech Correspondent

Why are drug overdose deaths declining? A new report points to policy measures like naloxone and harm reduction By Theresa GaffneySept. 3, 2026 Morning Rounds Writer and Reporter

https://www.statnews.com/2026/09/03/drug-overdose-deaths-down-sharply-commonwealth-fund-study/

Abivax has still not been acquired. What’s going on? The French drugmaker has been the subject of frenzied rumors, but it remains unbetrothed By Adam FeuersteinSept. 3, 2026 Senior Writer, Biotech

https://www.statnews.com/2026/09/03/abivax-acquisition-target-replimune-fda/

A surprising bright spot at the FDA on regulating unproven stem cells Two recent actions show that the FDA’s biologics branch continues to take action

https://www.statnews.com/2026/09/03/stem-cell-clinics-fda-cber-warning-letters-marketing/ By Paul KnoepflerSept. 3, 2026 Knoepfler is a professor of cell biology and human anatomy at UC Davis School of Medicine.

The pediatricians who take in vaccine-skeptical parents others won’t By Eric BoodmanSept. 3, 2026

The pediatricians who take in vaccine-skeptical parents others won’t At a ‘practice of last resort,’ doctors prioritize allaying concerns without hardline dismissals By Eric BoodmanSept. 3, 2026 In his reporting on the fallout from federal messaging on vaccines, Boodman interviewed nine pediatricians in six states and spent a day shadowing Aaron Bornstein during a meet-and-greet with a vaccine-hesitant parent. https://www.statnews.com/2026/09/03/vaccine-hesitant-parents-how-pediatrician-builds-trust/

Doctors groups release vaccination guidelines ahead of respiratory illness season Organizations have broken with CDC under Trump administration By Helen BranswellSept. 2, 2026 Infectious Diseases Correspondent

https://www.statnews.com/2026/09/02/vaccine-integrity-project-fall-winter-guidelines-rsv-covid-flu-shots/?utm_campaign=daily_recap&utm_medium=email&_hsenc=p2ANqtz-9uqry04zuRP0wDa0MRxrW8UUXS9uL2dD2zM_e2ObILzO5mXm7q8Vn05N6wEO_koNmug8L_C7JGIdCXXsXY6C9EE0jGjg&_hsmi=437195266&utm_content=437195266&utm_source=hs_email

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling September 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-hepatic-function-study-design-data-analysis-and-impact-dosing-and?utm_medium=email&utm_source=govdelivery FDA Publishes Draft Guidance on Pharmacokinetics in Patients with Impaired Hepatic Function Today, the U.S. Food and Drug Administration (FDA) published the draft guidance entitled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This draft guidance replaces the May 2003 guidance entitled “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling,” and when finalized, will represent FDA’s current thinking. Liver disease can lead to changes in a drug’s pharmacokinetics to a degree necessitating different recommendations for use of the drug in patients with hepatic impairment. This draft guidance is intended to provide recommendations to sponsors and applicants who plan to conduct studies to assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, pharmacodynamics of a drug, including therapeutic biological products. FDA seeks feedback on this draft guidance document. To ensure the FDA considers your comment, please submit your comments by Dec 1, 2026, at 11:59 PM EST to the docket (Docket No. FDA-2026-D-8693). https://www.regulations.gov/docket/FDA-2026-D-8693?utm_medium=email&utm_source=govdelivery

Good Clinical Practices Are Not Optional: The FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research

https://www.fda.gov/news-events/fda-voices/good-clinical-practices-are-not-optional-fdas-commitment-human-subject-protections-and-gold-standard?utm_medium=email&utm_source=govdelivery FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research For decades, Good Clinical Practice (GCP) has provided the ethical and scientific foundation for clinical investigations submitted to the U.S. Food and Drug Administration. Its purpose is straightforward: establishing a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that helps ensure that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. All clinical trials of investigational products submitted to the FDA must comply with GCP. Today, this foundation is being tested by the scale and globalization of modern clinical research. While there are various benefits to this global expansion, it is also introducing new risks to oversight, transparency, and data integrity. Multi-regional trials without an American patient at all or with only a small percentage of patients in the United States present a variety of concerns for American patients, for the FDA, and, increasingly, for policymakers in Congress. Trials that fail to enroll American patients can be less easily generalized to the population the products are intended to treat. It also means Americans are losing out on the opportunity to participate in trials of innovative or breakthrough medical products.

Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI September 3, 2026 By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

https://www.thefdalawblog.com/2026/09/regulating-a-moving-target-fda-seeks-comments-on-possible-framework-for-regulation-of-genai/?utm_source=rss&utm_medium=rss&utm_campaign=regulating-a-moving-target-fda-seeks-comments-on-possible-framework-for-regulation-of-genai On August 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) released Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback (Discussion Paper). The paper is not draft or final guidance; rather, it is intended to solicit feedback on the regulation of generative artificial intelligence (GenAI)-enabled medical devices. It poses 26 discussion questions in the categories of assessment of risk, a competency-based approach for premarket evaluation, postmarket monitoring, foundation model device master files, and considerations for agentic AI systems.

Alcohol-related liver cancer deaths were falling. Then the trend reversed during the COVID-19 pandemic Download PDF Copy

While deaths from several alcohol-attributable conditions have fallen globally, one cancer followed a strikingly different trajectory during the pandemic years. https://www.news-medical.net/news/20260901/Alcohol-related-liver-cancer-deaths-were-falling-Then-the-trend-reversed-during-the-COVID-19-pandemic.aspx In a recent study published in the journal npj Science of Food, researchers used data from the Global Burden of Disease (GBD) 2023 study to investigate global, regional, and national trends in alcohol-attributable mortality from four specific conditions (1990 to 2023). The study evaluated these mortality patterns across 204 countries and territories. It further assessed temporal shifts in alcohol-attributable mortality trends coinciding with the COVID-19 pandemic. Finally, trend data were modeled to estimate future alcohol-attributable mortality rates through 2050.

Radiologist supply fails to keep pace with rising imaging demand

https://www.news-medical.net/news/20260902/Radiologist-supply-fails-to-keep-pace-with-rising-imaging-demand.aspx Demand for medical imaging in the U.S. keeps rising, but the number of radiologists available to read those images has barely budged relative to the population, according to a new research study published in the JACR®.

From navigating a system that was not built for people with rare diseases, to working to change that system from both sides

https://rarerevolutionmagazine.com/from-navigating-a-system-that-was-not-built-for-people-with-rare-diseases-to-working-to-change-that-system-from-both-sides/ From overcoming daily physical and societal hurdles in the classroom to facing misconceptions within the medical community, Sarah Mullahy shares her personal journey of advocacy and her path toward becoming a doctor dedicated to patient-centered care. Written by Sarah Mullahy In 2003, after a short stay in the neonatal intensive care unit, I was discharged home, only to be readmitted months later with failure to thrive. An atrial septal defect was found during that admission. When I was still very young my family moved to South Africa for a year. It was a specialist there who looked at the wider picture and insisted we see a geneticist once we returned to Ireland. I was diagnosed clinically with Noonan syndrome in 2005, at the age of two. In 2008, when genetic testing became more available, an alteration in the PTPN11 gene confirmed what the clinicians had already recognised.

UnitedHealthcare to Drop Prior Authorization Requirements for Range Of Conditions From Oct. 1

https://www.medscape.com/s/viewarticle/unitedhealthcare-drop-prior-authorization-requirements-range-2026a1000vfv Sept 1 (Reuters) - UnitedHealth's insurance unit said on Tuesday that a broad range of conditions will no ⁠longer need prior approval, effective October 1, as it aims to eliminate prior authorization for 30% ⁠of healthcare services by the end of this year.

Oncology Firm Novocure Says Cyberattack Exposed US Patient Records

https://www.medscape.com/s/viewarticle/oncology-firm-novocure-says-cyberattack-exposed-us-patient-2026a1000vrc Sept 1 (Reuters) - Oncology company Novocure said on Tuesday a cybersecurity incident involving unauthorized ⁠access to certain information systems in mid-August exposed internal records of more ⁠than 1,400 U.S. patients.

Reviewing and Negotiating Contracts After Residency Aerial Petty, DO; Jane Simpson, DO

https://www.medscape.com/viewarticle/reviewing-and-negotiating-contracts-after-residency-2026a1000u8l Aerial Petty, DO: My name is Aerial Petty. I am a family physician and the outgoing Resident Member to the Board of the American Academy of Family Physicians (AAFP). I graduated from my residency program at NewYork-Presbyterian/Columbia University Irving Medical Center in New York city, and then recently completed the Family Medicine CPV-GW Health Policy Research Fellowship in Washington, DC. I’m in a new physician in practice.

Fiscal Year 2027 NIH HIV/AIDS Professional Judgment Budget

https://oar.nih.gov/sites/g/files/mnhszr366/files/OAR_FY_27_PJ_FINAL_508.pdf?j=3055719&sfmc_sub=6992026&l=6498_HTML&u=76636337&mid=100006181&jb=0 The NIH Office of AIDS Research (OAR) has released the Fiscal Year 2027 NIH HIV/AIDS Professional Judgment Budget. Each year, as required by the NIH Revitalization Act of 1993, OAR prepares the NIH HIV/AIDS Professional Judgment Budget (PJ) for submission to the President and Congress. The PJ highlights opportunities for further investment in HIV research, and estimates resources needed to fully fund HIV research, beyond the President’s budget, without expectation of receiving that funding. https://oar.nih.gov/hiv-policy-and-research/budget/fiscal-year-2027-nih-hivaids-professional-judgment-budget The FY 2027 NIH HIV/AIDS PJ highlights five areas where recent findings show exciting potential to advance the health of people affected by HIV. The highlighted areas cut across the research continuum. • Accelerate implementation science to end the HIV epidemic • Develop new technologies for self-testing and multiplex testing • Understand and treat HIV-related co-occurring conditions • Advance progress towards an HIV cure • Strengthen HIV data sharing and harmonization OAR estimates the additional funding for expanded NIH HIV research at $1.059 billion, or 32 percent, over the FY 2026 enacted budget of $3.294 billion.

FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory, and Submission Updates Tuesday, September 29, 2026

https://www.fda.gov/media/193623/download?utm_medium=email&utm_source=govdelivery FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates September 29, 2026 https://www.fda.gov/drugs/news-events-human-drugs/fdas-drug-registration-and-listing-workshop-compliance-regulatory-and-submission-updates-09292026?utm_medium=email&utm_source=govdelivery Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates September 29, 2026 | 8:45 a.m. - 4:00 p.m. ET In-Person or Virtual Join SBIA as the FDA shares the latest updates on registration and listing submissions, including current validation rules, and walks through the evolving regulatory requirements and compliance framework that shape how industry engages with these processes. We'll also dive into compliance strategies for drug amount reporting requirements — a great opportunity to ask questions and hear directly from those working at the forefront of these issues.

House votes to temporarily block Trump plan to politicize federal grants Research policy was included in must-pass government funding bill

https://www.statnews.com/2026/09/01/stopgap-spending-bill-contains-reprieve-nih-research-grant-control/ By John Wilkerson and Anil OzaSept. 1, 2026

The Ig Nobel Prizes, long held in the U.S., head to Europe due to Trump policies Organizers of the annual spectacle cited concerns about safety for international attendees

https://www.statnews.com/2026/09/02/ig-nobel-prizes-europe-trump-policies/ By Allyson Chiu — Boston GlobeSept. 2, 2026

Pharmalittle: We’re reading about a Huntington’s gene therapy, Novo’s challenges, and more New White House drug pricing deals might not amount to much, at least not immediately

https://www.statnews.com/pharmalot/2026/09/02/uniqure-huntingtons-fda-novo-nordisk-investors-pharmalittle-newsletter/ By Andrew JosephSept. 2, 2026 Europe Correspondent

The next DSM should address the algorithm’s role in eating disorders Clinicians already screen for trauma and family history. Digital exposure should be part of that

https://www.statnews.com/2026/09/02/dsm-6-eating-disorders-algorithms-social-media-influence-screening/ By Jessica Scheer and Riley NickolsSept. 2, 2026 Scheer is CEO of the National Eating Disorders Association. Nickols is a sports psychologist and clinical adviser for the NEDA.

NIH proposal to cap research grants draws mixed reception, agency says Many of the 3,300 commenters stress need to support early career scientists

https://www.statnews.com/2026/09/01/nih-grant-cap-proposal-researcher-feedback/ By Anil OzaSept. 1, 2026 General Assignment Reporter

I’m a reproductive psychiatrist. The Lindsay Clancy trial will cause terrible damage to my field Rather than prompting a renaissance in treating postpartum mental illness, the trial will make things worse

https://www.statnews.com/2026/09/01/lindsay-clancy-trial-verdict-postpartum-psychosis-psychiatry/ By Jennifer Adaeze OkwerekwuSept. 1, 2026 Okwerekwu is a reproductive psychiatrist in private practice.

How Trump’s latest pharma deals may undermine efforts to rein in drug costs In agreeing to lower prices in Medicaid, drugmakers are exempt from lowering prices in Medicare

https://www.statnews.com/2026/09/02/trump-most-favored-nation-drug-pricing-industry-analysts-skeptical/ By John WilkersonSept. 2, 2026 Washington Correspondent

Diabetes association CEO: What an independent review says happened at the ADA’s controversial June conference And how we can move forward

https://www.statnews.com/2026/09/01/american-diabetes-association-june-conference-independent-review/ By Charles "Chuck" HendersonSept. 1, 2026 Henderson is the CEO of the American Diabetes Association.

ADA review of members’ expulsion denies group censored opinions, called in police Five attendees were removed from conference because of conduct, according to findings

https://www.statnews.com/2026/09/01/ada-members-review-june-expulsion-denies-censoring-opinions-calling-new-orleans-police/ By Elizabeth CooneySept. 1, 2026 Cardiovascular Disease Reporter

Pharmacogenomics Education Series: How to Implement Pharmacogenomics into Medication Management (Module 3) September 16, 2026

https://www.dhaj7-cepo.com/content/pharmacogenomics-education-series-module-3?utm_source=newsletter&utm_medium=email&utm_campaign=september2026 How to Implement Pharmacogenomics into Medication Management Wednesday, September 16, 2026, at 12:00 p.m. ET Learn how to incorporate pharmacogenomic data into clinical decision-making and apply pharmacogenomic principles in real-world clinical settings.

OPDP’s Latest Reminder on Preapproval Promotion September 2, 2026 By Sarah Wicks & Dara Katcher Levy & Jeffrey N. Wasserstein —

https://www.thefdalawblog.com/2026/09/opdps-latest-reminder-on-preapproval-promotion/?utm_source=rss&utm_medium=rss&utm_campaign=opdps-latest-reminder-on-preapproval-promotion For anyone who thought FDA’s Office of Prescription Drug Promotion (OPDP) had lost interest in pre-approval promotion, think again. On August 21, 2026, OPDP issued an Untitled Letter to Alar Pharmaceuticals concerning promotional claims for ALA-3000 injection, an investigational extended-release ketamine product being developed for treatment-resistant depression (TRD) displayed at an exhibit booth at the American Psychiatric Association’s 2026 Annual Meeting earlier this year.

Health Ministry investigating another suspected Ebola case after traveler returns from DR Congo ByJERUSALEM POST STAFF AUGUST 31, 2026 22:26 +...

Health Ministry investigating another suspected Ebola case after traveler returns from DR Congo The person will be treated in isolation under procedures for handling high-risk infectious diseases and will be transferred to Ichilov Hospital. https://www.jpost.com/health-and-wellness/article-907180 ByJERUSALEM POST STAFF AUGUST 31, 2026 22:26 https://www.jpost.com/health-and-wellness

New guidelines on migraine prevention reflect increasing options for patients Since 2012, the FDA has approved a half dozen new medications By Isabella CuetoAug. 31, 2026 Chronic Disease Reporter

https://www.statnews.com/2026/08/31/migraine-prevention-medication-guidelines/?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-_138aT13bjrzopKXIlbkM30g3rgHkB6i8ewiBQfvOB5U9t-5jaxxSOgtGICE_HhvKxCsrDypD_P7nG7nGe-mCXlMuF9g&_hsmi=436432001&utm_content=436432001&utm_source=hs_email New migraine guidelines highlight growing treatment options The American Headache Society and the American Academy of Neurology released new migraine guidelines yesterday, the first time they've done so since 2012. The groups gave high marks on efficacy and tolerability to AbbVie's Qulipta, Lundbeck's Vyepti, Amgen and Novartis' Aimovig, Teva's Ajovy, and Lilly's Emgality. They also recommended the drugs as a preventive option for patients who frequently rely on pain medication once their attacks begin. Some experts, however, were concerned that the new guidelines are complicated and may scare off primary care doctors.

Can buying a drug patent application be seen as a bid to prolong a monopoly? Amgen and an insurer are battling over the answer, and the FTC has weighed in

https://www.statnews.com/pharmalot/2026/08/31/pending-drug-patent-applications-amgen-carefirst/ By Ed SilvermanAug. 31, 2026 Pharmalot Columnist, Senior Writer

The Trump administration is burying science and health care in paperwork Despite a stated focus on ‘finding efficiencies,’ the White House has increased the bureaucracy scientists, Medicaid beneficiaries must navigate

https://www.statnews.com/2026/09/01/white-house-science-medicaid-bureaucracy-paperwork/ By Abdullah Shihipar and Brandon D.L. MarshallSept. 1, 2026 Shihipar directs narrative projects and policy impact initiatives at the People, Place, and Health Collective at the Brown University School of Public Health. Marshall is a professor of epidemiology at the Brown University School of Public Health, and director of the People, Place, and Health Collective.

Pharmalittle: We’re reading about Novartis and Bristol pausing cell therapy trials, a $480K cancer drug, and more President Trump has announced the next round of pricing deals with drugmakers

https://www.statnews.com/pharmalot/2026/09/01/novartis-bristol-trials-paused-pancreatic-cancer-drug-price-pharmalittle-newsletter/ By Andrew JosephSept. 1, 2026 Europe Correspondent

NIH proposal to cap research grants draws mixed reception, agency says Many of the 3,300 commenters stress need to support early career scientists By Anil OzaSept. 1, 2026 General Assignment Reporter

https://www.statnews.com/2026/09/01/nih-grant-cap-proposal-researcher-feedback/

As MAHA champions nutrition, it’s ignoring the experts, dietitians say Highly trained nutrition workforce faces drooping enrollment, low pay, and new barriers By Lauren Chan and Isabella CuetoSept. 1, 2026

https://www.statnews.com/2026/09/01/maha-nutrition-makeover-hampered-dietitian-workforce-crisis/

5 burning questions on Trump’s latest deals with drugmakers Agreements leave open questions for patients, companies, and policymakers alike By Daniel Payne, Elaine Chen, and John WilkersonSept. 1, 2026

https://www.statnews.com/2026/09/01/trump-pharma-deals-analysis-latest-round-most-favored-nation-drug-pricing/

Trump strikes nine more deals with drugmakers to lower prices Many details of agreements with the companies remain unclear By Daniel Payne and Elaine ChenAug. 31, 2026

https://www.statnews.com/2026/08/31/trump-most-favored-nation-drug-pricing-new-round-price-cuts-announced/?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz--IAmaiNKoQUxkxAMKF-aFvX79Gyhz_zRr5c29Z-lLFc7eoZhZcgzeLjjeQ6hoDr956Q4hHqdK94P-5sD--kp74M_sCxw&_hsmi=436432001&utm_content=436432001&utm_source=hs_email Trump strikes more drug pricing deals with biotechs President Trump yesterday announced that his administration has made deals with nine new companies, joining the 17 that it previously struck agreements with. The new companies are: Alcon, Astellas, BeOne, BridgeBio, CSL, Sun Pharma, Kyowa Kirin, Teva, and UCB. The agreements are similar to the earlier ones — to sell new medications to U.S. patients at prices comparable to the lowest prices in peer countries, and to offer their drugs to Medicaid at “most-favored nation” prices. But also like the earlier deals, the details of these agreements have not been released and it's unclear what the impact on overall drug costs will be.

Fact vs misinformation: An official EU guide to GMOs and gene-edited foods European Parliament | September 1, 2026

https://geneticliteracyproject.org/2026/09/01/fact-vs-misinformation-an-official-eu-guide-to-gmos-and-gene-edited-foods/ The rules governing new gene editing techniques for plants – called “new genomic techniques” (NGTs) – are being changed at EU level. Gene-edited plants will be divided into two categories, depending on the type and number of edits involved. Those with few genetic changes that could have occurred through conventional breeding techniques will be considered conventional plants, while the rest will have to follow the same strict rules as GMOs.

‘Right-to-try’: Montana’s new law allows licensed center for therapies not yet approved by FDA Washington Post | September 1, 2026

https://geneticliteracyproject.org/2026/09/01/right-to-try-montanas-new-law-allows-licensed-center-for-therapies-not-yet-approved-by-fda/ Montana has become the first state to license clinics that can sell access to experimental treatments still working through the FDA’s approval pipeline — a striking expansion of the “right-to-try” movement, reports Vicki Norton for The Washington Post.

African science innovation is growing exponentially, but it’s almost entirely absent from Wikipedia. Why that’s a problem. SciDev.Net | September 1, 2026

https://geneticliteracyproject.org/2026/09/01/african-science-innovation-is-growing-exponentially-but-its-almost-entirely-absent-from-wikipedia-why-thats-a-problem/ Africa’s scientific output is surging, but you’d barely know it from Wikipedia: the continent accounts for roughly 10 percent of the site’s articles, yet science and technology topics make up less than 1 percent, as Duncan Mboya reports for SciDev.Net.

Five alarming ways ‘autonomous AI’ can go rogue New York Times | September 1, 2026

https://geneticliteracyproject.org/2026/09/01/five-alarming-ways-autonomous-ai-can-go-rogue/ In July 2026, Hugging Face discovered a cyberattack unlike any it had seen before — only to learn the culprit wasn’t a human hacker but a swarm of OpenAI’s own AI agents that had broken loose during a routine security test, as the The New York Times’ Dylan Freedman reports. Over months, the agents escaped their sandboxes, taught themselves to cooperate, and quietly hacked both OpenAI’s and Hugging Face’s systems for weeks before anyone caught on.

Politicizing science: Trump’s pick to head the FDA—Heidi Overton— promotes an ‘alternative system’ of ‘conservative-based science’ Scientic American | September 1, 2026

https://geneticliteracyproject.org/2026/09/01/politicizing-science-trumps-pick-to-head-the-fda-heidi-overton-promotes-an-alternative-system-of-conservative-based-science/ President Trump’s nominee to run the Food and Drug Administration once called for conservatives to build their own scientific journals and steer research funding toward right-wing policy goals, as Scientific American’s Adam Kovac reports.

Viewpoint: Follow the money: How Bloomberg Philanthropies and the NGO Lighthouse Reports manufactured a Big Food safety scandal David Zaruk | August 31, 2026

https://geneticliteracyproject.org/2026/08/31/viewpoint-heres-how-bloomberg-philanthropies-funded-lighthouse-reports-cynically-twisted-the-data-to-prove-big-food-is-trying-to-block-safety-measures/ What happens when you want to run a campaign, but you have very limited data and evidence? One strategy more increasingly used is to hire an activist NGO like Lighthouse Reports to fabricate an investigation they can funnel through their tried and tested noise machine. What happens if the budget has been cleared but there is no story? No problem. Lighthouse Reports has experienced spinmeisters capable of communicating insignificant research like it was a groundbreaking exposé. Just pay the Dutch NGO enough and they’ll deliver?

Viewpoint— ‘Only when it agrees with him’: How RFK Jr. bullies journals that run research that contradicts his anti-vaccine ideology Shelby Bradford | September 1, 2026

https://geneticliteracyproject.org/2026/09/01/viewpoint-only-when-it-agrees-with-him-how-rfk-jr-bullies-journals-that-run-research-that-contradicts-his-anti-vaccine-ideology/ The U.S. Secretary for Health and Human Services is once again questioning a publisher on an editorial action regarding a paper on vaccination.

FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate Levels FDA Drug Safety Communication – September 1, 2026

https://www.fda.gov/drugs/drug-safety-communications/fda-adds-boxed-warning-labeling-ferric-carboxymaltose-injection-injectafer-describe-risk-low?utm_medium=email&utm_source=govdelivery FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate Levels The Food and Drug Administration has approved revisions to the labeling for ferric carboxymaltose injection (currently marketed as Injectafer) that adds a boxed warning, the agency’s most prominent safety warning. This boxed warning describes the risk for symptomatic hypophosphatemia (low levels of phosphate in the blood) associated with ferric carboxymaltose injection and recommends phosphate monitoring in patients at risk of hypophosphatemia and in any patient who receives a repeat course of therapy within three months of the prior course. Clinical manifestations depend on the severity and duration of hypophosphatemia. Symptoms may include muscle weakness or pain, fatigue, tremors, confusion, seizures, and cardiac arrhythmias. Chronic severe hypophosphatemia may lead to osteomalacia (bone softening) and bone fractures. FDA has previously approved other labeling updates for Injectafer that describe this risk. In 2019, FDA determined that ferric carboxymaltose injection can cause serious symptomatic hypophosphatemia. As a result, in February 2020, FDA approved labeling revisions that, along with other changes, added a warning about this risk. In 2023, the warning was revised to include recommendations for serum phosphate level monitoring in patients at risk for hypophosphatemia and in any patient who receives a repeat course of treatment within three months. The revised warning also included osteomalacia and fractures as potential long-term complications and added inflammatory bowel disease as a possible risk factor for hypophosphatemia. In 2025, the warning was further revised to include additional risk factors for hypophosphatemia. In 2026, FDA conducted an assessment of hypophosphatemia in association with ferric carboxymaltose injection using multiple data sources, including the FDA Adverse Event Reporting System (FAERS) database (which has been incorporated into the FDA Adverse Event Monitoring System [AEMS] database), literature reports, and FDA’s Sentinel System. FDA found that symptomatic hypophosphatemia continues to be reported with ferric carboxymaltose injection and serum phosphate testing levels are low despite labeling changes in February 2020 and May 2023.

PFAS in Medical Devices: What You Need to Know

https://www.fda.gov/medical-devices/products-and-medical-procedures/pfas-medical-devices-what-you-need-know?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration has updated its webpage about PFAS (per- and polyfluoroalkyl substances) in medical devices to include new Frequently Asked Questions (FAQs) to help consumers understand what these materials are, why they are used, and how the FDA evaluates the safety and effectiveness of devices that contain these materials. The webpage explains: Fluoropolymers used in medical devices differ from those identified as potentially presenting health concerns for people in other contexts Certain fluoropolymers are critical components of life-saving medical devices, including catheters, cardiovascular implants, and wound dressings

Sports Unite Doctors in Spain and Beyond Laura Clavijo Villagrasa

https://www.medscape.com/viewarticle/sports-unite-doctors-spain-and-beyond-2026a1000uop From the soccer fields of Tarragona, Spain, to the roads of Córdoba, sports have become a key gathering point for healthcare professionals in Spain and beyond. Following the recent victory of the Metges de Tarragona Soccer Club — the medical soccer team of the Tarragona physicians’ association in Spain — in Spain’s 23rd National Medical Soccer Championship, which secured a berth in the 2027 World Medical Football Championship (WMFC) in Torrevieja, Spain, the article highlights a growing calendar of medical sports events. From soccer to cycling, these competitions underscore how teamwork and fair play can improve quality of life for clinicians while turning on-field camaraderie into a valuable support network for everyday medical practice.

Social Egg Freezing in the Spotlight: Choice, Business, or Burden? Roberta Villa, MD

https://www.medscape.com/viewarticle/social-egg-freezing-spotlight-choice-business-or-burden-2026a1000tqd US congresswoman Alexandria Ocasio-Cortez revealed that, at 36, she has decided to freeze her eggs. In an online social media video, she brought the issue of social egg freezing back to the spotlight. The term refers to the cryopreservation of eggs for nonmedical reasons, allowing women to postpone pregnancy until they feel more personally ready, find the right person to raise a child, or achieve greater financial or professional stability.

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling September 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-hepatic-function-study-design-data-analysis-and-impact-dosing-and

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.

The most shocking thing about the latest statistics on CTE in football is that we find them so shocking Since its earliest days, it’s been clear football is bad for the brain

https://www.statnews.com/2026/08/31/cte-nfl-boston-university-study-football-concussion-history/ By Emily HarrisonAug. 31, 2026 Harrison is a historian of science and public health at Wellesley College. A new study led by Boston-area researchers has set my media feeds abuzz with the finding that nearly 1 in 4 NFL players in their sample had CTE at time of death. CTE, or chronic traumatic encephalopathy, is a degenerative brain disease. It is caused by repeated concussions and smaller non-concussive hits.

Biotech’s bold new mandate: Breakthroughs beyond the lab Benches and bedsides can feel worlds apart, but technology and AI are closing the distance

https://www.statnews.com/sponsor/2026/08/31/biotechs-bold-new-mandate-breakthroughs-beyond-the-lab/

Cadre of radiopharmaceuticals experts pushes the bounds in cancer therapy Some researchers believe the pharma industry is being too cautious in the face of safety concerns

https://www.statnews.com/2026/08/31/radiopharmaceuticals-dosing-pushing-bounds-cancer-treatment/ By Allison DeAngelisAug. 31, 2026 Biotech Startups and Venture Capital Reporter Radiopharma researchers want bolder dosing Radiopharmaceuticals are powerful new tools in oncology. But are providers maximizing their potential? A small cadre of researchers believes that developers of these therapies may be sacrificing some efficacy by being overly cautious about dosing, STAT’s Allison DeAngelis writes. Among them is Louise Emmett, a leading nuclear medicine researcher in Australia, who is testing whether prostate cancer patients can safely receive radioactive drugs much more frequently than the six- or eight-week intervals typically used today — schedules partly inherited from decades-old external-beam radiation practices. “I'm interested in how we actually improve survival in our patients, not the toxicities,” Emmett said. Safety concerns with radiopharmaceuticals are real — and have led at least one company in the field to shut down recently. But early results suggest Emmitt’s approach can lower cancer markers without significant kidney or other healthy-tissue toxicity. Companies like Telix and AdvanCell are now exploring similarly aggressive dosing schedules.

After a rough stretch, mRNA gets a boost — at least for now Experts hope the success of a cancer vaccine using the technology can rehabilitate the field By Angus ChenAug. 31, 2026 Cancer Reporter

https://www.statnews.com/2026/08/31/mrna-cancer-vaccine-intersects-politics-medicine/ Can cancer vaccines thaw skepticism of mRNA? After years of political backlash against mRNA vaccines, the field’s researchers believe Moderna and Merck’s positive cancer vaccine readout might help turn the tides for the technology — and perhaps even soften some of the broader stigma around vaccines. That stigma has had real consequences: The Trump administration pulled back hundreds of millions of dollars for mRNA research in infectious diseases, and some cancer vaccine companies have actually stopped using the word “vaccine” altogether. But the approval of the Moderna-Merck therapy could open the door to a much broader wave of cancer vaccines, including personalized products as well as off-the-shelf shots targeting common cancer proteins like KRAS or HPV. And mRNA, which can be rapidly programmed to produce different proteins, may be particularly well suited to the task. “I don’t know how this will be received among parts of our society that have become suspicious of the word ‘vaccine.’ There’s a possibility that people will say, ‘Oh, if we can vaccinate against cancer, that’s good,’” said Ryan Sullivan, a Mass General Brigham melanoma physician and immunologist who has worked with Moderna. “Maybe that will thaw some of the stigma around vaccines. I don’t think it’ll fix all of it, but maybe just a little bit helps us think of ‘vaccine’ not as a dirty word, ‘mRNA’ as not a four-letter word.” https://www.statnews.com/2026/08/19/mrna-cancer-vaccine-trial-melanoma-merck-moderna/?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-_d9XAbIwD84KLgIzPkSk9ZszRpaM94ZuvFaoZ1jZZFzOYkmevUzMoJgEUg7qcin9Eh7czCX9et_dHta6sesBHn73IAwQ&_hsmi=436067550&utm_content=436067550&utm_source=hs_email

The perfect cookie? 3D-printed cookies made from upcycled plastic waste The Guardian | August 31, 2026

https://geneticliteracyproject.org/2026/08/31/the-perfect-cookie-3d-printed-cookies-made-from-upcycled-plastic-waste/ Scientists at Southern Illinois University Carbondale have found a way to turn plastic bottles and crop waste into protein-rich cookies, an unlikely fix for feeding astronauts on long missions, reports Hannah Devlin for The Guardian.

It’s not child’s play: Teaching a computer to use language requires an inhuman amount of data—and it still learns much more slowly than kids MIT Technology Review | August 31, 2026

https://geneticliteracyproject.org/2026/08/31/its-not-childs-play-teaching-a-computer-to-use-language-requires-an-inhuman-amount-of-data-and-it-still-learns-much-more-slowly-than-kids/ Chatting naturally with a computer now feels routine, but as MIT Technology Review’s Elise Cutts reports, the large language models behind that fluency are shockingly data-hungry compared to human toddlers. Meta’s Llama 3.1 trained on 15 trillion tokens; a preteen raised in a language-rich home hears something like 100 million words. “We still have to burn down a forest and scrape the entire sum of all human knowledge to re-create this milestone that happens in our living rooms over the course of a year,” says Stanford cognitive scientist Michael Frank.

Kennedy’s HHS set to define ultra-processed foods—but will the slippery designation make scientific sense? The Atlantic | August 31, 2026

https://geneticliteracyproject.org/2026/08/31/kennedys-hhs-set-to-define-ultra-processed-foods-but-will-the-slippery-designation-make-scientific-sense/ The federal government is about to attempt what nutrition scientists haven’t managed: a workable definition of “ultra-processed food.” HHS Secretary Robert F. Kennedy Jr. announced his department is finalizing the first official U.S. definition, as Nicholas Florko for The Atlantic reports, though the wording remains under White House review.

Rising costs of fertilizer, fuel, and machinery: Tariffs and stalled Iran war weigh heavily on American farmers Washington Post | August 31, 2026

https://geneticliteracyproject.org/2026/08/31/rising-costs-of-fertilizer-fuel-and-machinery-tariffs-and-stalled-iran-war-weigh-heavily-on-american-farmers/ American farmers are staring down what one Iowa grower calls “another farm crisis,” as President Trump’s tariffs and his war with Iran drive up fertilizer, fuel and machinery costs while crop prices stay weak, the Washington Post’s Jarrell Dillard reports.

Viewpoint: Follow the money: How Bloomberg Philanthropies and the NGO Lighthouse Reports manufactured a Big Food safety scandal David Zaruk | August 31, 2026

https://geneticliteracyproject.org/2026/08/31/viewpoint-heres-how-bloomberg-philanthropies-funded-lighthouse-reports-cynically-twisted-the-data-to-prove-big-food-is-trying-to-block-safety-measures/ What happens when you want to run a campaign, but you have very limited data and evidence? One strategy more increasingly used is to hire an activist NGO like Lighthouse Reports to fabricate an investigation they can funnel through their tried and tested noise machine. What happens if the budget has been cleared but there is no story? No problem. Lighthouse Reports has experienced spinmeisters capable of communicating insignificant research like it was a groundbreaking exposé. Just pay the Dutch NGO enough and they’ll deliver?

The destruction of healthcare in armed conflict: policy implications and accountability Athena Madan* [1]

https://www.academia.edu/3070-3530/3/2/10.20935/AcadMedHealth8372 This Perspective examines how the destruction of healthcare systems in armed conflict produces enduring public health harm and broad human insecurity. Drawing on social medicine, sociological theory, governance scholarship, and field observations from Afghanistan, it argues that attacks on healthcare infrastructure and personnel result in not only the loss of clinical services but also in the erosion of social and moral worlds of care. The paper advances three interrelated claims: first, that healthcare institutions function both as clinical and social infrastructures; second, that their destruction generates disproportionate psychosocial, gendered, and intergenerational harms extending far beyond immediate morbidity and mortality; and third, that the persistence of such attacks reflects abject failures in international protection and accountability mechanisms. Particular attention is given to the consequences for women and children, including preventable death, disability, and psychosocial distress with constrained possibilities for recovery and social ways of belonging. These harms are compounded by weakened international accountability, which has increasingly normalised attacks on healthcare as a feature of war rather than a violation demanding intervention. https://www.academia.edu/journals/academia-medicine-and-health/articles?source=journal-top-nav

Why reproducibility remains a challenge in preclinical research

Improving reproducibility requires more than stronger statistics alone. Across the research community, scientists are adopting new approaches to increase transparency, standardization, and rigor at every stage of the experimental workflow. Read this article to explore emerging strategies for strengthening reproducibility and building more robust preclinical studies. https://www.drugdiscoverynews.com/why-reproducibility-remains-a-challenge-in-preclinical-research-17198?utm_campaign=DDN%20Lead%20Generation&utm_medium=email&_hsenc=p2ANqtz-9SqHrV_7KQATNvLY977Pj57WOQGa71BxP4K1ICIj-HzN5Oc6GJ5egjQe9NsWqD67p_xHh_goN_nn0cH1rxU3PtIwHdjw&_hsmi=435425482&utm_content=435425482&utm_source=hs_email

From absorption to metabolism: predicting human oral drug exposure Tuesday, October 6th 2026 | 10:00 AM – 11:30 AM Eastern Time

From absorption to metabolism: predicting human oral drug exposure Explore how human gut-liver models can improve the translation of preclinical findings into clinical pharmacokinetic predictions. https://www.drugdiscoverynews.com/from-absorption-to-metabolism-predicting-human-oral-drug-exposure-17471?utm_campaign=DDN%20Webinars&utm_medium=email&_hsenc=p2ANqtz-_dEGVAc8X1XZ0yNk8I_gP_EeflCN6OCpSrkcgYOoBe6LC_0RlNKJYeGwRazUpCyvQ9_IyfaBjg7KAHnrNezp7ziSLjWA&_hsmi=435582994&utm_content=435582994&utm_source=hs_email Predicting human oral drug exposure remains a major challenge in preclinical drug development. Intestinal absorption, first-pass metabolism, and drug-drug interactions can all influence systemic exposure, while conventional in vitro and animal models may not fully capture the interplay between these processes. In this webinar, Yassen Abbas and Joseph Broomfield will discuss how integrated gut-liver microphysiological systems (MPS) can provide mechanistic insights into oral drug disposition, including bioavailability, metabolic variability, and drug-drug interactions. They will also explore how MPS data can support physiologically based pharmacokinetic modeling and improve translation to clinical studies. Topics to be covered: Modeling oral drug absorption, metabolism, and bioavailability Improving translation from preclinical studies to humans Identifying drug-drug interactions and their underlying mechanisms Understanding how metabolic variability affects drug exposure and dosing Tuesday, October 6th 2026 | 10:00 AM – 11:30 AM Eastern Time

ACI’s 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA August 30, 2026

https://www.thefdalawblog.com/2026/08/acis-6th-annual-passport-to-proficiency-on-the-essentials-of-hatch-waxman-and-bpcia/?utm_source=rss&utm_medium=rss&utm_campaign=acis-6th-annual-passport-to-proficiency-on-the-essentials-of-hatch-waxman-and-bpcia The American Conference Institute’s (ACI’s) virtual 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 20-29, 2026 (Eastern Standard Time). Led by an experienced faculty, the virtual training series is specifically designed for attorneys, regulatory affairs professionals, and industry executives working at the intersection of FDA law, IP strategy, and biopharmaceutical innovation to provide advanced training on the 1984 Hatch-Waxman and the 2010 Biologics Price Competition and Innovation Act (BPCIA). And the 2026 program has been refined, condensed, and refreshed to deliver an even more practical and efficient learning experience.

Former Stanford president releases emails to rebut fraud and cover-up allegations in new book Marc Tessier-Lavigne denies claims in Theo Baker’s book that a 2009 study had fabricated results By Jonathan WosenAug. 27, 2026

Former Stanford president releases emails to rebut fraud and cover-up allegations in new book Marc Tessier-Lavigne denies claims in Theo Baker’s book that a 2009 study had fabricated results By Jonathan WosenAug. 27, 2026 https://www.statnews.com/2026/08/27/marc-tessier-lavigne-responds-theo-baker-book-misconduct-stanford-genentech/

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.

We quit the CDC last year. The problems we protested remain Here’s how Congress can protect the health of our country

https://www.statnews.com/2026/08/28/cdc-protest-resignations-one-year-later-houry-jernigan-daskalakis/ By Debra Houry, Daniel Jernigan, and Demetre DaskalakisAug. 28, 2026 Houry was the CDC’s chief medical officer and is now a senior medical adviser for the California Public Health Network Innovation Exchange. Jernigan, M.D., M.P.H., was director of the National Center for Emerging and Zoonotic Infectious Diseases, and is a contributing scholar at Johns Hopkins Bloomberg School of Public Health. Daskalakis, M.D., M.P.H., was director of the National Center for Immunization and Respiratory Diseases and is a consultant for Sanofi, AstraZeneca, and ViiV Healthcare.

The CMP Plot Thickens: Solicitor General Letter Casts FDA’s Tobacco Civil Money Penalty Scheme into Further Doubt August 27, 2026 By Peter G. Dickos & JP Ellison —

https://www.thefdalawblog.com/2026/08/the-cmp-plot-thickens-solicitor-general-letter-casts-fdas-tobacco-civil-money-penalty-scheme-into-further-doubt/?utm_source=rss&utm_medium=rss&utm_campaign=the-cmp-plot-thickens-solicitor-general-letter-casts-fdas-tobacco-civil-money-penalty-scheme-into-further-doubt For the first time, the Department of Justice has backed off its prior vigorous defense of FDA’s tobacco product administrative Civil Money Penalty (CMP) scheme as constitutional under the 7th Amendment and Jarkesy. Earlier this week, the Solicitor General sent a letter to Congress saying that it will not seek cert to the Supreme Court from the 5th Circuit’s adverse Texas Tobacco Barn decision finding the CMP there (for sales of unauthorized e-cigarettes) unconstitutional. The big part is the why: because “the Fifth Circuit correctly rejected certain arguments emphasized by the government in this case,” namely, that “interstate commerce” and “public health” were sufficient justifications to overcome/exceptions around the 7th Amendment jury trial right recognized in Jarkesy.

Who’s getting vaccinated? Scientific American ranks states by kindergarten vaccination rates Scientific American | August 28, 2026

https://geneticliteracyproject.org/2026/08/28/whos-getting-vaccinated-scientific-american-ranks-states-by-kindergarten-vaccination-rates/ America’s kindergartners are heading back to school less vaccinated than ever. New CDC data analyzed by Scientific American’s Jackie Flynn Mogensen and Sanidhya Sharma show kindergarten MMR vaccination fell to 92.4 percent this year, down from about 95 percent a decade ago, while nonmedical exemptions have roughly doubled, to 4 percent. Measles, once eliminated in the U.S., has logged over 2,500 cases this year, the most since 2000.

Viewpoint: Rebranding questionable ‘anti-aging’ claims as ‘longevity’ treatments is a fashionable new online wellness con Cheek Media | August 28, 2026

https://geneticliteracyproject.org/2026/08/28/viewpoint-rebranding-questionable-anti-aging-claims-as-longevity-treatments-is-a-fashionable-new-online-wellness-con/ The global wellness industry has swapped “anti-aging” for “longevity” — same unproven promises, shinier vocabulary — as Cheek Media’s Varsha Yajman reports in a recent investigation into the sector’s marketing tactics. The industry, valued at $6.8 trillion and projected to hit $9.8 trillion by 2029, increasingly relies on influencers rather than clinicians to sell its products, often to people who can least afford to be misled