Know What's Happening in Healthcare
Know What's Happening in Healthcare
FDA approves KRESLADI, first CIRM‑backed gene‑editing therapy
The FDA cleared KRESLADI, a gene‑editing treatment from Rocket Pharmaceuticals for severe leukocyte adhesion deficiency‑I in children, eliminating the need for a bone‑marrow donor. It is the first product directly funded by California’s Institute for Regenerative Medicine to receive approval.
Also developing:
By the numbers: Syneron Bio raises $150M Series B
The Trump administration issued three final rules that expand the Mexico City Policy to all U.S. foreign assistance, tying roughly $40 billion in non‑military aid to compliance with anti‑abortion, gender‑ideology, and DEI restrictions. The rules prohibit NGOs receiving any U.S. funds from providing abortion services, gender‑affirming care, or advocating for LGBTQI+ rights, even when those activities are financed by other donors. Compliance demands strict separation of prohibited and funded activities, with penalties including funding termination and debarment. Analysts warn the policy will cripple health programs, humanitarian response, and U.S. strategic influence abroad.
By 2034, roughly one‑fifth of Americans will be over 65, creating the first senior‑majority population and an old‑age dependency ratio above 0.35. The surge strains healthcare staffing, with projected physician shortages exceeding 90,000, and inflates caregiver demand beyond the 50 million...
A letter to the BMJ highlights how a decade of austerity has eroded the UK health service and community support, leaving young people disproportionately affected by COVID‑driven educational disruption and isolation. The author argues that the government’s label of "economically...
The average woman waits 7 years to be diagnosed with an autoimmune disease. The average man waits 3. Why?
Flint, Michigan, has expanded its emergency services by adding a fourth ambulance and a $1.2 million fire engine to the city’s Fire Department fleet. The ambulance service, launched in 2024, has already completed more than 900 runs this year, and the...
The FDA announced a town hall to discuss its updated Quality Management System Regulation (QMSR) that will govern medical device inspections beginning February 2, 2026. The new inspection framework replaces the long‑standing Quality System Inspection Technique (QSIT) and supersedes older...
Orphan‑drug sales are projected to exceed $400 billion by 2032, more than double the 2025 level. Small‑molecule therapies dominate the pipeline, accounting for 45% of the 20 most valuable orphan candidates, signaling a resurgence after years of biologic focus. The Inflation...
Parkinson’s research has entered a pivotal phase, driven by deeper disease insights and advanced models such as patient‑derived iPSCs. Despite a pipeline of potential disease‑modifying therapies, funding shortfalls and outdated trial endpoints continue to impede progress. Parkinson’s UK’s Virtual Biotech...
The European Commission is pushing a 2026 Health Package that revises the MDR/IVDR framework, introducing risk‑based certification, digital‑only declarations of conformity and tighter cybersecurity reporting. Parallel work on the AI Act will align high‑risk medical AI with the MDR/IVDR pathway,...
The U.S. Food and Drug Administration issued final guidance titled “Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.” The document outlines recommended non‑clinical testing and clinical study designs for devices aimed at weight loss, obesity treatment, or...
I teach medical students that fatty liver disease (MASLD) affects 1 in 3 adults and has limited approved drug treatments. That may be changing. Hebrew University researchers found CBD and CBG -- two non-psychoactive cannabis compounds -- reversed fatty liver in mice...
Recent research highlights a striking overlap between autism spectrum disorder (ASD) and gender dysphoria, with studies reporting 35‑47% of youth in gender clinics also meeting autism criteria. Sensory processing challenges and body‑image discomfort often drive autistic individuals toward clothing and...
A new study published in the American Journal of Respiratory and Critical Care Medicine finds that policies enacted during Donald Trump's second term are poised to dramatically increase lung disease incidence and premature deaths in the United States. The analysis...
Epic Life’s founder Ben Davies partnered with Koto’s James Greenfield early on to embed brand and trust before building their AI‑powered health companion. They argue that while AI functionality can be duplicated, a credible brand and identity are hard to...
The 510(k) premarket notification pathway continues to dominate U.S. medical device approvals, but recent data show escalating safety failures and a persistent “predicate creep” problem. In Q1 2026 the FDA introduced electronic eSTAR submissions and issued draft guidance on predicate selection,...
Australian biotech Immutep saw its ASX shares tumble more than 88% after the independent data monitoring committee recommended halting its pivotal phase‑3 TACTI‑004 trial of the LAG‑3 inhibitor eftilagimod alfa (efti) in first‑line non‑small cell lung cancer. The trial, which...
Otsuka Pharmaceutical disclosed early open‑label extension (OLE) data for repinatrabit (JNT‑517) in adolescents with phenylketonuria (PKU). A 75 mg twice‑daily regimen achieved a 67% mean reduction in blood phenylalanine by day 56, with responses observed across prior sapropterin responders, non‑responders, and a...
Researchers at St Olavs Hospital in Trondheim equipped one half of a psychiatric intensive‑care ward with blue‑depleted evening lighting while the other half kept standard lighting. In a randomized trial of 476 short‑stay patients, the circadian‑adapted ward showed greater clinical improvement...
A head‑to‑head trial published in the New England Journal of Medicine compared Eliquis (apixaban) and Xarelto (rivaroxaban) in patients with deep‑vein thrombosis. The study found Eliquis significantly reduced major bleeding risk while maintaining equal efficacy in preventing clot recurrence. This...
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South Africa’s Red Cross Children’s Hospital is using donated Trikafta, a $300,000‑a‑year cystic fibrosis therapy, to keep seven‑year‑old Jaylin Leitjies alive after his lungs were severely damaged in infancy. The drug, produced by Vertex Pharmaceuticals, is not registered with SAHPRA...
A wave of Integrated Care Board (ICB) mergers and clustering is set to roll out across England, with many consolidations taking effect in April 2026 and further changes slated for 2027. The reforms aim to cut ICB operating and programme...
Alltrna's CEO Michelle Werner announced her resignation, moving to pharmaceutical giant Ipsen as its new chief executive. The biotech startup will rely on interim management while it searches for a permanent replacement. Simultaneously, Ionis Therapeutics disclosed that several long‑standing board...
Private‑equity firms Ardian, Charterhouse, CVC and L Catterton led six recent transactions across the women’s health sector. The deals span fertility services, menopause therapeutics, breast‑cancer diagnostics, digital mental‑health platforms, and pelvic‑floor care. Collectively, the investments total roughly $1.2 billion, reflecting heightened...
SteinCares and Shilpa Biologicals have signed a licensing deal to commercialize biosimilars across Latin America, with SteinCares handling regional registration and distribution while Shilpa oversees product development and long‑term manufacturing. The partnership targets broader patient access to cost‑effective biologics in...
Ten medical societies, including the American College of Radiology, have written to UnitedHealthcare and Cigna urging them to revise their coverage policies for peripheral nerve stimulation (PNS), a minimally invasive chronic pain treatment. The insurers currently classify PNS as experimental,...
A VA Office of the Inspector General review found that 13 of 15 sampled radiology clinics lack essential call‑tracking data, rendering nearly 338,000 radiology‑related calls unmonitored. The missing data hampers the department’s ability to gauge response times, leading to delays...
The numbers defining US healthcare. 11 years & $300,000 for an MD. 30 minutes & $38 for an insurance license. Primary care handles 90% of issues but gets only 5% of total healthcare spending. Who is wrong? We discuss the low value placed on...
What happens when Kennedy's MAHA base's hunger for further dismantling of vaccination policy is at odds with the White House's midterm election strategy? We may be about to find out, @_daniel_payne & @ChelseaCirruzzo report. https://t.co/uiTS6XJgP0
A recent Neuroscience Insights review highlights citicoline, a CDP‑choline derivative, as a potent neuroprotective agent. Clinical data show consistent improvements in memory, concentration, and visual‑motor coordination for patients with mild cognitive impairment, especially of vascular origin. The bioactive also benefits...
White House says it’s ‘done’ with vaccines. MAHA begs to differ https://t.co/atqj3ymMqe via @_daniel_payne @ChelseaCirruzzo
#GSK Arexvy RSV Vaccine approved by US FDA with a wider indication for Adults aged 18 to 49 who are at increased risk of Lower Respiratory Tract Disease caused by RSV.
The U.S. Supreme Court nullified President Trump’s emergency authority to impose tariffs, reigniting uncertainty for the pharmaceutical sector. Despite the ruling, most‑favored‑nation (MFN) pricing agreements between branded drug makers and the Administration are expected to hold, though new U.S. manufacturing...
![[Obituary] Nicholas White](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/18e02f397e47fea422ba4d31bfe3f731.webp)
Professor Sir Nicholas White, a pioneering pharmacologist and tropical‑medicine clinician, led the development and global adoption of artemisinin‑based combination therapies (ACTs) that transformed malaria treatment. His early trials in the 1990s demonstrated ACTs’ safety and efficacy, prompting a WHO guideline...
![[Correspondence] Health in Africa: The WHO African Region in the Next Decade](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/a9fe5635efddee78b24619bc1dc041d1.webp)
In 2025 the WHO African region faced profound public‑health disruptions that accelerated a shift away from donor‑driven, disease‑specific programmes toward domestically financed, system‑wide strategies. Health is being repositioned as a macro‑economic asset, with preparedness, universal coverage and disease control framed...
![[Correspondence] National Lung Cancer Screening Programme in Brazil: An Urgent Need](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/4fbfeafc7f96396bcc6e234922df9c92.webp)
Lung cancer caused 44,213 new cases and 38,292 deaths in Brazil in 2022, imposing heavy morbidity and costs on the public health system. Unlike many nations, Brazil lacks a national low‑dose CT (LDCT) screening programme, despite strong trial evidence that...
![[Perspectives] Lessons From the History of the Uganda Virus Research Institute](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/fa1fa72682f84e190ce5ce03ac058219.webp)
During the 1960s, Uganda’s Virus Research Institute exemplified how African health research was rebuilt after independence, navigating the collapse of colonial institutions while maintaining productive collaborations. Today, abrupt reductions in U.S. development assistance—withdrawal from USAID, WHO, and Gavi—are destabilizing similar...
![[Comment] Moving Integrated Care Into the Community in Sub-Saharan Africa](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/753ebea3da7faa88e67cea3df67e4d36.webp)
Vertical HIV programmes in East and Southern Africa have successfully expanded rapid treatment access, but rising non‑communicable disease (NCD) comorbidities among people living with HIV now demand integrated service delivery. Recent pragmatic trials such as INTE‑AFRICA (2023) and INTE‑COMM (2026)...
Hospitals that prioritize accurate clinical notes see measurable revenue gains because documentation directly drives coding and reimbursement. Vague or incomplete entries cause denied claims, audit flags, and lost tariffs, even when billing tools are sophisticated. Solutions such as Scribe X and...
Spain's High Court of Justice ordered Madrid to immediately create a registry of doctors who conscientiously object to performing abortions. The national law, introduced in 2023, obliges all autonomous communities to maintain such lists to ensure women can access legal...
PsiQuantum and Japan’s National Cancer Center have signed a research agreement to explore utility‑scale quantum computing for oncology drug discovery. The collaboration will focus on developing fault‑tolerant quantum algorithms and deploying PsiQuantum’s Construct platform across the healthcare value chain. Additional...
PsiQuantum has signed a research agreement with Japan's National Cancer Center to explore utility‑scale quantum computing for oncology drug discovery. The partnership will focus on developing fault‑tolerant quantum algorithms and clinically relevant applications using PsiQuantum's Construct platform. It also brings...
Ireland has published its first national AI strategy for health, outlining a five‑year roadmap across four strategic pillars: clinical care, operations, research and innovation, and public health. The plan emphasizes AI‑driven improvements such as shorter waiting times, personalised treatment, diagnostic...
Continuous positive airway pressure (CPAP) remains the clinical gold‑standard for obstructive sleep apnea, but adherence rates plummet as many patients find the mask noisy, uncomfortable, or claustrophobic. The article outlines a suite of less invasive alternatives—including daytime neuromuscular therapy, custom...
Pilatus Biosciences has begun dosing the first patient in a Phase I, open‑label trial of PLT012, its first‑in‑class anti‑CD36 monoclonal antibody, at Next Oncology in Houston. The FDA recently issued IND clearance along with orphan‑drug status for hepatocellular carcinoma and fast‑track...
Clinical laboratories face unpredictable crises ranging from equipment failures to cyber attacks, demanding proactive resilience. Experts Tracy Durnan and Jason Nagy stress embedding preparedness into daily routines, from identifying cascade failures to regular infrastructure testing. Cross‑training, scenario‑based drills, and redundant...
Abbott announced that its FreeStyle Libre continuous glucose monitoring system outperformed traditional finger‑stick testing in the FreeDM2 randomised trial involving 303 UK patients with type 2 diabetes on basal insulin. After four months, CGM users achieved a larger reduction in HbA1c...
Avahi, an AWS Premier partner, is launching a free webinar on March 18 to demystify AI agents for healthcare executives. The session, titled “The AI Agent Implementation Framework,” will explain how AI agents operate within hospitals and identify high‑impact use...
A December 2025 federal court ruling allows Medicaid to share enrollee names, addresses and immigration status with ICE, overturning long‑standing privacy assurances. The change, initiated by the Trump administration, removes the guarantee that health data would not be used for...
A recent KFF poll shows 41% of Americans believe the Trump administration’s policies will lower prescription drug costs, outpacing awareness of the Biden‑era Medicare price‑negotiation law. Support is sharply partisan—79% of Republicans versus 11% of Democrats share this view. Only...
Nevada regulators fined three individuals and a Texas private membership association for unlicensed peptide injections at the Revolution Against Aging and Death Festival, where two women became critically ill. The doctor and pharmacist each received $10,000 fines, the health coach...
