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
Regenerative medicine promises to shift healthcare from a reactive model to proactive disease modification by targeting early biological drivers of chronic degeneration. Cell‑based therapies such as mesenchymal stromal/stem cells (MSCs) can modulate inflammation, immune signaling, and tissue repair, showing benefits in early‑stage osteoarthritis and autoimmune disorders. However, U.S. reimbursement, clinical guidelines, and regulatory pathways still favor late‑stage interventions, limiting adoption. A systemic pivot toward earlier detection and treatment could unlock the full clinical and economic value of these therapies.
Health Dimensions Group (HDG) CEO Erin Shvetzoff Hennessey warned that skilled nursing facilities (SNFs) are facing "supercharged" payment pressures from Medicaid funding challenges, a drop in private‑pay residents, and managed‑care reimbursement cuts. The financial squeeze coincides with rising resident acuity...
The U.S. Food and Drug Administration issued an early alert for B. Braun Medical’s Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines after testing revealed a resin change that caused tiny air bubbles to cling to the arterial line...
Healthcare providers face escalating ransomware and cloud‑outage threats that can instantly cripple revenue cycle operations, halting claim submissions and cash flow. Recent incidents, such as the Change Healthcare clearinghouse outage and a regional system’s backup encryption, exposed critical blind spots...
The Xtalks Life Science Podcast featured Dr. Steve Levine, Chief Patient Officer at Compass Pathways, discussing the company’s push to develop psilocybin‑based therapies for treatment‑resistant depression (TRD). Levine, a board‑certified psychiatrist and founder of Actify Neurotherapies, highlighted the clinical promise...
The FDA issued a warning letter to ImmunityBio for misleading promotional claims about its bladder‑cancer drug Anktiva, triggering a roughly 26 percent drop in the company’s shares and giving it 15 days to submit a corrective plan. In parallel, Merck announced a...
Researchers at the University of Guelph announced that their sugar‑based vaccine candidate against Campylobacter jejuni demonstrated safety and immunogenicity in a small Phase 1 human trial. Participants experienced only mild side effects, and the formulation generated measurable antibody responses even at...
A recent Australian study uncovered a two‑phase relationship between integrated visual‑field loss and low‑light difficulties in glaucoma patients. Below an IVF total‑deviation of –6.3 dB (or sensitivity‑based IVF of 21.7 dB), LLQ scores drop sharply, indicating functional impairment. Inferior field defects were...
Anavex Life Sciences withdrew its European marketing authorisation application for blarcamesine, an add‑on therapy for early‑stage Alzheimer’s, after the EMA’s CHMP signaled a likely negative opinion. The committee criticized the trial’s efficacy data, methodological flaws, and safety reporting, including concerns...
Florida enacted a short‑term bill allocating roughly $31 million to keep its AIDS Drug Assistance Program (ADAP) operational, averting a gap in coverage for more than 12,000 residents. The funding reversal follows a March 1 policy that tightened eligibility and threatened to...
New research of 1,493 breast‑cancer survivors aged 65 and older shows that more than 60 % of those who received chemotherapy report moderate to severe neuropathy five years after treatment, compared with 36 % of non‑chemo patients. The risk is driven largely...
A historic nursing strike involving nearly 15,000 New York workers has exposed a deep health‑care affordability crisis. Hospitals such as NewYork‑Presbyterian and Mount Sinai are spending roughly $32,000 per nurse on health benefits, while procedure costs like hip replacements soar to...
Takeda Pharmaceutical announced that Julie Kim will assume the role of chief executive, continuing the company’s multi‑year restructuring agenda. The board approved a new phase of the transformation, emphasizing the rollout of upcoming product launches and accelerating late‑stage pipeline development....
Nonprofit health systems, shielded by $37‑$54 billion in annual tax exemptions, are allocating unrestricted surplus to high‑profile stadium naming‑rights deals, such as Texas Health’s $88 million agreement for a new venue in Mansfield, Texas. While these sponsorships boost brand visibility, charity‑care spending...
A secondary analysis of a Danish year‑long trial examined 193 adults on the GLP‑1 agonist liraglutide with or without a structured aerobic exercise program. Participants first lost an average of 29 pounds on a very‑low‑calorie diet, then were assigned to four...
The Centers for Medicare & Medicaid Services announced the Long‑term Enhanced ACO Design (LEAD) program, which will begin in January 2027 and pay participating physicians incentives to prevent falls among frail seniors and disabled adults. LEAD uses fixed episode payments...
The FDA’s Center for Drug Evaluation and Research (CDER) released its FY 25 Drug Quality Sampling and Testing results, showing that the vast majority of tested pharmaceuticals met USP specifications. The program uses a risk‑based, data‑driven approach introduced in 2018 to...
HFMA’s "Lead Now" initiative capitalized on the One Big Beautiful Bill Act of 2025, driving unprecedented growth and engagement across the healthcare finance sector. Membership surged to over 145,000—the highest in its 80‑year history—while more than 1,080 volunteers delivered 197,000...
One thing that really makes the in-person summits we run at STAT so amazing: the people in the room. Here's what happened when we asked some of them for the last big breakthrough they saw. Featuring: the infectious @DrBlytheAdamson, genomcis pioneer...
A Senate investigation led by Sen. Ron Johnson uncovered that federal health officials identified a statistically significant ischemic stroke risk associated with the Pfizer COVID‑19 booster for adults 65 and older as early as November 2022. Internal HHS records show...
The 2026 Memory Care Innovation Awards are accepting final entries until April 3, 2026. The program honors high‑performing employees with at least seven years of experience who drive cognitive‑care advances across home‑health, hospice, senior‑living and related sectors. Awardees receive dual press‑release recognition,...
World Health Day 2026, observed on April 7, adopts the theme “Together for Health, Stand for Science,” urging global unity around science‑driven health solutions. The WHO highlights One Health—linking human, animal and environmental health—and convenes two flagship events: the One Health...
Seaport Therapeutics is embedding a fail‑safe mechanism into its Phase 2b trial of SPT‑300, an experimental therapy for major depressive disorder. The study will enroll roughly 300 patients at multiple U.S. sites and uses an adaptive design that can halt...
Employers are rapidly moving from traditional defined‑benefit health plans to defined‑contribution models, chiefly through Individual Coverage Health Reimbursement Arrangements (ICHRA). Mercer projects average employer healthcare spending to hit $18,500 per employee by 2026, making cost predictability a priority. Employees cite...
Connecticut's Public Health Committee unanimously approved Senate Bill 194, mandating cardiac screening forms for every student athlete in intramural and interscholastic programs. The form probes chest pain during exercise, unexplained fainting, prior cardiac events, and family heart‑disease history. Students who...
GLP‑1 drugs such as Wegovy and Mounjaro require cool storage, yet airlines do not offer refrigeration for passenger medication. Flight attendants cannot place these injectables in aircraft fridges, which are intended for food and may vary in temperature. Travelers must...
A recent Substack post cites a study claiming COVID‑19 mRNA vaccines increase reports of rare neurological disorders by dozens to thousands of times compared with flu shots, based on VAERS data from 1990‑2024. The post lists specific conditions such as...
The FDA has approved relacorilant (Lifyorli), a glucocorticoid‑receptor antagonist, in combination with nab‑paclitaxel for adults with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received up to three prior regimens, including bevacizumab. The approval is based on...
Pharmaceutical firms are pivoting from healthcare providers to patients as the primary focus of their support programs, a shift accelerated by recent policy changes. The expiration of enhanced ACA subsidies and the One Big Beautiful Bill are reducing insurance enrollment, leaving millions uninsured...
The Electronic Frontier Foundation has filed a Freedom of Information Act lawsuit against the Centers for Medicare & Medicaid Services to obtain records on the WISeR program, a multi‑state Medicare pilot that uses artificial intelligence to evaluate prior‑authorization requests. WISeR,...
Resident doctors in England will commence a six‑day strike on 7 April after the British Medical Association (BMA) rejected a government offer of a 3.5% pay rise. The dispute, now the 15th walk‑out since March 2023, also centers on job shortages and...
Researchers conducted an explanatory sequential mixed‑methods study to develop patient‑safety strategies for public hospitals in Addis Ababa, Ethiopia. Using stratified sampling, questionnaires, checklists, and interviews, they combined descriptive statistics, logistic regression, and thematic analysis to identify safety culture gaps. The...
A large U.S. retrospective study of 295,016 gastroparesis patients found that 29.9% also suffered constipation, yet only 1.4% were diagnosed with a defecatory disorder. Among those diagnosed, just one‑third underwent anorectal manometry (ARM) and fewer than 4% received biofeedback therapy....
A NHANES cohort of 1,468 U.S. cancer survivors examined how combined cardiovascular‑kidney‑metabolic (CKM) stage and lifestyle affect mortality. Participants were grouped by early (stages 0‑2) or late (stages 3‑4) CKM and by high versus non‑high scores on the behavior‑only Life’s Essential 8 (diet,...
A Phase 1 randomized crossover trial will compare the hemodynamic impact of 1 liter oral tap water versus 1 liter intravenous Ringer’s lactate in 20 healthy volunteers. The primary endpoint is the change in mean arterial pressure 30 minutes after fluid administration, with secondary...
Researchers examined the link between estimated cerebral perfusion pressure (CPPe) and Doppler ultrasound measurements in newborns. Analyzing 446 daily samples from 137 preterm infants across multiple NICUs, they found end‑diastolic velocity (EDV) had the strongest correlation with CPPe (β = 0.571, p < 0.001)....
Researchers identified a drug combination that enhances the brain's glymphatic system, improving clearance of Alzheimer‑related proteins. The regimen pairs a widely used sedative with a medication that prevents dangerously low blood pressure, showing safe and effective removal of amyloid and...
Wearable devices and AI‑driven health mirrors now collect detailed physiological data before patients ever see a doctor. This influx of self‑generated metrics forces physicians to act as interpreters rather than primary decision‑makers. Many platforms promise direct data transmission to clinicians,...
A 2023 Lancet study analyzing 152 countries from 1971‑2021 finds that international sanctions, especially unilateral U.S. measures, are associated with an estimated 777,000 excess deaths each year. The mortality impact is most pronounced among children under five and older adults,...
Unused or expired medicines pose health and safety risks, prompting the FDA and DEA to promote safe disposal options. Consumers can drop off drugs at pharmacy or police take‑back sites, use prepaid USPS mail‑back envelopes, or follow the FDA’s Flush...
A retrospective analysis of nearly 600 urgent or emergent transcatheter aortic valve replacement (TAVR) procedures performed between 2012 and 2024 compared Medtronic self‑expanding valves (SEVs) with Edwards balloon‑expandable valves (BEVs). Adjusted Cox regression showed no significant difference in long‑term mortality...
On March 27, 2026, the U.S. Food and Drug Administration granted approval to Denali Therapeutics’ drug Avlayah for the treatment of Hunter syndrome, a rare lysosomal storage disorder. The decision arrives amid a recent wave of stricter FDA scrutiny of...
Researchers identified two conjugated polyunsaturated fatty acids, α‑eleostearic acid (α‑ESA) and its methyl ester (α‑ESA‑me), as potent senolytics that selectively eliminate senescent cells. In mouse models, short‑term dosing reduced senescence markers and SASP factors across liver, heart, kidney, and lung...
NOVOS launched a randomized, double‑blind, placebo‑controlled trial of a multi‑component supplement in adults over 40, enrolling 61 participants and completing six months with 43 finishers. Early preprint data show a 2.9% improvement in flow‑mediated dilation, a 1.18 m/s reduction in pulse‑wave...
EXCLUSIVE: in a sea of Terminator-looking bots, Aussie founder Grace Brown took a different direction for her robot, Abi: color, bubbles, and fun. Now her startup Andromeda, which has raised $16.6M, is launching for senior homes across the U.S. - with...
No one is going to come save you. That line is the center of this episode of The Podcast by KevinMD, and it lands because it names something many physicians feel but rarely say out loud. Hospice and palliative care physician Sarah...
Akeso, Inc. has obtained clearance from China’s National Medical Products Administration to begin Phase II trials of two novel antibody‑drug conjugates, AK146D1 and AK138D1. The studies will combine the ADCs with the company’s approved bispecific immunotherapies cadonilimab and ivonescimab, marking the...
Humanoid robots + AI will mean everyone on Earth has access to better medical care than the richest person alive today. THAT is what abundance looks like.
When people ask "How can we make #AAV #GeneTherapy accessible and affordable" --> this is how 👇
