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 FDA initially refused to review Moderna’s mRNA‑based flu vaccine, prompting surprise among industry observers. After a White House meeting, the agency reversed course and granted Moderna a Type A meeting, effectively resetting the review process. Lanton notes this regulatory flip‑flop underscores lingering skepticism toward mRNA platforms beyond COVID‑19. The episode raises questions about the stability of the U.S. approval pathway for future mRNA therapies.
New York’s legislation, signed by Governor Kathy Hochul, shifts the state’s oral‑health model. By mid‑2027, licensed dental hygienists can operate without direct dentist supervision under a collaborative agreement with one dentist. The law also adds foster‑care agencies to approved work...
Health care stakeholders in New York are mobilizing as the state budget negotiations intensify, with the Associated Medical Schools of New York lobbying for an additional $100 million to bolster biomedical research and life‑science jobs. The state already receives over $3.5 billion...
Daiichi Sankyo and AstraZeneca have received FDA priority review for ENHERTU® as a post‑neoadjuvant therapy in HER2‑positive early breast cancer. The decision follows the DESTINY‑Breast05 phase 3 trial, which showed a 53% reduction in invasive disease‑free survival events versus trastuzumab‑emtansine (T‑DM1). Three‑year...
The Scottish Ambulance Service (SAS) does not maintain a central record of employees with Armed Forces ties, but it runs a voluntary internal network for veterans, reservists, and their families. Between 2022 and 2025, 166 staff members logged 12,976.5 hours...
Charlotte’s Bechtler Museum of Modern Art, partnered with Novant Health, launched the Charlotte Art on Prescription pilot, providing free year‑long access to museums, ballet, theater, and pottery classes for socially isolated residents. Participants are referred by Novant’s 68 behavioral‑health specialists...
Ipsen is voluntarily withdrawing its EZH2 inhibitor Tazverik worldwide after an interim safety analysis in the phase 1b/3 SYMPHONY‑1 trial linked the drug to secondary hematologic malignancies. The pull‑back includes terminating all ongoing Tazverik studies and recalling the product in markets...
The March edition of Health Tech Tracker has been released, offering a concise monthly snapshot of the health‑tech ecosystem. It aggregates recent deals, emerging trends, regulatory challenges, and market opportunities observed over the past 30 days. The report also features...
California Governor Gavin Newsom is positioning the state as a national public‑health bulwark by hiring former CDC officials, forming the West Coast Health Alliance with Oregon, Washington and Hawaii, and becoming the first state to join a WHO‑coordinated outbreak network....
In this episode, philosophy researcher Atay Kozlovski discusses the ethical challenges of AI, focusing on how to maintain meaningful human control over increasingly autonomous systems. He highlights common failure modes such as automation bias and algorithmic bias, illustrating them with...
Healthcare providers, suppliers, and distributors are tackling fragmented IT systems that impede supply‑chain data sharing. Leaders at Nebraska Medicine, Heartland Dental, and Sinceri Senior Living have implemented procurement interoperability solutions—primarily through Amazon Business integrations—to automate purchase orders, gain real‑time spend...
Healthcare logistics is moving from disposable to circular cold chain packaging, turning boxes into reusable infrastructure. Studies show reusable containers can lower per‑shipment costs by 30‑50% and cut global warming potential by 75%. By engineering packs to reduce dimensional weight,...
Process Performance Qualification (PPQ) is the final validation step before commercial manufacturing of cell and gene therapies, but its complexity often triggers delays and compliance risks. The article highlights three proven strategies—early master‑plan development, continuous quality improvement, and data‑driven analytics—to...
The NHS is moving from a fragmented, market‑led patient‑engagement model to a centrally managed "digital front door" anchored in the NHS App. Funding for the Wayfinder programme will cease in March 2026, saving an estimated £11 million annually and shifting integration directly...
Modern wellness clinics are expanding beyond cosmetic services to include IV hydration therapy as a preventive health option. By delivering fluids, electrolytes, and vitamins directly into the bloodstream, these treatments aim to quickly restore balance for athletes, frequent travelers, and...
Roche’s oral breast‑cancer therapy, touted as a potential blockbuster, missed its primary endpoint in the pivotal Phase 3 persevERA trial. The study evaluated the drug as a first‑line treatment for hormone‑receptor‑positive, HER2‑negative metastatic breast cancer and enrolled more than 1,200 patients...
Researchers propose a comprehensive green additive manufacturing (AM) cycle for medical devices, integrating circular‑economy principles into design, material selection, and process control. The roadmap emphasizes digital inventory, on‑site production, and validated reuse pathways while addressing strict sterilization and biocompatibility regulations....
Hesta Health has opened early access to its postnatal health‑check programme, Recovery, for women in the first six months after birth. The service combines a clinically designed online questionnaire, an at‑home blood test that measures 51 biomarkers across eight domains,...
The NIHR HealthTech Research Centre in Exeter and Sanome have secured a £300,000 Innovate UK SMART grant to advance MEMORI, an AI‑driven clinical decision support platform that predicts hospital‑acquired infections up to seven days before symptoms appear. Early trials show...
Under the Trump administration, the U.S. government slashed nearly $500 million in mRNA research funding, canceling 22 projects and a $766 million Moderna contract. The FDA’s initial refusal then reversal to review Moderna’s flu vaccine highlighted regulatory skepticism toward the platform. Private‑sector...
USC’s Alfred E. Mann School of Pharmacy will open its first community pharmacy in South Los Angeles next month, located beside the T.H.E. Health and Wellness Center in Hyde Park. The modest launch will start with three staff members and expand...
Robert F. Kennedy Jr., now HHS Secretary, is intensifying his anti‑vaccine campaign by supporting a MAHA Institute roundtable titled “Massive Epidemic of Vaccine Injury.” The event, held in Washington, D.C., features oncologist Dr. Wafik El‑Deiry alongside well‑known antivax activists such...
Seoul’s municipal government announced plans to expand its pool of medical‑tourism interpreter‑coordinators to roughly 1,000 this year, a ten‑fold jump from the current cadre. The expansion follows a newly signed memorandum of understanding with the K‑Medical Tourism Association, which will...
Comparative analysis of senolytic drugs reveals mitochondrial determinants of efficacy and resistance "findings suggest that mitochondrial quality control is a key determinant of resistance to ABT263-induced and ARV825-induced senolysis, providing a possible framework for rational combination senotherapies." https://t.co/xB0wFkzIW9
A key read regarding some (just some) examples of inappropriate, offensive, and/or inaccurate comments by Vinay Prasad (from May of last year) An Anti-Science MAHA Extremist Is Playing a Major Role at the FDA https://t.co/oFNaYm0qlD via @newrepublic https://t.co/P1V9lMdDjn
IV vitamin therapy is gaining popularity as a wellness service that delivers nutrients directly into the bloodstream, bypassing the digestive system. Proponents claim benefits such as improved mental clarity, fatigue reduction, and immune support, while critics point to limited high‑quality...
Pacemakers and implantable cardioverter defibrillators (ICDs) are small, sub‑cutaneous devices that correct abnormal heart rhythms, but they operate differently. Pacemakers deliver mild electrical pulses to keep a slow or irregular heartbeat steady, while ICDs monitor for rapid, life‑threatening arrhythmias and...
Kristof De Smedt, a veteran with over 25 years in pharma logistics, was promoted on October 1 2025 to Global Market Segment Director for Airlines and Logistic Providers at Cold Chain Technologies (CCT) following its acquisitions of Tower Cold Chain and Global...
Mammography should include AI assessment of breast artery calcification, since it provides very useful information about cardiovascular risk https://t.co/yfTbTRrOuY https://t.co/h1C8ZnHepJ
A European Migraine and Headache Alliance survey of 5,410 women revealed major gaps in diagnosing and treating hormonally linked migraine. Forty‑two percent of respondents had never received a formal diagnosis, and 35% reported that doctors never discussed their symptoms. While...
Singapore’s Ministry of Health unveiled three new measures to curb rising healthcare costs as the nation becomes a super‑aged society. From 2027, MediSave withdrawal limits will rise to S$700 for basic chronic care and S$1,000 for complex cases, while the...
Researchers at Emory University used artificial intelligence to evaluate arterial calcium visible on routine mammograms, linking it to future cardiovascular events. The study examined 123,762 women without prior heart disease and found that mild, moderate, and severe breast arterial calcification...
My latest Substack: Why predictions that radiologists will be replaced by AI (including, famously, by genAI founding father and Nobel laureate Geoffrey Hinton) have been wildly off base, and what that teaches us about job replacement for doctors. https://t.co/hz2gKz6Ewh https://t.co/waJUY22Qk1
Epic Systems has launched a series of lawsuits targeting patent trolls and other entities it deems harmful to the healthcare software ecosystem. The company’s legal offensive seeks injunctions and damages to safeguard its multi‑billion‑dollar portfolio. Simultaneously, industry observers note a...
NHS England has temporarily stopped new prescriptions of cross‑sex hormones for 16‑ and 17‑year‑olds after an evidence review deemed the existing research on benefits and harms “really weak.” The pause applies only to new cases; current patients will continue treatment...
NHS England has temporarily stopped issuing new cross‑sex hormone prescriptions to 16‑ and 17‑year‑olds after an independent review deemed the existing evidence on benefits and harms "remarkably weak." The pause applies only to NHS‑funded care; patients already on treatment will...
Presbyterian Healthcare Services in New Mexico is expanding its use of GW RhythmX’s AI‑powered precision‑care platform, now deployed with 200 primary‑care clinicians across its nine‑hospital system. The tool, embedded in the Epic EHR, surfaces clinical insights and evidence‑based recommendations at...
Healthdirect Australia has launched a Patient Consult Summary (PCS) application within its video‑call platform, which handles more than 150,000 virtual consultations each month. The tool lets clinicians create and share concise, plain‑English summaries instantly via typing, speech‑to‑text, or copy‑paste, and...
The Hong Kong Polytechnic University and the University of Toronto have signed a memorandum of understanding to launch a Joint Research Centre on Healthy Ageing and AgeTech. The centre will conduct cross‑border pilots in hospitals, long‑term care homes and community...
Arcutis Biotherapeutics reported record Q4 2025 results, with net product revenue of $127.5 million, an 84% year‑over‑year increase, and full‑year revenue up 123% to $372.1 million. Management raised its 2026 net product revenue guidance to $480‑$495 million, citing strong prescription growth, expanded Medicare...
Biodesix reported fiscal 2025 revenue of $88.5 million, a 4,124 % year‑over‑year increase driven largely by its lung‑diagnostics business. Gross margins rose to 83 % in Q4 and the company posted its first positive adjusted EBITDA of $530 k. A strengthened balance sheet now...
Beta Bionics reported a 54% jump in 2025 net sales to $100.3 million, with Q4 revenue climbing 57% to $32.1 million. Gross margin improved to 55.4% for the year and 59% in Q4, driven by scale and a growing pharmacy channel that...
Zevra Therapeutics reported Q3 2025 net revenue of $26.1 million, driven primarily by $22.4 million from its FDA‑approved NPC therapy MyPlayFa. The company narrowed its net loss to $0.5 million, a dramatic improvement from a $33.2 million loss a year earlier, while cash and...
Editas Medicine reported Q2 2024 progress on its gene‑edited cell therapy reni‑cel, presenting interim data from the RUBY sickle‑cell and EdiTHAL beta‑thalassemia trials. All 18 RUBY patients were free of vaso‑occlusive events, with hemoglobin levels above 14 g/dL and fetal hemoglobin exceeding...
Researchers have engineered a dual‑stimuli‑responsive nanoparticle that activates the STING pathway only when both acidic pH and hypoxic NQO1 activity are present, creating an AND‑logic release of the agonist MSA‑2. In preclinical models of lung carcinoma, triple‑negative breast cancer and...
ARS Pharmaceuticals reported a pivotal quarter, with U.S. Neffy net product revenue soaring to $31.3 million—a 2.5‑fold quarter‑over‑quarter increase that beat consensus. New prescriber market share reached 10.3% and provider adoption rose 85% since August, while the Get Neffy On...
Are you looking to be part of a meaningful conversation, Seattle? On April 1, I’ll be at Elliott Bay Book Company for the launch of my book, The Cost of Healing in Silence. We’ll be in conversation about racial trauma, culturally...
University of Hong Kong researchers unveiled SonoMeta, an AI‑powered ultrasound system that uses engineered metamaterials to steer sound waves around rib bones. The meta‑lens design improves imaging depth, allowing clear visualization of cardiac valves up to 10 cm behind the ribcage...
Australian news site news.com.au has launched the four‑week “Fire Up” campaign to spark a national conversation on menopause, partnering with Priceline Pharmacy. The initiative, informed by a survey of over 2,000 Australians, highlights that 37% of respondents know little about...
A large meta‑analysis of 32 studies involving over 100 million people found that recreational drug use significantly raises stroke risk. Amphetamine users face a 122 % higher risk, cocaine users 96 % higher, and cannabis users 37 % higher compared with non‑users. The risk...
