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
Shoulder Innovations reported a record fourth‑quarter revenue of $56.3 million, up 15 % year‑over‑year, and full‑year sales of $200.9 million, reflecting 20 % growth. Gross margin stayed near 79 % while adjusted EBITDA turned positive at $5.1 million, a 176 % improvement, and the company generated its first quarter of positive free cash flow. Management highlighted FDA clearance for Intra TI, an upcoming Breakthrough Device, and a new partnership with Smith + Nephew to expand trauma market access. Guidance for 2026 targets $228.5‑$232.5 million revenue, indicating continued double‑digit growth.
BioNTech’s Q4 2024 earnings call highlighted a strategic pivot toward oncology, emphasizing the advancement of its bispecific antibody BNT327 and the recent acquisition of Biotheus to secure Chinese manufacturing and development capabilities. The company reported positive Phase 2 data for...
ADC Therapeutics reported Q4 2025 product revenue of $15.8 million, down from $18 million a year earlier, while GAAP net loss narrowed to $41 million ($0.30 per share). Non‑GAAP operating expenses fell 12.1% to $45 million, driven by lower R&D spend. A $60 million private...
Amarin reported fourth‑quarter 2025 net revenue of $49.2 million, down 21% year‑over‑year, while U.S. sales slipped 7% due to proactive pricing. Operating expenses fell 31% as the company pursued a global restructuring, narrowing the non‑restructuring operating loss to $2.3 million and generating...
Mainland Chinese investors can now trade more than a dozen newly added Hong Kong‑listed biotech and pharmaceutical firms through the Stock Connect southbound leg, reflecting the sector’s rising prominence. Shares of Insilico Medicine surged over 58% after a string of...
Researchers from the University of Birmingham, Rwanda Biomedical Centre and the University of Rwanda have validated an IgG ELISA assay for mpox antibodies during the clade 1b outbreak in Rwanda. The MpoxCARE test, built on four key antibody signatures, demonstrated high...
The Australian National Audit Office (ANAO) has criticised the Department of Health, Disability and Ageing for spending almost $1 billion on suicide‑prevention programs without any evaluation criteria. Between 2022‑23 and 2025‑26 the department administered 41 measures, yet failed to establish performance...
The Hong Kong Productivity Council has opened the Future Life and Health Tech Centre, a research‑development hub designed to fast‑track AI‑driven innovations across medical technology, biotechnology, functional foods and modernised traditional Chinese medicine. The facility offers an end‑to‑end platform that...
Australia’s Western NSW Local Health District has deployed a virtual support service that continuously monitors patient data across 35 rural hospitals. Algorithm‑driven early warning scores flag clinical deterioration in real time, allowing clinicians at a central hub to alert frontline...
Indiana University researchers linked clonal hematopoiesis of indeterminate potential (CHIP) to heightened severity of inflammatory bowel disease. Analysis of UK Biobank and All of Us data showed women with DNMT3A mutations and younger individuals with TET2 mutations face higher Crohn’s...
An international team genetically deleted the ENA1 gene from Saccharomyces boulardii, a common probiotic yeast. In immunosuppressed mice, the ENA1‑deficient strain showed no mortality, raising survival from 30‑40% to 100% compared with wild‑type isolates. The edit also reduced osmotic stress...
Senate Democrats have pressed major pharmaceutical companies to clarify the secretive most‑favored‑nation (MFN) pricing agreements they struck with the Trump administration in December. Lawmakers are questioning how those deals align with the Centers for Medicare & Medicaid Services’ new GENEROUS...
Researchers at King's College London identified genetic markers that determine whether donor microbes persist after fecal microbiota transplantation (FMT). By tracking biosynthetic gene clusters in 86 healthy adults over a year, they distinguished stable clusters that remain long‑term from transient...
Health care leaders in Western New York warned that chronic underfunding and looming federal Medicaid cuts are creating a $2 billion budget gap that could force additional nursing homes and hospitals to close. Recent shutdowns of Weinberg Campus, Eastern Niagara Hospital...
The article highlights e‑prescribing’s rapid national rollout, which eliminated paper scripts and enabled direct provider‑to‑pharmacy transmission. However, critical gaps remain: pharmacies cannot share real‑time inventory data, and pharmacy‑to‑pharmacy transfers still rely on fax and phone calls. The author’s personal experience—an...
A new Common Health Coalition report warns that a modest 1% annual decline in childhood MMR vaccination rates could trigger a seven‑fold surge in measles cases. The model predicts an additional 17,000 infections, 4,000 hospitalizations and 36 preventable deaths each...
Oroville Hospital President and CEO Robert Wentz is retiring after more than four decades of service, with the board approving a leadership transition to COO Scott Chapple. The change will take effect once the Chapter 11 reorganization plan receives court...
The Malcolm Baldrige National Quality Award has named two healthcare organizations—Nor Lea Hospital District in New Mexico and Northwell Glen Cove Hospital in New York—as its 2025 recipients. Both institutions demonstrated sustained, patient‑centered excellence across leadership, operations, and community impact,...
Montrose Regional Health and Grand Junction’s Community Hospital have signed a letter of intent to explore forming a tax‑exempt nonprofit entity. The partnership would focus on nonclinical functions such as information technology alignment, group purchasing, long‑term planning, and revenue‑cycle optimization....
Roche’s oral selective estrogen receptor degrader (SERD) giredestrant failed to meet its primary endpoint in a late‑stage Phase III trial, but the data revealed meaningful activity in specific patient subgroups, particularly those with ESR1 mutations. The miss prompted Roche to...
Lumina Health Partners has joined ECG Management Consultants, integrating its co‑founders into ECG’s Payer Strategy and Contracting Division. The move deepens ECG’s expertise in value‑based care, combining Lumina’s ten‑year track record advising hospitals with ECG’s national scale and tech‑enabled solutions....
U.S. life expectancy has essentially plateaued since 2010, delivering only a few months of gain compared with the steady improvements of previous decades. A new PNAS study identifies the Baby Boomer cohort as a mortality inflection point, with earlier generations...
Vertex Pharmaceuticals announced that its experimental IgA nephropathy drug povetacicept met primary and key secondary endpoints in a Phase 3 trial, cutting urine protein by roughly 50% versus placebo after 36 weeks. The interim results also showed reductions in abnormal antibodies...
Researchers at Rice University and Baylor College of Medicine used a non‑editing CRISPR system to activate the PPARGC1A gene, boosting mitochondrial production in human cardiomyocytes. The technique safely increased cellular energy output, as shown by higher oxygen consumption in cell...
Regional One Health received a certificate of need from the Tennessee Health Facilities Commission to build a $900 million hospital on the former Commercial Appeal site in Memphis. The project, slated to break ground in late September 2025, is underpinned by a...
At HIMSS26 Executive Summit, senior leaders from Parkland Health and AltaMed debated how to quantify AI’s return on investment in healthcare. They highlighted the difficulty of measuring hard financial gains while acknowledging that AI can free clinicians from documentation and...
The American Diabetes Association praised South Dakota Governor Larry Rhoden for signing House Bill 1143, which allows students with diabetes to possess and self‑administer insulin and related supplies during school hours and activities. The legislation requires written authorization from a...
San Francisco agreed to a $500,000 settlement with the Pham family, who sued over the wrongful death of their father after his transfer from Laguna Honda Hospital. The settlement comes as the safety‑net hospital, which lost certification in 2022, regained...
A new guide extension catheter, CrossFAST, received FDA clearance in December 2024 and has shown improved efficiency and safety in complex percutaneous coronary interventions. Early clinical experience with four patients demonstrated rapid, deep coronary intubation without balloon‑assisted tracking, reducing dissection risk...
The FDA announced a draft guidance that would permit e‑cigarette flavors such as mint, coffee, tea, and spices while maintaining a ban on sweet and fruity varieties. The shift follows earlier attempts to curb teen vaping with a broad flavor...
Stryker, the world’s fifth‑largest medical‑device maker, has been awarded the first Healthcare Industry Resiliency Collaborative (HIRC) Enterprise Gold Resiliency Badge for its overall supply‑chain performance. The badge, based on a third‑party assessment of demand planning, inventory management, visibility, supplier and...
Shield Therapeutics announced that the FDA has approved Accrufer, its ferric maltol oral iron formulation, for children ages 10 and older, making it the first prescription oral iron therapy for this age group. The approval expands the drug’s label beyond...
Nick Hut and Katie Gilfillan outline a forthcoming accountable care organization (ACO) model slated for 2027. The proposal calls for deeper financial risk sharing, real‑time analytics, and a stronger focus on patient‑centered outcomes. It builds on recent CMS payment reforms...
Adventist HealthCare announced it will close the Germantown Emergency Center, a freestanding ER in Maryland, effective July 1 pending state approval. The decision follows a roughly one‑third drop in patient volume, with many visits for low‑acuity conditions that could be...
The latest #CareTalk episode highlights how decades of chronic underfunding have left America’s public health infrastructure fragile. Dr. Stella Safo of Civic Health Alliance warns that essential health‑security institutions are being dismantled and calls on the healthcare sector to defend...
A fourth federal trial opened in Chicago alleging Abbott Laboratories' cow‑milk‑based infant formula triggered necrotizing enterocolitis (NEC) in premature infants. The case follows a $495 million Missouri verdict against Abbott and a $60 million Illinois verdict against Mead Johnson, both in 2024. A...
Pregnancy is an immunological paradox. Half the baby's DNA comes from someone else. Your immune system should reject it the way it rejects a transplant. But it doesn't. Your body pulls off this precise immune shift where the immune cells...
Actually he has it a bit backwards, those vaccinated with IPV can still acquire poliovirus and shed virus, but it prevents the virus from entering the bloodstream + protects almost 100% paralytic polio, just like the Covid vaccine protects 80-90%...
Coherus Oncology posted FY 2025 revenue of $42.2 million, driven by a 64% year‑over‑year jump in LOQTORZI sales and a $12.4 million Q4 boost. The company cut its debt by more than 90% to $38.8 million and lifted cash reserves to $172.1 million after two...
Vertex $VRTX says its drug successfully reduced marker of kidney disease in late-stage trial https://t.co/TbEkcHVYBB via @Jasonmmast
Oracle isn’t just working to keep pace with industry change. We’re setting the standard by delivering intelligent and secure solutions that can directly impact patient care and boost efficiency across the healthcare ecosystem. Here’s what you can expect this week at...
Statista projects that the U.S. pharmaceutical market will be led by ten blockbuster drugs in 2026, with Merck’s Keytruda topping the list at $12.7 billion in sales. Four oncology therapies—Keytruda, Opdivo, Imbruvica and Ibrance—are among the top ten, underscoring cancer’s continued...
Bristol Myers claims success in study of another next-gen blood cancer drug https://t.co/fqPbZ2Szv8 by @gwendolynawu $BMY
At HIMSS26, CEO Hal Wolf will host a panel examining AI tools' "attitude." Leaders will discuss why understanding both the data provenance and the designer's identity, values, and goals is critical. The session aims to guide healthcare organizations in evaluating...
Community‑driven programs such as Go for Bold demonstrate measurable weight loss and BMI improvements, but their impact stalls without supportive food‑system policies. Research on national sodium‑reduction laws shows dramatic drops in fractures, heart attacks, strokes and health‑care costs when intake...
The link between exposure to DEHP and its metabolite MEHP, found in plastics, and risk of breast cancer in a 20-year prospective study https://t.co/wKEVlMxWHT https://t.co/j5NL5QfTBu
The 1199SEIU Healthcare Workers East union is rallying for the Home Care Savings and Reinvestment Act, which would strip private insurers from New York's Medicaid home‑care payment system and replace them with a state‑run fee‑for‑service model. Proponents claim the change...
A new Annenberg Public Policy Center survey reveals a growing trust gap in U.S. health information. About 73% of Americans say they trust physicians and the American Medical Association, while confidence in federal health agencies has slipped. However, career scientists...
The U.S. Food and Drug Administration issued a warning‑letter close‑out to APS BioGroup, Inc. on April 5, 2018, confirming that the company’s corrective actions addressing the July 2017 warning letter were satisfactory. The agency stressed that this closure does not relieve APS BioGroup...
The FDA issued a Warning Letter to Dr. James Findling after a 2019 inspection revealed serious protocol violations in a clinical trial of an investigational drug. The investigator randomized two subjects who had exceeded permitted dose levels and failed to...
