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
ARUP Laboratories has unveiled the Innovation Central Laboratory, a dedicated hub for co‑development with pharmaceutical and biotech partners. The facility is designed to validate technologies and move next‑generation diagnostics from concept through to commercial readiness. It will host projects ranging from rare‑disease assay development to advanced genomic sequencing, AI‑driven digital pathology, and neurodegenerative biomarker discovery. By creating a collaborative ecosystem, ARUP aims to accelerate test adoption in clinical labs worldwide.
Boston’s life‑sciences sector is adding thousands of well‑paying technician positions that often don’t require a four‑year degree. To address the fragmented training ecosystem, the city funded the Life Sciences Career Alliance with $4.7 million, appointing Year Up United as the coordinating...
The FDA approved KOMZIFTI (ziftomenib) on November 13 2025 as an oral 600 mg capsule for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring an NPM1 mutation. Approval rests on the single‑arm KO‑MEN‑001 trial, which enrolled 112 participants across seven...
Actor Eric Dane’s death has thrust ALS into the national spotlight, highlighting the disease’s relentless progression and the emotional toll on patients and families. Palliative‑care physician Dr. Maria Mapa stresses that early goals‑of‑care conversations can preserve dignity and reduce costly...
The January 2026 Patent Highlights roundup spotlights a wave of new intellectual‑property activity across several cutting‑edge drug discovery areas. Notable filings include lysine‑directed covalent inhibitor chemotypes, strategies to balance potency with drug‑like properties, refined target‑selection frameworks, dozens of Polθ synthetic‑lethal patents...
Healthcare M&A activity surged in 2025, with financial distress driving a record 43% of transactions. Regulatory scrutiny intensified, highlighted by California’s new law tightening oversight of private‑equity deals. Major deals included UnitedHealth’s $3.3 billion acquisition of Amedisys, Baptist Memorial’s $55 million purchase of...
The FDA has issued online advisory letters to multiple companies for illegally marketing dietary supplements and other products as treatments or preventatives for serious diseases. The letters, dated between April and December 2025, give each firm a 30‑day window to...
The new book Physicians With Lived Experience by Dr. Michael F. Myers compiles personal narratives that illuminate the hidden crisis of physician mental health and suicide. Forewords by Jennifer Breen Feist and Dr. Darrell Kirch highlight the power of storytelling, the passage...
Oregon and Oklahoma are set to launch their own state‑based ACA exchanges, bringing the total to 23 states (including DC) that will operate independent marketplaces by 2028. This shift will push state‑run exchanges past the 50 percent population mark, a milestone...
What is Infinite Healthcare Worth? As AI becomes a new site of care and automates administrative orchestration, it rapidly eats into $5T+ worth of traditional health care services spend, and potentially represents the biggest market opportunity in all of healthtech....
VITAS Healthcare, a Chemed Corp subsidiary, saw Q4 2025 revenue pressured by a Medicare payment‑cap liability that spiked to $6.1 million, largely in Florida. To offset the cap, the hospice shifted toward hospital‑based short‑stay referrals, which boosted patient volume but lowered...
A recent study demonstrates that a machine‑learning pipeline combining advanced feature selection with ensemble classifiers markedly improves chronic kidney disease (CKD) risk prediction. Gradient‑boosting models achieved the highest performance, reaching 98% accuracy, 99% recall and an AUC of 0.99, while...
The Centers for Medicare & Medicaid Services entered the third year of its Medicare drug price negotiation program, selecting 15 drugs—including, for the first time, therapies covered under Medicare Part B. Patient advocacy groups have until March 1 to submit written comments...
Physician Francisco M. Torres argues that the bedside physical exam remains a vital diagnostic tool despite rapid advances in imaging and lab tests. He recounts two personal cases—a misdiagnosed sciatica caused by shingles and a postoperative fluid collection missed without...
Walgreens has added a virtual weight‑management clinic to its digital health platform, charging a flat $49 per video visit with no monthly subscription. The service targets self‑pay adults aged 18‑64 who need FDA‑approved GLP‑1 medications, and it bundles prescription discounts...
Researchers at UNIST, KAIST and Yonsei have developed a reusable molybdenum disulfide (MoS₂) radio‑frequency biosensor for liquid‑biopsy cancer detection. The sensor detects single‑stranded DNA fragments as low as 154.67 nM by monitoring shifts in resonant frequency, and can be washed and...
Medtech M&A kicks off 2026 with several multibillion‑dollar deals. Boston Scientific announced a $14.5 billion acquisition of Penumbra, while Danaher disclosed a $9.9 billion purchase of Masimo. At the same time, major divestitures are underway, including BD’s planned $17.5 billion sale of its...
Positrigo, a Swiss developer of nuclear medical devices, has launched the BrainPET Accelerator Program in the United States, offering neurology practices a ready‑to‑operate brain PET solution. The program bundles a compact NeuroLF scanner, radiotracer logistics, regulatory assistance, reimbursement support, and...
Eko Health has partnered with Wayne General Hospital in Mississippi to roll out its SENSORA AI‑assisted cardiac detection platform across emergency and primary‑care units. The system pairs a digital stethoscope with FDA‑cleared AI that analyzes heart sounds in under a...
University of Missouri School of Medicine received a $4.6 million federal grant to launch a mobile pre‑hospital blood transfusion program in Columbia. The initiative aims to equip EMS crews with training and portable blood supplies, targeting rapid intervention for trauma victims,...
(Hopefully) Final word today on the Makary $QURE (or was it $RGNX) thing: Bottom line: Makary shouldn't be talking publicly about unresolved drug applications. Uniqure doesn't even have an application submitted; and RegenxBio's CRL letter isn't posted to the FDA's...
Bristol Myers Squibb reported that its antibody‑drug conjugate iza‑bren, licensed from Chinese partner SystImmune, achieved statistically significant improvements in progression‑free and overall survival versus chemotherapy in a Phase III trial for advanced triple‑negative breast cancer. The study, conducted in mainland China...
Sentara’s high‑volume TAVR center adopted the AI‑enabled DASI 3‑D planning platform to move beyond static CT measurements. The software dynamically simulates valve frame expansion, calcium deformation, and tissue interaction, allowing clinicians to test multiple valve sizes and depths before the...
Beta Bionics received an FDA warning letter citing failure to report serious adverse events, unreported software and cybersecurity changes, and hardware defects in its iLet Bionic Pancreas system. The agency highlighted delayed reporting of hypoglycemia and hyperglycemia incidents, a five‑minute...
You've got to watch this Makary interview on CNBC. He attacks a drug, hits the Old FDA and circles all the wagons around Vinay Prasad, who "loves President Trump" and faces a fatwa (WSJ). Makary is getting major props for...
India’s Generation X is projected to spend over $500 billion on goods and services by FY 30, according to RedSeer. The cohort’s spending will be led by preventive healthcare ($73 billion, 17% CAGR) and nutraceuticals ($20 billion, 25% CAGR). Premiumisation will also drive growth in...
A recent OurCare survey found 5.9 million Canadians lack a primary‑care provider, and those with one face long waits and rushed visits, driving emergency‑department crowding. The federal government responded by creating 5,000 Express Entry slots for international doctors, but experts argue...
The FDA granted 510(k) Class II clearance to Qure.ai’s qXR-Detect, adding six new chest‑X‑ray detection indications. The tool now flags findings across lung, pleura, mediastinum/hila & heart, bone, hardware and other regions, expanding the company’s U.S. portfolio to 26 FDA clearances. The clearance...
FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad "Vinay Prasad is a genius,” Makary said. “He’s on loan from UCSF. He’s published over 500 scientific peer-reviewed articles, and some of the drugs they are criticizing him for...
I've written so much about various details of healthcare's AI revolution that it was time to come up with a high-level overview of what we can certainly expect from AI in the next few years. 10 predictions, coming from four...
An international team led by the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust and Bristol Myers Squibb has produced the most detailed spatial atlas of pancreatic ductal adenocarcinoma (PDAC) to date. Using spatial transcriptomics and spatial molecular imaging...
![[Comment] Impact of Adding Hormone Therapy to Postoperative Radiotherapy in Prostate Cancer](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/f1452ec53e5201a4460c9aaf141538d3.webp)
Adding androgen deprivation therapy (ADT) to definitive radiotherapy improves overall survival for men with high‑risk prostate cancer, but its benefit when combined with postoperative radiotherapy (PORT) after prostatectomy is less clear. Randomised trials such as GETUG‑AFU 16, SPPORT, and the RADICALS‑HD...
Owners of a concierge medical practice attempted a sale, but the first Letter of Intent (LOI) collapsed, leaving them to restart the process. They turned to Axial's Advisor Finder, which quickly presented four vetted M&A advisors with healthcare expertise. After...
The FDA announced it will default to a single pivotal trial for new drug applications, extending a practice long used in oncology and rare‑disease approvals. In 2024, 66% of new molecular entities were cleared based on one trial, signaling a...
Cisco Talos has identified a new threat cluster, UAT-10027, delivering a novel backdoor called Dohdoor that leverages DNS‑over‑HTTPS for command‑and‑control. The malware uses DLL side‑loading through legitimate Windows executables and drops a Cobalt Strike beacon that unhooks NTDLL calls to evade...
FDB’s Virginia Halsey introduced Model Context Protocols, a set of contractual guardrails for healthcare AI. The protocols require AI models to achieve a predefined confidence threshold before influencing clinical decisions and restrict their behavior to approved use‑cases. By embedding these...
Healthcare providers are increasingly dependent on multi‑layered vendor ecosystems to deliver AI, blockchain and IoT solutions, extending HIPAA liability to every downstream partner. The rise of “nth‑party” suppliers creates a hidden growth tax, delaying projects, inflating M&A costs, and exposing...
Dr. Daganzo recounts paying $78 for identical lab tests through a direct‑pay platform versus an estimated $900 cash price at Quest Diagnostics, highlighting extreme price opacity in traditional settings. Patients increasingly bypass insurance‑based pathways, preferring transparent, upfront pricing and predictable...
Smart D8, Dublin’s first health‑focused smart district, has opened its sixth open call for pilot projects, offering up to €10,000 per project to test innovations in real community settings. The 2026 call targets three priority themes—nutrition, social connectedness and workplace...
The latest episode of BioSpace’s Denatured podcast spotlights a growing partnership between ALS patients and pharmaceutical developers, featuring insights from EverythingALS founder Indu Navar and VectorY Therapeutics CMO Dr. Olga Uspenskaya. The discussion highlights how patient‑driven collaborations are accelerating trial timelines...
The U.S. Food and Drug Administration rejected a rare‑disease cell therapy that had already secured approval in Europe, despite earlier internal support from the agency. The decision comes under the FDA’s new leadership and has sparked debate over whether the...
$QURE down this morning on comments made by FDA Commissioner Marty Makary to CNBC's Becky Quick. In a discussion about rare-disease drug approvals and Vinay Prasad, Makary said this: "I think there has been a bit of an effort to...
🆕 @ScienceMagazine How gut bacteria interactions [cooperation vs competition, positive vs negative] shape risk for health and disease https://t.co/q8TvbaHDQI https://t.co/kS0S3uUIli
Some hospitals start the SEP-1 bundle early… but ~25% of those patients don’t actually have sepsis. Better prediction could mean fewer unnecessary antibiotics. Learn from Robin Carver: https://t.co/tPRGLQGdIV @PrenosisInc #patientsafety #HITSM https://t.co/CFk7cA5Wib
An Interoperable Vaccine Record: A Roadmap to Realization https://t.co/H1yL7kXH8z #mdpivaccines via @Vaccines_MDPI @HardeepSinghMD @McWilliamsSBMI @HarvardDBMI https://t.co/UCP8IXdHve
As national networks mature, the strategy is shifting. Jay Nakashima shares how eHealth Exchange is expanding beyond treatment exchange in 2026. 👀 🔗 https://t.co/uK1RKnn15e @eHealthExchange #QHIN #HITSM https://t.co/7qKBmbZ6FY
What accounts for the progression from healthy aging to Alzheimer's disease over an extended period of time? The critical role of the immune system, particularly T cells and microglia. A new, excellent review @ImmunityCP https://t.co/XqEBcptTuG https://t.co/Xt24BvkDWe
We'll be gearing up today's webinar on biotech venture capital at the top of the hour. Great guests, great topics. If this is a central issue in your life, tune in. Thousands have signed up already. https://t.co/c16y04mFsD
Direct-to-consumer gut microbiome assessments are unreliable, problematic: a review of 7 companies with significant methodologic issues https://t.co/atwmZUNjVE https://t.co/SqlMljuW0y
Head-to-head trial of the oral GLP-1 drugs in people with T2D. Orforglipron was superior https://t.co/9B7RXIgdJY
