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
Emergent BioSolutions reported a successful completion of its stabilization phase, cutting net debt by $156 million and improving leverage to 3.3x adjusted EBITDA. Adjusted EBITDA surged to $183 million, a $205 million swing from the prior year, while operating cash flow rose to $59 million. The company highlighted strong NARCAN nasal spray sales—22 million doses—and secured $550 million in medical countermeasure contracts. For 2025, Emergent projects revenue of $750‑$850 million with adjusted EBITDA between $150 million and $200 million, emphasizing margin expansion and continued growth in its core product lines.
Ascendis (SNDX) reported €720 million total 2025 revenue, driven by €477 million from Yorvipath and €206 million from Skytrofa. Q4 operating profit hit €10 million and cash flow reached €73 million, leaving €616 million in cash at year‑end. Management guided 2026 operating cash flow of roughly...
Researchers injected acetate, a common metabolic by‑product, into mice and tested long‑term memory using spatial and object‑recognition tasks. Female mice that received acetate showed significantly better performance 24 hours later, while male mice displayed little to no improvement. The memory...
Amphastar Pharmaceuticals reported full‑year 2025 net revenues of $719.9 million, a modest 2% decline, while its flagship product Baqsimi grew 12% to $185.4 million. The company secured FDA approval for ipratropium bromide HFA (AMP‑007), gaining 180‑day generic exclusivity, and announced a major...
Pacira BioSciences reported a record $726 million in total 2025 revenue and an all‑time high non‑GAAP gross margin of 80%, driven by growth in its flagship product EXPAREL. EXPAREL sales rose 7% year‑over‑year to $155.8 million, though the increase was partially offset...
Alpha Teknova reported Q4 2025 revenue of $10.5 million, a 9% year‑over‑year increase and the fifth consecutive quarter of growth, driven primarily by its Lab Essentials catalog line. Lab Essentials revenue rose 16% to $8.3 million, while Clinical Solutions revenue slipped 13%...
Teleflex reported 2025 adjusted EPS of $6.98, an 8.7% increase, while outlining a $2.03 billion divestiture plan that will net roughly $1.8 billion after tax. Management pledged to allocate $1 billion to share repurchases and use the remaining $800 million to reduce debt, bolstering...
Privia Health reported a robust 2025, with implemented providers rising 12.3% to 5,380 and attributed lives increasing 22.7% to 1.54 million. Practice collections grew 16.9% to $3.47 billion and adjusted EBITDA surged 38.8% to $125.5 million, delivering a 130% free‑cash‑flow conversion. The company...
Recent pre‑clinical work has mapped the synaptic changes that underlie benzodiazepine tolerance. Chronic exposure uncouples GABA(A) receptors from their benzodiazepine binding site, down‑regulates α1‑subunit mRNA, and reshapes receptor trafficking through auxiliary proteins such as Shisa7. These alterations weaken inhibitory signalling,...
Delcath Systems reported record 2025 revenue of $85.2 million, driven by over 40% volume growth and 28 REMS‑certified treatment centers. Gross margins held at 85% for Q4 and 86% for the full year, while adjusted EBITDA turned positive to $25.1 million and...
Personalis reported a record $18.2 million Q4 2019 revenue, a 38% year‑over‑year increase, and full‑year revenue of $65.2 million, up 73% from 2018. The VA Million Veteran Program (MVP) remained the core revenue driver, contributing $43.5 million for the year and $13.8 million in...
Organogenesis Holdings posted a record fourth‑quarter 2025, delivering $225.1 million in net product revenue, a 78% year‑over‑year increase driven largely by an 83% surge in advanced wound‑care sales. Gross profit rose to 78% of revenue and GAAP operating income jumped 519%...
Researchers have engineered ligand‑conjugated mRNA‑lipid nanoparticles that home specifically to the endometrium, delivering therapeutic mRNA directly to uterine tissue. In a murine model of endometrial injury, the targeted formulation restored embryo implantation rates to near‑normal levels. Safety profiling showed reduced...
BioCryst Pharmaceuticals reported a 37% year‑over‑year rise in Orladeyo revenue to $159.1 million in Q3 and lifted its 2025 sales guidance to $590‑$600 million. The company completed the divestiture of its European business, repaid a $200 million term loan and entered Q3 with...
Lantheus reported Q4 2025 revenue of $406.8 million and full‑year revenue of $1.54 billion, while announcing a strategic pivot to PET radiodiagnostics after completing the SPECT divestiture. The company highlighted acquisitions of Neuraceq and OCTEVY, positioning Neuraceq for triple‑digit growth and targeting...
Cytek Biosciences reported Q3 2025 revenue of $52.3 million, a modest 2% year‑over‑year increase driven by strong APAC growth and expanding recurring service and reagent streams. The company posted a net loss of $5.5 million and adjusted EBITDA of $2.5...
Heron Therapeutics reported full‑year 2025 net product sales of $155 million and adjusted EBITDA of $14.7 million, surpassing its guidance. Acute Care drove growth, with ZYNRELEF revenue up 48% YoY and the franchise expanding 57% overall, helped by the CrossLink IGNITE incentive program,...
Nautilus Biotechnology reported a 23% drop in operating expenses to $15.4 million for Q4 2025, driven by lower R&D and administrative costs, while ending the quarter with $156.1 million in cash and a reduced cash burn of $50.2 million. The...
Castle Biosciences reported $344.2 million revenue for 2025, beating its own guidance, and projected $340‑$350 million for 2026. Core test volumes surged, with TissueCypher reports up 86% to 39,014 and total reports reaching 105,053, while DecisionDx‑Melanoma grew modestly 9%. The company posted...
Vericel Corp. reported record third‑quarter revenue of $67.5 million, driven by a 25% jump in MACI sales to $55.7 million and a 21% rise in burn‑care revenue. Margin expansion outpaced top‑line growth, with adjusted EBITDA climbing 70% to $17 million and gross profit...
Intellia Therapeutics announced that the FDA has placed a clinical hold on its nex‑z MAGNITUDE and MAGNITUDE‑2 Phase III trials after a patient death and liver enzyme abnormalities. The company is implementing intensified safety monitoring and data reviews while awaiting regulatory...
Align Technology reported a record $1.05 billion Q4 2025 revenue, up 5.3% year‑over‑year, driven by strong clear‑aligner sales and expanding Systems & Services. Non‑GAAP operating margin improved to 26.1%, the highest since 2021, while cash balances rose to $1.09 billion. The company...
The combination of GLP-1 drugs (such as Ozempic) and healthy lifestyle factors was associated with less major adverse cardiovascular events in ~100,000 people with T2D @TheLancetEndo https://t.co/phNzEBy7zY https://t.co/DDVi8uedRP
A prospective analysis of 1,903 first‑degree relatives of multiple sclerosis (MS) patients found an incidence of 211 cases per 100,000 per year—about 100‑fold higher than the general population—and a median conversion time of two years, with diagnosis typically at age...
President Trump nominated Casey Means, a 38‑year‑old Stanford‑trained physician‑influencer, as surgeon general, but she has not completed her residency and holds an inactive medical license. During her HELP Committee hearing, senators pressed her on vaccine positions, past social‑media statements, and...
UFP Technologies, a $600 million medical‑device maker, disclosed a cyberattack detected on February 14 that compromised several IT systems. The company isolated the breach, removed the threat and engaged external advisors, but confirmed that data was stolen and some functions, such as...
Chief medical information officers are reframing EHR and AI investments from pure operational upgrades to strategic tools for clinician recruitment, retention, and burnout mitigation. Leaders at Sentara Health report over 75% adoption of AI‑generated discharge summaries, citing significant time savings...
The Centers for Medicare & Medicaid Services (CMS) issued a Request for Information on a prospective rule called Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH), opening a 30‑day comment period after its Feb. 27 Federal Register publication. Simultaneously, CMS announced a...
The Centers for Medicare & Medicaid Services (CMS) announced a $259.5 million deferral of federal Medicaid matching funds to Minnesota, citing questionable and potentially fraudulent claims. The agency also imposed a six‑month nationwide moratorium on new enrollment for Durable Medical Equipment,...
From glucose to vascular health: the future of diabetes care https://t.co/UMhK4BkOE3 #Conditions #Diabetes via @kevinmd
Fourteen health systems have signed multiyear extensions for Altera Digital Health’s Sunrise electronic health record, reinforcing the vendor’s foothold in the acute‑care market. The renewed contracts cover institutions such as Phoenix Children’s, St. Mary’s, Grand Lake Health System and Hospital for...
A dentist refused to perform a routine cleaning without bitewing X‑rays, despite the patient’s low‑risk status and recent radiographs. The practice cited a two‑year imaging policy and warned that proceeding could jeopardize the hygienist’s license. After consulting the supervising dentist,...
AI isn’t just exposing workflow gaps in healthcare — it’s exposing content fragmentation. The future of clinical AI may depend less on model architecture and more on knowledge integrity. More from @ElsevierConnect at #ViVE2026.👇👇 https://t.co/zbay0c1z1x
Aktis Oncology announced that its investigational radiopharmaceutical AKY-1189 has earned FDA Fast Track designation. The drug targets Nectin‑4, present in 80‑90 % of urothelial cancers, and delivers the alpha‑emitter actinium‑225 directly to tumors. AKY-1189 is in a Phase 1b trial covering urothelial,...
Health systems are realizing significant cost savings by consolidating their IT application portfolios. Emplify Health eliminated over 30 applications, cutting $3 million in direct costs and $1.3 million in soft savings, while Providence reduced its portfolio by more than a third, saving...
The American Hospital Association (AHA) submitted comments on the Department of Education’s proposed rule that redefines “graduate student” and “professional student” for federal loan eligibility. The rule limits the new definition of a professional degree to 11 fields, granting up...
A new Nature study led by ETH Zurich researchers sequenced the genomes of 645 bacteria and archaea from over 800 coral samples, revealing that more than 99% of these reef‑dwelling microbes were previously unknown. The analysis showed that each coral...
Long‑acting cabotegravir/rilpivirine (CAB+RPV LA) demonstrated strong virologic control and high patient preference in both treatment‑naïve and treatment‑experienced cohorts presented at CROI 2026. In the VOLITION trial, 85% of ART‑naïve adults switched early from DTG/3TC to a q2‑month injectable, achieving 95% overall suppression...
Clalit Health Services, Israel’s largest HMO, announced it is probing a suspected cyberattack after the Iranian‑linked group Handala claimed to have breached its systems. The hackers released thousands of documents containing patients' personal and medical information on public platforms. Clalit...
A new American Heart Association study released Feb. 25 projects that 60% of U.S. women will develop cardiovascular disease by 2050. The analysis shows rising rates of heart disease, heart failure, atrial fibrillation and stroke, driven by higher prevalence of...
The DEA and HHS have extended the pandemic‑era telehealth rule that lets providers prescribe buprenorphine for opioid use disorder without an in‑person visit, now allowing up to six months of remote treatment. Effective Jan. 1, the rule also eliminates record‑keeping requirements...
A Hawaii district court has upheld the state’s 340B contract‑pharmacy law, ruling that it is not preempted by federal regulations. The decision aligns with recent rulings in Minnesota and Louisiana that support state authority over 340B contract arrangements. The law...
Terry Rubin, co‑founder of The Professional Communicators, will address the “Tech Talk Trap” at HIMSS 2026, highlighting how jargon, information overload, and rapid delivery can alienate healthcare audiences. He explains that experts often lose message control when they prioritize technical...
A new 20‑year follow‑up of 130 patients who received transcatheter patent foramen ovale (PFO) closure after a paradoxical embolism shows sustained safety and efficacy. The cohort, with a mean age of 46, experienced a recurrent stroke rate of 0.04 per...
Brazilian researchers have shown that an iron‑based compound, ferroin, encapsulated in lipid nanoparticles, completely eradicated Mycobacterium tuberculosis from mouse lungs after a 30‑day course. The formulation, LNP@FEP, stabilizes the drug, enhances the activity of existing antibiotics, and targets bacterial cell‑wall synthesis....
Zimmer Biomet announced that its machine‑learning tool SynTuition dramatically improves diagnostic certainty for periprosthetic joint infection (PJI). In a study of 274 real‑world cases, the algorithm matched expert diagnoses 96% of the time, outpacing a pooled physician group that achieved...
Cornell researchers unveiled EdemaFlex, a soft‑robotic glove equipped with 37 shape‑memory‑alloy actuators that apply sequential pressure across all five fingers and the palm. In a small home‑use study of seven edema patients, a single 30‑minute session reduced hand volume by...
Oregon‑based Housecall Providers has signed a definitive agreement to affiliate with Chapters Health System, extending the nonprofit’s footprint in the Pacific Northwest. The transaction is slated to close in late spring or early summer 2026, subject to regulatory clearance. The...
The FDA has removed several accelerated approvals for non‑malignant hematological, neurological, and other disorder indications after post‑marketing requirements were withdrawn. These withdrawn indications are not reflected in official listings until a Federal Register notice or label update is issued. The...
Dotinurad (FYU‑981), marketed as Urece®, is a URAT1 inhibitor approved for gout and hyperuricemia in Japan and China. The drug was chemically refined from the older uricosuric benzbromarone to retain potency while eliminating rare hepatotoxic events. Crystalys Therapeutics is now...
