🎯Today's Healthcare Pulse
Updated 1h agoWhat's happening: FDA places Regeneron's anti‑activin A antibody garetosmab under priority review
The agency has granted priority review to Regeneron's garetosmab for the rare disease fibrodysplasia ossificans progressiva, with a decision expected by August. Phase 3 OPTIMA results showed a 94% reduction in new heterotopic ossification lesions at the lower dose and a 90% reduction at the higher dose, alongside a >99% drop in lesion volume.
Also developing:
- •Nanozyme‑aptamer colorimetric array achieves 100% accuracy in Staphylococcus aureus strain identification
- •UK firm Biocomposites ramps up production of Synicem bone cement to mitigate NHS supply shortage
- •Novartis to sell majority stake in its India generics business to a private‑equity‑led consortium for $159 million
By the numbers: Hims & Hers acquires Eucalyptus in $1.15B deal
News•Feb 13, 2026
Gilead Gets Cancer Drug From China-Based Genhouse for $80M Upfront
Gilead Sciences announced it will acquire the worldwide rights to an oral cancer therapy from China‑based Genhouse Bio, paying an $80 million upfront fee. The deal comes as Genhouse prepares for a Hong Kong IPO, positioning the drug for rapid global development. Gilead aims to bolster its oncology portfolio with a convenient, small‑molecule option that could address solid‑tumor indications. The transaction underscores a growing trend of U.S. pharma firms tapping Chinese biotech pipelines for innovative assets.
By Endpoints News
News•Feb 13, 2026
VENUS Safety Expands PPE and Air Filtration Portfolio, Prepares New Launches to Support India's Manufacturing-Led Growth
VENUS Safety & Health Pvt. Ltd., a Mumbai‑based PPE and air‑filtration manufacturer, announced an expansion of its product portfolio and upcoming launches to back India’s Make‑in‑India drive. The firm now operates seven facilities with a daily capacity of 1.5 million units,...
By Business Standard — Economy/Markets
News•Feb 13, 2026
Health Cover to Be Bundled with Pension Schemes, Says PFRDA Chief
India’s PFRDA is piloting pension plans that bundle health insurance, allowing up to 30% of the retirement corpus to be earmarked for medical expenses. ICICI, Axis and Tata‑backed funds are testing the “Swasthya” product, which could leverage pooled investors to...
By The Hindu Business Line – All
News•Feb 13, 2026
Hims Jumps Into Cancer Detection Market, Awaits Medicare Coverage
Telehealth and wellness brand Hims & Hers Health announced it will enter the multi‑cancer early‑detection market. The move comes as the company’s GLP‑1 weight‑loss segment slows and it seeks new growth avenues. Hims is leveraging the current regulatory gap for...
By Inside Health Policy
Podcast•Feb 13, 2026•21 min
Sami Inkinen of Virta Health on AI-Native Healthcare and Reversing Metabolic Disease
In this fireside chat, Sami Inkinen, CEO and founder of Virta Health, explains how his personal pre‑diabetes diagnosis inspired the creation of a company that uses nutrition, technology and AI to reverse type‑2 diabetes and obesity. He describes Virta’s massive...
By StartUp Health NOW
News•Feb 13, 2026
Akron Children's Uses Epic and Real-Time Analytics to Reduce Waste Anesthesia Gases
Akron Children’s Hospital leveraged its Epic EHR and real‑time analytics to dramatically cut waste anesthesia gases, a source of 5‑10% of its greenhouse‑gas emissions. By introducing low‑flow reminders in Epic and on anesthesia machines, the team achieved an initial 5%...
By Healthcare IT News (HIMSS Media)
News•Feb 13, 2026
Lilly Appeals Retatrutide Classification Ruling in Case that Could Impact Compounders
Eli Lilly has filed a notice of appeal challenging the FDA’s classification of its experimental obesity injection, retatrutide. The agency labeled the product as a new molecular entity, granting it a 12‑year data exclusivity period. Lilly argues the classification is incorrect...
By Endpoints News
News•Feb 13, 2026
Georgia Advances Bill Expanding Pharmacists’ HIV Care Role
Georgia’s House of Representatives approved a bill, 155‑7, that would let pharmacists prescribe and administer HIV prevention drugs such as pre‑exposure prophylaxis (PrEP) and post‑exposure prophylaxis (PEP). The legislation aims to remove the prerequisite of a primary‑care visit, expanding access...
By Becker’s Hospital Review
News•Feb 13, 2026
HCA Texas Hospital Names Chief Medical Officer
DeVry Anderson, MD, has been appointed chief medical officer of St. David’s North Austin Medical Center, a 465‑bed HCA Healthcare facility in Texas. In his new role, Anderson will oversee clinical operations at both the North Austin Medical Center and the...
By Becker’s Hospital Review
News•Feb 13, 2026
FDA Staff Dropoff Continues In First Quarter Of FY 2026
FDA’s drug and biologic product centers reported a continued decline in staff during the first quarter of fiscal 2026, extending a year‑long downward trend. The reduction persists even as Commissioner Marty Makary publicly pledged to accelerate hiring. The agency has...
By Inside Health Policy
Social•Feb 13, 2026
PET Scans Miss Cancer; System Needs Diagnostic Overhaul
Merkel cell carcinoma log, day #566. Completed my 6th PET scan at Dana-Farber yesterday. The radar, such as it is, doesn’t reflect any Merkel cell carcinoma. Lymph nodes look clean. The more I do PET scans, though, the more I...
By John Carroll
Social•Feb 13, 2026
IMMX Gains Momentum as CAR‑T Landscape Heats Up
$IMMX momentum continues >Mizuho analyst initiates $14 PT >Lily acquisition of Orna Therapeutics $2.4 billion >AbbVie acquired Capstan Therapeutics $2.1 billion CAR-T heating up >Next milestone: imminent enrollment completion >Could NXC-201 be an eventual front-line therapy for AL Amyloidosis? >BLA submission projected Q3’26 https://t.co/cPpiiFHQal
By BowTiedBiotech
News•Feb 13, 2026
Biopharma Money Raised: Jan. 1-Feb. 12, 2026
BioWorld’s latest brief highlights three emerging biotech advances. Researchers pinpointed the SCAN network as a central circuit disrupted in Parkinson’s disease, offering a new therapeutic target. Astellas presented promising preclinical data on ASP-2246, an mRNA‑encoded NeuroD1 candidate aimed at neural...
By BioWorld (Citeline) – Featured Feeds
News•Feb 13, 2026
Generic Drug User Fee Amendments
On September 30, 2022 the FDA User Fee Reauthorization Act of 2022 re‑authorized the Generic Drug User Fee Amendments (GDUFA) through September 2027, marking the start of GDUFA III. The legislation sets new user‑fee rates for FY 2025 and FY 2026, including a...
By FDA – U.S. Food & Drug Administration (RSS Feeds)
News•Feb 13, 2026
What's New Related to Drugs
Between January and February 2026 the FDA issued a cascade of regulatory updates covering new drug approvals, safety‑label revisions, draft guidances, and consumer alerts. The agency granted approval for pembrolizumab combined with paclitaxel to treat platinum‑resistant ovarian, fallopian tube, or...
By FDA – U.S. Food & Drug Administration (RSS Feeds)
News•Feb 13, 2026
CBO: CMS Skin Substitute Policy To Save $245B By 2035
CMS announced a comprehensive overhaul of its reimbursement rules for skin substitutes, high‑cost dressings used in chronic wound care. The policy tightens medical‑necessity criteria, promotes evidence‑based alternatives, and leverages negotiated pricing. The Congressional Budget Office incorporated these changes into its...
By Inside Health Policy
News•Feb 13, 2026
What Interoperability in Healthcare Really Means for Security and Privacy
Healthcare interoperability is accelerating data exchange among hospitals, labs, insurers and pharmacies, but each connection expands the sector's attack surface. Misconfigured integrations, outdated protocols and weak identity controls can leak sensitive patient records, turning routine sharing into a security liability....
By HackRead
News•Feb 13, 2026
3 Trends Shaping the GLP-1 Landscape
GLP‑1 therapies are entering a new regulatory phase as the FDA stripped suicide‑ideation warnings from Saxenda, Wegovy and Zepbound and signaled tighter controls on compounded pills. At the same time, Novo Nordisk’s oral Wegovy has become the fastest drug launch...
By Becker’s Hospital Review
Social•Feb 13, 2026
AI Is Adding Work, Not Reducing Clinician Burden
Working on a story about where AI is actually creating more, rather than less, work for clinicians. (As in, adding additional grunt work or even creating entirely new and tiresome workflows.) Reach out if you'd like to contribute.
By Erin Brodwin
News•Feb 13, 2026
Facing Regulatory, Reimbursement Changes, Pharmacy Execs Also See Opportunities
Pharmacy leaders are navigating tighter regulations and shifting reimbursement models while uncovering growth avenues in specialty and home‑infusion services. Executives emphasize the need for pharmacists to act as connectors between clinicians, payers, and manufacturers, blending clinical insight with business acumen....
By Healthcare Innovation
News•Feb 13, 2026
Boner Bears Chocolate May Be Harmful Due to Hidden Drug Ingredient
The FDA has issued a warning that Boner Bears Chocolate, sold as a sexual‑enhancement supplement, contains undeclared sildenafil, the active ingredient in prescription Viagra. Laboratory testing confirmed the hidden drug, which is not listed on the product label. The agency...
By FDA – U.S. Food & Drug Administration (RSS Feeds)
News•Feb 13, 2026
Renown Health Names VP of Payer Contracting
Renown Health announced the promotion of longtime executive Jenny Juchtzer to vice president of payer contracting. Juchtzer, who has spent nearly two decades at the organization and most recently led payer contracting, will now oversee all hospital and professional managed‑care...
By Becker’s Hospital Review
News•Feb 13, 2026
Dexcom Seeks Expanded Medicare Coverage of CGMs for Type 2 Diabetes
Dexcom is lobbying the Centers for Medicare & Medicaid Services for expanded coverage of its continuous glucose monitors (CGMs) for Type 2 diabetes patients who do not use insulin. The company estimates the change could make CGMs available to roughly 12 million...
By MedTech Dive
News•Feb 13, 2026
PA Pay by State
The National Commission on Certification of Physician Assistants released its 2024 compensation report, showing a mean PA salary of $129,291 nationwide. California tops the list with a mean income of $151,351, while Nevada, Connecticut, Alaska, and Washington round out the...
By Becker’s Hospital Review
News•Feb 13, 2026
Humana Approaches $1B Acquisition of Florida Primary Care Company: Bloomberg
Humana is negotiating a roughly $1 billion purchase of Florida‑based MaxHealth, a primary‑care network focused on adults and seniors. MaxHealth is owned by Arsenal Capital Partners’ Best Value Healthcare, and the deal would deepen Humana’s primary‑care footprint after recent growth in...
By Becker’s Hospital Review
News•Feb 13, 2026
10 Systems Seeking Supply Chain Leaders
Hospitals are redefining supply chain leadership to encompass enterprise strategy, digital transformation, and resilience. This shift is prompting health systems nationwide to recruit senior supply chain executives with broader, analytics‑driven responsibilities. In the past week, ten systems—including Baptist Memorial, Boston...
By Becker’s Hospital Review
News•Feb 13, 2026
Vertex, CRISPR Set Lofty Goal for Casgevy Gene Therapy as Patient Starts Ramp
Vertex Pharmaceuticals and CRISPR Therapeutics forecast combined Casgevy gene‑therapy and Journavx pain‑drug sales of $500 million in 2026, a 185 % jump from 2025. The therapy generated $115.8 million in 2025, with Q4 revenue of $54.8 million, and treated 111 patients that year, up...
By BioSpace
News•Feb 13, 2026
Epigenetic Editing Startup Moonwalk Shifts Focus to siRNA for Obesity
Moonwalk Biosciences, founded by CRISPR pioneer Feng Zhang and former Illumina CTO Alex Aravanis, announced a strategic pivot from epigenetic editing to siRNA‑based obesity therapies. The company secured a $120 million Series A round to fund the new platform, which targets liver‑expressed...
By Endpoints News
News•Feb 13, 2026
Siemens Healthineers, Mayo Clinic Partner on Neurodegenerative Disease, Cancer
Siemens Healthineers and Mayo Clinic have expanded their strategic partnership to accelerate AI‑driven imaging and interventional technologies for neurodegenerative disease, prostate cancer, and metastatic liver tumors. The agreement emphasizes AI‑enabled ultra‑high‑field MRI protocols for Alzheimer’s detection, AI tools to reduce...
By MedTech Dive
News•Feb 13, 2026
AI Forecasting Model Targets Healthcare Resource Efficiency
University of Hertfordshire researchers, in partnership with regional NHS bodies, have built an AI forecasting model that uses five years of historical data to predict healthcare demand. The system integrates admissions, bed capacity, workforce availability, and demographic factors to generate...
By Artificial Intelligence News
News•Feb 13, 2026
Diabetes Is Linked to Higher Risk of Pancreatic Cystic Neoplasms
A Korean nationwide cohort of 3.86 million adults found that diabetes raises the risk of pancreatic cystic neoplasms (PCNs), with longer disease duration conferring greater risk. Incidence rose from 0.72 per 1,000 person‑years in normoglycemic individuals to 1.82 in those with...
By AJMC (The American Journal of Managed Care)
News•Feb 13, 2026
CCTA Becoming an Essential Tool for Interventional Cardiologists
Coronary computed tomography angiography (CCTA) is becoming a core tool for interventional cardiologists, enabling comprehensive pre‑procedure planning and reducing reliance on costly intravascular imaging. The addition of fractional flow reserve derived from CT (FFR‑CT) merges anatomical and physiological assessment, streamlining...
By Cardiovascular Business
News•Feb 13, 2026
Moderna's Flu Shot Dilemma Muddies 2028 Break-Even Guidance
Moderna’s chief financial officer indicated that the company cannot yet confirm whether its 2028 cash‑flow break‑even goal will hold, as the outlook for its seasonal flu vaccine remains uncertain. The flu shot, once expected to be a steady revenue stream,...
By Endpoints News
News•Feb 13, 2026
Novel Drug Approvals for 2026
The FDA’s 2026 novel drug approvals catalogue highlights all new molecular entities receiving first‑time U.S. marketing authorization. A novel drug is defined as a product never previously approved or sold in the United States, and each entry links to the...
By FDA – U.S. Food & Drug Administration (RSS Feeds)
News•Feb 13, 2026
AAPS National Biotechnology Conference
The AAPS National Biotechnology Conference will take place May 11‑14, 2026 in San Diego, gathering leading pharmaceutical scientists to discuss the latest advances in biologics, biotechnology products, and advanced therapies. The four‑day event offers sessions on new modalities, technologies, and novel strategies...
By European Pharmaceutical Review
Blog•Feb 13, 2026
University of Minnesota Medical School Nixes Its Classroom “Partnership” With UnitedHealth Group After HEALTH CARE Un-Covered’s Expose
The episode examines the University of Minnesota Medical School’s decision to discontinue a UnitedHealth Group‑sponsored course after investigative reporting by Dr. Allison Leopold exposed the curriculum as corporate propaganda rather than unbiased medical education. Leopold, a participant in the pilot,...
By HEALTH CARE un-covered
News•Feb 13, 2026
Closing the CKD Care Gap with Value-Based Care Models
Chronic kidney disease (CKD) impacts more than one in seven U.S. adults and kills more people annually than breast or prostate cancer, yet it remains under‑diagnosed, especially among women and minority groups. Value‑based care (VBC) models shift focus to early...
By MedCity News
Social•Feb 13, 2026
Stable FDA Rules Essential for Patient Safety and Investment
To invest the billions it costs to make new medicines, companies need to be able to trust the word and actions of the FDA. To capaciously change the rules at the end of the game ultimately hurts patients.
By Robert Nelsen
News•Feb 13, 2026
Oregon Considers Bill to Stop Hospice Scammers From Entering State
Oregon lawmakers are reviewing Senate Bill 1575, which would bar hospices with fraud histories or substandard care in other states from obtaining licenses in Oregon. The bill mandates the Oregon Health Authority to review applicants' Consumer Assessment of Healthcare Providers...
By Hospice News
News•Feb 13, 2026
Lilly Stockpiles $1.5B Worth of Weight Loss Pill Ahead of US Approval
Eli Lilly has amassed roughly $1.5 billion worth of its experimental obesity drug orforglipron. The company began stockpiling the product months before the U.S. Food and Drug Administration is expected to grant approval later this year. Orforglipron, a GLP‑1 receptor agonist, joins...
By Endpoints News
News•Feb 13, 2026
STAT+: Pediatricians Confront HHS in Vaccine Showdown
The FDA unexpectedly refused to review Moderna’s mRNA‑based flu vaccine, sparking alarm across biotech firms. Pediatricians are confronting the Department of Health and Human Services (HHS), demanding transparent guidance on pediatric flu immunization. The decision highlights perceived regulatory volatility under...
By STAT (Biotech)
News•Feb 13, 2026
Generic Drug Facilities, Sites and Organization Lists
The FDA has published a series of downloadable spreadsheets detailing self‑identified generic drug facilities, sites and organizations for fiscal years 2014 through 2026. Each annual file lists manufacturers, contract manufacturers, and other entities that the agency has flagged as part...
By FDA – U.S. Food & Drug Administration (RSS Feeds)
Social•Feb 13, 2026
Genetic Evidence Shows BMI Directly Shapes Gut Microbiome
A successful hunt of human genome variants identifying some (with MR) that provide causal evidence that BMI affects microbe composition @NatureGenet https://t.co/1uxvnFNrbK https://t.co/SuItRHAnFe
By Eric Topol
News•Feb 13, 2026
SMART Toolkit Helps Map Healthcare Cyber Risk
Intermountain Health’s chief information security officer Erik Decker unveiled the SMART toolkit, a framework that maps an organization’s critical clinical and administrative functions to assess cyber‑risk exposure. The tool helps leaders identify which services must remain operational during a breach...
By MobiHealthNews (HIMSS Media)
News•Feb 13, 2026
The Medical Device Industry: The Real Effects of Tariffs
The medical device sector is grappling with a wave of new and proposed tariffs that have lifted costs for metals, electronics, and finished components throughout global supply chains. Manufacturers must decide whether to absorb these higher expenses, pass them to...
By Medical Economics
News•Feb 13, 2026
Aveanna CEO: Hospice Multiples Still Too High
Aveanna Healthcare Holdings CEO Jeff Shaner warned that hospice acquisition multiples remain excessively high, often exceeding 10x and sometimes reaching 15x‑17x. The company, which is evaluating growth options, says it will not pursue hospice deals unless valuations fall into the...
By Hospice News
News•Feb 13, 2026
Immunic's Private Placement; Vertex's Cystic Fibrosis Data in Young Kids
Immunic announced an oversubscribed private placement raising up to $400 million to fund its shift toward a commercial‑stage biotech. The capital injection will support late‑stage development programs and accelerate the search for a new chief executive officer. Meanwhile, Vertex Pharmaceuticals disclosed...
By Endpoints News
News•Feb 13, 2026
Drugs
The FDA’s consumer‑updates page aggregates more than 60 articles that explain how the agency regulates prescription and over‑the‑counter drugs and communicates risks and benefits to the public. Topics range from hormone‑replacement therapy and antibiotic stewardship to product recalls, safe disposal,...
By FDA – U.S. Food & Drug Administration (RSS Feeds)
News•Feb 13, 2026
Simplified Psoriasis Severity Measure Shows Strong Correlation With PASI
A new psoriasis severity tool, G2‑PASE, combines Physician Global Assessment and body surface area with a nonlinear weighting to approximate the Psoriasis Area and Severity Index. In a Canadian registry of 1,803 patients, it demonstrated a Pearson correlation of 0.83...
By AJMC (The American Journal of Managed Care)
Blog•Feb 13, 2026
The CMS ACCESS Model Update and Payment Rates
The episode breaks down CMS’s new ACCESS Model, which replaces fee‑for‑service chronic care payments with a per‑beneficiary Outcome‑Aligned Payment (OAP) that is partly withheld until specific clinical and patient‑reported outcomes are met. It explains the four clinical tracks—early and advanced...
By Health Tech Happy Hour