What'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:
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 and prioritize protective measures accordingly. By visualizing dependencies, SMART enables scenario‑based continuity planning that aligns IT safeguards with patient‑care priorities. The rollout is part of a broader HIMSS26 preview aimed at standardizing cyber‑resilience practices across health systems.

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...

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...

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...

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,...

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...

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...
The CDC announced a multistate outbreak of extensively drug‑resistant Salmonella linked to Rosabella brand moringa powder capsules, with seven confirmed illnesses across seven states and three hospitalizations. The strain’s resistance means standard antibiotics may be ineffective, requiring alternative treatments. Listeners...

Virtual care has shifted from a convenience to a core delivery model, prompting physicians to rethink how they build trust through a screen. Small adjustments in communication style, workflow, and technology can deepen patient connections and mitigate the risk of...

Healthcare systems are rapidly deploying AI for diagnosis, documentation, scheduling and patient communication, but many clinicians and support staff lack the training to use these tools effectively. The article argues that one‑time, checkbox‑style training creates risks such as automation bias...

The episode opens with a celebration of Women in Science Day, highlighting the historic origin of the term “scientist” and the push for greater female leadership in biotech. Medra CEO Michelle Lee discusses how the company is merging robotics with...
$CMPS first-in-line for potential psychedelic approval for Treatment Resistant Depression (TRD) . Likely war between "Old School FDA" and MAHA movement. Will be exciting to see the outcome. $HELP with strong data for Major Depressive Disorder (MDD) and Breakthrough Therapy Designation. New...
The American Academy of Pediatrics has become a leader in the effort to reverse RFK Jr.'s vaccine policies. The success — or failure — of the group's approach will have consequences for kids' health nationwide. Inside the AAP's plan for the MAHA...
Ovid Therapeutics, under new CEO Meg Alexander, is re‑orienting its neuroscience pipeline toward first‑in‑class KCC2 modulators while advancing a drug‑resistant epilepsy candidate toward Phase 2. The company’s earlier flagship, soticlestat, failed in Phase 3, eliminating $600 million in potential milestones, prompting a strategic...

Vertex Pharmaceuticals reported that its late‑stage RAINIER trial of povetacicept in IgA nephropathy is proceeding without safety concerns, with primary data expected in the first half of 2026. The company is leveraging a priority‑review voucher for the upcoming FDA filing...

Organotics, a new biotech startup, is leveraging patient‑derived brain organoids to accelerate early‑stage testing of neuropsychiatric drugs. By reprogramming a patient’s blood or skin cells into induced pluripotent stem cells, the company creates vascularized, multi‑region mini‑brains that reflect individual genetics....

India‑based health‑AI startup Krigat captured the Supernova AI MEA Champion title in Cairo, outpacing 74 finalists from over 30 countries. The win includes a $10,000 equity‑free cash prize and heightened visibility at the AI Everything MEA summit. Krigat’s platform leverages...

Jason Wilt, an emergency and sports‑medicine physician, recounts his stint at Williams‑Sonoma and how the harsh retail environment taught him to handle difficult patients. He draws parallels between customer aggression and patient hostility, noting that many patients’ frustration stems from...

Paul Hudson has struggled to revitalize Sanofi’s R&D engine despite a series of high‑profile acquisitions since becoming CEO in 2019. The French group’s pipeline has underperformed, and recent buyouts have failed to deliver the expected boost in innovative drug candidates....

The episode dissects OpenClaw, an open‑source, agentic AI platform that can autonomously interact with files, commands, and dozens of applications, and evaluates its viability for payer and provider health organizations. It explains why the default, unsecured version violates HIPAA, outlines...

Montreal‑based Secai announced a $6.2 million Series A round to scale its dual AI platform—Voxira, an autonomous voice receptionist, and NoteGen, a real‑time clinical documentation tool. The solutions automate patient intake and EMR entry, directly tackling staffing shortages and physician burnout. Secai...

PTC Therapeutics has withdrawn its FDA filing for Translarna (ataluren) as a treatment for nonsense‑mutation Duchenne muscular dystrophy after the agency indicated the data would not meet the threshold for substantial evidence of effectiveness. The decision ends a decade‑long effort...
Medicare Part B lab spending reached $8.4 billion in 2024, up 5 % year‑over‑year. Genetic tests, though only 5 % of test volume, accounted for 43 % of the dollar value, driving a $3.6 billion surge. Utilization of molecular diagnostics jumped 160 % since 2018, while routine...

Novo Nordisk has filed a patent lawsuit against telehealth firm Hims & Hers, alleging illegal compounding of semaglutide after the FDA declared the drug no longer in shortage. The case targets the surge in compounded Wegovy and Ozempic that emerged...

KFF Health News published a Valentine‑themed roundup of reader‑submitted poems and cartoons that lampoon current health‑policy woes. Submissions spotlight upcoding scandals, soaring insurance premiums, the rise of AI‑driven telehealth, and gaps in menopause expertise. The piece blends humor with genuine...

The Centers for Medicare & Medicaid Services abruptly terminated the Making Care Primary initiative, a ten‑year federal program designed to bolster primary care in rural areas, after just one year of operation. The model had enrolled roughly 700 practices across...
Philips has launched the InkSpace Imaging Snuggle, a flexible paediatric body array coil for its 3.0 T MRI platforms. The blanket‑like, lightweight design wraps around children, aiming to reduce anxiety and improve comfort. Its high‑density array delivers sharp, high‑resolution images, cutting...
Lyell Immunopharma has administered the first dose of its investigational CAR‑T therapy, ronde‑cel (LYL314), in the Phase III PiNACLE‑H2H trial for relapsed or refractory large B‑cell lymphoma. The head‑to‑head study randomizes roughly 400 patients to receive either ronde‑cel at 100 × 10⁶ cells...

The UK government announced a 3.3% pay rise for roughly 1.5 million NHS nurses, midwives and allied health staff in England and Wales, effective 2026‑27. The increase outpaces the Office for Budget Responsibility's 2.2% inflation forecast but falls short of the...

AMPLY Discovery, a Belfast‑based AI drug discovery company, secured a strategic investment from Keeps Biomed, the biotech arm of South Korea’s Keeps Biopharma. Although the deal size was not disclosed, the capital will accelerate AMPLY’s oncology research, expand its drug...

ProPhet, an Israeli AI‑driven startup founded in late 2024, leverages a novel machine‑learning platform that projects proteins and small molecules into a common interaction space. This approach allows the company to screen billions of compounds against targets previously deemed undruggable,...

The U.S. FDA declined to review Moderna's mRNA influenza vaccine, even though two phase‑3 trials involving 43,800 participants demonstrated a 27% efficacy advantage over the standard Fluarix vaccine and a 49% reduction in hospitalizations. FDA officials cited the comparator arm...

HealthMark Group announced the acquisition of Purview, an Annapolis‑based cloud medical imaging platform, to strengthen its clinical information exchange portfolio. The deal targets the persistent reliance on physical discs for radiology image sharing, which still accounts for roughly two‑thirds of...
Novocure received FDA clearance for its Optune Pax tumor‑treating‑field device in locally advanced pancreatic cancer, marking the company’s first indication beyond brain tumors. The pivotal trial of 571 patients showed a statistically significant two‑month overall‑survival gain (16.2 vs 14.2 months) when the device was...
Biometric authentication is now mainstream in U.S. healthcare, with roughly 78% of organizations deploying fingerprint or facial‑recognition systems. The technology promises stronger identity assurance, faster workflow access, and reduced patient misidentification, directly addressing HIPAA compliance and safety concerns. However, high...

Healthcare payers are increasingly judged on billing accuracy and financial predictability, making data integrity a strategic priority. Clean, verified data enables faster eligibility checks, claim approvals, and reduces manual interventions, directly improving operational efficiency. By minimizing billing errors, payers lower...

Medicomp Systems unveiled a Model Context Protocol (MCP) that links generative AI models to its 45‑year clinical knowledge graph, filtering hallucinations before data enters electronic health records. The suite enables safe AI APIs for diagnostic prompting, chart summarization, quality‑measure evaluation,...

The episode explores the rapid convergence of organoid technology and artificial intelligence, highlighting how AI-driven image analysis, multidimensional data integration, and high‑throughput screening are transforming organoid research. It introduces the emerging field of Organoid Intelligence, where brain organoids act as...

Specialized mobility restoration providers are increasingly judged on multidisciplinary expertise, advanced prosthetic technology, and measurable outcomes. The article outlines key components such as individualized assessments, integrated rehab services, and continuous patient education that signal high‑quality care. It also highlights the...
Insights from Mark Molinaro, founder and CEO of SkySpigot
Snuggle body array coil from InkSpace Imaging was recently FDA cleared
The University of South Florida installs Allia Moveo image-guided therapy system

British Airways cabin crew members were hospitalized after unknowingly consuming cannabis‑infused gummies presented by a passenger following a London‑Los Angeles flight. The edibles contained a high 300 mg dose of THC, causing panic, disorientation and intense anxiety before the crew recovered...

Encompass Health and its spin‑off Enhabit have secured a $43.1 million award in attorneys’ fees and mitigation damages from VitalCaring. A Delaware federal judge ordered that 43% of VitalCaring’s future profits and any exit proceeds be placed in trust and split...

Northwestern researchers engineered a spherical nucleic acid (SNA) vaccine in which the HPV16 E7 peptide is displayed at the nanoparticle surface via its N‑terminus. This N‑terminal orientation (N‑HSNA) generated up to eight‑fold higher interferon‑γ secretion and 2.5‑fold greater cytotoxicity than...

Iliad Biotechnologies announced a $115 million Series B round, the largest venture deal of the week, led by RA Capital Management. New investors Janus Henderson and BNP Paribas Asset Management Alts also participated. The funding will accelerate Iliad’s intranasal vaccine program targeting pertussis...

Chinese‑founded Distinct Healthcare debuted on Hong Kong’s main board, branding itself as the “Costco of healthcare.” The company posted a compound annual growth rate above 30% from 2022‑2024, driven by a trust‑centric, referral‑only model that keeps marketing spend near 1%...