Today's Healthcare Pulse
FDA greenlights durvalumab combo for high‑risk bladder cancer
The FDA approved durvalumab (Imfinzi) combined with Bacillus Calmette‑Guerin for BCG‑naïve, high‑risk non‑muscle invasive bladder cancer. The POTOMAC trial enrolled 1,018 patients and showed a 32% reduction in disease recurrence risk (hazard ratio 0.68, p=0.015). Durvalumab is given at 1,500 mg IV every four weeks for up to 13 cycles.
Also developing:
By the numbers: Apogee Therapeutics raises $1.3B royalty financing
Grail Inc (GRAL) Q4 2025 Earnings Call Transcript
Grail reported Q4 2025 revenue of $36.2 million, a 26% year‑over‑year rise, driven by 45,000 Gallery tests sold—a 39% volume increase. The company completed a $325 million private placement, boosting cash to roughly $850 million, and announced a strategic partnership with Samsung that includes a $110 million equity investment and plans to launch Gallery in South Korea and other Asian markets. Clinical updates from PATHFINDER II and the SIMPLIFY study showed a seven‑fold boost in cancer detection and a PPV of 61.6% and 84.2% respectively. Management tightened the FDA PMA submission timeline to Q1 2026 and cut full‑year cash‑burn guidance to $290 million.
Host Control of Persistent Epstein–Barr Virus Infection
A multinational consortium investigated how host genetics influence persistent Epstein‑Barr virus (EBV) infection. Using large‑scale genome‑wide association studies across diverse cohorts, the team identified several host loci that modulate viral load and serostatus. Functional analyses linked these loci to immune...
AMN Healthcare Services Inc (AMN) Q4 2025 Earnings Call Transcript
AMN Healthcare reported Q2 2025 revenue of $658 million, hitting the top of its guidance but falling 11% year‑over‑year. A $110 million goodwill impairment drove a GAAP net loss of $116 million, while adjusted EBITDA slipped to $58 million with an 8.9% margin. Gross...
Guardant Health Inc (GH) Q4 2025 Earnings Call Transcript
GE HealthCare reported Q4 2025 revenue of $5.7 billion, up 4.8% organically, and posted a record backlog of $21.8 billion with a book‑to‑bill ratio of 1.06. Adjusted EBIT margin slipped to 16.7% after a $100 million tariff hit, while adjusted EPS fell 0.7%...
Travere Therapeutics Inc (TVTX) Q4 2025 Earnings Call Transcript
Vertex Pharmaceuticals reported fourth‑quarter 2025 revenue of $3.2 billion, a 10% year‑over‑year increase, and full‑year revenue of $12 billion, up 9%. The company highlighted strong growth in its cystic fibrosis (CF) franchise, with 7% global expansion and double‑digit gains in the...
‘An AlphaFold 4’ – Scientists Marvel at DeepMind Drug Spin-Off’s Exclusive New AI
Isomorphic Labs unveiled IsoDDE, a proprietary AI engine touted as an “AlphaFold 4”‑level breakthrough in drug discovery. The 27‑page technical report claims the model outperforms AlphaFold 3, the open‑source Boltz‑2, and traditional physics‑based methods in predicting binding affinity and antibody‑protein interactions. Researchers...
A Transcriptional Program Associated with Neurotransmission in the Living Human Brain
Researchers from the Living Brain Project combined prefrontal cortex biopsies from 130 neurosurgical patients with intracranial recordings of dopamine, serotonin, and other neurotransmitters. Differential‑expression analyses of single‑nucleus and bulk RNA‑seq data revealed reproducible gene‑expression signatures that correlate with fast‑scan cyclic...
Weave Communications Inc (WEAV) Q4 2025 Earnings Call Transcript
Weave Communications reported Q2 2025 revenue of $58.5 million, a 15.6% year‑over‑year increase, and beat the top end of its non‑GAAP guidance. Gross margin rose to 72.3%, up 40 basis points, while free cash flow reached $4.5 million and cash balances stood...
Exercise Mimetics as Unexplored Therapeutics for Treating Depression
The paper proposes exercise mimetics—pharmacological agents that imitate endurance training—as a novel class of antidepressants. While regular physical activity cuts depression risk by about 18 percent, adherence challenges limit its real‑world impact. Exercise mimetics activate muscle signaling pathways and alter the...
Tandem Diabetes Care Inc (TNDM) Q4 2025 Earnings Call Transcript
Tandem Diabetes Care reported record 2020 results, generating roughly $500 million in revenue—a 38% year‑over‑year increase—and shipping more than 90,000 insulin pumps. The company now serves over 200,000 customers worldwide and has expanded its Control‑IQ automated insulin‑delivery algorithm, which has driven...
Select Medical Holdings Corp (SEM) Q4 2025 Earnings Call Transcript
Select Medical disclosed that its Board is evaluating a non‑binding take‑private proposal from the Executive Chairman, adding strategic uncertainty to the near‑term outlook. Fourth‑quarter revenue grew more than 6% year‑over‑year, but adjusted EBITDA dropped 10% to $104.7 million, driven by an...
Insmed Inc (INSM) Q4 2025 Earnings Call Transcript
Insmed reported a $144.6 million net revenue for Brinsupri’s first full U.S. quarter, surpassing internal launch benchmarks. Management set a minimum $1 billion Brinsupri revenue target for 2026 and projected total company revenue to more than double 2025 levels, driven by continued...
Materialise NV (MTLS) Q4 2025 Earnings Call Transcript
Materialise posted a mixed third‑quarter 2025 performance, with overall revenue slipping 3.5% year‑over‑year but the Medical segment hitting a record €33.3 million, up more than 10%. Software and Manufacturing revenues fell 7% and 17% amid macro‑economic headwinds, while operating cash flow...
Madrigal Pharmaceuticals Inc (MDGL) Q4 2025 Earnings Call Transcript
Gilead Sciences reported total product sales of $28.9 billion for 2025, a 1% increase that topped the high end of its guidance. The HIV franchise generated $20.8 billion, up 6% overall and 10% on an underlying basis after removing the Medicare Part D...
Genentech’s Fenebrutinib Yields Positive Results in Phase III MS Trial
Genentech’s oral BTK inhibitor fenebrutinib met its primary endpoint in the Phase III FENtrepid trial for primary progressive multiple sclerosis, showing non‑inferiority to Ocrevus and a 12% risk reduction in confirmed disability progression. The drug also delivered a 26% lower risk...
![[Therapeutics] Adaptive Deep Brain Stimulation in Parkinson's Disease](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/3742a25a994e69efcb711edfa308902b.webp)
[Therapeutics] Adaptive Deep Brain Stimulation in Parkinson's Disease
Adaptive deep brain stimulation (aDBS) introduces real‑time modulation of stimulation amplitude by tracking subthalamic beta activity, shifting Parkinson's therapy from fixed to physiomarker‑guided. Clinical trials report superior motor improvement, reduced stimulation‑related side effects, and markedly lower energy consumption compared with...
Researchers Develop RNA-Activated Implant to Stimulate Nerve Regrowth After Spinal Cord Injury
Researchers at RCSI have created a 3‑D biomaterial implant that releases PTEN‑targeting siRNA to injured spinal cord neurons, reactivating growth pathways. The scaffold replicates spinal cord mechanical properties and delivers RNA particles directly to the lesion site, silencing the PTEN...
Higher Medicaid Rates Boost Chances of 4- and 5-Star Ratings for Nursing Homes, JAMDA Study Finds
A new JAMDA cross‑sectional study of 9,473 freestanding nursing homes finds that higher Medicaid payment rates are linked to a greater likelihood of earning 4‑ or 5‑star overall, health‑inspection and staffing ratings on CMS’s Care Compare. Nearly 79% of facilities...
Cautious on Acquisitions, Some Nursing Home Operators Shift Focus to Value-Based Investments
Nursing home operators are slowing mergers and acquisitions in 2026 as inflated asset prices and an aging facility stock raise concerns about long‑term sustainability. Leaders such as A.G. Rhodes, Diversicare and Focused Post‑Acute are prioritizing capital for modernization, data analytics...
Solera Health Launches Behavioral Health Network with Calm and Lyra
Solera Health announced a new behavioral health network that links its HALO platform with Calm Health and Lyra Health. The service directs members to self‑guided apps or therapist‑led care based on their reported needs, expanding support beyond anxiety and depression...
Top HHS Officials Tout TEFCA Data-Sharing Framework As Central To MAHA
Top officials at the Department of Health and Human Services highlighted the Trusted Exchange Framework and Common Agreement (TEFCA) as a cornerstone of the "Make America Healthy Again" (MAHA) initiative. TEFCA, mandated by the 2016 bipartisan law, seeks to create...
US Vaccine Policy Shift Boosts MRNA Stock Appeal
Macro: US vaccine-policy swing heightens regulatory risk; FDA will review Moderna’s flu shot. Key: public dispute, amended filing; decision by Aug 5. Risk: political oversight. Trade: Buy MRNA. — Viktor Kopylov, PhD, CFA More insights: t.me/si14Kopylov
FDA Chief Warns U.S. Is Losing Ground to China in Early Drug Development, Calls for Faster Trial Approvals
FDA Commissioner Marty Makary warned that the United States is falling behind China in early‑stage drug development, citing slower Phase 1 trial volumes and cumbersome regulatory steps. He identified three primary bottlenecks—hospital contracting, ethical review processes, and the IND application workflow—that...
CBO: Part D Contributed To Higher Medicare Spending Than Expected
The Congressional Budget Office’s latest 10‑year budget outlook reveals that Medicare spending will be higher than previously projected, largely due to the Part D prescription‑drug benefit. CBO estimates the drug benefit adds several hundred billion dollars to federal outlays over the...
'Revolutionary' Mobile Imaging Pilot Program Excels at Preventing Unnecessary ED Visits
A pilot program in Ashford, England uses portable Fuji Xair imaging at patients' homes after falls. A radiographer and an advanced paramedic review 999 calls, travel to the scene, capture X‑rays and transmit them instantly to a hospital for interpretation....
The Blueprint for Commercializing Breakthrough Healthtech
AI‑driven medtech firms must prove tangible ROI for patients, providers and payers to move from lab to bedside. Brent Ness outlines three pillars—capital efficiency with payer alignment, rigorous evidence and reimbursement pathways, and operational scalability paired with strong IP—that determine...
NACHC Announces Center for Mobile Health to Advance Mobile Healthcare Delivery
The National Association of Community Health Centers (NACHC) unveiled the Center for Mobile Health, a dedicated hub to accelerate mobile health programs across community health centers. Backed by the Leon Lowenstein Foundation, Direct Relief and mobile‑vehicle firms, the Center will...
STAT+: New FDA Guidance for Antibiotic Use in Food-Producing Animals Prompts Criticism over Antibiotic Resistance
The FDA’s Center for Veterinary Medicine issued new guidance urging drugmakers to add explicit duration limits to medically important antibiotics used in food‑producing animals. Currently, about 28% of these drugs are administered continuously for approved indications, but the guidance seeks...
Cassidy, GOP Colleagues File Brief In LA Case On Comstock Act
Senate health committee chair Bill Cassidy and 59 Republican lawmakers filed an amicus brief supporting Louisiana’s lawsuit that the FDA violated the 1870 Comstock Act by permitting telehealth prescribing of mifepristone. The brief argues the agency overstepped its authority, seeking...
SPT Labtech, BellBrook Labs Automate Screening for VPS4B ATPase Inhibitors for Cancer Drug Discovery
SPT Labtech and BellBrook Labs announced a joint effort to automate a high‑throughput, cell‑based assay for VPS4B ATPase inhibitors, pairing BellBrook’s Transcreener® ADP2 fluorescence‑polarization assay with SPT’s dragonfly® liquid‑handling system. The miniaturized platform operates in 384‑ and 1536‑well formats and...
Ultrasound-Jiggled Nanobubbles Can Crack Cancer's Collagen 'Fortress'
Researchers at Case Western Reserve University have shown that ultrasound‑activated nanobubbles can mechanically disrupt the dense collagen matrix surrounding solid tumors, creating a temporary “softening” effect that lasts several days. In a breast‑cancer model, the approach enabled deeper penetration of...
Transfer Delays Tied to Worse Acute Stroke Intervention Results
A new Lancet Neurology study of 22,410 ischemic‑stroke patients shows that door‑in‑door‑out (DIDO) times exceeding the 90‑minute guideline are tied to poorer functional outcomes and lower rates of endovascular therapy. Patients with DIDO intervals of 91‑180 minutes, 181‑270 minutes, and...
Anti-Aging Gene Therapy in Alzheimer’s and ALS with Klotho Neurosciences’ Dr. Joseph Sinkule — Episode 243
The Xtalks Life Science Podcast featured Joseph Sinkule, CEO of Klotho Neurosciences, discussing the company’s secreted α‑Klotho gene therapy platform aimed at age‑related neurodegenerative diseases such as Alzheimer’s, ALS and Parkinson’s. Klotho leverages a patented anti‑aging gene to develop cell‑ and...
Oz: Codifying MFN Deals Could Avert ‘Draconian’ Pricing Measures
Pfizer CEO Albert Bourla met with CMS Administrator Mehmet Oz to negotiate a "most‑favored‑nation" (MFN) drug pricing agreement, though the specific terms were not disclosed. Oz indicated that the Trump administration plans to codify such voluntary MFN deals into law...
Oz: Codifying MFN Deals Could Avert ‘Draconian’ Pricing Measures
Pfizer CEO Albert Bourla disclosed a direct collaboration with CMS Administrator Mehmet Oz on a "most favored nation" (MFN) drug pricing arrangement, though the specific terms remain undisclosed. Oz indicated that the Trump administration intends to codify such voluntary MFN...
Quantum-Level Effects in Biology: Weak Magnetic Fields and Isotopes Can Alter Cell Protein Structures
University of Waterloo researchers demonstrated that weak magnetic fields and isotopic substitution can alter the structure of cellular proteins, specifically tubulin polymerization, in a quantum‑consistent manner. Published in Science Advances, the study bridges structural biology, biophysics, and quantum biology, revealing...
Pediatric Myopia Drug Is Latest In String Of Unexpected FDA Rejections
The FDA has rejected a pediatric myopia drug, citing a lack of substantial evidence for its efficacy. Pediatric ophthalmologists argue the drug, already used in compounded form, effectively slows myopia progression in children. The decision follows a series of recent,...
‘Mass Layoffs’ at PeaceHealth Include Hospice Staff
PeaceHealth announced a systemwide reduction of 94 positions, affecting less than 1% of its Washington workforce and including hospice staff, nurse practitioners, and administrative roles. The cuts trigger Washington's WARN Act, requiring a 60‑day notice before mass layoffs. This is...
Cutting-Edge Technologies Are Poised to Transform Orthopedics
Orthopedic surgery is rapidly adopting AI, robotic assistance, VR/AR and wearable digital tools, shifting from experimental concepts to routine practice. AI now supports imaging interpretation, predictive risk modeling, personalized surgical planning, training simulations and remote postoperative monitoring. Robotic platforms improve...
The “Ethical Canary”: How Moral Injury Signals Systemic Failure
Psychiatrist Courtney Markham‑Abedi describes personal experiences of moral injury triggered by caring for vulnerable patients and the killing of immigrant activist Renee Good. She expands the concept of moral injury, originally defined for veterans, to healthcare workers, coining it as...
FDA Backtracks On Moderna mRNA Flu Vaccine Refusal, Sets Aug. 5 Review Deadline
The U.S. Food and Drug Administration has reversed its earlier decision to decline a review of Moderna's mRNA influenza vaccine candidate. Following a Type A meeting with the company, the agency set an August 5, 2026 deadline for completing its evaluation. The...
An Oral Mucosa‐Inspired Wet‐Adhesion Janus Hydrogel With Asymmetric Bifunctionalities of Antifouling/Antioxidant for Treating Oral Ulcer in Diabetes
Researchers have engineered a wet‑adhesion Janus hydrogel (WAJH) that mimics oral mucosa to treat diabetic oral ulcers. The hydrogel features an antifouling agar/polyacrylamide layer and a tannic‑acid‑rich adhesive layer, delivering adhesion energies of 15 J m⁻² and 316 J m⁻² respectively. Its antioxidant tannic...
AI Will Slash Decades-Long Lag in Medical Adoption
It can take decades for new medical research to change what happens in the exam room. AI is going to massively accelerate this process. The dissemination of medical research into clinical practice is not slow because the science is slow. It...
AI Skill Automates Faxing Healthcare Requests in 2026
It's 2026, so... I just wrote a Claude Skill that faxes a request form to my healthcare provider.
N.I.H. Director Will Temporarily Run C.D.C. in Leadership Shake-Up
Dr. Jay Bhattacharya, the current NIH director, has been named acting director of the CDC, a role he will hold while continuing to lead the National Institutes of Health. He replaces Jim O’Neill, who is slated for a nomination to...
AI Automates Cytology, Streamlining Cell Pre‑Screening
AI automates cytology, which is a laborious, manual, human subjective task, for pre=screening cells for abnormalities and making initial diagnoses today @Nature https://t.co/ZI3F2pkMxE https://t.co/WsUcRjkHFN https://t.co/mdz1DM6xs7
Finalizing Top 100 Biotech VCs, Join 2026 Webinar
We're wrapping up the fact checking process for our annual Top 100 biotech VCs list and prepping for our companion webinar on VC investing in 2026. If this is a topic near and dear to your heart, be sure to...
Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
The FDA and UTMB are hosting a free, week‑long training course on data quality and integrity for BSL‑4 laboratories from July 28 to August 1, 2025, with in‑person seats in Manhattan, Kansas and a virtual option. The curriculum covers GLP requirements, Animal Rule...
Reduced APOE Expression Improves Bone Regeneration in Aged Mice
Researchers discovered that elevated circulating APOE in older mice suppresses bone regeneration by inhibiting osteoblast differentiation. Liver‑specific knockout of APOE or a single dose of a neutralizing antibody lowered serum APOE, restored Wnt/β‑catenin signaling, and markedly improved fracture callus density...
FDA Chief: Most Drugs Belong Over‑the‑counter
FDA chief Marty Makary says 'everything should be over the counter' unless drug is unsafe or addictive https://t.co/HiYBuxvyWC