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
KUKA FLEX CBD May Be Harmful Due to Hidden Drug Ingredient
The FDA issued a safety alert after laboratory testing revealed that KUKA FLEX CBD, sold online and in some stores for joint pain, contains the prescription NSAID diclofenac, which is not disclosed on the label. Diclofenac can trigger cardiovascular events, serious gastrointestinal damage, and dangerous drug interactions. The agency warns consumers to avoid the product and to report any adverse reactions through its MedWatch program. This notice underscores growing concerns about hidden drug ingredients in products marketed as dietary supplements.
![Stark Integrity Podcast: Artificial Intelligence in Healthcare Law & Compliance, and Compliance Program Effectiveness [Podcast]](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://natlawreview.com/sites/default/files/styles/article_image/public/2026-04/AI%20Artificial%20Intelligence-475590125_0.jpg.webp?itok=nA2QHgWv)
Stark Integrity Podcast: Artificial Intelligence in Healthcare Law & Compliance, and Compliance Program Effectiveness [Podcast]
The Stark Integrity podcast released a three‑part series on artificial intelligence (AI) in healthcare law and compliance, hosted by Nelson Mullins partner Bob Wade and featuring partners Bob Coffield and Darren Skyles. Episodes explore how AI is already adding value, the...
Legislative Efforts to Curb Prescription Drug Prices Gain Momentum Across the U.S.
Virginia’s General Assembly is holding a special session to vote on the Affordable Medicine Act, a bipartisan bill that would extend Medicare‑negotiated drug prices to state‑regulated health plans. The legislation follows successful price‑cap measures in Maryland and Colorado, which have...
CFOs Feel Healthcare Pain Rising as GLP-1s Stretch Budgets: Mercer
A Mercer survey of 161 CFOs reveals that nearly three‑quarters now rank healthcare among their top five operating‑expense concerns, driven largely by soaring GLP‑1 weight‑loss drug costs. Employer‑sponsored health insurance expenses are projected to climb 6.7% in 2026, pushing average...
The Gold Rush Is Over: Navigating the 2026 Hospice Regulatory Crackdown
The hospice sector, once booming in California, faces a sharp regulatory reversal in 2026 as CMS and Congress intensify oversight. The Unified Program Integrity Contractor, Qlarant, is deploying predictive analytics to audit eligibility, length‑of‑stay, and live‑discharge patterns, with non‑compliance risking...
Curcuflex May Be Harmful Due to Hidden Drug Ingredients
The U.S. Food and Drug Administration has warned consumers to avoid Curcuflex, a joint‑pain product sold online and in some stores, after laboratory testing revealed it contains the prescription drugs dexamethasone and diclofenac, neither of which appear on the label....
Can Facet Arthroplasty Outperform TLIF for Spondy?
A prospective, multicenter FDA IDE trial compared the Total Posterior Spine (TOPS) facet arthroplasty system with traditional transforaminal lumbar interbody fusion (TLIF) in 249 patients with single‑level grade I degenerative spondylolisthesis. At 24 months, TOPS achieved an 85% composite clinical success rate...
AI in Rural and Critical Access Healthcare: Closing the Technology Gap
Rural and critical access hospitals lag behind larger systems in adopting generative and agentic AI because half operate at a deficit and have thin IT staff. Experts recommend starting with narrow, revenue‑cycle problems such as claim‑denial processing, where AI can...
RM Joe May Be Harmful Due to Hidden Drug Ingredients
The FDA has issued a safety alert that the joint‑pain product RM Joe, sold online and in some stores, contains undeclared dexamethasone phosphate and diclofenac. Laboratory testing confirmed the hidden prescription‑drug ingredients, which can trigger severe steroid‑related and NSAID‑related side effects....
Cataract Surgery Success in Most Patients Defined by MIPS
A new JAMA Ophthalmology study finds that the Merit‑Based Incentive Payment System (MIPS) measure 191 labels cataract surgery as successful for most patients, but it excludes nearly half of all cases, disproportionately affecting older and Black patients. Using data from...
Evaluation of Depot Buprenorphine Provision in Treatment and Recovery Services in England
Depot buprenorphine (DB), a long‑acting injectable opioid substitution therapy, expanded in England under the Supplemental Substance Misuse Treatment and Recovery Grant. By 2024 DB accounted for about 6.9 % of opioid substitution treatments, with uptake fastest in areas that received early...
The Barriers and Facilitators to Supporting, Commissioning and Working with Lived Experience Recovery Organisations in Systems of Care in England
The RAND Europe study reveals that lived‑experience recovery organisations (LEROs) remain under‑utilised in England, with only about one‑third of local areas recognising a LERO despite policy emphasis on peer‑led support. LEROs provide direct assistance to people using alcohol or drugs,...
Parliament Urged to End Assisted Suicide for Non-Terminal Patients
Canada's medical‑assistance-in-dying (MAID) law was expanded in 2021 with a second stream, “Track 2,” allowing non‑terminal patients—including those with mental illness—to access assisted death. Between 2021 and 2024, 2,050 Canadians died under this provision. Disability group Inclusion Canada is urging Parliament...
Factors that Influence Employees' Perceptions and Experiences of Working Within the Treatment and Recovery Sector in England
A new study evaluating England’s Drug and Alcohol Treatment and Recovery Workforce Transformation Programme finds that staff remain highly engaged and committed despite the sector’s demanding nature. The three‑year drug‑strategy funding has bolstered job resources, improving employee experience in many...
Integrated Care for People Who Use Alcohol And/Or Other Drugs
The UK’s Supplementary Substance Misuse Treatment and Recovery Grant (SSMTRG) is showing early signs of reshaping how alcohol and drug services coordinate with broader health care. A mixed‑methods study of ten sites uncovered five distinct integration models, from single‑point access...
Implementation of the Treatment and Recovery Portfolio of the 'From Harm to Hope' Drug Strategy in England
The UK government’s ‘From Harm to Hope’ Treatment and Recovery Portfolio injected ring‑fenced funding into a drug‑treatment sector that had suffered years of disinvestment. Over the first three years the portfolio was largely delivered as planned, though long‑term funding uncertainty...
Implementation and Early Impacts of the Housing Support Grant in England
The UK government allocated roughly $67 million over three years to launch the Housing Support Grant (HSG) pilot in England, targeting people who use alcohol or drugs. Twenty‑eight local authorities delivered intensive, person‑centred housing assistance, combining financial aid and dedicated support...
Why Heart Failure Care Requires Spaced Repetition for Doctors
Heart failure patients benefit from four guideline‑directed drug classes, yet real‑world use lags dramatically. Only about 44% of hospitalized patients receive all four therapies and roughly 1% achieve target doses. The article argues that the shortfall stems not from ignorance...
The BioPharm Brief: Early Design Risks, Oncology Signals, and a Biosimilars Power Move
The BioPharm Brief highlights three pivotal biopharma trends: early‑stage process design flaws can cripple cell and gene therapy scale‑up, leronlimab demonstrates early clinical and biomarker activity in metastatic colorectal cancer, and Amneal Pharmaceuticals’ acquisition of Kashiv BioSciences creates a vertically...
Zepbound Sparks Diet Shift, Slashes LDL by One‑third
Patient started Zepbound and cut their LDL cholesterol essentially by a third and no longer in the range to start a cholesterol medicine. The medicine doesn't lower LDL cholesterol that much, but it did allow her to eat a more plant-forward...
Alzheimer's Drugs Show Minimal Benefit, Review Reveals Deeper Issues
Alzheimer’s drugs offer little benefit, major review finds – and the reasons go deeper than the science https://t.co/cnMPAEQumY https://t.co/wtg8llquON
State Legislatures Consider Oversight of Artificial Intelligence in Health Insurance Decisions
State lawmakers across six states are introducing bills that tighten oversight of artificial intelligence in health‑insurance decisions such as prior authorization and utilization review. The proposals generally allow AI as an assistive tool but require a qualified healthcare professional to...
FDA Criticizes Replimune's Melanoma Trial Design
Some observers, including @US_FDA, have criticized @Replimune for the design of the trial that led to the decision not to grant accelerated approval of their melanoma treatment. I asked the company's Chairman about that view. Watch the full interview: https://t.co/XYVmSeodLv https://t.co/OO8eXTZOXh
Creating Baby Geniuses to Thwart the AI Threat? (Yes, Really.)
A cluster of Silicon Valley billionaires—including Peter Thiel, Sam Altman, Marc Andreessen and Vitalik Buterin—are financing embryo‑editing startups that aim to prevent disease and, for some, create children capable of outthinking advanced AI. The firms, such as Nucleus, are leveraging CRISPR...
Prices Rose After No Surprises Arbitration for some Care: Analysis
New Brookings research shows that prices set through the No Surprises Act’s independent dispute resolution (IDR) arbitration are dramatically higher than pre‑law in‑network rates. In 2024, imaging costs after arbitration were 767% above Medicare benchmarks, far exceeding the roughly 200%...
Oncology Leaders Address Testing, Access, Equity, and Pharmacy in Cancer Care
On March 12, 2026, the American Journal of Managed Care convened Chicago oncology leaders to discuss precision testing, equity, and pharmacy integration in cancer care. Panels emphasized universal biomarker testing for lung cancer, highlighted gaps such as low EGFR testing...
STAT+: At AACR, Talk of Chinese Biotech, Oncology’s Comms Issue, and More
Revolution Medicines highlighted two key updates at the AACR meeting: promising frontline pancreatic cancer data for its RAS inhibitor daraxonrasib and the introduction of a novel compound, RM-055. RM-055 is described as a catalytic inhibitor that can strip a phosphate...
How Can We Help Early Social Development?
The latest Neurosense podcast features child psychiatrist Jonathan Green discussing his research on early social development in autistic children. Green’s approach centers on parent‑mediated interventions rather than direct work with the child, teaching caregivers strategies to foster social skills. The...
When Bioprosthetic Mitral Valves Fail: Redo Surgery Bests Transcatheter Treatment After 5 Years
New research published in The Annals of Thoracic Surgery compares redo surgical mitral valve replacement (SMVR) with transcatheter mitral valve‑in‑valve (mViV) in patients whose bioprosthetic mitral valves have failed. Over a 5‑year follow‑up, SMVR patients experienced an all‑cause mortality of...
Re: Palantir: NHS Pilot’s “Success” Is Questioned as Second Figure at Major Trust Is Linked to the Tech Giant
Palantir Technologies' NHS pilot has come under fire after a Westminster Hall debate where health minister Dr Zubir Ahmed reiterated the company's claim that more than 100,000 additional patients were helped to undergo procedures. A retired GP, Nick Mann, wrote...
FDA Warns Device Manufacturers of Nitrosamine Impurities that Could Cause Cancer
The FDA’s Center for Devices and Radiological Health has issued a warning to manufacturers of drug‑device combination products about the presence of nitrosamine impurities, specifically 1‑methyl‑4‑nitrosopiperazine, detected in rifampin‑impregnated devices. The agency highlighted that catheters, cardiac‑implant envelopes, and other devices...
The AI Therapy Crisis: Why the AMA Is Urging Congress to Regulate Mental Health Chatbots
The American Medical Association has written to the Congressional AI and Digital Health Caucuses urging lawmakers to impose strict regulations on mental‑health chatbots. While acknowledging AI’s potential to broaden access to care, the AMA warns that unregulated bots can encourage...
How Many “Mentally Fine” Adolescent Scoliosis Patients Are, in Fact, Quietly Struggling?
A prospective study of 93 adolescent idiopathic scoliosis (AIS) patients compared the traditional SRS-22 mental health questionnaire with PROMIS well‑being measures (Positive Affect, Life Satisfaction, Meaning & Purpose). While the two tools showed moderate‑to‑strong correlations, PROMIS identified 14‑40% of teens...
CVS Claims It’s on the Verge of Losing All Its Pharmacies in Tennessee
CVS Health warns that the Tennessee Fair Rx Act, now passed by the state Senate, would force it to shut down all more than 100 retail pharmacies and 25 MinuteClinic locations in the state. The bill bars companies that own...
51 Cases that Reframe Methylene Blue Serotonin Syndrome
The article argues that the FDA’s 2011 serotonin‑syndrome warning for methylene blue applies only to high‑dose intravenous use, not to the low‑dose oral supplements many clinicians prescribe for mitochondrial support. A review of 51 published cases found 50 involved IV...
WATCH LIVE: RFK Jr Testifies on Proposed HHS Budget at Senate Hearing
Health and Human Services Secretary Robert F. Kennedy Jr. testified before the Senate HELP Committee on the administration's proposed HHS budget. The live hearing, streamed by Fox Business, centered on funding allocations for Medicare, Medicaid, public health, and pandemic preparedness....
Social Support Beats Policy‑blind Trauma Treatment for Recovery
Treating trauma while ignoring the social and political conditions that generate it risks turning medicine into a repair shop for problems our policies continue to produce. The strongest predictor of sustained recovery from addiction is social support. https://t.co/HoXy8efgWf
BioMérieux Unveils BIOFIRE SPOTFIRE Molecular Testing Solution for Biopharma
bioMérieux has launched BIOFIRE SPOTFIRE, a molecular testing system aimed at biopharma quality control. The instrument delivers mycoplasma results in less than an hour, leveraging automated workflows, touchscreen operation, and barcode scanning. Designed to be compact and stackable, it integrates with...
Ocrelizumab in PPMS. Complementing Regulatory History with a Decade of Clinical Evidence
Roche’s ocrelizumab (Ocrevus) is the only FDA‑approved disease‑modifying therapy for primary progressive multiple sclerosis (PPMS). Since its 2017 approval based on the ORATORIO trial, a decade of data—including the 2025 O’HAND study and ten‑year extension analyses—has confirmed robust efficacy across...
Pharmaceutical Executive Daily: Idvynso Receives FDA Approval
The FDA granted approval to Idvynso, a new oral therapy for HIV‑1 infection in adults, citing trial data that showed sustained viral suppression and a safety profile on par with existing regimens. The drug adds to a shifting HIV market...
Only 9% of Americans Know How to Maintain Brain Health, Alzheimer’s Association Finds
The Alzheimer’s Association’s 2026 Brain Health in America report reveals a stark knowledge gap: while 88% of U.S. adults aged 40+ consider brain health very important, only 9% say they know “a lot” about how to protect it. Respondents recognize...
Strategic IP Considerations for the Medtech Market Rebound After Record Investment and M&A in 2025
Record venture investment of $10.4 billion and a median M&A deal value of $570 million signal a strong medtech rebound in 2025. The surge has pushed median upfront payments to $529 million, prompting acquirers to intensify IP due diligence. Recent rulings—Amgen’s enablement standard,...
CDRH Director Tarver Previews AI Guidance at AAMI Event
At the AAMI neXus conference, FDA CDRH Director Michelle Tarver announced that final guidance on AI lifecycle management will be issued later this year, building on the draft released in January 2025. The guidance will codify requirements for representative training...
Outside FDA, Inside the Crosshairs: Cybersecurity Risks for General Wellness and Fitness Products
The FTC’s Health Breach Notification Rule (HBNR) now reaches low‑risk general‑wellness apps that aggregate personal health data, even though the FDA’s 2026 guidance excludes them from device regulation. Developers risk being classified as personal health record (PHR) vendors when their...
Therapeutic Alliance in Psychiatry Matters More than Ever
Timothy Lesaca argues that the therapeutic alliance—rooted in Karl Menninger’s credo of understanding before judgment—is more vital than ever in psychiatry. He warns that modern, metric‑driven practices and shrinking appointment times erode the relational space essential for genuine patient connection....
Re: Measles: 38 Children Dead in Bangladesh Outbreak
A measles outbreak in Bangladesh has claimed 38 children’s lives, underscoring severe gaps in routine immunisation. Coverage for the first measles‑containing vaccine (MR1) slipped to 86.1% and the second dose (MR2) to 80.7%, well below the 95% target. UNICEF, WHO...
FDA Clinical Trials Training Modules
The FDA’s Center for Drug Evaluation and Research has released new clinical‑trial training modules that capture the agency’s latest regulatory intelligence, emerging guidance, and real‑world compliance experience. The curriculum serves as a global benchmark, helping organizations demonstrate regulatory excellence and...
WTWH Healthcare Announces the Memory Care Innovation Awards Class of 2026
WTWH Healthcare, a WTWH Media subsidiary, announced the Memory Care Innovation Awards Class of 2026, honoring leaders who are advancing cognitive care across home health, behavioral health, hospice, senior living and skilled nursing. The awardees include directors, COOs and clinical...
Family Challenges W.Va. EMS Account, Demands Charges After Fatal Ambulance Incident
John Lucas, 45, died after being struck by a Kanawha County Emergency Ambulance Authority vehicle on April 15. Family members dispute the sheriff’s office account that Lucas was armed, presenting surveillance video that suggests he was seeking help. Radio logs...
Relaxing the Rules: How Claim Type Supported Patent Validity for Teva Pharmaceuticals’ “Headache Patents”
The Federal Circuit reversed a lower‑court ruling that invalidated Teva Pharmaceuticals’ “headache patents,” holding that the method‑of‑treatment claims satisfied written description and enablement requirements. The court emphasized that the claims were directed to using humanized mouse antibodies, not the antibodies...