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
NIHR Funding for Kidney Care App Study at Portsmouth NHS Trust
Portsmouth Hospitals University NHS Trust has received almost £100,000 (≈ $128,000) from the NIHR to evaluate the MyRenalCare app’s ability to make kidney care more inclusive. The INCLUDE‑CKD study will compare about 1,000 app users with a similar number receiving standard care over the next year. Researchers will interview patients and staff to gauge real‑world experiences and assess whether digital kidney care reduces or worsens health inequalities. Findings are intended to shape future NHS rollout of equitable digital kidney services.
Philip Morris Secret Hearing Angers Health Advocates over Double Standard
A secret, private appearance by Philip Morris at a Senate inquiry into Australia’s illegal tobacco trade sparked outrage among health officials and advocacy groups. The company’s representatives were not listed on the public agenda, and their identities were redacted for alleged...
CDC Leader Calls for New Journal to ‘Elevate Scientific Rigor’
Acting CDC director Jay Bhattacharya halted a COVID‑19 vaccine‑effectiveness study slated for the agency’s Morbidity and Mortality Weekly Report (MMWR) and publicly questioned the bulletin’s peer‑review practices. He argued that MMWR, which has operated for 65 years without formal external review, should...
STAT+: Johnson & Johnson Advances IBD Therapy, Despite Trial Miss
Johnson & Johnson's combination therapy JNJ-4804, pairing Tremfya and Simponi, failed to meet the primary clinical remission endpoint in two Phase 2b trials for ulcerative colitis and Crohn's disease, though it outperformed each drug alone. The DUET study results were...
Neonatal Steroids Affect Preterm Infant Body Composition
A recent correction in Pediatric Research by Kraemer et al. re‑examines how neonatal corticosteroid therapy alters body composition of preterm infants at hospital discharge. Using dual‑energy X‑ray absorptiometry, the study finds a relative increase in fat mass and modest reductions...
Sertraline Manufacturer Recalls Antidepressant Batch After UK Packaging Mix-Up
Amarox, a subsidiary of India’s Hetero Group, is recalling a batch of 100 mg sertraline tablets after a packaging error placed citalopram strips in the same cartons. The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued the recall following a...
How RFK, Jr.’s False Vaccine Claims Are Holding up $600 Million to Fight Diseases in Poor Countries
Robert F. Kennedy Jr. is blocking the release of roughly $600 million earmarked for vaccines to low‑income nations by pressuring Gavi, the global vaccine alliance. He claims U.S. shots contain obsolete, unsafe ingredients and wants the same formulations used abroad. A...
CDC HoSt-TT Certification for Siemens Healthineers Total Testosterone Test Expands Patient Access to Gold Standard Equivalent Results
Siemens Healthineers’ Atellica IM Testosterone II (TSTII) assay has received CDC Hormone Standardization Program certification for total testosterone (HoSt‑TT), confirming its results match the gold‑standard LC‑MS/MS method. The assay, available on Atellica IM and CI analyzers, is the only fully automated immunoassay to...
Taking GLP-1s? Make Sure You Exercise
GLP‑1 drugs such as semaglutide and Wegovy accelerate weight loss but can also erode muscle if not paired with exercise. Endocrinologist Dr. Anira Iqbal advises a mixed routine of strength, aerobic, plyometric and flexibility work to protect lean tissue and boost...
Sarepta, Amylyx and Neumora Look Ahead to Key Catalysts as Q1 Earnings Roll In
Sarepta Therapeutics, Amylyx, and Neumora Therapeutics are set to report Q1 results amid pivotal milestones. Sarepta faces scrutiny after two DMD patient deaths and awaits FDA review of Amondys 45 and Vyondys 53, plus a sirolimus safety study. Amylyx, after pulling its...
The FDA Wants to Make Many Popular Prescription Drugs OTC—A Great Idea. Here’s Why It’s Unlikely to Happen
FDA Commissioner Marty Makary argues that most prescription drugs should be reclassified as over‑the‑counter unless safety concerns exist. The article highlights how prescription status inflates prices by routing purchases through insurance, citing lower cash prices for OTC versions of Claritin,...
Telomeres: History, Health and Hallmarks of Aging
Bill Andrews, a co‑discoverer of human telomerase, argues that telomere shortening is the primary limiter of human lifespan and that systemic activation of telomerase can reverse biological aging. He promotes small‑molecule activators such as TAM‑818 and botanical blends like Telo‑Vital,...
I Built a Startup and Failed—AI Might Have Changed That
The author reflects on a 2012 medical‑device startup that failed because administrative overload eclipsed core product work. He argues that starting a social enterprise today with AI agents could have automated grant writing, reporting, and coordination, turning a one‑person effort...
Dignified Food for Seniors: Closing Gaps in an Ageing World
Singapore’s Institute of Technology (SIT) has unveiled MAKANsoft, a halal‑certified food texturant that reshapes puréed dishes into familiar forms while meeting IDDSI Levels 4‑5. The innovation tackles choking risks and the loss of dignity for seniors with dysphagia, costing roughly SG$2...
Molecular Hydrogen May Reduce Fatigue and Support Physical Function in People with Long COVID
A single‑blind, 14‑day pilot trial published in *Nutrients* examined hydrogen‑rich water versus regular water in 32 adults with long‑COVID. Participants drinking the hydrogen‑infused water reported statistically significant reductions in fatigue and showed measurable gains in six‑minute walk distance (42‑62 m), chair‑stand...
AI Model Helps Discern Patients' Need for Supplemental Breast Imaging
A deep‑learning model called Mirai, developed by MIT and Mass General, predicts a woman’s five‑year breast‑cancer risk from routine mammograms with an AUROC of 0.71, markedly higher than the 0.53 achieved by traditional density‑based BI‑RADS categories. The study evaluated over...
Comparing Antibiotic Outcomes in Preterm Infants
A recent multicenter cohort study examined how different antibiotic regimens affect outcomes in preterm infants born before 32 weeks. Researchers compared broad‑spectrum empiric therapy with a targeted, shorter‑duration approach, tracking mortality, necrotizing enterocolitis (NEC), late‑onset sepsis, and antimicrobial resistance. The...
Is the Atrium-WakeMed Merger Already Hitting a Wall?
North Carolina’s two largest health systems, Atrium Health and WakeMed, announced a $2 billion merger that would create 3,300 jobs in Wake County. The Wake County Board of Commissioners postponed its vote, citing transparency and cost concerns raised by the state...
Disruptions Threaten Progress in Inclusive Clinical Trials and Health Equity
JMIR Publications highlighted recent disruptions to inclusive clinical trials after a 2025 White House executive order targeting DEI programs. The order led to the termination and delayed funding of NIH‑funded studies, such as Dr. Mohottige’s kidney disease trial, affecting 383...
Study Finds Weak Penalties for Medicare Advantage Rule Violations
A Brown University study published in JAMA Internal Medicine examined CMS enforcement of Medicare Advantage plans from 2010‑2023. It found that 87% of the 844 actions were modest monetary penalties, with fines averaging under $3 per enrollee and a peak...
TGA Updates Australian Manufacturing Licences with New Approvals and Regulatory Actions
The Therapeutic Goods Administration (TGA) released its latest licensing decisions, granting 14 new manufacturing licences for therapeutic goods while suspending two and revoking eight existing licences. The approvals cover a diverse set of entities, including pharmaceutical firms, biotech innovators, logistics...
Former Governor Joins Radiology Partners Board of Directors
Radiology Partners, the nation’s largest physician‑owned radiology practice, announced that former Maryland Governor Larry Hogan has joined its board of directors. Hogan, who served from 2015 to 2023, led the state’s $216 million Cancer Moonshot initiative and survived stage 3 non‑Hodgkin lymphoma...
Takeda's TAK-881 Shows PK Parity with HYQVIA in Pivotal PID Trial
Takeda announced today that its investigational subcutaneous immunoglobulin, TAK-881, met the primary pharmacokinetic endpoint in a pivotal Phase 2/3 trial, showing comparable exposure to HYQVIA while offering reduced infusion volume and flexible dosing for primary immunodeficiency disease patients.
FDA Clears Incyte's Jakafi XR Extended‑Release for MF, PV and GVHD
The U.S. Food and Drug Administration approved Incyte's Jakafi XR extended‑release tablets for adults with intermediate‑ or high‑risk myelofibrosis, polycythemia vera resistant to hydroxyurea, and for patients 12 years and older with steroid‑refractory acute or chronic graft‑versus‑host disease. The once‑daily formulation...
Physician‑Owned Hospitals Seek Voice in Medicare’s New TEAM Model
The Centers for Medicare & Medicaid Services (CMS) has opened a public comment period through June 9 for physician‑owned hospitals to weigh in on the Transforming Episode Accountability Model (TEAM). Advocates say the move could give doctors more control over payment...
Advances in Neonatal Cell Therapies: 2025 Update
The 2025 Neonatal Cell Therapies Symposium underscored the rapid maturation of manufacturing for cord blood, placental and amniotic‑derived cellular products, now operating under GMP certification. Robust quality‑management systems integrate donor eligibility, informed consent and continuous environmental monitoring to guarantee batch...
Medtronic Secures FDA Clearance for Mosaic Neo Mitral Valve Bioprosthesis
Medtronic plc won FDA approval for its Mosaic Neo mitral bioprosthesis, a next‑generation valve designed for sternotomy, minimally invasive and robotic implantation. The device launches at the AATS meeting, promising improved durability and ease of use for complex mitral repairs.
Depression Worsens Rapidly in the Final Four Years of Life
A multinational twin study of 2,411 older adults found that depressive symptoms sharply accelerate about four years before death. The acceleration is more pronounced in men, who experience steeper increases after the four‑year mark, while women’s rise begins slightly earlier....
CB Exclusive: Mosh Puts Family Judgement in the Spotlight for New Weight Loss Campaign
Mosh and its women‑focused brand Moshy have launched a "Weight Loss Without The Judgement" campaign that puts family criticism at the centre of a POV horror‑style video. The spot, directed by in‑house talent Yarno Rohling, dramatizes unsolicited advice during dinner...
Kennedy Launches Initiative to Reduce Antidepressant Use
Bad timing, guy. You are one reason among many why the nation is so depressed. Kennedy Starts a Push to Help Americans Quit Antidepressants https://t.co/nSnwWeUqcW
Study Maps Suicide Ideation as Core Trauma Symptom in Palestinian Refugees in Egypt
A team led by Noha Fadl of Alexandria University surveyed 558 Palestinian refugees in Egypt and found suicidal ideation to be the most central symptom in gender‑specific trauma networks. The findings, published in Psychiatry Research, call for targeted mental‑health interventions...
U.S. Dietary Guidelines Raise Protein Targets as Consumer Demand Hits Record High
The U.S. Department of Health and Human Services released revised Dietary Guidelines that increase recommended protein intake to 1.2‑1.6 g per kilogram of body weight. The change aligns with a cultural boom in protein consumption, where 70% of Americans say protein...
MCRI Launches World‑first Trial Giving Obese Parents GLP‑1 Drugs to Curb Child Obesity
The Murdoch Children’s Research Institute (MCRI) announced a world‑first clinical trial that will provide GLP‑1 weight‑loss medication to obese parents enrolled in its Generation Victoria cohort, testing whether parental weight loss can shift household food environments and reduce childhood obesity...
New Trial Compares Dara‑Bor‑Dex vs Cy‑Bor‑Dex in MM with LCCN
EAA241 - Ph 2 RCT Dara-Bor-Dex vs Cy-Bor-Dex in the treatment of Newly Diagnosed Multiple Myeloma with Light Chain Cast Nephropathy (LCCN) [Study activated 8/11/25] @keruakous https://t.co/1NgvVZ3fTA #NCT07085728 #mmsm @eaonc https://t.co/Jrh4teOxUK
Daratumumab Boosts Revlimid Efficacy in Smoldering Myeloma
#EAonc EAA173 - Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM) - PI: @nsc_natalie https://t.co/VtBMJUjI5X Activated: Apr 30, 2019 #mmsm @eaonc #NCT03937635 @VincentRK @mweissmdphd https://t.co/oQzEYsPoU4
FDA Launches Real‑Time Clinical Trial Initiative, AstraZeneca and Amgen Lead First Pilots
On April 28, 2026, the U.S. Food and Drug Administration unveiled a two‑step plan to roll out real‑time clinical trials, launching two proof‑of‑concept studies and issuing a Request for Information on a summer pilot. AstraZeneca and Amgen are already running...
Phase 3 Trial
.@SWOG S2213 Ph3 RCT Dara-VC Induction Followed by ASCT or Dara-VCD Consolidation & Daratumumab Maintenance in Pts w/ Newly Diagnosed AL Amyloidosis [Activated: 12/1/23] https://t.co/OizUfJCc2c #mmsm #bmtsm https://t.co/zWMK1RfCFW
Senate Introduces Clinical Trial Modernization Act to Cut Patient Costs
Senators Tim Scott (R‑SC) and Mark Warner (D‑VA) unveiled the Clinical Trial Modernization Act (S.4440), a bipartisan effort to remove financial and geographic obstacles for patients in clinical trials. The legislation would permit sponsors to reimburse up to $2,000 annually...
Bristol Myers Squibb Posts $11.5B Q1 Revenue, Reaffirms Full-Year Guidance
Bristol Myers Squibb announced first‑quarter 2026 revenue of $11.5 billion, up 1% year‑over‑year, and reaffirmed its full‑year guidance. The company highlighted a 9% growth in its oncology portfolio, a 280‑basis‑point dip in gross margin, and several late‑2026 regulatory milestones.
Tonight in Your Rights: A Shadow Docket Surprise
The Supreme Court’s shadow docket, led by Justice Samuel Alito, issued a one‑week administrative stay that temporarily restores nationwide mail‑order access to the abortion pill mifepristone. The stay halts a Fifth Circuit ruling that had blocked remote dispensing after Louisiana...
ENDING "NO JAB, NO PAY" COERCIVE KIDS VACCINATION
An amendment to the NSW Public Health Act, introduced by Libertarian MLC John Ruddick, seeks to repeal the "No Jab, No Pay" scheme that ties child support and school enrollment to vaccination status. The proposal is backed by former pharmaceutical...
GRIN Therapeutics Launches European Phase 3 Beeline Trial of Radiprodil
GRIN Therapeutics announced the initiation of its pivotal Phase 3 Beeline trial in eight European countries, expanding a global registrational program for radiprodil. The study targets GRIN‑related neurodevelopmental disorder (GRIN‑NDD) caused by gain‑of‑function variants, aiming to become the first disease‑modifying therapy...
Neuronetics Inc (STIM) Q1 2026 Earnings Call Transcript
Neuronetics reported Q1 2026 results highlighting an 86% revenue surge to $41.8 million, driven largely by the integration of Greenbrook clinic operations. The company posted a net loss of $7.2 million, but achieved positive operating cash flow in the fourth...
Ocugen Inc (OCGN) Q1 2026 Earnings Call Transcript
Ocugen reported major clinical progress across its gene‑therapy pipeline, completing enrollment for the OCU400 Phase 3 Limelight trial and delivering strong 12‑month efficacy data for OCU410 in geographic atrophy and OCU410ST in Stargardt disease. The company announced a rolling Biologics License...
Jazz Pharmaceuticals PLC (JAZZ) Q1 2026 Earnings Call Transcript
Jazz Pharmaceuticals reported a record $1.126 billion third‑quarter revenue, up 7% year‑over‑year, driven by double‑digit growth in its sleep franchise and Epidiolex. Xywav sales rose 11% to $431 million with 450 net patient adds, while Epidiolex posted a 20% increase to $303 million....
AtriCure Inc (ATRC) Q1 2026 Earnings Call Transcript
AtriCure reported $534.5 million revenue for 2025, a 15% increase year‑over‑year, with adjusted EBITDA rising to $61.8 million and cash generation of $45 million. Gross margin held steady at 75% and the company launched two new products, the AtriClip Pro Mini and Cryo XT...
Alkermes Plc (ALKS) Q1 2026 Earnings Call Transcript
Alkermes reported $1.5 billion in 2025 revenue, driven by a 9% rise in its proprietary product portfolio, and closed the $775 million cash Avadel acquisition in February 2026, adding the LUMRIZE sleep‑medicine platform. The company forecast 2026 total revenue of $1.73‑$1.84 billion with...
Supernus Pharmaceuticals Inc (SUPN) Q1 2026 Earnings Call Transcript
Supernus Pharmaceuticals announced FDA approval of Qelbree, a non‑controlled ADHD medication for children aged 6‑17, with a U.S. launch planned for the second quarter of 2021. The company reported first‑quarter revenue of $130.9 million, a 38% year‑over‑year increase, driven by growth...
Adaptive Biotechnologies Corp (ADPT) Q1 2026 Earnings Call Transcript
Adaptive Biotechnologies reported $277 million total revenue for 2025, a 55% year‑over‑year increase, driven by a 46% jump in MRD revenue to $212 million and a 43% rise in clonoSEQ test volume to 30,038. Average selling price per test climbed 17% to...
NIH Grant Cuts Disproportionately Hit Minority and Female Scientists
In early 2025 the Trump administration ordered the termination of more than 2,000 NIH biomedical research grants, many of which were later reinstated after university negotiations and lawsuits. A survey of roughly 940 affected investigators shows that the cuts fell...