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
Pharma Pulse: The FDA Shake-Up and Growing Frustration with Prior Auth Reform
FDA Commissioner Marty Makary announced his resignation, with deputy Kyle Diamantas stepping in as acting commissioner. Eli Lilly released data indicating patients can sustain weight loss when transitioning from higher‑dose injectables to lower‑dose Zepbound or its oral GLP‑1, Foundayo. The FDA also proposed excluding GLP‑1 therapies such as semaglutide and tirzepatide from the 503B bulk drug substances list, curbing large‑scale compounding. A new AMA survey shows only one in three physicians think recent insurer promises on prior‑authorization reform will meaningfully improve patient access.
3 Physical Markers Beyond Blood Pressure That Can Predict Stroke Risk
A new UK Biobank analysis of 483,000 participants over 14 years identifies three simple physical markers—walking pace, grip strength, and muscle mass—that independently predict stroke risk. Slow walkers face a 64% higher risk, each 5 kg loss in grip strength adds...
Thinking About Stopping an Antidepressant? Here’s What to Consider.
Health Secretary Robert F. Kennedy Jr. announced initiatives encouraging people to consider stopping antidepressants, especially selective serotonin reuptake inhibitors (SSRIs), while emphasizing that no one is being told to quit abruptly. The American Society of Clinical Psychopharmacology recently urged clinicians...
Behind The Raise: Peripear
Peripear, founded by former midwife Nina van Schaick, has built a hands‑free wearable that delivers therapeutic warmth to the perineum during crowning, reducing severe tears by up to 50 %. The device targets hospital labour units, with MOUs in Singapore covering...
Trump Demands Medicaid Data for Deportation. Some States Go a Step Further.
Republican‑led states are expanding federal immigration enforcement by requiring their public health agencies to report Medicaid recipients whose legal status is doubtful. North Carolina joined Indiana, Louisiana, Montana and Wyoming in passing laws that flag Medicaid users to the Department...
License To Deliver: Some Midwives Break the Law To Assist With Home Births
In Georgia, certified professional midwives (CPMs) who attend home births operate illegally, facing cease‑and‑desist letters or criminal charges. Demand for home births has surged, up 72% in the state and 42% nationwide since 2020, prompting advocates to push for licensing...
Osel and Partners Launch Phase IIb FLIP-2 Trial of Lactin-V
Osel, Imperial College London and the March of Dimes have launched the Phase IIb FLIP‑2 trial to evaluate Lactin‑V, a live‑biotherapeutic containing Lactobacillus crispatus, for preventing preterm birth in high‑risk pregnancies. The study will enroll 360 women across four UK maternity...
Pfizer Receives EC Approval for Hympavzi to Treat Haemophilia
Pfizer secured European Commission marketing authorisation for Hympavzi (marstacimab) to treat hemophilia A or B with inhibitors in patients aged 12 years and older weighing at least 35 kg. The once‑weekly subcutaneous therapy showed a 93% reduction in mean annualised bleeding rate versus on‑demand...
Initiation Setting and Persistence of Medications Affecting Cognition in Older Adults
A RAND‑sponsored cross‑sectional analysis of Health and Retirement Study data linked to Medicare claims examined where medications that impair cognition are first prescribed to adults 66 and older, and how many remain on them after one year. The study covered...
Reimbursement Potential of Collaborative Care Model (CoCM) Billing Codes for Opioid Use Disorder Co-Occurring with Mental Disorders
A RAND‑sponsored pragmatic trial evaluated how Medicare’s Collaborative Care Model (CoCM) billing codes translate into revenue for treating opioid use disorder with co‑occurring depression or PTSD. Across 381 patients and 90,996 care‑manager minutes, only 56% of activity met billing criteria,...
Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML
The U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) in combination with venetoclax for newly diagnosed acute myeloid leukemia patients who are 75 years or older or otherwise ineligible for intensive induction chemotherapy. The decision is based on...
PreVenTB Trial: A Critical Appraisal
WHO’s technical advisory group welcomed the PreVenTB phase 3 trial results but warned that the interpretation may be flawed. The letter points out that the study emphasized per‑protocol analyses despite the protocol designating a modified intention‑to‑treat (mITT) analysis as primary, which...
Living ‘Tumour on a Chip’ Could Offer New Brain Cancer Insights
Researchers at Nottingham Trent University, in partnership with biotech firm Kirkstall Ltd, have built a living tumour‑on‑chip that mimics the human blood‑brain barrier to study glioblastoma. The microfluidic device cultivates patient‑derived brain‑cancer cells alongside a synthetic barrier, enabling real‑time monitoring...
BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma
BeOne Medicines received FDA accelerated approval for its BCL‑2 inhibitor Beqalzi (sonrotoclax) to treat adults with relapsed or refractory mantle‑cell lymphoma after at least two prior lines, including a BTK inhibitor. The decision was based on a global Phase I/II...
Solis Mammography Opens 4 New Imaging Centers
Solis Mammography announced the opening of four new imaging centers—two in Texas (Houston’s Sawyer Heights district and Pflugerville) and two in Pennsylvania (Doylestown) and Corpus Christi, Texas. The Doylestown location is a joint venture with Jefferson Health, the 18th such partnership...
82% of Radiologists and Other Physicians Now Employed by Corporate Entities
A new Physicians Advocacy Institute and Avalere Health analysis shows 82% of U.S. radiologists and other physicians are now employed by hospitals, insurers, private‑equity firms or other corporate entities. The shift added over 48,000 physicians in the past two years...
Report: How States Are Preparing to Implement Medicaid Work Requirements
A KFF survey reveals that states implementing Medicaid work requirements under the One Big Beautiful Bill Act are scrambling for clearer guidance from CMS Administrator Mehmet Oz. The federal deadline is Jan 1 2027, with Iowa, Montana and Nebraska moving ahead early. Most states intend to verify...
Viewpoint: ‘Measles Is a Canary in the Healthcare Coal Mine’: Challenging RFK, Jr.’s Scare Campaign
U.S. health officials are alarmed by a sharp uptick in measles cases, describing the outbreak as a “canary in the coal mine” for the nation’s vaccination system. The article attributes the surge largely to a years‑long anti‑vaccine campaign spearheaded by...
Truveta and Knit Health Team Up to Fuse 130M‑Patient Dataset with Clinical Behavior AI
Truveta and Knit Health announced a collaboration that merges Truveta’s 130 million‑patient real‑world data set with Knit’s Large Clinical Behavior Model. The partnership aims to embed dynamic AI pathways into everyday clinical workflows, promising faster, more coordinated care.
BMS Signs $15.2 B Deal with China's Hengrui on 13 Drug Programs
Bristol Myers Squibb has agreed to pay $600 million up front and commit up to $15.2 billion in milestones to partner with China’s Hengrui Pharma on 13 early‑stage oncology and immunology candidates. The deal splits rights by geography and therapeutic area, giving...
Benadryl Challenge Linked to 100 ER Visits, One Death
Fort Worth children's hospital warns parents about "Benadryl challenge" after 100 ER visits, 1 death 👀"The videos on TikTok claimed that users could get high and hallucinate if they took a dozen or more of the allergy pills..." https://t.co/FFeG1jr40U
FDA Clears Oral Decitabine/Cedazuridine + Venetoclax for Elderly AML Patients
The FDA approved the oral combination of decitabine/cedazuridine (Inqovi) and venetoclax (Venclexta) for newly diagnosed acute myeloid leukemia patients who are 75 years or older or otherwise ineligible for intensive chemotherapy. The decision rests on phase‑2 ASCERTAIN‑V data showing a...
Dare Bioscience Inc (DARE) Q1 2026 Earnings Call Transcript
Daré Bioscience announced the imminent commercial launch of its DARE to PLAY sildenafil cream through a 503B outsourcing facility in December 2025, providing a near‑term revenue stream while full FDA approval is pursued. The company highlighted a strong cash position...
Biofrontera Inc (BFRI) Q1 2026 Earnings Call Transcript
Biofrontera Inc. posted record Q1 2026 results, with quarterly revenue of $17.1 million—a 36% year‑over‑year increase—and achieved its first profitable quarter after a $6.3 million swing in adjusted EBITDA to $4.9 million. The company completed a strategic acquisition of U.S. rights, patents and...
Kalvista Pharmaceuticals Inc (KALV) Q1 2026 Earnings Call Transcript
Vanda Pharmaceuticals reported Q1 2026 net product sales of $51.7 million, a modest 3% year‑over‑year increase driven primarily by a 26% surge in Fanapt revenue. Hetlioz sales continued to decline under generic pressure, while Ponvory posted modest growth. The company raised...
Pelthos Therapeutics Inc (PTHS) Q1 2026 Earnings Call Transcript
Pelthos Therapeutics reported a record Q1 2026, with U.S. BRIUMVI net product revenue of $195 million, 63% year‑over‑year growth, and total revenue of $205 million. The company raised its full‑year U.S. revenue outlook to $885‑$900 million and global guidance to about $925 million, nearing...
Jasper Therapeutics Inc (JSPR) Q1 2026 Earnings Call Transcript
Agios Therapeutics reported first‑quarter 2026 net revenues of $20.7 million, a 138% year‑over‑year increase driven by the U.S. launch of AQVESME for thalassemia. The company recorded 242 prescriptions by REMS‑certified physicians, indicating rapid early adoption. Management announced plans to file an...
Aveanna Healthcare Holdings Inc (AVAH) Q1 2026 Earnings Call Transcript
Aveanna Healthcare reported Q1 2026 revenue of $662 million, a 27.4% increase, and adjusted EBITDA of $85 million, up 54%, boosted by an extra 53rd accounting week and strong volume across Private Duty Services, Home Health & Hospice, and Medical Solutions. The...
Atrium Therapeutics Inc (RNA) Q1 2026 Earnings Call Transcript
Sarepta Therapeutics reported Q1 2026 revenue of $731 million, a modest 2% decline, while posting GAAP operating profit of $358 million and ending the quarter with $748 million in cash. The company reiterated full‑year revenue guidance of $1.2‑$1.4 billion and highlighted non‑cash collaboration income...
Co-Diagnostics Inc (CODX) Q1 2026 Earnings Call Transcript
Co‑Diagnostics reported a dramatic revenue drop to $200,000 in Q2 2025, reflecting the loss of $2.5 million in grant funding that powered the prior year. Operating expenses were trimmed to $8.2 million, improving cash reserves to $13.4 million. The company outlined a near‑term pipeline...
Elutia Inc (ELUT) Q1 2026 Earnings Call Transcript
Elutia Inc. completed an $88 million sale of its Bioenvelope business to Boston Scientific, using the proceeds to retire $28 million of SWK debt and lift its cash balance to $44.4 million. The company reported a 16% revenue increase to $3.3 million and a...
Lucid Diagnostics Inc (LUCD) Q1 2026 Earnings Call Transcript
Lucid Diagnostics reported a record 3,664 EsoGuard tests in Q1 2026, a 29% quarter‑over‑quarter rise that pushed recognized revenue to $1.5 million, up 24% year‑over‑year. The company secured a VA Federal Supply Schedule contract covering 170 medical centers and roughly 9 million...
Fennec Pharmaceuticals Inc (FENC) Q1 2026 Earnings Call Transcript
Fennec Pharmaceuticals reported Q2 2025 net product sales of $9.7 million, a 33% year‑over‑year increase and 10% sequential growth, driven by 14 new U.S. accounts and two large community oncology GPO activations. Cash operating expenses rose to roughly $11 million, while cash...
Sangamo Therapeutics Inc (SGMO) Q1 2026 Earnings Call Transcript
Sangamo Therapeutics announced that the FDA reaffirmed the use of eGFR slope as an endpoint for an accelerated Biologics License Application for its Fabry gene therapy ST-920, positioning a filing as early as Q1 2026. The STAR study showed a mean...
RenovoRx Inc (RNXT) Q1 2026 Earnings Call Transcript
RenovoRx reported Q3 2025 revenue of $266,000, bringing year‑to‑date sales to roughly $900,000 as it expands RenovoCath adoption across 14 approved cancer centers, up from five earlier in the year. The company ended the quarter with over $10 million in cash,...
Use Lancet PMOS Study to Challenge Providers
For those who want to bring attention to their care providers about PMOS, this is the link to the Lancet PDF: https://www.thelancet.com/action/showPdf?pii=S0140-6736%2826%2900717-8 And this is the main landing page: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00717-8/fulltext These will be important when you challenge your current care provider...
State Health Authorities Investigating Radiology Group's Handling of Fatal MRI Incident
Tennessee health officials have opened an investigation into Premier Radiology after a patient with a pacemaker and implantable cardioverter‑defibrillator died during an MRI on July 11. The patient showed distress before the scan, became unresponsive, and staff struggled to locate and...
CMS Halts New Medicare Enrollment for Hospice, Home Care Amid Fraud Crackdown
The Centers for Medicare & Medicaid Services announced a six‑month moratorium on new Medicare enrollment for hospice and home‑health agencies to curb a surge in fraud. The freeze applies to new applications and certain ownership changes, while existing providers stay...
Aspirin Offers Minimal Short‑term CRC Benefit, Definite Risks
Aspirin and other nonsteroidal anti‐inflammatory drugs (NSAIDs) for preventing colorectal cancer and colorectal adenoma in the general population ⚠️"Evidence of very low to moderate certainty shows little to no benefit for CRC or CRA incidence in the first 15 years, and...
Why Rural Is the Perfect Setting for Innovation: Mayo Clinic Health System CEO
Mayo Clinic Health System’s CEO Dr. Prathibha Varkey argues that rural settings, despite financial strain and staffing shortages, are ideal testbeds for disruptive health‑care innovation. By integrating 16 community hospitals and 50+ clinics into a single network, Mayo has rolled...
Exclusive: Dr. Oz Announces Health Coalition to Streamline Prior Authorizations
Dr. Mehmet Oz, CMS administrator, announced a new coalition of 29 insurers, hospitals and health‑record firms aimed at streamlining prior authorizations for medical treatments. The group plans to shift to electronic prior‑auth workflows by next January, eliminating fax and clipboard...
Doctor Who Helped Ship Take Care of Passengers with Hantavirus Is Isolated in Nebraska Medical Unit
An oncologist, Dr. Stephen Kornfeld, who assisted fellow passengers during a hantavirus outbreak on the cruise ship MV Hondius, has been released from a biocontainment unit at the University of Nebraska Medical Center. Kornfeld was the only American placed in...
‘Case Mix Creep’: CMS Scrutinizes PDPM Coding Trends as SNF Providers Warned of Potential Margin Hits
CMS is scrutinizing a sharp rise in PDPM coding for conditions such as malnutrition, depression and swallowing disorders, fearing potential upcoding. The agency’s proposed SNF Prospective Payment System (PPS) for July includes a 2.4% payment boost—about $888 million—but could be reduced...
3,000 Endeavor Nurses Seek Unionization
Nearly 3,000 nurses at Illinois‑based Endeavor Health are seeking representation by Teamsters Local 743 amid staff shortages and wage reductions. The organizing drive spans four of Endeavor’s nine hospitals, including its legacy facilities in Evanston, Glenbrook, Highland Park and Skokie....
CoxHealth Changes Service Lines, Leadership Structure
CoxHealth announced a June 1 restructuring that realigns its leadership and operating model to unify the physician enterprise, tighten service‑line coordination, and assign clear accountability. The plan introduces a chief physician executive, a chief clinical officer, and a senior vice...
CMS Taps 30 Healthcare Organizations for Prior Authorization Initiative
CMS launched the Electronic Prior Authorization Acceleration initiative, naming 30 early‑adopter organizations to speed electronic prior‑auth adoption before the 2027 federal rule. Participants include major health systems such as Cleveland Clinic and EHR vendors Epic, Oracle, Athenahealth, and Meditech. The...
Exclusive: Sen. Welch Would Back Trump's Most Favored Nation Drug Policy Plan
Sen. Peter Welch (D‑Vt.) announced he would not only vote for President Trump’s “most‑favored nation” drug pricing plan but also work aggressively to pass it. The proposal aims to align U.S. prescription drug prices with those paid in other developed...
CMS Announces 6-Month Enrollment Moratorium on Home Health and Hospice Providers
The Centers for Medicare & Medicaid Services (CMS) announced a six‑month nationwide moratorium that blocks enrollment of new home health agencies and hospice providers, effective immediately. The pause is tied to Vice President JD Vance’s Anti‑Fraud Task Force and is...
Hantavirus Response Spans 2 US Biocontainment Facilities: 6 Updates
The CDC has declared a level‑3 emergency after an Andes hantavirus outbreak on the MV Hondius cruise ship, prompting U.S. health officials to monitor 18 American passengers. Sixteen are housed at the University of Nebraska Medical Center’s biocontainment and quarantine units,...
Majestic Care Sees Nursing Home Recruitment, Quality Gains Through Certification Push
Majestic Care partnered with the American Association of Post‑Acute Care Nursing to offer AAPACN certifications, beginning with MDS coordinators and expanding to medical directors. The company now requires its MDS coordinators to obtain the RAC‑CT credential, a move that coincided...