// Biotech and Pharma Therapeutics
AstraZeneca’s Enhertu and Akeso’s bispecifics win national coverage in China as CAR-T therapies miss out again
December 4, 2024 / China / Drug Costs / Drug Reimbursement / AstraZeneca
AstraZeneca’s Enhertu, Akeso’s bispecific therapies, and others secured spots on China’s National Reimbursement Drug List (NRDL) amid pricing negotiations. Meanwhile, CAR-T therapies missed inclusion due to high costs exceeding reimbursement thresholds.
TEFCA’s Moment and Policy Changes on the Horizon: A Conversation with Eric Musser at NCQA
December 4, 2024 / TEFCA / NCQA Healthcare Data Standardization / Network Participation / Value-based Care Policy Changes
TEFCA advances interoperability with increasing QHIN participation, while NCQA drives standardization through USCDI+. Healthcare leaders must engage with policymakers to shape upcoming changes in data standards, quality measures, and value-based care policies.
A Biotech Startup’s Quest to Relieve Pulmonary Mucus Obstruction for Respiratory Care
December 4, 2024 / MucoLife MLT-001 Therapy / Pulmonary Mucus Obstruction Treatment / COPD Innovative Therapies / Cystic Fibrosis Muscus Clearance / Respiratory Disease Solutions
MucoLife Therapeutics is developing MLT-001, an innovative inhalable therapy targeting pulmonary mucus obstruction in COPD, cystic fibrosis, asthma, and pulmonary fibrosis. Preclinical studies show 90% efficacy in mucus clearance, with clinical trials planned by 2026.
5 Trends to Watch for Outpatient Therapists in 2025
December 4, 2024 / Outpatient Therapy Trends 2025 / StrataPT Billing Solutions / AI in Outpatient Therapy / Therapy Clinic Operations
StrataPT highlights 2025 trends for outpatient therapy, including financial transparency, AI integration, referral optimization, cash-pay services, and enhanced front desk operations. These strategies aim to improve clinic profitability, streamline workflows, and enhance patient outcomes.
10 Imperatives of a Medication Intelligence System to Streamline the Pharmacy Lifecycle
December 4, 2024 / Medication Intelligence System Benefits / Pharmacy Supply Chain Automation / Drug Shortages
A medication intelligence system streamlines pharmacy operations through automation, data-driven insights, and predictive modeling. Key imperatives include digitizing supply chains, ensuring compliance, managing recalls, preventing drug diversion, and optimizing costs to enhance safety and efficiency.
// 4th Industrial Revolution
Tips from a small hospital CIO to succeed with legacy vendors
December 3, 2024 / Legacy IT Systems in Healthcare / Social Determinants of Health Data / Hospital EHR Systems / Rural Hospital IT Strategies / Artesia General Patient Care
Artesia General Hospital optimizes legacy IT systems to enhance care delivery, prioritizes collaboration with vendors and cross-departmental teams, and uses social determinants of health (SDOH) data to address community needs like transportation gaps.
A deep dive into a new RCM tech adoption model
December 4, 2024 / Revenue Cycle Management Technology / RCM Technology Modernization / Financial Performance Optimization Healthcare
The Revenue Cycle Management Technology Adoption Model (RCMTAM) helps health systems assess RCM technology maturity, optimize financial performance, and streamline workflows through a five-stage framework. It enables data-driven planning and modernization tailored to organizational needs.
AI Tops ECRI’s Top 10 Health Technology Hazards for 2025
December 4, 2024 / AI Risks in Healthcare / ECRI Health Techonology Hazards / Cybersecurity in Healthcare Technology / Patient Safety / Medical Device Quality Assurance
ECRI’s 2025 Health Technology Hazards report highlights AI risks, including bias and inaccuracies, alongside cybersecurity threats, home care challenges, and medication errors. Recommendations focus on AI governance, safety protocols, and robust technology oversight.
Ultrahuman Launches Free AI-Powered Ovulation Tracking
December 4, 2024 / AI-powered Ovulation Tracking / Ultrahuman Ring AIR Fertility Feature / Women’s Health / Biomarker-based fertility predictions
Ultrahuman’s AI-powered Cycle & Ovulation PowerPlug offers free, precise fertility tracking by analyzing biomarkers like skin temperature, RHR, and HRV. Integrated with the Ultrahuman Ring AIR, it provides personalized, affordable insights for women’s reproductive health.
Ambient AI doesn’t improve efficiency across the board, study finds
December 4, 2024 / Nuance DAX AI Documentation / AI in Clinical Efficiency Studies / Clinician Burnout
A study on Nuance’s AI-driven DAX documentation tool found minimal efficiency improvements overall, with modest reductions in note time for high users. Broad implementation may reduce clinician burnout selectively but lacks widespread productivity gains.
// Business & Markets
Why One Investor Still Believes in Retail Health
December 4, 2024 / Retail Healthcare Models / One Medical Amazon Acquisition / VillageMD Primary Care Clinics / Retail Healthcare
Retail health models like One Medical and VillageMD remain promising for convenient care delivery. Annie Lamont emphasizes the need for scalable, patient-centric systems that integrate care continuity and avoid disconnected, episodic care for sustainable growth.
Staffing company Aya Healthcare acquires Cross Country Healthcare for $615M
December 4, 2024 / Aya Healthcare Acquisition / Cross Country Healthcare Merger / Healthcare Staffing Solutions / Digital Staffing in Healthcare
Aya Healthcare will acquire Cross Country Healthcare for $615M, integrating staffing capabilities across clinical and non-clinical settings nationwide. The merger aims to enhance staffing solutions, expand services, and address healthcare workforce shortages through innovative technologies.
UnitedHealthcare CEO Brian Thompson became one of the country’s most powerful insurance execs before tragic killing
December 4, 2024 / UnitedHealthcare CEO Brian Thompson / Medicare Advantage Leadership / Health Insurer
UnitedHealthcare CEO Brian Thompson, a pivotal leader in the health insurance sector, was tragically killed. Under his leadership, UnitedHealthcare prioritized Medicare Advantage, strengthening its position as the largest U.S. health insurer with $300B projected revenue in 2023.
Dewpoint, Mitsubishi partner on ALS drug in deal worth up to $480M
December 4, 2024 / Dewpoint ALS Drug Partnership / Mitsubishi Tanabe ALS Treatment / Biomolecular Condensates / Drug Development
Dewpoint Therapeutics partnered with Mitsubishi Tanabe on a potential ALS drug targeting abnormal TDP-43 protein accumulations. The deal, worth up to $480M, combines Dewpoint’s innovative research with Mitsubishi Tanabe’s expertise in ALS treatment and patient networks.
Genmab buys 2nd anti-glycan antibody from Scancell, commits up to $630M in biobucks
December 4, 2024 / Genmab / Scancell / Monoclonal Antibodies / Development Deals
Genmab acquired exclusive rights to a second anti-glycan antibody from Scancell’s GlyMab platform in a deal worth up to $630M. The antibody targets tumor-specific glycans, offering potential for novel cancer therapies across multiple modalities.
// Legal & Regulatory
FDA issues guidance on predetermined change control plan for AI-enabled device software functions
December 4, 2024 / FDA Guidance / AI Medical Devices / Machine Learning in Healthcare Devices
The FDA issued guidance for manufacturers on creating predetermined change control plans (PCCPs) for AI-enabled medical devices, enabling iterative improvements while ensuring safety and effectiveness. Recommendations address modifications, labeling, and pre-submission feedback.
FDA finalizes AI-enabled medical device life cycle plan guidance
December 4, 2024 / FDA AI Medical Device Guidance / Device Regulatory Updates / FDA Marketing Submission AI Devices
The FDA finalized guidance for marketing AI-enabled medical devices, enabling streamlined modifications through predetermined change control plans (PCCPs) without new market submissions. This approach ensures safe, effective, and adaptable AI/ML device development and regulation.
Applied Therapeutics’ trial conduct scrutinized in FDA warning letter
December 4, 2024 / FDA Warning Applied Therapeutics / Govorestat Trial Data Issues / Galactosemia Drug Rejection / Clinical Trial Dosing Error Impact / FDA Challenges
The FDA warned Applied Therapeutics over data deletion and dosing errors in its govorestat trial for classic galactosemia, complicating plans to resubmit the drug for approval after its recent rejection and a prior phase 3 trial failure.
With Makary set to face FDA commissioner hearings, how deep do his industry ties run?
December 4, 2024 / Dr. Marty Makary FDA Nomination / GLP-1 Drug Compound Regulation / Senate Hearings FDA Commissioner
Dr. Marty Makary, nominated as FDA Commissioner, faces scrutiny over pharma and insurance industry ties, including advisory roles and connections to GLP-1 drug controversies. These affiliations may pose ethical challenges during Senate confirmation hearings.
Vaxcyte doses first subject in pneumococcal conjugate vaccine trial in infants
December 4, 2024 / Vaxcyte VAX-31 Infant Vaccine / Pediatric Immunization Safety Evaluation
Vaxcyte initiated a Phase II trial for its 31-valent pneumococcal conjugate vaccine, VAX-31, in infants. The study evaluates tolerability, immunogenicity, and safety, aiming to protect against invasive pneumococcal disease with results expected by mid-2026.
// Research & Development
Atea reports high efficacy in Phase 2 HCV treatment study
December 4, 2024 / Atea Pharmaceuticals HCV Treatment / HCV Trial Results / Clinical Trials
Atea Pharmaceuticals’ Phase 2 trial of its HCV regimen with bemnifosbuvir and ruzasvir showed a 98% sustained virologic response (SVR12) in treatment-adherent patients. The safe, effective treatment sets the stage for a Phase 3 trial in 2025.
Arrowhead seeks approval to begin RNAi therapy trial for obesity treatment
December 4, 2024 / Arrowhead RNAi Therapy Obesity / Obesity Treatment Target / RNA Interference in Adipose Tissue / Tirzepatide Combination Therapy Obesity
Arrowhead Pharmaceuticals seeks approval for a Phase I/IIa trial of ARO-ALK7, an RNAi therapy targeting obesity by reducing ALK7 production in adipose tissue. The trial will evaluate safety, tolerability, and efficacy, including combination with tirzepatide.
Moving into Phase III, Cartesian data show momentum
December 4, 2024 / Cartesian Descartes-08 CAR-T Therapy / mRNA CAR-T Cell Therapy / Myasthenia Gravis Trial Results
Cartesian Therapeutics’ Phase IIb trial of Descartes-08 for generalized myasthenia gravis shows promising outcomes. The mRNA-engineered CAR-T therapy targeting BCMA moves toward Phase III trials without preconditioning chemotherapy.
Roivant spinout ends development of lung disease asset after phase 2 fail
December 3, 2024 / Roivant / Monoclonal Antibodies / Lung Disease / Inflammatory Diseases / Clinical Data / Takeda
Kinevant Sciences is halting development of namilumab after its Phase II trial for chronic pulmonary sarcoidosis failed to meet primary and secondary endpoints. The anti-GM-CSF monoclonal antibody showed no efficacy, ending its prospects as a treatment.
Vaccine clinical trial spotlight on Southeast Asia as “unique” opportunity beckons
December 3, 2024 / Southeast Asia / Vaccine Trials / Post-pandemic Clinical Trial Opportunities / Cost-effective Vaccine Trial Locations
Southeast Asia is emerging as a prime location for vaccine trials due to cost efficiency, large vaccine-naive populations, and high medical needs. Enhanced trial designs post-COVID-19 have accelerated vaccine development for infectious diseases globally.
// Politics
Why the CFPB Medical Debt Credit Reporting Ban Could Hurt More Than It Helps
December 4, 2024 / CFPB Medical Debt Reporting Ban / Healthcare Credit Reporting Impacts / Patient Financial Assistance Programs / Medical Debt / Healthcare Billing
The CFPB’s proposed medical debt credit reporting ban aims to shield patients from financial harm but risks reducing healthcare payments, straining provider finances, raising costs, and increasing litigation. Enhanced patient financial education and assistance programs may offer better solutions.
Pfizer, Eli Lilly execs push back as senators scrutinize drugmakers’ telehealth moves
December 3, 2024 / PfizerForAll Telehealth Scrutiny / LillyDirect / Telehealth / Drugmakers / Telehealth Compliance / Eli Lily Pfizer Senate Inquiry
Pfizer and Eli Lilly defended their telehealth platforms, PfizerForAll and LillyDirect, against Senate scrutiny over potential anti-kickback violations, emphasizing that linked telehealth providers are not incentivized to prescribe their drugs.
Republicans want changes from HHS on AI assurance labs
December 3, 2024 / HHS AI Assurance Labs Debate / Healthcare AI Regulation Concerns / GOP Stance
Republican lawmakers urged HHS to reconsider government-led AI assurance labs, advocating for industry partnerships to avoid regulatory capture and innovation stifling. Concerns focus on overlapping responsibilities, fairness, and competition in AI oversight within healthcare.
IRA price negotiations and M&A among topics to watch after Republican ‘red wave,’ analyst group says
December 3, 2024 / Donald Trump / RFK Jr. FDA / HHS / Medicare Drug Price Negotiations / Pharma Mergers and Acquisitions
Under a Republican-controlled government, healthcare may see shifts in Medicare drug price negotiations, FTC oversight of pharma M&A, tariffs on medical supplies, and regulatory policies. RFK Jr.’s HHS nomination raises concerns about vaccine policy implications.
Musk and Ramaswamy think they have new power to cut federal regulations. Here’s why it’s not so simple
November 28, 2024 / Musk Ramaswamy Federal Regulation Cuts / Supreme Court Rulings / Administrative Law
Musk and Ramaswamy aim to leverage recent Supreme Court rulings to reduce federal regulations via DOGE, but experts argue the rulings restrict agency discretion rather than facilitate rule rescissions, complicating regulatory rollback efforts.