// Biotech and Pharma Therapeutics
With narcolepsy trial win, Axsome looks to revive former Pfizer antidepressant on the US market
November 27, 2024 / Axsome Therapeutics AXS-12 / Narcolepsy Cataplexy Treatment / FDA Approval Process
Axsome Therapeutics’ AXS-12 showed significant efficacy in reducing cataplexy attacks and improving narcolepsy symptoms with sustained safety in a Phase 3 trial. The company plans an FDA submission to compete with current treatments like Xyrem and Lumryz.
Specialized CROs aim to boost participation among women and other underrepresented groups
November 27, 2024 / Women in Clinical Trials / Drug Development / Lindus Health Clinical Trials
Specialized CROs like Lindus Health are addressing underrepresentation in clinical trials, focusing on women and underserved groups by redesigning protocols, offering support like childcare stipends, and closing research gaps in areas like pharmacokinetics and diverse health conditions.
Cash-strapped Idorsia in timely talks to out-license aprocitentan
November 27, 2024 / Idorsia Aprocitentan Licensing / Hypertension Treatment Advancements / Dual Endothelin Receptor Antagonist / Drug Approvals / Idorsia Financial Strategy
Idorsia is negotiating global out-licensing for aprocitentan, a dual endothelin receptor antagonist recently approved in the US and EU for hypertension treatment, reflecting its strategic shift amidst financial challenges.
Transforming biotech training
November 25, 2024 / Digital PCR Training Innovation / QIAGEN University of Delaware Partnership / Molecular Diagnostics Education
QIAGEN’s donation of a QIAcuity digital PCR system to the University of Delaware enhances biotech training by providing students with hands-on experience in advanced molecular diagnostics, preparing them for careers in research, healthcare, and industry.
Biotech leader champions targeted cancer treatments and diversity
November 25, 2024 / Targeted Cancer Therapies / iOnctura Roginolisib Development / Women in STEM
Dr. Catherine Pickering, CEO of iOnctura, advances targeted cancer treatments, including next-generation PI3K inhibitors like roginolisib, while championing diversity in STEM, ensuring innovative therapies address unmet needs and inspiring gender equity within biotech leadership and clinical research.
// 4th Industrial Revolution
Third-Party Cyberattacks: The Healthcare Sector’s Achilles’ Heel
November 27, 2024 / Healthcare Cybersecurity Threats / Vendor Risk Management / AI / Patient Data Breaches
Healthcare faces escalating risks from third-party cyberattacks, endangering patient data and care delivery. Strategies like robust vendor risk management, employee training, compliance, advanced security technologies, and AI/ML adoption are vital to mitigate these growing threats effectively.
How ePaper Digital Whiteboards are Improving the Patient Experience
November 27, 2024 / ePaper Digital Whiteboards / Healthcare / Patient Communication / EMR Integration / Sustainable Hospital Technology
ePaper digital whiteboards improve patient communication, comfort, and satisfaction in hospitals by providing real-time, energy-efficient updates integrated with EMR systems, reducing staff burden, enhancing recovery experiences, and aligning with sustainability goals.
Siriraj Piyamaharajkarun Hospital sets up AI-powered pathology service
November 27, 2024 / AI-powered Pathology System / Prostate Cancer Screening AI
Siriraj Piyamaharajkarun Hospital’s AI-powered pathology system enhances speed and accuracy in diagnostics, automating workflows and aiding prostate cancer screening. The system integrates imaging, data analysis, and AI to improve efficiency and expand cancer detection capabilities.
Korean AI predicts mood episodes using sleep-wake data
November 26, 2024 / AI Mood Disorder Prediction / Circadian Rhythm and Depression / Wearable Device Mental Health Data / Machine Learning e
South Korean researchers developed machine learning models using wearable sleep-wake data to predict mood episodes with up to 98% accuracy, highlighting circadian rhythm shifts as key predictors and reducing data collection costs for clinical applications in mood disorder management.
How 3 Health Systems Are Scaling Hybrid & Home-Based Models
November 26, 2024 / Hybrid Healthcare Models / Remote Patient Monitoring Benefits / Hospital-at-home Programs
Providence, OSF HealthCare, and UMass Memorial Health are advancing hybrid and home-based care models using remote monitoring, hospital-at-home services, and mobile health teams to improve outcomes, enhance access, reduce costs, and prevent hospital readmissions.
// Business & Markets
WellRX Acquires Bioreach Lab to Enhance Preventative Healthcare Offerings
November 27, 2024 / WellRX Biotech Acquisition / Advanced Diagnostic Healthcare / Telehealth Solutions
WellRX’s acquisition of Bioreach Lab enhances preventative healthcare through in-house advanced diagnostics, enabling faster bloodwork results and supporting personalized care across telehealth, weight-loss, hormone therapy, and regenerative medicine programs.
Neoplas Med Secures $18M Investment to Advance Cold Plasma Wound Care Tech
November 27, 2024 / Cold Plasm Wound Care / Argon Jet Plasma Therapy / Chronic Wound Healing Innovation / Medical Device Regulation Certified Solutions
Neoplas Med secured $18M to advance its MDR-certified cold plasma wound care technology, kINPen® MED, which accelerates healing, treats chronic wounds, and offers painless, effective care. Funding supports global expansion and enhanced production capacity.
Cofactor AI secures $4M in funding for combating claims denials
November 27, 2024 / Cofactor AI Claims Denial / Hospital Claims Appeal Platform / AI Healthcare Revenue Cycle
Cofactor AI raised $4M to enhance its Denial Suite platform, which uses AI to streamline hospital claims appeals by analyzing medical documentation and payer policies, addressing rising denial rates and inefficiencies in healthcare claims processing.
Practice Better secures $13M to scale health practice management offering
November 27, 2024 / Practice Management Platform Funding / AI in Healthcare Administration / Telehealth Scheduling Tools / Practice Better Health Platform
Practice Better secured $13M to enhance its health practice management platform with AI, expanding tools for scheduling, telehealth, billing, and client engagement, empowering practitioners to improve operational efficiency and focus on patient-centered care.
Sarepta rebuilds drug pipeline with Arrowhead deal
November 27, 2024 / Sarepta Arrowhead RNAi Partnership / Muscular Dystrophy Treatment Pipeline / RNA Interference Drug Development
Sarepta Therapeutics partnered with Arrowhead Pharmaceuticals, acquiring seven RNAi-based therapies targeting muscular, CNS, and lung diseases. This $500M upfront deal strengthens Sarepta’s pipeline, addressing concerns about thin assets while leveraging complementary genetic medicine platforms.
// Legal & Regulatory
Hippocratic AI receives its first U.S. patent for LLM innovations
November 27, 2024 / Hippocratic AI Polaris System / Safety-focused Healthcare AI / Large Language Models in Healthcare
Hippocratic AI secured its first U.S. patent for Polaris, a safety-focused LLM system tailored for nondiagnostic healthcare tasks, emphasizing patient safety and compliance. Its innovations advance healthcare AI with applications in intake, chronic care, and more.
PTC Therapeutics ALS drug fails to meet endpoints as trials shut down
November 27, 2024 / PTC Therapeutics ALS Trial Failure / Neurofilament Light Chains Biomarker / ALS Drug Development Challenges
PTC Therapeutics halted trials for utreloxastat after failing to meet ALS Phase II primary endpoints. Despite safety and tolerability, the lack of efficacy ends development. The company sold a Priority Review Voucher for $150M to sustain operations.
FDA to hold AdCom on Exelixis’ cabozantinib sBLA
November 27, 2024 / Cabozantinib FDA Advisory Meeting / Advanced Neuroendocrine Tumor Treatment / Pancreatic Neuroendocrine Tumor Therapy
The FDA will hold an advisory meeting in March 2025 to review Exelixis’ supplemental NDA for cabozantinib (Cabometyx) for treating advanced pancreatic and extra-pancreatic neuroendocrine tumors, following Phase III CABINET trial results.
OCR’s HIPAA audit program lacked mettle, OIG says
November 27, 2024 / HIPAA Audit Program Shortcomings / OCR Cybersecurity Enforcement / Patient Data Protection Standards
The HHS OIG criticized the Office of Civil Rights (OCR) HIPAA audit program (2016–2020) for lacking effectiveness in enforcing cybersecurity safeguards. Recommendations include expanding audits to physical and technical safeguards and enforcing corrective actions for compliance issues.
EC nod for GSK’s Menveo meningococcal vaccine
November 27, 2024 / GSK Menveo Vaccine Approval / Meningococcal Disease Prevention / Invasive Meningococcal Disease
The European Commission approved GSK’s single-vial liquid Menveo vaccine for meningococcal serogroups A, C, W, and Y, simplifying immunization for children (2+), adolescents, and adults while supporting increased vaccine uptake and IMD prevention.
// Research & Development
Elon Musk’s Neuralink announces study to connect brain implant to robotic arm
November 27, 2024 / Neuralink Brain-computer Interface / N1 Implant Robotic Arm Control / Quadriplegia Assistive Technology / Elon Musk
Neuralink’s CONVOY study will test its N1 brain-computer interface implant to control an assistive robotic arm, advancing quadriplegia care by enabling device control through neural signals. The study builds on Neuralink’s PRIME trial progress.
New therapies aim to improve Down syndrome care
November 27, 2024 / Down Syndrome Treatment Market / Emerging Down Syndrome Therapies / Down Syndrome Drug Pipeline
The Down syndrome treatment market, valued at $250M in the U.S., is poised for growth with therapies like AEF0217, ACI-24.060, and buntanetap under development by companies including Aelis Farma, AC Immune, and Annovis Bio.
Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry; Availability
November 27, 2024 / FDA Ovarian Toxicity Guidance / Oncology Drug Development Standards / Premenopausal Ovarian Health Biomarkers / Cancer Trial Reproductive Impact / Oncology
The FDA released draft guidance for assessing ovarian toxicity in premenopausal adults during oncologic drug trials. It emphasizes evaluating ovarian function through biomarkers to inform patients and clinicians of potential long-term reproductive and health impacts of cancer treatments.
Alector AL002 INVOKE-2 Phase II Alzheimer’s trial misses goal
November 27, 2024 / Alector AL001 Alzheimer’s Trial / INVOKE-2 Phase II Results / Alzheimer’s Disease Biomarker Study
Alector’s AL002 failed to meet primary or secondary endpoints in the Phase II INVOKE-2 Alzheimer’s trial, showing no impact on clinical progression, biomarkers, or amyloid reduction. The company is halting the long-term extension study.
Biohaven’s Phase III SMA miss: was it the target or the trial design?
November 26, 2024 / Biohaven SMA Trial Results / Taldefgrobep Alpha Resilience Study / Biomarker Analysis / Obesity Drug Development
Biohaven’s Phase III RESILIENCE trial of taldefgrobep alpha for SMA missed its primary endpoint. While showing potential clinical benefit, results lacked statistical significance. Biohaven shifts focus to biomarker analysis and accelerates taldefgrobep development for obesity treatment.
// Politics
Biden administration pushes anti-obesity drug pressure to Trump
November 27, 2024 / Medicare GLP-1 Coverage Proposal / Anti-Obesity Drugs Medicare Expansion / Ozempic / Obesity Chronic Condition Coverage / Biden Medicare Drug Proposal
The Biden administration aims to expand Medicare coverage for GLP-1 anti-obesity drugs like Ozempic and Wegovy, reframing obesity as a chronic condition. The proposal faces cost concerns, potential legal challenges, and uncertainty under the Trump administration.
Senators intro bipartisan bill to bolster healthcare cybersecurity
November 27, 2024 / Healthcare Cybersecurity Legislation / Cybersecurity Grants for Hospitals / Health Care Cybersecurity Resiliency Act / Rural Healthcare Cyber Protection
The bipartisan Health Care Cybersecurity and Resiliency Act of 2024 aims to protect healthcare organizations from cyberattacks by offering grants, enhancing federal coordination, modernizing regulations, and developing incident response plans, focusing on underserved communities and rural hospitals.
Biden Medicare plan to drastically expand GLP-1 access
November 27, 2024 / Medicare GLP-1 Obesity Drug Coverage / Wegovy and Mounjaro Medicare Access / Biden Obesity Medication Proposal / Medicaid GLP-1 Drug Expansion
The Biden administration proposes expanding Medicare and Medicaid coverage to include GLP-1 obesity drugs like Wegovy and Mounjaro, potentially benefiting 7.4 million Americans while reducing patient costs but adding $40 billion in federal expenses over 10 years.
Trump taps biotech investor Jim O’Neill for HHS deputy secretary
November 26, 2024 / Jim O’Neill HHS Nomination / Trump Health Policy Leadership / HHS Deputy Secretary Role / Medicare / Medicaid Oversight
President-elect Trump nominated biotech investor Jim O’Neill as HHS deputy secretary, tasking him with overseeing Medicare, Medicaid, public health emergency preparedness, and regulatory development under HHS Secretary Robert F. Kennedy Jr.’s leadership.
Biopharma status quo ‘likely to persist’ under Trump 2.0, though changes to IRA, FTC and more could be on the way: analyst
November 21, 2024 / Trump Biopharma Policy Outlook / RFK Jr. Healthcare Influence / FDA Leadership in Biopharma / Medicaid / IRA Policy Changes / Trump Administration
Analysts predict limited immediate healthcare changes under Trump’s second term, maintaining the biopharma status quo. Key areas to watch include Medicaid spending, IRA amendments, FDA leadership, HHS policies under RFK Jr., and potential increased M&A activity.