// Biotech and Pharma Therapeutics
Eyeing drug launch in 2025, Cytokinetics rolls out HCM awareness campaign
November 8, 2024 / Hypertrophic Cardiomyopathy Awareness / HCM Diagnosis / Patient-centered Treatment
Cytokinetics launched an educational campaign on hypertrophic cardiomyopathy (HCM) ahead of its 2025 drug release, aficamten, emphasizing holistic HCM awareness, diagnosis improvement, and a patient-focused approach to differentiate from larger competitors.
How Can Healthcare Organizations Earn Trust with Marginalized Communities?
November 10, 2024 / Trust in Healthcare / Patient-centered Healthcare Partnerships / Addressing Healthcare Disparities
Healthcare organizations can build trust with marginalized communities by acknowledging systemic harms, promoting transparency, fostering collaborative partnerships, and delivering culturally responsive care, experts discussed at the Behavioral Health Tech conference.
The Rapid Growth of GLP-1s and Their Impact on Bariatric Surgery
November 13, 2024 / GLP-1 Impact on Bariatric Surgery / Ozempic Weight Loss Trent / Obesity Treatment / Semaglutide vs. Bariatric Surgery
GLP-1 medications are revolutionizing obesity treatment, reducing bariatric surgery demand by offering a less invasive alternative. However, long-term weight loss requires ongoing use, and bariatric surgery remains the gold standard for severe cases.
Unraveling the Maze: Tackling Out-of-State Medicaid Claims and Credentialing Challenges
November 13, 2024 / Out-of-State Medicaid Claims Challenges / Reducing Medicaid Claim Denials / Healthcare Reimbursement Strategies
Managing out-of-state Medicaid claims challenges healthcare providers due to complex credentialing and regulatory requirements. Effective strategies, including proactive credentialing, thorough eligibility checks, and technology solutions, can reduce claim denials and improve reimbursement.
Where Can Self-Insured Employers Look to Find Healthcare Savings?
November 13, 2024 / Self-Insured Employer Healthcare Savings / Healthcare Fraud Prevention Strategies / AI in Healthcare / Cost Management
A MedCity News webinar explores healthcare savings strategies for self-insured employers, focusing on well-being programs, reducing fraud, waste, and abuse, and improving third-party administration efficiency to counter rising healthcare costs.
// 4th Industrial Revolution
WHO releases handbook for digital transformation in primary care
November 8, 2024 / WHO Digital Transformation Healthcare / Primary Care Digital Roadmap / Patient-centered Digital Health
WHO’s new handbook guides countries in digitizing primary healthcare systems, focusing on interoperability, patient-centered care, and training for effective digital transformation of health services.
ASPR seeks feedback on public health orgs’ cybersecurity needs
November 13, 2024 / Public Health Cybersecurity Survey / ASPR Cybersecurity Initiatives / Cyber Threats in Public Health / SLTT Public Health Cybersecurity
ASPR’s survey gathers feedback on public health cybersecurity needs to guide funding and policy decisions. The results aim to improve cyber resilience amid growing threats impacting public health infrastructure and patient safety.
MedAdvisor adds mobile telehealth feature and more briefs
November 10, 2024 / MedAdvisor Telehealth App / Pharmacy Telehealth Solutions / BESTMED Medication Management / Digital Health in Aged Care
MedAdvisor’s new telehealth feature enables virtual consultations, e-prescriptions, and pharmacy orders. Additional updates include secure messaging for chronic care at Gold Coast Health and a meds management module from BESTMED for real-time updates in aged care.
Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence
November 10, 2024 / Genetic Testing / Precision Medicine / HER Integration / Genetic Data / Personalized Medicine Advancements / Genetic Testing Patient Care Benefits
Genetic testing adoption in clinical care relies on secure, interoperable data-sharing, EHR integration, and collaborative registries. These advancements drive personalized medicine, enabling earlier diagnoses, optimized treatments, and enhanced patient outcomes.
AI-driven precision healthcare is here – what you need to know
November 8, 2024 / AI in Precision Healthcare / Genomic Data Security Blockchain / Multi-omic Data Integration / Ethical Challenges in Precision Medicine
Dr. Anmol Kapoor emphasizes AI and blockchain’s transformative potential in precision healthcare, enhancing genomic data security, personalized care, and workforce health. Integrating multi-omic data aids in proactive, personalized treatments while addressing ethical challenges.
// Business & Markets
NVentures Invests in Genesis Therapeutics’ AI Platform for Drug Development
November 13, 2024 / AI in Drug Discovery / Genesis Therapeutics GEMS Platform / NVIDIA Investment in Biotech / AI-driven Small Molecule Discovery
Genesis Therapeutics received further investment from NVIDIA’s NVentures to enhance its AI-driven GEMS platform, aimed at advancing small molecule drug discovery for complex targets, using NVIDIA’s computational expertise for optimized drug development processes.
Bluespine Raises $7.2M to Combat Medical Overbilling with AI
November 13, 2024 / AI Medical Overbilling Solution / Bluespine Healthcare Cost Reduction / Self-insured Employer Savings / Healthcare Fraud / Claims Analysis Platform
Bluespine raised $7.2M to advance its AI-powered platform that combats medical overbilling for self-insured employers, analyzing claims for errors to reduce financial losses and support fiduciary compliance.
GSK calls it quits on trade group BIO for 2025, following exits by Takeda, UCB and more
November 8, 2024 / GSK exits BIO Trade Group / Pharam Trade Group Membership Changes / Takeda / BIO Membership Industry Shifts
GSK will exit the Biotechnology Innovation Organization (BIO) in 2025, following other industry leaders like Takeda, Pfizer, and UCB, as part of a strategic shift to prioritize resources elsewhere amid changing policy dynamics.
Eisai Cuts Fiscal 2024 Guidance for Biogen-Partnered Leqembi as Sales Disappoint Analysts
November 6, 2024 / Eisai Leqembi Sales Forecast / Alzhimer’s Therapy Leqembi Uptake / Biogen / Revenue Challenges
Eisai cut its 2024 revenue forecast for Leqembi, its Alzheimer’s therapy with Biogen, due to slow U.S. uptake driven by diagnostic, coverage, and infrastructure challenges, despite growth in eligible patients and prescriber interest.
Monash’s clinical AI collab with India’s Apollo Hospitals and more briefs
November 10, 2024 / Monash Apollo Clinical AI Partnership / Aged Care Funding / Robotic Microsurgery / Australia / Health Data / Digital Health Collaboration
Monash University and Apollo Hospitals partner to test clinical AI using Apollo’s extensive de-identified health data, aiming to improve disease detection. Additional updates include AI funding in aged care and robotic surgery advances in Australia.
// Legal & Regulatory
‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer
November 10, 2024 / Autolus Aucatzyl FDA Approval / CAR T-cell Therapy / Aucatzyl Safty Profile in Cancer / B-cell Acute Lymphoblastic Leukemia Treatment
Autolus’s cell therapy, Aucatzyl, has gained FDA approval for treating advanced B-cell ALL, with a unique safety profile that could drive adoption and reduce the need for risk management programs required by other CAR T therapies.
FDA Takes Step Toward Removal of Ineffective Decongestants From the Market
November 8, 2024 / FDA Approvals / FDA Oral Phenylephrine Review / OTC Phenylephrine Regulatory Changes
The FDA proposes removing oral phenylephrine from OTC decongestants due to lack of efficacy, following new data and an advisory committee recommendation. Public feedback will be considered before the final decision on phenylephrine’s regulatory status.
Johnson & Johnson Takes the 340B Drug Rebate Fight to Federal Court
November 13, 2024 / J&J 340B Program Lawsuit / HHs / Drug Pricing Transparency / Medicaid Duplicate Discount Prevention
Johnson & Johnson is suing HHS to implement a rebate-based model in the 340B drug pricing program, arguing it would prevent abuse by ensuring transparency and compliance, especially regarding duplicate discounts and IRA requirements.
FDA hits Kezar’s zetomipzomib program with 2nd clinical hold in 2 months
November 13, 2024 / Kezar Life Sciences / FDA / Clinical Hold / Hepatitis / Autoimmune Drugs
The FDA has placed a partial clinical hold on Kezar’s zetomipzomib trial in autoimmune hepatitis, following a full hold and termination of its lupus nephritis study due to safety concerns. Kezar continues assessing zetomipzomib’s safety profile.
Argenx and Zai Lab secure China approval for Vyvgart Hytrulo
November 13, 2024 / Vyvgart Hytrulo China Aproval / CIDP Treatment / NMPA Approved Autoimmune Therapy
Argenx and Zai Lab’s Vyvgart Hytrulo has received NMPA approval in China for chronic inflammatory demyelinating polyneuropathy, becoming the first approved treatment for this progressive autoimmune disorder after demonstrating a 69% relapse risk reduction in trials.
// Research & Development
Researchers make glioblastoma cells visible to attacking immune cells
November 8, 2024 / Glioblastoma Immunotherapy Breakthrough / Immune Targeting in Brain Cancer / Epigenetic Therapy Glioblastoma Treatment / Washington University
Researchers at Washington University have developed a strategy using FDA-approved drugs to make glioblastoma cells visible to immune cells by inducing them to produce immune targets, potentially enabling effective immunotherapy for this aggressive cancer.
New data for amlitelimab published in JACI
November 9, 2024 / Amlitelimab Atopic Dermatitis Treatment / Sanofi / Eczema Treatment
Phase IIb trial results show Sanofi’s anti-OX40 ligand antibody amlitelimab significantly reduces symptoms of atopic dermatitis, with effects persisting post-treatment. Extended 12-week dosing is under further investigation in a Phase III program.
Bipolar disorder: how lithium as a treatment fell out of favour
November 9, 2024 /Lithium Bipolar Disorder Treatment / Decline in Lithium Prescription / Side Effects
Lithium, once a staple for bipolar disorder treatment, has seen declining use due to complex side effects and monitoring needs, despite strong efficacy. Renewed research into its targeted use, tracking technology, and protective benefits may revive interest.
AstraZeneca, Amgen’s Tezspire scores in rhinosinusitis study
November 8, 2024 / Tezspire Chronic Rhinosinusitis Treatment / AstraZeneca / Amgen / COPD
Tezspire, AstraZeneca and Amgen’s anti-inflammatory antibody, demonstrated significant reduction in nasal polyp size and congestion in severe CRSwNP patients in a Phase 3 trial, potentially expanding its indications beyond asthma.
Scientists discover how specific E. coli bacteria drive colon cancer
November 7, 2024 / E. Coli Colon Cancer Mechanism / Gut Bacteria / Cancer Risk
Scientists found that pks+ E. coli bacteria promote colon cancer by binding to gut cells and releasing DNA-damaging colibactin. Blocking these bacteria’s adhesins significantly reduced tumor development, suggesting a potential preventative treatment.
// Politics
Pharma’s Influence on India’s Global Health Engagement
November 12, 2024 / India Global Health Diplomacy / Health Policy / Indian Pharma IP Policy Shift / Compulsory Licensing Debate
India’s global health engagement, anchored by its pharmaceutical sector, navigates a delicate balance between championing low-cost drug access for developing countries and aligning with Western IP norms. This dynamic reflects India’s evolving stance on international health diplomacy.
What can Trump and RFK Jr. actually do on health care?
November 9, 2024 / Tepublican Health Policy Changes / RFK Jr. Chronic Disease Agenda / Public Health Agency Reform
With Republicans poised to lead in Washington, they aim to reshape public health policy, including pandemic response and pharmaceutical industry oversight, influenced by RFK Jr.’s stance on chronic disease and vaccine scrutiny.
What RFK Jr.’s influence could mean for pharma
November 8, 2024 / RFK Jr. Drug Pricing Cap / Vaccine Safety Stance / NIH Funding Preventive Health / Chronic Disease Policy
RFK Jr., poised to play a significant role in Trump’s administration, seeks to cap drug prices, shift NIH funding toward preventive health, reexamine vaccine safety, reduce drug advertising influence, and address chronic disease, especially childhood obesity.
After election, FDA’s Califf lays out hopes for his Trump-appointed successor
November 13, 2024 / FDA Leadership Qualities Califf / Trump / Post-market Drug Evidence FDA / RFK Jr. Healthcare Policy Role
FDA Commissioner Califf hopes his successor prioritizes executive skill, scientific rigor, and evidence-based practice amidst potential FDA shifts under Trump’s administration. He advocates for stronger post-market evidence to guide clinical decisions.
With a push from RFK Jr., baseless fears about fluoride go mainstream
November 13, 2024 / Fluoride Opposition / Trump / RFK Jr. / Public Health
RFK Jr., empowered by President-elect Trump, plans to challenge water fluoridation, which has historically been regarded as a major public health achievement, potentially fueling unfounded fears about fluoride’s safety.