// Biotech and Pharma Therapeutics
A Strategic Growth Plan for Primary Care Practices
January 14, 2025 / Primary Care Growth Strategies / Healthcare / Sustainable Primary Care Practices
Elation Health’s eBook offers a strategic checklist for primary care practices, focusing on operational efficiency, team scalability, patient services, and advanced technology to drive growth, improve patient care, and ensure long-term sustainability amid industry challenges.
Merck is broadening its pipeline as Keytruda’s patent cliff looms
January 14, 2025 / Merck Keytruda Patent Strategy / Cardiometabolic Drug Pipeline / Winrevair
Merck is diversifying its pipeline to mitigate Keytruda’s patent cliff by expanding into cardiometabolic treatments, immunology, neuroscience, ophthalmology, and GLP-1 therapies, while advancing promising assets like Winrevair and oral PCSK9 inhibitors for broader patient access.
NIH aims to boost access to government-funded meds
January 14, 2025 / NIH / Government-Funded Drugs / Drug Affordability Advocacy Efforts
The NIH will now require drugmakers using government-funded technology to submit access plans ensuring affordability and accessibility, addressing advocacy calls to make taxpayer-funded medical advancements more publicly beneficial.
Rethinking Long-Term Care Infection Control for an Aging America
January 14, 2025 / Aging America / Long-term Care Infection Control / Data-driven LTC Oversight
The COVID-19 pandemic exposed critical flaws in infection control within long-term care (LTC) facilities. Proactive, data-driven strategies, like California’s risk-based oversight model, demonstrate the need for nationwide reform to prevent outbreaks, protect vulnerable residents, and modernize oversight systems.
Broader population could benefit from Novartis spinal muscular atrophy treatment
January 13, 2024 / Novartis Spinal Muscular Atrophy Treatment / SMA Phase III Steer Study Results
Novartis’ intrathecal SMA gene therapy, OAV101 IT, showed promising Phase III results, potentially expanding treatment to type II SMA patients under 18. If approved, it could improve accessibility, patient outcomes, and market reach beyond Zolgensma’s current pediatric indications.
// 4th Industrial Revolution
Mayo Clinic to Deploy Abridge’s AI-Powered Clinical Documentation Across Enterprise
January 14, 2025 / Mayo Clinic / AI Clinical Documentation / Abridge AI-powered Healthcare Innovation / Automation Solutions
Mayo Clinic is deploying Abridge’s AI-powered clinical documentation platform to reduce administrative burdens, enhance provider well-being, and improve patient-centered care. This collaboration reflects Abridge’s growing adoption among leading health systems for high-quality, innovative solutions.
Grifols pioneers high-tech analysis of plasma bank to detect Parkinson’s disease
January 14, 2025 / Early Parkinson’s Disease Detection Biomarkers / Micheal J. Fox Foundation / Chronos-PD Early Detection
Grifols, supported by a $21M grant from The Michael J. Fox Foundation, is leveraging its vast plasma repository to identify biomarkers for early Parkinson’s disease detection, aiming to improve diagnostics and develop disease-modifying therapeutics.
WindRose Invests in CIVIE, an AI-Powered Radiology Solutions Provider
January 14, 2025 / WindRose Health Private Equity Investment / Radiology Technology Platform / Innovation / Revenue Cycle Management
WindRose Health Investors has invested in CIVIE, an AI-powered radiology solutions provider, to enhance revenue cycle management, imaging workflows, and patient outcomes. This partnership aims to drive innovation and efficiency in radiology practices and hospital systems.
4 ways HHS plans to help shape a national strategy for healthcare AI
January 13, 2025 / HHS Healthcare AI Strategy / AI Workforce Development in Healthcare
HHS released a roadmap for advancing healthcare AI focused on innovation, ethical development, equitable access, and workforce development. The plan emphasizes trustworthy AI, public engagement, and partnerships to enhance adoption while addressing risks like bias and privacy concerns.
Telemedicine helps SSM Health triple volume of psychiatric care
January 15, 2025 / Telemedicine / Pediatric Psychiatric Care / SSM Health Telemedicine Program Success
SSM Health Cardinal Glennon tripled psychiatric care volume through telemedicine, reducing ED hold times by 50% and improving patient access. Their success stems from integrated workflows, patient engagement, and partnerships with telepsychiatry provider Iris Telehealth.
// Business & Markets
Solera Health Secures $40M to Expand Access to Digital Healthcare
January 14, 2025 / Solera Health / HALO Platform / Digital Healthcare / Reducing Healthcare Costs / Digital Innovation
Solera Health secured $40M to expand its HALO™ platform, connecting users with value-based digital health solutions that improve outcomes, reduce care costs, and modernize healthcare delivery for payers and employers through seamless integration and personalized care options.
Lilly takes a nibble at Scorpion program
January 14, 2025 / Eli Lilly / Acquisition / Oncology Therapy / Breast Cancer Treatment / Scorpion Therapeutics Deal
Eli Lilly acquires Scorpion Therapeutics’ PI3Kα inhibitor STX-478, a precision oncology therapy in Phase I/II trials for breast cancer and solid tumors, with a potential $2.5 billion investment to advance small molecule cancer treatments.
Scribe achieves milestone under Sanofi collaboration
January 14, 2025 / Scribe Therapeutics / Sanofi / CRISPR / Collaboration / Genetic Medicine Milestone Payments / Genome Editing
Scribe Therapeutics achieved a milestone in its collaboration with Sanofi to develop in vivo CRISPR-based therapeutics, advancing potentially curative genetic medicines. The partnership includes over $1.2 billion in milestone payments and future royalties.
Improving the Healthcare Financial Experience to Help Care Flow
January 14, 2025 / Healthcare Payment Modernization / Transparent Healthcare Billing Solutions
Zelis is modernizing the healthcare financial experience with integrated tools that enhance transparency, improve provider data accuracy, streamline payments, and empower consumers to make informed decisions, ultimately reducing inefficiencies and improving access to affordable, high-quality care.
Obesity challenger reveals impressive Phase II data
January 14, 2025 / HRS9531 / Obesity Drug Trial Results / GLP-1 Dual Agonist Weight Loss / Obesity Treatment
Jiangsu Hengrui Pharmaceuticals’ GLP-1/GIP dual agonist HRS9531 demonstrated 21.1% placebo-adjusted weight loss in Phase II trials, with 60% achieving ≥20% weight loss. These results position it as a potential competitor in the obesity treatment market.
// Legal & Regulatory
How the FDA’s new nutrition labels could prod the food industry to get healthier
January 15, 2025 / FDA / Nutrition Label Proposal / Chronic Disease Prevention
The FDA’s proposed front-of-package nutrition labels aim to combat chronic diseases like heart disease and diabetes by highlighting sodium, sugar, and fat content. This initiative may push manufacturers to reformulate healthier food products over time.
Novartis prevails in US patent dispute over Entresto
January 14, 2025 / Novartis / Entresto Patent Dispute / Heart Failure Drug Market Exclusivity
Novartis secured a legal victory as the US Court of Appeals upheld the Entresto (sacubitril/valsartan) patent, preserving market exclusivity for its $6 billion heart failure drug despite generic competition efforts by manufacturers like MSN.
Datopotamab Deruxtecan Granted Priority Review in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
January 13, 2025 / Datopotamab Deruxtecan Priority Review / AstraZeneca / Lung Cancer Therapy / Clinical Trial Results
AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate, has received FDA Priority Review for EGFR-mutated advanced NSCLC. Phase II/III trials demonstrate promising efficacy, with regulatory action expected by Q3 2025.
Federal watchdog cites concerns with FDA’s accelerated approval process
January 15, 2025 / FDA Accelerated Approval / Aduhelm Approval Controversy / Improving Drug Oversight and Transparency / Drug Approval
A federal watchdog report highlights flaws in the FDA’s accelerated approval process, citing inadequate oversight, poor documentation, and inconsistent practices, especially with drugs like Aduhelm, Makena, and Exondys 51. Recommendations aim to enhance transparency and stricter standards.
FTC finds PBMs charge significant markups for specialty generics
January 15, 2025 / FTC PBM Specialty Drug Markups / OptumRx Pricing / Drug Pricing
The FTC found that major PBMs, including Caremark, Express Scripts, and OptumRx, imposed excessive markups on specialty generics, generating $7.3 billion in revenue from 2017-2022. These markups affected critical drugs for cancer, HIV, and other conditions.
// Research & Development
BlueRock accelerates Parkinson’s disease therapy to Phase III
January 14, 2025 / BlueRock Therapeutics / Parkinson’s Disease / Dopaminergic Neuron Progenitor / Cell Therapy / RMAT Designation
BlueRock Therapeutics, a Bayer subsidiary, is advancing bemdaneprocel, a dopaminergic neuron cell therapy for Parkinson’s disease, to Phase III trials after Phase I showed tolerability and motor function improvement. The registrational trial will begin in 2025.
Trans-Atlantic pairing unite on MAbs research
January 14, 2025 / LifeArc Cleveland Ckinic / Mabs Research Cancer Therapeutics / Trans-Atlantic Biotech Collaboration
LifeArc and Cleveland Clinic have signed a 10-year agreement to develop monoclonal antibody-based therapeutics targeting cancer and complement-mediated diseases, leveraging LifeArc’s expertise in antibody humanization and their ongoing collaborative success since 2019.
Pheno Therapeutics granted trial authorisation for MS candidate
January 14, 2025 / PTD802 Remyelination Therapy MS / Pheno Therapeutics / Clinical Trial Approval / Neuroprotective Treatment for MS
Pheno Therapeutics received UK MHRA approval to begin first-in-human trials of PTD802, a GPR17 antagonist designed to promote remyelination in multiple sclerosis, offering a neuroprotective approach to address the unmet need in progressive MS treatments.
Onera’s validation trial of home polysomnography sleep device succeeds
January 13, 2025 / Onera Health / Sleep Diagnostics / Remote Monitoring / Sleep Disorder Testing Access
Onera Health’s wireless, home-based polysomnography system (STS) demonstrated comparable accuracy to in-lab testing for sleep staging and respiratory event detection in a 206-patient validation trial, potentially revolutionizing access to sleep disorder diagnostics and treatment.
Neumora’s dig into phase 3 depression data disappoints analysts
January 15, 2025 / Neumora Navacaprant Phase 3 Failure / High Placebo Response / Kappa Opioid Receptor / Clinical Trial Designs for Depression Drugs
Neumora’s navacaprant failed to outperform placebo in its Phase 3 KOASTAL-1 depression trial, with identical MADRS scores at key timepoints. The company will refine trial designs for KOASTAL-2 and -3, addressing high placebo responses and potential sex differences.
// Politics
Healthcare Dealmakers Eye M&A Resurgence in Second Trump Term
January 13, 2025 / Healthcare M&A Resurgence 2025 / Trump Administration Antitrust Policy / JPMorgan Healthcare Conference / Healthcare Mergers
Healthcare dealmakers anticipate a resurgence in M&A exceeding $10 billion under President-elect Trump, driven by expectations of reduced antitrust scrutiny and pro-business policies. However, a full recovery to pre-pandemic levels may take years.
What to expect in the sequel to Medicare’s drug price negotiation program
January 15, 2025 / Medicare Drug Price Negotiation / CMS Semaglutide Price Negotiation / Novo Nordisk Obesity and Diabetes Drugs / Inflation Reduction Act / Medicare Pricing
CMS will soon announce the next 15 drugs for Medicare price negotiations under the Inflation Reduction Act, likely including Novo Nordisk’s semaglutide products. Legal challenges and potential Trump administration changes could impact the program’s future.
A biotech legend, pharma CEO, and two Trump admin vets walk into JPM Day 2
January 14, 2025 / JPM Healthcare Conference / Eli Lilly Earnings / Johnson & Johnson / GSK / Dave Ricks
Day 2 of the JPM Conference reflected cautious optimism for biotech M&A following major deals from J&J, Eli Lilly, and GSK, despite Lilly reporting an earnings miss. Industry leaders, including Lilly CEO Dave Ricks, shared strategic insights.
US lawmakers ask government to consider curbs on biotech exports to China’s military
January 10, 2025 / Biotech Export Restrictions to China / Clinical Trials in China
U.S. lawmakers urged the Biden administration to consider restricting biotech exports to China’s military, citing risks of pathogen weaponization, intellectual property theft, and human rights concerns in Chinese military-run clinical trials, particularly involving Uyghur populations.
5 questions facing pharma in 2025
January 9, 2025 / Pharma Regulatory Changes / Obesity Drug Competition / Eli Lilly / Novo Nordisk / Trump Administration
Pharma in 2025 faces key questions, including regulatory impacts under a Trump administration, competition in obesity drugs, vaccine sales challenges, a pivot toward immunology, and underperforming stocks, with economic and political uncertainties shaping industry trends.