// Biotech and Pharma Therapeutics
Ascletis’ swift surge into obesity continues with competitive oral GLP-1 data
February 19, 2025 / Ascletis Pharma / Obesity Drug / Oral GLP-1 Receptor Agonist / ASC30 Clinical Trial Results / Weight Loss Drug Development
Ascletis Pharma’s oral GLP-1 receptor agonist, ASC30, demonstrated up to 6.3% mean body weight loss in 28 days during a Phase 1 trial. The drug was generally well tolerated, with mild-to-moderate gastrointestinal side effects. Further dose escalation studies are ongoing.
Teva and Alvotech advance biosimilar portfolio in USA
February 19, 2025 / Teva Alvotech / AVT06 / Eylea Aflibercept / FDA Review / Wet AMD
Teva and Alvotech’s biosimilar AVT06 for Eylea (aflibercept) is under FDA review for treating wet AMD, macular edema, and diabetic retinopathy. The companies are also developing AVT29, a biosimilar for Eylea HD (8 mg) in the U.S.
Exelixis Looks to Next-Gen Cancer Drug as Cabometyx Underwhelms Again
February 19, 2025 / Exelixis Zanzalintinib / Clinical Trials / Cabometyx Kidney Cancer Results / Renal Cell Carcinoma Treatment / Drug Development
Exelixis is shifting focus to zanzalintinib, a next-generation tyrosine kinase inhibitor, after Cabometyx failed to improve overall survival in renal cell carcinoma (RCC). Zanzalintinib is in trials for RCC, colorectal, neuroendocrine, and head-and-neck cancers, with key readouts in 2025.
What Sets 2025’s Digital Health Funding Environment Apart from Previous Years?
February 18, 2025 / Digital Health Funding 2025 / Healthcare Startup / Investment Trends / Scalable Digital Health Platforms
Digital health funding in 2025 is stabilizing, with increased investment activity after two years of capital preservation. Investors favor scalable, integrated platforms over standalone solutions. Startups must align with healthcare’s slow adoption cycle and focus on proven value delivery for sustained growth.
Gilead loses interest in Arcus’ kidney cancer rival to Merck’s Welireg
February 18, 2024 / Gilead Arcus Casdatifan Decision / HIF-2a Inhibitor / Kidney Cancer / Phase 3 Renal Cell Carcinoma Trial / Arcus Biosciences
Gilead declined to license Arcus Biosciences’ HIF-2a inhibitor casdatifan, a potential kidney cancer treatment rivaling Merck’s Welireg. Arcus will self-fund Phase 3 trials, testing casdatifan in combination with Cabometyx and AstraZeneca’s volrustomig to position it as a leading HIF-2a inhibitor.
// 4th Industrial Revolution
ATA airs concerns about DEA’s proposed special telehealth registration
February 19, 2025 / DEA Telehealth Prescribing Rule / Controlled Substances Telemedicine / ATA Concerns / Buprenorphine Telehealth Prescribing
The American Telemedicine Association (ATA) is urging the DEA to clarify and adjust its special telehealth registration rule for prescribing Schedule II-V controlled substances. Concerns include barriers for specialists, administrative burdens, and potential disruptions in patient care via telemedicine.
AI computer vision enables big OR efficiency gains for Houston Methodist Hospital
February 19, 2025 / AI in Operating Room Efficiency / Houston Methodist Surgical AI / OR Workflow Automation
Houston Methodist improved OR efficiency using AI-powered computer vision to automate surgical workflow tracking. The technology increased OR capacity by 15%, enhancing scheduling, coordination, and patient throughput while reducing manual documentation burdens and improving perioperative decision-making.
Tackling Healthcare Claims with AI and Agentic Workflows
February 19, 2025 / AI in Healthcare / Agentic Workflowers for Payers / Healthcare Automation / Medical Billings
AI-driven agentic workflows are transforming healthcare claims processing by automating data validation, adjudication, and prior authorizations. These AI agents adapt, learn, and integrate across systems, reducing errors, costs, and administrative burden while improving efficiency and patient-provider experiences.
Asan Medical Center streamlines international patient service with AI
February 18, 2025 / AI in International Patient Care / Asan Medical Center Telemedicine / Healthcare Data Management AI / Global Telehealth Services
Asan Medical Center launched an AI-powered international patient platform, streamlining registration, record sharing, telemedicine, and post-treatment monitoring. AI enhances translation, data management, and security, improving accessibility for global patients while reducing manual administrative burdens and privacy risks.
AI and VBC go mainstream in 2025 amid cybersecurity gains, expert predicts
February 18, 2025 / AI in Value-based care / Healthcare It Modernization AI / Agentic AI Workflows
In 2025, AI will drive mainstream adoption of value-based care (VBC), enhance claims processing security, and modernize legacy health IT systems. AI-powered automation will improve care coordination, cost efficiency, and patient engagement, while private LLMs ensure secure AI integration in healthcare.
// Business & Markets
Deep Track nominates candidates for Dynavax’s board, launching proxy fight to end company’s ’empire-building’ strategy phase 3 program
February 19, 2025 / Dynavax / Proxy Fight / Hepatitis B / Adult Vaccines / Biotech
Deep Track Capital is launching a proxy fight to refocus Dynavax on its Hepatitis B vaccine, Heplisav, rather than external acquisitions. The firm, holding 13.5% of shares, criticizes the board’s strategy and seeks leadership changes to prioritize Heplisav’s growth.
Hims & Hers acquires at-home-testing company
February 19, 2025 / Hims & Hers / At-home testing / Trybe Labs / Acquisition / Telehealth / GLP-1 Medications / Virual Care
Hims & Hers acquired Trybe Labs to expand at-home testing, enabling blood draws, biomarker analysis, and personalized treatments for conditions like low testosterone and menopause. This move strengthens its telehealth platform, supporting preventive care and GLP-1 medication offerings.
Altitude Lab sources funding, lab space for biotechs concerned about fate of NIH grants
February 19, 2025 / Recursion Pharma / National Institutes of Health / SBIR / Grants / Venture Capital
Altitude Lab launched a $2.5M fund to support biotechs impacted by NIH SBIR funding uncertainty, offering pre-seed capital, lab space, and mentorship. The initiative aims to sustain biotech innovation and foster diversity in life sciences entrepreneurship.
Stock stagnation prompts a 16% pay cut for AstraZeneca CEO Pascal Soriot despite strong sales sheet
February 19, 2025 / AstraZeneca / Pascal Soriot / Stock Performance / Revenue Growth
Despite 18% revenue growth in 2024, AstraZeneca CEO Pascal Soriot’s compensation dropped 16% due to stock stagnation. His long-term incentives fell, reflecting investor concerns, despite strong blockbuster drug sales and sustained pipeline success under his leadership.
Recursion CEO launches pre-seed fund in response to NIH cuts
February 19, 2025 / Recursion Biotech / Funding Initiative / Startup Accelerator / Biotech Investment / Life Sciences Funding Challenges
Recursion CEO Chris Gibson launched a pre-seed biotech fund through Altitude Lab to support startups affected by NIH SBIR funding cuts. The fund provides $100K–$250K, lab space, and mentorship, aiming to sustain early-stage life sciences innovation.
// Legal & Regulatory
FDA Neuralink reviewers fired as Musk’s DOGE cuts jobs
February 19, 2025 / Neuralink / FDA / Layoffs / Elon Musk / DOGE Governemnt Cuts / Neuralink SEC Investigation
FDA Neuralink reviewers were among 20 staffers laid off as part of government-wide job cuts under Elon Musk’s Department of Government Efficiency (DOGE). Neuralink faces regulatory scrutiny over animal testing violations and SEC investigations into potential investor misinformation.
Aidoc receives FDA clearance for AI-enabled rib fractures triage
February 19, 2025 / Aidoc / FDA Clearance / Rib Fractures / Radiology Triage / CARE1 Foundation Model Healthcare
Aidoc received FDA clearance for its AI-powered rib fracture triage tool, built on the CARE1 Foundation Model for scalable medical imaging analysis. The model, backed by AWS collaboration, enhances radiology workflow efficiency and supports future AI-driven diagnostics.
FDA disrupts Harmony’s expansion dreams for excessive sleepiness drug Wakix with refusal letter
February 19, 2025 / FDA Refusal Wakix IH Approval / Harmony Biosciences / Wakix Setback / Jazz Pharma
The FDA rejected Harmony Biosciences’ bid to expand Wakix (pitolisant) for excessive daytime sleepiness in idiopathic hypersomnia (IH) due to a missed Phase 3 endpoint. Harmony plans a higher-dose version study in 2025, targeting FDA approval by 2028.
AskBio wins FDA RMAT designation for Parkinson’s gene therapy
February 19, 2025 / AskBio Parkinson’s Gene Therapy / FDA RMAT Designation / Regenerative Medicine / Clinical Trial Update / Bayer Gene Therapy Pipeline
AskBio’s gene therapy AB-1005 for Parkinson’s disease received FDA RMAT designation, expediting development. Currently in Phase II trials, AB-1005 also holds Fast Track (FDA) and Innovation Passport (UK MHRA) status, aiming to improve PD treatment options.
FDA sets June date for Gilead’s twice-yearly HIV PrEP
February 19, 2025 / Gilead Lenacapavir / FDA Review / HIV Prevention
The FDA is reviewing Gilead’s twice-yearly injectable PrEP, lenacapavir, with a decision expected by June 19. Phase 3 trials showed near-complete HIV prevention, positioning lenacapavir as a potential market leader over ViiV’s Apretude, which requires six annual doses.
// Research & Development
Allay doses first subject in trial of ATX101 for post-surgical pain relief
February 19, 2025 / Allay Therapeutics / Post-surgical Pain Relief / Innovation / Knee Replacement / Pain Management / Non-Opioid Analgestic Development
Allay Therapeutics dosed the first patient in a Phase IIb trial of ATX101, a bupivacaine-based biopolymer for post-surgical pain relief in knee replacement patients. The therapy aims to reduce opioid use and provide weeks of sustained analgesia.
Bristol Myers Squibb notches overall survival win with Opdivo in preoperative NSCLC
February 19, 2025 / Bristol Myers Squibb / Non-small Cell Lung Cancer / AstraZeneca / Imfinzi / Merck / Keytruda
Bristol Myers Squibb’s Opdivo plus chemotherapy demonstrated a significant overall survival benefit in resectable NSCLC in the final analysis of CheckMate-816. Already FDA-approved for neoadjuvant use, Opdivo remains the only I-O therapy approved pre-surgery.
Supernus reports less than super data for depression drug
February 19, 2025 / Supernus SPN-820 Trial Failure / Treatment-resistant Depression Drug / Trial Results
Supernus Pharma’s SPN-820 failed to show a statistically significant benefit in a Phase 2b trial for treatment-resistant depression, despite earlier promising results. The company is analyzing data and reassessing the drug’s future with partner Navitor Pharmaceuticals.
Recce Pharma reports positive Phase II trial of RECCE 327 Gel
February 19, 2025 / Recce 327 Gel Phase II Results / ABSSSI Treatment Clinical Trial / Topical Antibiotic RECCE 327 / Recce Pharamceutical
Recce Pharmaceuticals’ RECCE 327 Gel (R327G) showed positive Phase II results for acute bacterial skin infections (ABSSSI), demonstrating rapid efficacy and strong safety. The company plans Phase III trials in Australia and Indonesia to advance regulatory approval.
UK study highlights importance of GP data in understanding atrial fibrillation
February 19, 2025 / Atrial Fibrillation GP Data Study / Early AF Detection UK Research / Oxford Populationo Health / Cardiology / Elecrtonic Health Records
A UK study highlights that GP data significantly improves atrial fibrillation (AF) detection, identifying 28% more cases and earlier diagnoses than hospital data alone. Comprehensive healthcare records can enhance stroke prevention and AF patient management.
// Politics
After high-profile pledge to secure confirmation, RFK Jr. now says panel will review childhood vaccine schedules
February 19, 2025 / RFK Jr. / Vaccine Policy Reversal / HHS Childhood Vaccine Review / SSRIs / Chronic Disease Inquiry / Trump Administration Health Policies
HHS Secretary RFK Jr. reversed his pledge to leave childhood vaccine schedules untouched, announcing a review under the Make America Healthy Again commission. The panel will also investigate SSRIs, electromagnetic radiation, and environmental factors linked to chronic disease.
FTC retains stricter merger guidelines under Trump
February 19, 2025 / FTC Healthcare Merger Guidelines / Trump Administration Antitrust Policy / Health Insurer Acquisitions Regulation / FTC Leadership
The FTC will retain stricter merger guidelines from the Biden administration, impacting healthcare consolidation, insurer acquisitions, and private equity roll-ups. Chair Andrew Ferguson emphasized regulatory stability, though future revisions remain possible under the Trump administration.
Trump set to break WTO rules with potential pharma tariffs
February 19, 2025 / Trump Pharmaceutical Tariffs / WTO Drug Trade Regulations / Prescription Drug Price Increases / Supply Chain Impact
Trump plans 25%+ tariffs on pharmaceuticals, breaking WTO rules and impacting European drug exporters. While intended to boost U.S. manufacturing, experts warn of rising drug prices, supply chain disruptions, and long delays in expanding domestic production capacity.
RFK Jr. says HHS is ‘bringing back common sense’ with new messaging on ‘biological truth’
February 18, 2025 / HHS Biological Truth Policy / RFK Jr. Gender Ideology Stance / Trump Administration
HHS, under RFK Jr., is enforcing “”biological truth”” policies, rejecting gender diversity in medicine and limiting LGBTQ+ health resources. Federal health pages now carry anti-gender ideology statements, sparking criticism from scientists and advocacy groups over policy-driven misinformation.
One issue that RFK Jr. and his critics agree on
February 19, 2025 / RFK Jr. / GRAS Loophole Reform / FDA Food Additive Regulations / Food Safety
HHS Secretary RFK Jr. aims to close the “”generally recognized as safe”” (GRAS) loophole, which allows food additives to bypass FDA approval. Both advocates and critics agree on the need for stronger oversight of food safety regulations.