// Biotech and Pharma Therapeutics
3 trial readouts that could shake up the obesity market this year
January 8, 2025 / Obesity Treatment Market / GLP-1 Weight Loss Drugs / Metsera Obesity Trials / Skye Bioscience / CB1 Inhibitor / Eli Lilly Oral GLP-1
Upcoming 2025 obesity trial readouts spotlight Metsera’s long-acting GLP-1 injection, Skye Bioscience’s CB1 inhibitor targeting alternative weight loss mechanisms, and Eli Lilly’s oral GLP-1 candidate, poised to expand accessibility and competition in the rapidly growing obesity treatment market.
Alloy Thera and Sanofi join forces on CNS drug research
January 8, 2025 / Alloy Therapeutics Sanofi / CNS-targeted Therapies / Drug Development / Partnership
Alloy Therapeutics partners with Sanofi to develop CNS-targeted therapies using Alloy’s antisense platform, with potential milestone payments exceeding $400M, highlighting a collaborative commitment to advancing innovative central nervous system treatments.
What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations
January 8, 2025 / Healthcare CIO Challenges / AI in Healthcare / Healthcare Access
Healthcare CIOs face challenges balancing tech investments, operational efficiency, and patient expectations. Modernizing voice channels with conversational AI enhances accessibility, promotes health equity, and meets diverse consumer preferences while addressing financial pressures and workforce constraints.
AbbVie opts in for first genetic medicine program with Capsida
January 8, 2025 / AbbVie Capsida Collaboration / Neurodegenerative Diseases
AbbVie exercised its first genetic medicine option with Capsida Biotherapeutics, leveraging engineered AAV capsids for targeted neurodegenerative therapy. Capsida receives $40M upfront, with additional milestone and royalty opportunities as AbbVie advances clinical development and Capsida manages manufacturing.
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction; Draft Guidance for Industry; Availability
January 8, 2024 / FDA Obesity Drug Guidence / Weight Management Biologics / Drug Development
The FDA released updated draft guidance for developing drugs and biologics targeting weight reduction and long-term weight management in obesity and overweight patients, replacing the 2007 guidance to align with evolving scientific and regulatory advancements.
// 4th Industrial Revolution
HHS proposes HIPAA update to boost healthcare cybersecurity
January 6, 2025 / HIPAA / Cybersecurity Regulations / Health Data Breaches
HHS proposes HIPAA security rule updates to strengthen healthcare cybersecurity, requiring written policies, technology inventories, multi-factor authentication, and regular risk analyses. The changes address increasing cyberattacks and aim to improve protection of electronic health data across the healthcare sector.
Cedar Exec Talks The Untapped Potential of AI in Healthcare Call Centers in 2025
January 8, 2025 / AI in Healthcare Call Centers / Patient Billing Optimization / AI Solutions
AI in healthcare call centers offers transformative potential to reduce call volumes, enhance patient experiences, and boost financial efficiency. Cedar emphasizes combining AI with human empathy to optimize billing interactions and address staffing challenges while maintaining trust and clarity.
AI that identifies undiagnosed cognitive impairment could improve VBC
January 8, 2025 / Linus Health RADAR Algorithm / Milliman Healthcare
Milliman’s report confirms that Linus Health’s RADAR AI algorithm, using claims data, effectively identifies patients at high risk of undiagnosed cognitive impairments like Alzheimer’s, enhancing predictive accuracy to support proactive care in value-based healthcare settings.
Pfizer doubles down on AI partnership with antibody-drug conjugate deal
January 7, 2025 / Pfizer PostEra AI Collaboration / ADCs / AI in medicinal Chemistry / Drug Discovery
Pfizer expands its AI collaboration with PostEra to include antibody-drug conjugates (ADCs), leveraging generative chemistry software to design optimized payloads. The $350M deal underscores AI’s role in accelerating preclinical milestones for antivirals, cancer drugs, and innovative therapeutics.
Two new smart rings unveiled at CES
January 7, 2025 / Smart Ring Health Monitoring / AI-Driven Wearables / Wearable Health Devices
At CES 2025, Circular debuted the Ring 2 with ECG and AFib detection, while VIV Health unveiled the VIV Ring featuring AI-driven generative sleep-aid technology, expanding smart ring innovation in personalized health monitoring and wellness.
// Business & Markets
FIRE1 Secures $120M for Heart Failure Management Platform
January 8, 2025 / Fire1 Heart Failure Management / Norm System / FDA / Heart Failure Remote Monitoring / Chronic Disease Management / Medical Devices Funding
FIRE1 secured $120M to advance its Norm™ heart failure management system, combining FDA Breakthrough Device Designation with patient-directed self-management to improve outcomes, reduce healthcare burdens, and empower at-home chronic disease care.
Galapagos Keeps Focus on Cancer Cell Therapy, Spins Out Rest of Biz Into NewCo Backed by €2.4B
January 8, 2025 / Galapagos Cell Therapy Focus / Oncology Pipeline / SpinCO / Cancer Treatment
Galapagos shifts focus to cell therapy, spinning off SpinCo with €2.4B to pursue oncology, immunology, and virology. This restructuring enhances cell therapy manufacturing speed while divesting small molecule programs and consolidating resources for sustainable growth in advanced cancer treatments.
Arch-backed Tenvie unveils with $200M and a neuro pipeline with assets from Denali
January 8, 2025 / Tenvie Therapeutics Neuro Pipeline / Neurological Disease Treatment Innovation
Tenvie Therapeutics launched with $200M, acquiring assets from Denali, including IND-stage NLRP3 and SARM1 inhibitors targeting neurological diseases. Tenvie aims to transform brain-penetrant treatments addressing inflammation, metabolic dysfunction, and lysosomal disorders in Alzheimer’s, Parkinson’s, and peripheral neuropathies.
Alesta Therapeutics Raises €65 Million Series A Financing to Advance Oral Small Molecules for Rare Diseases
January 8, 2025 / Alesta Therapeutics / Rare Diseases /Oral Small Molecule Therapies / Drug Developemt
Alesta Therapeutics raised €65M Series A to advance oral small molecules for rare diseases. Lead assets ALE1 (for hypophosphatasia) and ALE2 (for Charcot-Marie-Tooth disease) target novel pathways, with clinical trials planned for 2025 to address unmet patient needs.
Roche to complete $1.5 billion acquisition of U.S. biopharma company Poseida
January 8, 2025 / Roche Poseida Acquisition / Immune Cell Therapy Development
Roche is finalizing its $1.5 billion acquisition of Poseida Therapeutics, a leader in immune cell therapies for blood cancers, to strengthen its oncology pipeline amidst declining cancer drug sales, highlighting strategic investment in advanced biopharma innovation.
// Legal & Regulatory
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy
January 7, 2025 / FDA / RSV Vaccines / Guillain-Barre Syndrome Vaccine Risk / GBS Precaution
The FDA mandates Guillain-Barré Syndrome (GBS) risk warnings for RSV vaccines Abrysvo (Pfizer) and Arexvy (GSK), citing postmarketing studies showing increased GBS risk within 42 days post-vaccination, reflecting updated safety labeling for at-risk patient populations.
FDA updates recommendations to enhance pulse oximeter performance
January 7, 2025 / FDA Pulse Oximeter Guidance / Medical Devices / FDA / Clinical Study Recommendations
The FDA released draft guidelines to improve pulse oximeter accuracy by ensuring performance validation across diverse skin tones. Recommendations include expanded clinical studies, standardized skin tone assessments, and labeling updates to address disparities in medical device efficacy.
Eli Lilly seeks to join lawsuit on compounded drugs
January 6, 2025 / Eli Lilly / Lawsuit / Clinical Updates / Biotech Q1 2025 Scorecard
Eli Lilly seeks to join a lawsuit concerning compounded drugs, reflecting its interest in safeguarding market exclusivity. Separately, key biotech updates include Phase 3 data on Ultragenyx’s setrusumab for osteogenesis imperfecta and Praxis’ ulixacaltamide for essential tremor.
Aetna sues drugmakers for widespread price-fixing and collusion
January 3, 2025 / Aetna Generic Drug Lawsuit / Price-fixing / Pfizer + Novartis + Teva Collusion / Drug Price Manipulation
Aetna sued Pfizer, Novartis, Teva, and others for alleged price-fixing of generic drugs, claiming collusion inflated prices for insurers, consumers, and the government. This follows state lawsuits and DOJ scrutiny over widespread antitrust violations in the pharmaceutical industry.
FDA pushes makers of AI devices to disclose more details on testing, performance
January 9, 2025 / FDA / AI Medical Device Guidance / Device Data Disclosure / AI
The FDA’s draft guidance urges AI medical device developers to disclose data sources, demographics, biases, and performance blind spots in approval applications. This transparency aims to enhance safety and accountability in AI-driven healthcare technologies.
// Research & Development
Using lab-grown human mini-brains, scientists find links between head trauma, herpes, and Alzheimer’s
January 7, 2025 / Alzheimer’s Head Trauma Link / Herpes Virus / Lab-grown Mini-brain Research / Concussion Connection
Tufts University researchers used lab-grown human mini-brains to reveal that concussions activate latent herpes simplex virus type 1, triggering inflammation, amyloid plaques, and neuronal damage—hallmarks of Alzheimer’s disease—linking head trauma, herpes infection, and Alzheimer’s risk.
Sana’s cell therapy may be ‘transformative cure’ for type 1 diabetes: analysts
January 8, 2025 / Sana UP421 Cell Therapy / Type 1 Diabetes / Hypoimmue Platform Insulin Production
Sana Biotechnology’s allogeneic cell therapy, UP421, showed initial success in a Type 1 diabetes patient by avoiding immune rejection without immunosuppression, producing insulin, and demonstrating graft survival. Analysts view it as a potential transformative cure for diabetes.
J&J says its lung cancer drug combination keeps people alive longer
January 7, 2025 / Johnson & Johnson / AstraZeneca / Lung Cancer Treatment / Non-small Cell Lung Cancer Innovation
Johnson & Johnson’s Rybrevant and Lazcluze combination extends survival by at least a year compared to AstraZeneca’s Tagrisso in EGFR-mutated non-small cell lung cancer. Targeting EGFR and MET pathways, it offers a new treatment option despite added side effects.
GSK bags breakthrough status for bone cancer drug
January 7, 2025 / ADC osteosarcoma treatment / Antibody-drug conjugates / Bone Cancer
GSK’s ADC, GSK5764227, targeting B7-H3, received FDA breakthrough designation for relapsed/refractory osteosarcoma, supported by Phase 2 data showing a 20% response rate. This rare bone cancer currently lacks FDA-approved treatments, underscoring the therapy’s potential impact.
Verona touts ‘exceptionally strong’ launch of blockbuster hopeful COPD treatment Ohtuvayre
January 7, 2025 / Ohtuvayre COPD Treatment Launch / COPD / Verona Pharma
Verona Pharma’s Ohtuvayre, a novel dual PDE3/PDE4 inhibitor for COPD, launched strongly with $42M in 2024 sales, demonstrating significant physician adoption and refill rates. Positioned as a maintenance therapy, Ohtuvayre offers airway-opening and anti-inflammatory benefits.
// Politics
Pfizer, PhRMA rank among groups pledging funding for Trump’s inauguration: NYT
January 6, 2025 / Pfizer / Trump / Political Donations /Trump Biopharma Collaborations
Pfizer and PhRMA contributed to Donald Trump’s record $150M inauguration fundraising, signaling efforts to maintain influence in shaping healthcare policies under his administration, despite previous criticism of the Capitol riots and evolving political engagement strategies.
Nevada sues Kroger to ensure opioid settlement payment
January 7, 2025 / Navada Kroger Opioid Lawsuit / Opioid Crisis Settlement Compliance / Pharmacy Overprescription Allegations
Nevada sued Kroger to secure $26M from a $1.37B opioid settlement, alleging pharmacies knowingly over-dispensed opioids, fueling the crisis. The complaint ensures settlement terms compliance and highlights Kroger’s alleged failure to address suspicious opioid dispensing practices.
HMPV: Drug supplies from China not likely to be affected by virus
January 7, 2025 / HMPV Impact on Pharma Supplies / Respiratory Infactions Drug Demand / China API Supply Stability
India’s pharmaceutical industry, heavily reliant on Chinese APIs, is unlikely to face supply disruptions from the HMPV outbreak. Experts emphasize controlled conditions in China and limited virus severity, projecting strong industry growth amid rising respiratory infections in India.
Michigan Senate Democrats Make Lowering Costs, Increasing Access to Affordable Health Care a Top Priority in 2025
January 8, 2025 / Michigan Prescription Drug Affordability Board / Reducing Prescription Drug Costs / Healthcare Affordability Legislation
Michigan Senate Democrats proposed creating a Prescription Drug Affordability Board (PDAB) to lower medication costs and enhance access. The board would set pricing limits, provide transparency, and address affordability challenges for residents struggling with rising prescription expenses.
Biden administration bans unpaid medical bills from appearing on credit reports
January 7, 2025 / Biden Medical Debt Credit Reform / Consumer Financial Protection Bureau Rule / Medical Debt Credit Score Impact
The Biden administration’s rule removes unpaid medical bills from credit reports, improving credit scores for 15 million Americans and enhancing access to loans. This change aims to reduce economic barriers tied to medical emergencies and debt.