// Biotech and Pharma Therapeutics
Three issues to watch in global health in 2025
December 26, 2024 / Global Health 2025 / Infectious Disease Outbreaks / Mpox Transmission Trends / Bird Flu / Pandemic Preparednes
Global health in 2025 will likely focus on persistent challenges: post-COVID-19 pandemic issues, mpox transmission, and H5N1 bird flu evolving into widespread “moo flu” concerns across animals and environments.
The Chase for Novel Oral GLP-1 Obesity Meds Adds a New Contender
December 26, 2024 / Oral GLp-1 Agonist / Obesity Drug Development / Corxel Pharmaceuticals CX11 / Weight Loss Medicine Innovation / Cardiometabolic Treatment Pipeline
Corxel Pharmaceuticals acquires VCT220 (CX11), a Phase 2-ready oral GLP-1 agonist for obesity treatment, aiming to rival injectables like Ozempic. CX11 shows competitive weight loss with safety and tolerability, progressing to global trials in 2025.
From AI and layoffs to supply chains and political unknowns, Deloitte outlines key areas for biopharma to watch in 2025
December 26, 2024 / Biopharma 2025 Outlook / Generative AI in Healthcare / R&D Strategy Evolution / Suppy Chain Resilience Biopharma
Deloitte’s 2025 biopharma outlook highlights optimism despite challenges, emphasizing R&D rethinking, generative AI adoption, business volatility preparations, and strategic responses to political and economic uncertainties to drive innovation and improve patient outcomes.
How retractions get weaponized on social media
December 24, 2024 / Scientific Retractions Transparency / Hydroxychloroquine Retraction
Scientific retractions ensure research integrity but can fuel distrust and attacks in politicized environments. Experts urge transparent, accessible retraction processes to maintain trust and clarify peer-reviewed science’s reliability.
Three strikes and kids’ cancer is out
December 20, 2024 / Pediatric Drug Development Cuts / US Spending Bill Pediatric PRVs / Pediatric Cancer Research Funding
Pediatric drug development incentives, including PRVs, were excluded from the U.S. House’s third spending bill, raising concerns over stalled progress in childhood cancer treatment amid broader budgetary and legislative cuts.
// 4th Industrial Revolution
Dexcom Adds Generative AI Platform to Its Over-the-Counter CGM
December 22, 2024 / Dexcom Adds Generative AI Platform to Its Over-the-Counter CGM
Dexcom integrates generative AI into its Stelo CGM, enhancing personalized metabolic health insights by analyzing glucose levels, meal patterns, sleep, and lifestyle habits, empowering users to make informed health decisions without sharing user data externally.
UVA Health RAMPs up AI and real-time analytics
December 26, 2024 / UVA Health RAMP AI / Real-time Predictive Analytics / AI in Healthcare / Clinical Decision Support
UVA Health’s RAMP integrates real-time predictive analytics into clinical workflows, enhancing decision-making and patient care through explainable AI models. Its transparent, actionable insights improve outcomes and exemplify customizable healthcare AI solutions.
Ascension cyberattack exposed medical data of 5.6M customers
December 26, 2024 / Ascension Cyberattack / Healthcare Data Breaches / Medical Cybersecurity Threats / Healthcare Cybersecurity Act / Protecting Patient Information
A May cyberattack on Ascension exposed medical and personal data of 5.6M individuals. While EHR systems were not breached, sensitive patient, payment, and identification data were compromised, highlighting growing cybersecurity risks in healthcare.
10 signs AI is ‘eating the world (of venture capital)’
December 23, 2024 / AI in Venture Capital / Healthcare AI Adoption Callenges / Tech Giants AI Investments
AI’s transformative impact on venture capital reshapes innovation priorities, with life sciences and healthcare seeing slower uptake due to accuracy risks. AI investment dominates, driving labor efficiency gains and expanding R&D by tech giants like Meta and Microsoft.
Medical Drone Delivery Services Market to Reach $1.9B by 2032
December 23, 2024 / Medical Drone Delivery Market / Healthcare Drone Technology / Emergency Medical Drone Services
The medical drone delivery market, projected to reach $1.9B by 2032, grows due to advancements in accessibility, efficiency, and cost-effectiveness. Drones enhance emergency response, public health efforts, and EMS delivery, particularly in remote or underserved areas.
// Business & Markets
Shionogi to acquire full ownership of joint ventures with Ping An
December 23, 2024 / Shionogi Ping An Acquisition / Pharma Joint Venture Dissolution / Drug Development / China / Ping An Healthcare Partnerships
Shionogi will fully acquire its joint ventures with Ping An subsidiaries, transitioning them into wholly-owned entities to prioritize its core drug R&D and sales operations in China, aligning with its strategic objectives.
Another bump in the road for XBiotech and bermekimab
December 23, 2024 / Xbiotech Bermekimab Trial / Rheumatoid Arthritis Phase II Failure / Clinical Program Suspension
XBiotech suspended its rheumatology program after bermekimab failed to meet Phase II rheumatoid arthritis trial endpoints. Study irregularities complicated data interpretation, leading to a 25% drop in the company’s share price.
Ikena, after tough year of layoffs, merges with Inmagene to focus on phase 2 dermatitis prospect
December 23, 2024 / Ikena Inmagene Merger / Atopic Dermatitis Treatment / Immunology-focused Biopharma / Mergers and Acquisitions
Ikena Oncology merges with Inmagene Biopharmaceuticals to prioritize IMG-007, an OX40-targeting monoclonal antibody for atopic dermatitis. With $175M funding, the new company, InmageneBio, shifts focus to inflammatory diseases, leaving oncology behind.
Sanofi expands SK bioscience deal for pneumococcal conjugate vaccines
December 23, 2024 / Sanofi SK Bioscience Partnership / Next-generation pneumococcal vaccines / Clinical Trials / Vaccine Developemnt
Sanofi and SK bioscience expanded their collaboration to develop next-generation pneumococcal conjugate vaccines (PCVs) addressing broader Streptococcus pneumoniae serotypes for pediatric and adult populations, aiming to reduce invasive pneumococcal disease burden through enhanced vaccine coverage.
Why Walgreens Is Reportedly Considering a Private Equity Buyer
December 22, 2024 / Walgreens / Sycamore Partners Walgreens Deal / Retail Health Transformation / Pharmacy Industrys
Walgreens is exploring a potential sale to Sycamore Partners amid financial struggles and declining market value. The move aims to stabilize operations, shift focus to retail health and beauty, and address challenges in pharmacy and primary care ventures.
// Legal & Regulatory
FDA approves Lilly drug for obstructive sleep apnea
December 23, 2024 / Zepbound FDA Approval / Tirzepatide for obstructive sleep apnea / Eli Lilly / Sleep Apnea Treatment
The FDA approved Eli Lilly’s Zepbound (tirzepatide) as the first prescription medication for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity, addressing a common condition linked to excess weight.
FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
December 23, 2024 / Generic Liraglutide Approval / Type 2 Diabetes Treatment Aptions / GLP-1 Generic Approval / Affordable Diabetes Medications
The FDA approved the first generic liraglutide injection for type 2 diabetes, improving glycemic control in patients aged 10 and older. This approval addresses medication shortages and promotes affordable treatment options for diabetes management.
FDA digs in its heels with another rejection for Lexicon’s diabetes prospect Zynquista
December 23, 2024 / Lexicon Pharmaceuticals / Sotagliflozin / FDA Rejection / Zynquista / Type 1 Diabetes / Drug Approval
The FDA rejected Lexicon’s Zynquista (sotagliflozin) for Type 1 diabetes due to safety concerns, particularly diabetic ketoacidosis. Lexicon is scaling back operations, focusing on its clinical pipeline, including diabetic neuropathic pain and cardiometabolic therapies.
Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off
December 23, 2024 / Alyftrek FDA Approval / Cystic Fibrosis Treatment / Vertex CFTR Modulators
The FDA approved Vertex’s Alyftrek, a once-daily cystic fibrosis (CF) triple therapy for patients 6+ with responsive CFTR mutations. Alyftrek offers broader mutation coverage than Trikafta, improving convenience and eligibility for about 150 additional U.S. patients.
Novo Nordisk wins hard-fought FDA approval for once-daily hemophilia med Alhemo
December 23, 2024 / Alhemo FDA Approval / Hemophilia Inhibitor Treatment / Novo Nordisk
Novo Nordisk secures FDA approval for Alhemo, a once-daily subcutaneous injection for hemophilia A or B with inhibitors, reducing annual bleeding rates by 86%. Alhemo offers a groundbreaking alternative for patients with limited treatment options.
// Research & Development
Why bone marrow transplants are becoming less common
December 24, 2024 / Bone Marrow Transplant Decline / Immune Therapy Blood Cancer / Cancer Treatments / Stem Cell Therapy Evolution
Bone marrow transplants, once central to treating blood cancers, are now less common for lymphomas as safer and more effective immune and targeted therapies emerge. Allogeneic transplants, however, are increasing for specific malignancies.
CDC says H5N1 bird flu sample shows mutations that may help the virus bind to cells in the upper airways of people
December 26, 2024 / H5N1 Bird Flu Mutations / CDC Human Adaptation
The CDC reports H5N1 bird flu samples from Louisiana and British Columbia show mutations enhancing the virus’s ability to bind to human upper airway cells, potentially increasing its adaptation for human infection but not yet enabling person-to-person spread.
With pair of trial wins in psoriatic arthritis, Bristol Myers Squibb looks to jump-start stagnant Sotyktu
December 23, 2024 / Bristol Myers Squibb / Sotyktu / Otexla / Psoriatic Arthritis / Amgen / Johnson & Johnson
Bristol Myers Squibb’s Sotyktu showed positive Phase 3 results in psoriatic arthritis, expanding its potential beyond plaque psoriasis. Despite market challenges and competition, BMS aims for first TYK2 inhibitor approval for psoriatic arthritis.
CagriSema Demonstrates Superior Weight Loss in Adults with Obesity or Overweight in the REDEFINE 1 Trial
December 20, 2024 / CagriSema Weight Loss Trial / Novo Nordisk / Semaglutide cagrilintide combination / Obesity treatment innovation
Novo Nordisk’s REDEFINE 1 trial shows CagriSema, a combination of cagrilintide and semaglutide, achieved superior weight loss (22.7%) in adults with obesity or overweight compared to individual components or placebo, with a tolerable safety profile.
Traws Pharma soars as it advances H5N1 bird flu treatment
December 24, 2024 / Traws Pharma H5N1 Treatment / Tivoxavir marboxil bird flu therapy / Clinical Trials
Traws Pharma advances its H5N1 bird flu treatment, tivoxavir marboxil, after Phase I success in healthy adults. With Phase II trials planned for 2025, the company addresses rising human infections and pandemic potential of avian influenza.
// Politics
Bipartisan House Task Force releases report on AI innovation
December 26, 2024 / AI in Healthcare Innovation / AI Data Privacy / Clinical Tools / Bipartisan AI Task Force Findings
A Bipartisan House Task Force report highlights AI’s potential to enhance healthcare efficiency, accuracy, and patient outcomes while addressing challenges like data standards, interoperability, and privacy risks. Recommendations focus on safety, transparency, and regulatory support.
Why One Startup CEO Is Excited About the White House’s New AI Czar Role
December 26, 2024 / AI Czar Healthcare Innovation / David Sacks AI Regulation / US Medical AI Policy
David Sacks’ appointment as the U.S. AI and cryptocurrency czar is expected to foster a more innovation-friendly healthcare AI environment. Experts predict looser regulations may accelerate the adoption of lifesaving technologies and improve patient outcomes.
Healthcare Leaders Slam Exclusion of Key Healthcare Provisions in Spending Package
December 23, 2024 / Healthcare Spending Bill Exclusions / Drug Pricing Reform Delay / Medicare Reimbursement Cuts / Telehealth Extensions
The new spending bill excluded key healthcare reforms, including drug pricing, prior authorization, and Medicare reimbursement rate adjustments. Delayed reforms impact affordability and care delivery, though temporary Medicare telehealth extensions offer limited progress.
NSF offers $1.6M for research on the International Space Station
December 23, 2024 / NSF ISS Research Funding / Tissue Engineering in Microgravity / Regenerative Medicine ISS Projects / Biomedical Research International Space Station
The NSF is offering $1.6M for projects leveraging the International Space Station’s microgravity environment to advance tissue engineering and mechanobiology research, with applications in disease treatment, regenerative medicine, and bioengineering.
United States Prevails in USMCA Dispute with Mexico on Biotech Corn
December 23, 2024 / USMCA Biotech Corn Dispute / Genetically Engineered Corn Trade / Mexico / Agricultural Policy / Market Access
The U.S. won a USMCA dispute, overturning Mexico’s restrictions on genetically engineered (GE) corn. The panel emphasized science-based trade policies, ensuring fair market access for U.S. corn exports, which totaled $4.8 billion to Mexico in 2024.
Artificial Intelligence (AI)
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