Curated news and analysis on clinical trials, drug approvals, and medical research.
NICE has upheld appeals to review its guidance on Alzheimer's drugs lecanemab and donanemab, sending the decision back to committee. The manufacturers argued NICE failed to account for the treatments' wider impact on unpaid carers. This comes amid broader challenges in neurodegenerative disease research following recent high-profile clinical trial failures.
An experimental immunotherapy drug shows tumor shrinkage in prostate cancer patients, while Eli Lilly's selpercatinib reduces recurrence risk in early-stage lung cancer. A separate study reveals persistent racial disparities in curative treatment for lung cancer patients.
Researchers have identified DOPA decarboxylase as a quantitative biomarker in cerebrospinal fluid that improves diagnosis of Parkinson's disease and Lewy body dementia. The protein levels are up to 2.5 times higher in affected patients and can differentiate these conditions from Alzheimer's disease. The discovery provides clinicians with an objective diagnostic tool for conditions that are frequently misdiagnosed due to overlapping symptoms.
OpenAI Foundation has pledged $1 billion in grants over the next year to support life science and health research while addressing AI's impacts on jobs and mental health. The nonprofit will recruit a new executive director to oversee grantmaking as part of its revitalized philanthropic mission.
The FDA approved subcutaneous amivantamab for EGFR-mutated NSCLC in December 2025 based on phase 3 PALOMA-3 trial data showing noninferior efficacy with reduced infusion reactions and 5-minute administration time. The formulation decreases infusion-related reactions from 66% to 13% and improves patient convenience and quality of life. Recent MARIPOSA trial updates show amivantamab plus lazertinib extends median overall survival by at least 12 months versus osimertinib monotherapy.
The cell therapy manufacturing market is projected to reach $14.01 billion by 2035, with CAR-T therapies dominating at 65% market share. Recent FDA approvals for new CAR-T indications and Japanese regulatory acceleration highlight growing clinical adoption, while research advances include new anti-aging protein platforms and CRISPR-based treatments.
Egetis Therapeutics completed its rolling New Drug Application for Emcitate® (tiratricol) for MCT8 deficiency in the USA on January 29, 2026. The drug received European Commission approval in February 2025 and launched in Germany in May 2025. The company also provided updates on Japanese regulatory progress and the status of its Aladote® candidate for paracetamol overdose.
Elicio Therapeutics granted inducement stock options to new employees, with one grant of 1,600 options at $12.16 per share and another of 30,300 options at $8.59 per share. The clinical-stage biotech company is developing novel immunotherapies targeting mKRAS-positive cancers, with its ELI-002 program showing promising Phase 1 results including 16.3-month median recurrence-free survival.
A meta-analysis of 20,806 cancer patients shows women have significantly improved survival rates but higher risk of severe treatment side effects compared to men. Separate research indicates nutrition counseling could support fertility in female cancer survivors, though implementation faces barriers. Specialized cancer nurses play a crucial role in providing stability and support throughout cancer treatment.
Ocular Therapeutix's experimental drug Axpaxli showed superior vision maintenance compared to Regeneron's Eylea in a late-stage wet AMD trial. Meanwhile, Ocugen reported 12-month data showing its gene therapy OCU410 reduced geographic atrophy lesions by 31%, though less than earlier interim results. Both companies are advancing toward regulatory submissions and further clinical development.
Ocugen reported Phase 2 data for its geographic atrophy gene therapy OCU410 showing 31% lesion growth reduction versus control. The company plans Phase 3 initiation in Q3 2026 and maintains its goal of three BLA filings in three years. Shares fell 11.48% following the data release which trailed earlier interim results.
The AI-driven precision medicine market is projected to grow from $0.7 billion in 2025 to $9.7 billion by 2035 at a 26.8% CAGR. North America dominates with 62-67% market share, while machine learning accounts for 39% of the market. The market is moderately consolidated with the top five players controlling over 64% share.
Immunotherapy is increasingly used in earlier cancer stages before or after surgery across seven tumor areas. Research shows neoadjuvant and adjuvant immunotherapy can reduce recurrence risk and improve immune recognition of tumor cells. However, challenges remain including side effects, costs, and determining which patients benefit most from earlier treatment.
Researchers used cryo-EM/ET imaging to analyze the HTLV capsid protein structure, revealing insights into virus assembly and potential therapeutic targets for adult T-cell leukemia/lymphoma. The study identified how the virus is assembled and reproduced, with findings that could inform drug design similar to HIV treatments. This research addresses a critical need as there are currently no approved therapeutics for HTLV infection.
CAMP4 Therapeutics appoints Michael MacLean to its Board of Directors as the company advances CMP-002 toward a Phase 1/2 trial for SYNGAP1-related disorder. The company also announced an inducement stock option grant of 8,000 shares at $3.85 per share to a new employee. CAMP4 is developing regulatory RNA-targeting therapeutics to upregulate gene expression for genetic diseases.
Researchers have discovered that vitamin B3 (niacin) can effectively target microRNA-93, a key genetic driver of fatty liver disease. The study shows niacin reduces miR-93 levels and increases SIRT1 activity, restoring normal fat-processing pathways in the liver. This finding suggests a widely available vitamin could become a new treatment for metabolic-associated fatty liver disease affecting 30% of people globally.
A study of 1.9 million births in Sweden found new fathers have a 30% increased risk of depression and anxiety disorders by their baby's first birthday. The research highlights the need for better mental health screening and support for fathers during the postpartum period.
The World Health Organization has recommended new portable TB diagnostic tests that deliver results in under an hour, while researchers developed an inhalable nanoparticle treatment that could replace daily pills. TB remains the world's deadliest infectious disease, killing 1.2 million people in 2024 despite being preventable and curable.
Sanofi has submitted a revised acquisition bid for Ocular Therapeutix ahead of pivotal Phase 3 trial results for AXPAXLI, a sustained-release treatment for wet AMD. The deal could position Sanofi to re-enter the ophthalmology market it previously abandoned. The acquisition would give Sanofi access to innovative hydrogel delivery technology with potential applications beyond eye disease.
Kelun-Biotech reported 2025 revenue of RMB2.06 billion with four products now marketed in China. The company's TROP2 ADC received multiple regulatory approvals for breast and lung cancer indications. A Phase 3 trial combining the ADC with pembrolizumab met its primary endpoint in first-line NSCLC treatment.
