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Lilly’s Alzheimer’s Drug Gains EMA Favor After Reversal
Eli Lilly's monoclonal antibody, Kisunla (donanemab), has seen a turnaround at the European Medicines Agency’s CHMP. Following an earlier rejection due to safety concerns and unclear benefits in...
Executive Moves Shake Up Biopharma and Med-Tech Leadership
Bristol Myers Squibb announced Cristian Massacesi, former AstraZeneca CMO, as its new chief medical officer starting August 1. Massacesi replaces Samit Hirawat amid Bristol Myers’ pipeline...
Innovations in Flexible Electronics and Sustainable Conductive Materials
Recent research advancements reveal novel materials for flexible and sustainable electronic devices. Electropolymerized poly(3,4-ethylenedioxythiophene) (PEDOT) has been utilized to create...
AI-Powered Advances in Immunotherapy Targeting T Cell Receptor Binding
Cold Spring Harbor Laboratory researchers introduced BATMAN, an AI model trained on a comprehensive TCR-peptide interaction database (BATCAVE) with over 22,000 entries. This technology...
Microbiome and Radiotherapy Interaction in Cancer Immunity
Emerging studies highlight the pivotal role of the microbiota in modulating cancer immunotherapy outcomes, particularly in the context of radiotherapy. Pilot research indicates that fecal...
Funding Trends and Market Sentiment in Emerging Biotech Companies
The 2025 Biotechnology Innovation Organization report and recent market data reveal a cautious but evolving funding climate for emerging biotech firms. While overall investment levels are...
European Regulatory Approvals and Decisions on Orphan Drugs and Med-Tech Support
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for five orphan drugs, reinforcing orphan drug development momentum in Europe. Simultaneously,...
Novel Insights Into Human Ageing Through Proteomics and Organ-Specific Effects
A comprehensive proteomic study of human tissues from individuals aged 14 to 68 unveiled accelerated ageing patterns starting around 50 years old, with distinct organ-specific trajectories....
New AI Models Boost mRNA-Based Therapeutics Development
A novel artificial intelligence framework improves prediction of mRNA translation efficiency, enhancing the design of mRNA vaccines and therapies for viruses, cancer, and genetic disorders. By...
Sarepta's Duchenne Gene Therapy Faces Regulatory Setbacks
Sarepta Therapeutics' gene therapy Elevidys for Duchenne muscular dystrophy (DMD) has encountered significant regulatory challenges. The European Medicines Agency's Committee for Medicinal...
Lilly’s Alzheimer’s Drug Gains Favor in Europe After EMA Reversal
Eli Lilly's monoclonal antibody, Kisunla (donanemab), has reversed its regulatory fortunes in Europe. After earlier rejection by the EMA due to safety concerns over brain edema and hemorrhage, the...
Bristol Myers Appoints AstraZeneca’s Massacesi as New Chief Medical Officer
Bristol Myers Squibb (BMS) announced the appointment of Cristian Massacesi, formerly chief medical officer at AstraZeneca and Alexion, as its new CMO effective August 1. Massacesi replaces...
FDA Delays Bayer’s Menopause Therapy Approval
The U.S. Food and Drug Administration has extended its review timeline for Bayer’s non-hormonal menopause treatment, elinzanetant, citing a need for additional data. While regulators in Canada and...
Biotech Financing and Market Trends Reflect Industry Challenges and Growth
Recent financial reports reveal mixed trends in biotech funding. While public and private financings continue, there is a noted bearish sentiment among emerging biotechs, with investment...
AI Advances in Predicting Immune Responses and mRNA Translation
Artificial intelligence is advancing biotech precision medicine and drug discovery. Cold Spring Harbor Laboratory introduced BATMAN, an AI model trained on a comprehensive T cell receptor-peptide...
Proteomic and Spatial Technologies Transforming Disease Research
Emerging proteomic methods are reshaping biomedical research and precision oncology. Spatial proteomics, recognized as Nature’s 2024 Method of the Year, enables detailed disease progression and...
Innovations in Plant Immunity and Sustainable Agriculture
Plant biology breakthroughs have uncovered novel immune regulation and sustainable farming strategies. Research elucidated a root-based N-hydroxypipecolic acid circuit that controls Arabidopsis...
Breakthroughs in Parkinson’s Research and Therapeutic Approaches
Recent Parkinson’s disease studies shed light on underlying neurobiological mechanisms and innovative therapies. Investigations link glymphatic system asymmetry to the lateralized onset of...
CHMP Rejects Sarepta’s Elevidys, Reverses on Lilly Alzheimer’s Drug
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) announced a negative opinion on Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy Elevidys,...
FDA Investigates Safety of Sarepta’s Duchenne Gene Therapy Amid Shipment Pause
U.S. regulators are requiring Sarepta Therapeutics to conduct additional studies to confirm the safety of Elevidys, the FDA-approved gene therapy for Duchenne muscular dystrophy, following reports...