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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...
Bristol Myers Squibb Names AstraZeneca’s Massacesi as New Chief Medical Officer
Bristol Myers Squibb appointed AstraZeneca executive Cristian Massacesi as its new chief medical officer, succeeding Samit Hirawat. Massacesi, effective August 1, brings a strong track record in...
Leads Biolabs Nears Double Stock Price After $189M Hong Kong IPO
Chinese biotech Leads Biolabs successfully raised approximately $189 million in its Hong Kong stock exchange debut, with shares nearly doubling on the first day. The company plans to use proceeds...
AI Accelerates Immunotherapy Design via T Cell Receptor Cross-Reactivity Prediction
Researchers at Cold Spring Harbor Laboratory developed BATCAVE, a comprehensive database of over 22,000 TCR-peptide interactions, and BATMAN, an AI-driven model that predicts T cell receptor...
Protein Design Breakthrough Challenges Conventional Stability Concepts
A large-scale study led by the Centre for Genomic Regulation and the Wellcome Sanger Institute overturns the notion that protein core mutations universally destabilize structure. Testing thousands...
New AI Designed Protein Binders Target Disease Markers for Immunotherapy
The Baker lab at the University of Washington harnessed AI to design highly specific protein binders for diverse peptide–MHC complexes, enhancing personalized immunotherapy targeting. Detailed in...
European Regulators Approve New Orphan Drugs, Reject Sarepta’s Elevidys
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for five orphan drugs but rejected Sarepta’s Elevidys gene therapy for Duchenne muscular dystrophy due to...
Deloitte Survey: Life Sciences Face 'Pivotal Moment' Amid Tariffs and Pricing Changes
A global Deloitte survey of healthcare and life sciences executives reveals that tariffs and evolving pricing policies are reshaping strategic planning. Nearly two-thirds expect moderate to major...
Single-Cell Genomics Scaling Revolutionizes Biological Insights
Experts from the Chan Zuckerberg Initiative and Wellcome Sanger Institute highlighted breakthroughs in single-cell RNA sequencing that are transforming biomedical research. Increasing project...
Sarepta’s Elevidys Gene Therapy Faces Regulatory Rejections and Safety Concerns
Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy, Elevidys, faces mounting regulatory hurdles and safety concerns. The European Medicines Agency’s Committee for Medicinal Products...
Lilly’s Alzheimer’s Drug Kisunla Gains Partial Approval in Europe After Reversal
Eli Lilly’s Alzheimer’s treatment Kisunla (donanemab) experienced a regulatory turnaround by the European Medicines Agency’s CHMP, which changed its previous negative opinion. The CHMP recommended...
Bristol Myers Squibb Names AstraZeneca’s Cristian Massacesi as Chief Medical Officer
Bristol Myers Squibb appointed Cristian Massacesi, formerly chief medical officer at AstraZeneca, as its new CMO effective August 1. Massacesi succeeds Samit Hirawat, who led Bristol Myers’...
Long-Read Sequencing Consortium Expands for 1000 Genomes RNA and DNA Analysis
The 1000 Genomes Project Long-Read Sequencing (1KGP-LRS) Consortium has expanded its scope by incorporating PacBio sequencing in addition to Oxford Nanopore Technologies data. Led by researchers...