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FDA and EMA Regulatory Updates Spotlight Approvals and Delays
Regulatory agencies continue to navigate complex reviews amid novel therapies and market dynamics. The FDA has extended its review of Bayer’s non-hormonal menopause drug elinzanetant by up to...
Cutting-Edge AI and Computational Biology Accelerate Drug Discovery
Artificial intelligence (AI) and computational models are significantly advancing biotech research. Cold Spring Harbor Laboratory introduced BATMAN, an AI model trained on a vast TCR-peptide...
Proteomic and Single-Cell Technologies Unveil New Insights in Biology and Disease
Recent proteomic and single-cell advances are transforming understanding of human aging, disease, and cellular heterogeneity. A comprehensive study revealed protein expression shifts accelerating...
Gene Therapy and Cell Therapy Landscape Evolves with New Trials and Pipeline Shifts
The gene and cell therapy sectors continue dynamic shifts with new clinical data and strategic realignments. AstraZeneca’s gefurulimab showed positive phase III results in generalized myasthenia...
Biopharma Financing and Venture Trends Reflect Market Challenges
The biotech investment landscape is experiencing contraction and concentration of capital. Brandon Capital Partners closed its largest life sciences fund at A$439 million ($290 million), targeting...
Leadership Changes Reshape Biopharma and Med-Tech Executives Ranks
Corporate leadership turnover continues in biotech and pharma. Bristol Myers Squibb announced AstraZeneca’s Cristian Massacesi will succeed Samit Hirawat as chief medical officer on August 1,...
Advances in Genomics and Long-Read Sequencing Illuminate Human Genetic Diversity
The 1000 Genomes Project continues to deepen insights into human genome complexity. The Long-Read Sequencing Consortium, led by the University of Washington, expanded its scope by integrating...
Emerging Technologies in Diagnostics and Viral Infection Monitoring
Innovative diagnostic technologies are emerging to improve clinical decision-making and infectious disease management. Geneoscopy received FDA clearance for an updated stool collection kit...
Bristol Myers Taps AstraZeneca’s Cristian Massacesi as New CMO
Bristol Myers Squibb named Cristian Massacesi, previously AstraZeneca's chief medical officer, as its new CMO effective August 1. Massacesi replaces Samit Hirawat, who contributed to launching...
FDA Seeks New Safety Studies for Sarepta’s Duchenne Gene Therapy Elevidys
The FDA requires Sarepta Therapeutics to perform new studies to confirm the safety of its Duchenne muscular dystrophy gene therapy Elevidys, after safety concerns led to a voluntary shipment...
European Medicines Agency Backs Lilly’s Alzheimer’s Drug and Gilead’s HIV Prevention Shot
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) reversed a prior negative decision and recommended approval for Eli Lilly’s Alzheimer's drug Kisunla for...
Deloitte Survey Highlights Industry Challenges from Tariffs and Pricing Policy Shifts
An extensive survey by Deloitte reveals life sciences firms confronting significant strategic and operational impacts due to evolving tariffs and pricing policies globally. About two-thirds of...
Cold Spring Harbor Lab’s BATMAN AI Outperforms in TCR-Peptide Binding Predictions
Researchers at Cold Spring Harbor Laboratory developed BATMAN, an AI model trained on the expansive BATCAVE database of over 22,000 TCR-peptide interactions, achieving superior accuracy in...
TCG Labs Soleil Raises Additional $400M, Expands Biotech Startup Portfolio to China
TCG Labs Soleil, a venture firm specializing in creating single-drug biotechnology startups, secured an additional $400 million, doubling its initial fund to $800 million. The firm also launched...
Roche Faces Revenue Pressure from China Pricing Reforms Yet Sees Global Growth
Roche reported a 3% decline in diagnostic division revenues for H1 2025, weighed down by healthcare pricing reforms and volume-based procurement programs in China, leading to a 26% drop in local...
AstraZeneca’s Gefurulimab Meets Phase 3 Endpoints in Myasthenia Gravis Trial
AstraZeneca announced positive Phase 3 trial results for gefurulimab, a once-weekly, self-administered C5 complement inhibitor for adults with generalized myasthenia gravis who have...
AI Advances Enable Rapid Design of Protein Binders for Precision Immunotherapy
Scientists led by Nobel Laureate David Baker have harnessed AI-driven protein design to create highly specific, low-immunogenicity binders targeting diverse peptide-MHC complexes essential for...
1000 Genomes Project Expands with Long-Read Sequencing Data, Enhancing Genetic Variation Insight
The 1000 Genomes Project Long-Read Sequencing Consortium has incorporated PacBio sequencing data to complement existing Oxford Nanopore datasets, aiming for comprehensive telomere-to-telomere...
Sarepta’s Duchenne Gene Therapy Faces Regulatory Roadblocks
Sarepta Therapeutics’ gene therapy Elevidys for Duchenne muscular dystrophy (DMD) has been halted amid growing safety concerns and regulatory setbacks both in the U.S. and Europe. After the FDA...
AI Advances in Protein and RNA Therapeutics
Artificial intelligence continues to revolutionize biotech with significant breakthroughs in protein design and RNA therapy development. Researchers at the University of Washington and Salk...