European Medicines Agency– tag –
-
Samsung Biologics Acquires PolyPeptide in All-Cash Offer: Accelerating Multi-Modality Strategy and Global Network Expansion
PR Newswire South Korea Overview Samsung Biologics announced an all-cash offer to acquire PolyPeptide, accelerating its multi-modality strategy and expanding its global manufacturing network across the U.S., Europe, and India. This acqui... -
Regeneron to Seek Approval for Hearing Loss Gene Therapy Following “Game-Changing” Clinical Data
BioPharma Dive USA Overview Regeneron plans to seek regulatory approval for its gene therapy for rare genetic hearing loss, based on "game-changing" clinical trial data published in the New England Journal of Medicine. The therapy demons... -
PharmTech Analyzes Mid-2026 Key Trends: AI Integration in Drug Discovery and Manufacturing, Strengthened Supply Chains, and New Drug Approvals
PharmTech USA Overview PharmTech released its 'Midyear 2026 Check-in' report, analyzing key pharmaceutical industry trends: AI integration in drug discovery and manufacturing, reinforced supply chain resilience, and new drug approval dyn... -
The Critical Need for Human-Relevant Models in Drug Discovery to Accelerate Development with AI and Organoids
Technology Networks UK Overview This article discusses advancements in New Approach Methodologies (NAMs) in drug discovery, emphasizing their potential beyond the laboratory. It highlights the necessity for new training approaches and st... -
Overcoming Cell Therapy Manufacturing Bottlenecks: Mandating Closed, Reproducible, and Scalable Production Platforms
Frontiers Switzerland Overview As cell therapy products move towards commercialization, their manufacturing processes pose significant challenges regarding critical quality attributes, patient safety, and commercial viability. Addressing... -
Gyros Protein Technologies Streamlines Biotherapeutic Impurity Testing with Automated Immunoassay Platform: Enhancing Reproducibility and Throughput
Bioprocess International (via Gyros Protein Technologies webcast summary) USA Overview Gyros Protein Technologies is addressing impurity testing challenges in biotherapeutic development with its Gyrolab automated immunoassay platform. Th... -
Securecell Unveils APIES Multi-Attribute Analysis Platform for Biopharmaceuticals: Real-time Monitoring of Protein Concentration, Aggregation, and Stability
Securecell Switzerland Overview Securecell has launched APIES, a multi-attribute analysis platform providing comprehensive insights into biopharmaceutical samples. APIES leverages absorbance, intrinsic fluorescence, and scattering to ena... -
SNS Insider Analysis: Viral Vector Manufacturing Market Surges as Leading CDMOs Expand Capacity with Advanced AAV and Lentiviral Technologies
SNS Insider India Overview SNS Insider's market overview highlights that the increasing number of gene therapy clinical trials and the reliance on CDMOs are driving growth in the viral vector manufacturing market. Key CDMOs like Fujifilm... -
Cell and Gene Therapy Manufacturing Advances: Continuous Processing and Automated Bioreactors Tackle Scalability and Cost Challenges
News-Medical.net UK Overview Cell and gene therapy (CGT) manufacturing faces significant challenges in scalability, efficiency, and cost reduction, but new advancements in continuous processing and closed, automated bioreactor technologi... -
Biologics Outsourcing Redefined: Modality Expertise & End-to-End Integration Key for Partnerships
Bioprocess Online USA Overview Biologics manufacturing outsourcing is evolving into strategic partnerships focused on modality expertise, regulatory excellence, and end-to-end integration, moving beyond mere cost savings. To support incr...
