FDA and EMA Issue Joint AI Principles for Drug Development
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on January 14, 2026, jointly published ten guiding principles for good artificial
Axplora Announces Multi-Million-Euro Investment to Expand ADC Lyophilization at Le Mans Site
Axplora, a global CDMO partner for complex small molecules and antibody-drug conjugates (ADCs), has announced a multi-million-euro investment to expand lyophilization (freeze-drying) capabilities at its
Andelyn Biosciences Selected to Manufacture Clinical-Grade AAV for NKH Gene Therapy
Andelyn Biosciences, Inc. has been selected by the Drake Rayden Foundation to manufacture clinical-grade adeno-associated virus (AAV) using its AAV Curator® Platform for the treatment
BIOEMTECH Partners with NorthStar to Provide Actinium-225 for Targeted Radiotherapeutic Research
BIOEMTECH has signed a strategic supply agreement with NorthStar Medical Radioisotopes to secure Actinium-225 (Ac-225) for use in preclinical studies conducted by its customers. The
Scinai Immunotherapeutics Acquires Recipharm Israel and Expands CDMO Platform
Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) has acquired 100% of the shares of Recipharm Israel Ltd., which operates a cGMP manufacturing site in Yavne, Israel, and
ProBioGen Launches CMC Navigator™ With Four Defined CMC Service Models
ProBioGen has introduced CMC Navigator™, a set of four defined CMC service models designed to support biopharmaceutical companies across key stages of protein Chemistry, Manufacturing
Continuous Bioprocessing Market to Reach $2.3B by 2035, Driven by Biosimilar Pressure and Mega-Site Investment
A once-niche manufacturing technology is going mainstream, as biopharma’s biggest players bet billions on replacing batch production with “always-on” continuous bioprocessing. According to Astute Analytica’s
Terumo expands its Drug Product operations in Germany [CDMO Spotlight]
Terumo Corporation has completed its acquisition of a drug product plant and quality control laboratory operations from WuXi Biologics in Leverkusen, Germany. The transaction officially
EU Critical Medicines Act: What Manufacturing Leaders Must Prepare For
Europe took a decisive step toward pharmaceutical sovereignty on January 21, when the European Parliament overwhelmingly approved the Critical Medicines Act. With 503 MEPs backing
Why Pharmaceutical Contract Negotiations Are Flawed and How to Fix Them
Picture the scene: the Sales teams from a CDMO and Sponsor are delighted to have finalized the principles of a manufacturing deal, the relationship is