Roche (Basel, Switzerland, www.roche.com) and the biopharmaceutical company Alnylam Pharmaceuticals, Inc. (Cambridge, MA, www.alnylam.com), have entered into a major alliance in which Roche obtains a nonexclusive license to Alnylam's technology platform for developing RNAi (RNA interference) therapeutics.
Roche (Basel, Switzerland, www.roche.com) and the biopharmaceutical company Alnylam Pharmaceuticals, Inc. (Cambridge, MA, www.alnylam.com), have entered into a major alliance in which Roche obtains a nonexclusive license to Alnylam’s technology platform for developing RNAi (RNA interference) therapeutics. The alliance will initially cover four therapeutic areas: oncology, respiratory diseases, metabolic diseases, and certain liver diseases.
Alnylam and Roche also will collaborate on RNAi drug discovery for one or more disease targets in these therapeutic areas. In addition, Roche will acquire Alnylam’s European research site located in Kulmbach, Germany (Bavaria), subject to regulatory approval. This site will become Roche’s Center of Excellence for RNAi therapeutics discovery. Under the terms of the agreement, Roche will pay Alnylam $331 million in upfront cash payments and equity investment.
Roche has also acquired NimbleGen Systems, Inc. (Madison, WI, www.nimblegen.com), to gain entry into the high-growth research microarrray market. DNA microarrays are a widely used discovery and research tool in pharma research for the understanding of genetic causes of disease and predisposition factors, comparative genomic analysis, and identification of potential drug targets. Under the terms of the agreement, Roche will pay NimbleGen’s shareholders 272.5 million US dollars.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.