ERBC, a France-based preclinical contract research organisation (CRO), announced on Thursday that it has formed a strategic partnership with Italy-based Menarini Biotech, a Menarini Group company.
The companies say that the collaboration is aimed at streamlining and accelerating the transition of biopharmaceuticals from the research stage to First-In-Human (FIH) clinical trials.
The partnership is intended to lower entry barriers for early-stage innovation by offering a continuum from preclinical development to Chemistry, Manufacturing and Controls (CMC) which includes efficient and cost-effective development strategies for biopharmaceuticals, delivery of such molecules on time, and of the required level of quality (GLP and/or GMP, support in preclinical and clinical studies, delivery of regulatory-ready data through CMC and safety modules which can accelerate a smooth Initial New Drug (IND) submission, as well as expert guidance in navigating the complexities of regulatory requirements for the development of biopharmaceuticals.
Menarini Biotech also provides an early integration of manufacturability and scalability through platform-based manufacturing processes and scalable systems as well as tailored support for scale-up and production.
Galmed reveals novel pharmacodynamic blood markers for Aramchol SCD1 inhibitor
Evommune initiates EVO756 Phase 2b trial in adults with chronic spontaneous urticaria
Telix Pharmaceuticals' TLX101 glioma therapy candidate shows promising efficacy
FluoGuide begins phase II trial of FG001 for head and neck cancer
Sanofi advances respiratory pipeline with positive amlitelimab data and expanded clinical programmes
PRISM BioLab agrees drug discovery collaboration with Elix
Sumitomo Pharma America signs research and development agreement with NCI
IDEAYA Biosciences advances Phase 3 design for darovasertib in primary uveal melanoma
Scancell partners with NHS Cancer Vaccine Launch Pad to accelerate melanoma trial recruitment
Genflow Biosciences enters into AI-driven research agreement with Heureka Labs
Sichuan Kelun-Biotech reveals sacituzumab tirumotecan (sac-TMT) clinical studies results
Kyowa Kirin completes construction of new Drug Substance manufacturing facility
Amgen's IMDELLTRA shows superior overall survival in small cell lung cancer trial
OncoZenge AB signs licensing deal with Avernus Pharma for BupiZenge in GCC region