Electra Therapeutics has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for ELA026, an antibody therapy to treat hemophagocytic lymphohistiocytosis (HLH).
Shanghai Henlius Biotech (Henlius) and Organon have announced the US Food and Drug Administration (FDA) acceptance of the biologic license application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).
Kivu Bioscience has completed a $92m Series A funding round, spearheaded by Novo Holdings to propel the development of next-generation antibody-drug conjugates (ADCs).
Astria Therapeutics received the European Commission's orphan medicinal product designation (OMPD) for navenibart (STAR-0215) to treat hereditary angioedema (HAE).
RTI International has announced a strategic collaboration with Codetta Bio, a company specialising in multi-omics for precision medicine development, to fast-track healthcare innovation.
Samsung Biologics, a contract development and manufacturing organisation (CDMO), has launched S-HiCon, a new high-concentration formulation platform designed to enhance the development and manufacturing of high-dose drugs.
MinervaX, a Danish biotechnology company, has joined forces with contract development and manufacturing organisation (CDMO) Wacker Biotech for the manufacturing of MinervaX’s active protein ingredients for its Group B Streptococcus (GBS) vaccine.
Persist AI and Nivagen have joined forces to co-develop an advanced AI-driven manufacturing process for long-acting injectable (LAI) drugs.
Global healthcare holding company OSR Holdings has entered into a memorandum of understanding (MoU) with SillaJen, a South Korea-based biotechnology company with a pipeline of immuno-oncology drug candidates.
AGC Biologics has completed the facility expansion for its new plasmid DNA (pDNA) and messenger RNA (mRNA) production line at Heidelberg, Germany.
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