Drug Manufacturing

Insignis Therapeutics’ IN-001 clinical programme receives positive FDA response

Insignis Therapeutics has received a positive response from the US Food and Drug Administration (FDA) on IN-001 clinical programme for needle-free anaphylaxis treatment.

Electra Therapeutics secures FDA ODD status for HLH treatment

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, Organon announce FDA acceptance of BLA for HLX14

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 secures $92m in Series A funding for ADC development

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’ navenibart gains orphan medicinal status from EC

Astria Therapeutics received the European Commission's orphan medicinal product designation (OMPD) for navenibart (STAR-0215) to treat hereditary angioedema (HAE).

RTI partners with Codetta Bio to boost healthcare innovation

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 launches biopharmaceutical platform S-HiCon

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 collaborates with Wacker Biotech for GBS vaccine production

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 to develop AI-driven LAI manufacturing process

Persist AI and Nivagen have joined forces to co-develop an advanced AI-driven manufacturing process for long-acting injectable (LAI) drugs.