US FDA approves Ajinomoto Bio-Pharma’s new fill line
The US Food and Drug Administration (FDA) has granted approval for Ajinomoto Bio-Pharma Services’ high potency vial line to manufacture a commercial product.
The US Food and Drug Administration (FDA) has granted approval for Ajinomoto Bio-Pharma Services’ high potency vial line to manufacture a commercial product.
Chiesi Farmaceutici has completed the previously announced acquisition of global, commercial-stage biopharmaceutical company Amryt Pharma.
Biotechnology company ImmuneBridge has raised $12m seed financing to advance new natural killer (NK) cell-based immunotherapies.
Shenzhen Hepalink Pharmaceutical Group’s subsidiary OncoVent has entered into a licence and distribution agreement with Orient EuroPharma (OEP) for the immunotherapeutic drug candidate, oregovomab.
Timber Pharmaceuticals has received orphan drug designation from the European Commission (EC) for TMB-001 to treat X-linked recessive ichthyosis (XLRI).
Icosavax has received fast track designation from the US Food and Drug Administration (FDA) for its bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) VLP vaccine candidate, IVX-A12, in older adults aged 60 years and above.
Ligand Pharmaceuticals’ partner Travere Therapeutics has received the US Food and Drug Administration (FDA) accelerated approval for FILSPARI (sparsentan) to reduce proteinuria in adult subjects with primary IgAN at risk of rapid disease progression.
Nanoscope Therapeutics has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) for the treatment of Stargardt disease to improve visual function.
Hyloris Pharmaceuticals’ partner AFT Pharmaceuticals (AFT) and Salus Pharmaceuticals have signed an exclusive licensing and distribution agreement for new, dual mode-of-action non-opioid pain treatment Maxigesic IV.
Hikma Pharmaceuticals has signed a new exclusive licensing and commercialisation agreement with Junshi Biosciences for the cancer treatment drug, toripalimab.