Drug Manufacturing

Timber’s TMB-001 receives orphan drug designation from EC to treat XLRI

Timber Pharmaceuticals has received orphan drug designation from the European Commission (EC) for TMB-001 to treat X-linked recessive ichthyosis (XLRI).

Icosavax receives fast track designation for IVX-A12 vaccine candidate

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.

Travere Therapeutics receives FDA accelerated approval for FILSPARI

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’s Stargardt disease treatment gets fast track designation

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.

AFT and Salus Pharmaceuticals sign agreement for pain treatment Maxigesic IV

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 signs licensing deal with Junshi for toripalimab

Hikma Pharmaceuticals has signed a new exclusive licensing and commercialisation agreement with Junshi Biosciences for the cancer treatment drug, toripalimab.

ReiThera receives AIFA approval to open new production facility in Italy

Italian Medicines Agency (AIFA) has granted operational authorisation to biotech company ReiThera to open its new production area at its pharmaceutical facility located at the Castel Romano Technopole.

CSL and Translational Sciences sign license deal for thrombus dissolving drug

Global biotechnology firm CSL has signed a strategic option and license deal with biopharmaceutical company Translational Sciences for thrombus dissolving drug candidate, TS23.

Celregen signs license deal with Cellusion for bullous keratopathy therapy

Shanghai Fosun Pharmaceutical’s member Hangzhou Celregen Therapeutics has entered into an exclusive license agreement with Japanese regenerative medicine start-up Cellusion for CLS001.