Drug Manufacturing

CHMP endorses ExCellThera’s stem cell transplantation product

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for ExCellThera's cryopreserved haematopoietic stem cell transplantation product, Zemcelpro.

Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab

Johnson & Johnson has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) to extend the use of the human interleukin (IL)-12 and IL-23 antagonist, Stelara (ustekinumab), for paediatric patients aged two and above with moderately to severely active Crohn's disease (CD).

Ferrer’s progressive supranuclear palsy therapy gains FDA fast track status

Ferrer's FNP-223 has secured fast-track designation from the US Food and Drug Administration (FDA), intended to slow down the development of progressive supranuclear palsy (PSP), a neurodegenerative disease.

FDA grants fast-track status to SolasCure’s gel for calciphylaxis ulcers

The US Food and Drug Administration (FDA) has granted fast track designation to SolasCure's investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers.

MRI and Astellas to support Japanese drug-discovery startups

Japan’s Mitsubishi Research Institute (MRI) and Astellas Pharma have signed a memorandum of understanding (MoU) to support Japanese drug-discovery startups.

GRIN Therapeutics and Angelini Pharma collaborate on radiprodil development

GRIN Therapeutics has announced a collaboration with Angelini Pharma to develop and commercialise radiprodil outside of North America.

Henlius receives ODD for HLX22 from European Commission

Henlius has secured orphan drug designation (ODD) for its anti-HER2 monoclonal antibody, HLX22, from the European Commission (EC) for gastric cancer treatment.

Orion partners with Shilpa Biocare for recombinant human albumin in Europe

Orion Corporation and Shilpa Medicare’s fully-owned subsidiary Shilpa Biocare, have entered into an agreement to commercialise recombinant human albumin in Europe.

Genentech gains FDA approval for diabetic retinopathy treatment

Roche’s Genentech has gained the US Food and Drug Administration (FDA) approval for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR).