September 16, 2019 Off

Janssen files for sBLA to FDA for Tremfya

By Dino Mustafić

The Janssen has filed for a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of guselkumab brand Tremfya, for the treatment of adult patients with active psoriatic arthritis (PsA), and expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.

September 16, 2019 Off

Darzalex combination induced higher response rates in new patients

By Dino Mustafić

The addition of daratumumab – or in this particular study – Darzalex to bortezomib, lenalidomide and dexamethasone (VRd) induced higher response rates in newly diagnosed patients with multiple myeloma who were eligible for high-dose therapy and autologous stem cell transplantation (ASCT) compared with VRd alone.

September 16, 2019 Off

Tiziana Life Sciences gets FDA approval to kick-off Phase I clinical trial with orally administered foralumab in healthy volunteers

By BusinessWire

Tiziana Life Sciences got from the U.S. Food and Drug Administration (FDA) signal to start a Phase I clinical trial in healthy volunteers using a novel oral enteric-coated capsule formulation of Foralumab, a fully human monoclonal antibody (mAb), in collaboration with the Brigham and Women’s Hospital (BWH), Harvard Medical School, Boston, MA.