Author: Dino Mustafić

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 13, 2019 Off

BioPharma Credit in new investment deal

By Dino Mustafić

BioPharma Credit, the specialist life sciences debt investor, is in a senior secured note purchase agreement for the issuance and sale of senior secured notes in an aggregate original principal amount of up to $150 million by OptiNose US, Inc. alongside BioPharma Credit Investments, a private fund also investing in life sciences debt managed by Pharmakon Advisors launched in June 2019.