Category: North America

Janssen files for sBLA to FDA for Tremfya
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.

Darzalex combination induced higher response rates in new patients
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.

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

Accenture and Bayer streamline drug development processes through Intient clinical platform
September 16, 2019 Off

Accenture and Bayer streamline drug development processes through Intient clinical platform

By BusinessWire

Accenture (NYSE: ACN) has announced a collaboration with Bayer to implement the Accenture INTIENT Clinical platform to help simplify and speed its drug development processes. The platform, which went live at Bayer earlier this year, brings internal and external clinical data together with Oracle cloud-based technologies into a single data management and warehousing platform, creating actionable insights to accelerate drug development and improve patient outcomes.

Dr. Reddy’s launches OTC, Store-Brand Equivalent of Prevacid 24HR Capsules in the U.S. Market
September 16, 2019 Off

Dr. Reddy’s launches OTC, Store-Brand Equivalent of Prevacid 24HR Capsules in the U.S. Market

By BusinessWire

-Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Lansoprazole Delayed-Release Capsules USP, 15 mg, an over-the-counter (OTC) store-brand equivalent of Prevacid® 24HR Capsules, in the United States market, as approved by the U.S. Food and Drug Administration (USFDA).

BioPharma Credit in new investment deal
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.