Pharmaceuticals, Biotechnology and Life Sciences
DALLAS–(BUSINESS WIRE)–The Food and Drug Administration (FDA) has awarded Perspectum Inc $250,000 to qualify its proprietary biomarkers for NASH in…
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.
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 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 (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 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).
Catalyst Pharmaceuticals, said Friday it will not conclude the offering of shares of its common stock announced on Wednesday, September…
Sygnature Discovery has moved its US office to the heart of the Cambridge–Boston biotech hub, describing it as a small but a significant move, as it will have more than 100 pharma/biotech companies within a mile of the new office, and many more in the wider Boston–Cambridge area.
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.
FARMINGTON, Conn.–(BUSINESS WIRE)–#Rallybio—Rallybio LLC, a development-stage biotechnology company, today announced that it has broadened its drug development capabilities with the…