Busulfan

AVROBIO to Collaborate with Saladax Biomedical on New High-Speed Diagnostic Assay Used with Busulfan Conditioning to Enable Widespread Commercialization of AVROBIO’s Proprietary Platform Globally

Retrieved on: 
Monday, May 4, 2020
Research, FDA, Genetics, Clinical trials, Biotechnology, Other Health, Health, Other Science, Science, Articles, Branches of biology, Life sciences, Medical genetics, Busulfan, Gene therapy, Therapy, Plato

AVROBIOs state-of-the-art plato gene therapy platform incorporates TDM protocols designed to optimize busulfan dosing over four days, with the goal of maximizing stem cell engraftment while minimizing side effects.

Key Points: 
  • AVROBIOs state-of-the-art plato gene therapy platform incorporates TDM protocols designed to optimize busulfan dosing over four days, with the goal of maximizing stem cell engraftment while minimizing side effects.
  • The technology used to deliver these rapid test results is based on an extensive intellectual property portfolio developed by Saladax in the field of TDM.
  • AVROBIO is powered by the plato gene therapy platform, our foundation designed to scale gene therapy worldwide.
  • AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Pii to Manufacture FDA-approved Busulfan Injection Drug Product

Retrieved on: 
Friday, March 15, 2019
Chemistry, RTT, Drugs, Physical sciences, Busulfan, Cyclophosphamide, Leukemia, Chronic myelogenous leukemia

Pii is responsible for all commercial production and Athenex will market and distribute the product in the U.S. Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.

Key Points: 
  • Pii is responsible for all commercial production and Athenex will market and distribute the product in the U.S. Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
  • "We are pleased to announce the licensing and launch of Busulfan Injection (FDA approved 9/21/2018) through our collaborative partnership.
  • Busulfan Injection is the4thinjectable product approved by the FDA, for Pii and its partners, during the past two years," said Dr. Kurt Nielsen, Pii's President and CEO.
  • Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry.

Nexus Pharmaceuticals announces FDA approval of Busulfan Injection

Retrieved on: 
Thursday, January 17, 2019
Health, Pharmaceutical, Research, FDA, Science, General Health, Specialty drugs, Busulfan, Chemistry, Health, Biotechnology, Generic drug

Nexus Pharmaceuticals Inc. announced today the U.S. Food and Drug Administration (FDA) approval of Busulfan Injection, the company's AP-rated therapeutic equivalent for Busulfex60 mg/10 mL (6 mg/1 mL).

Key Points: 
  • Nexus Pharmaceuticals Inc. announced today the U.S. Food and Drug Administration (FDA) approval of Busulfan Injection, the company's AP-rated therapeutic equivalent for Busulfex60 mg/10 mL (6 mg/1 mL).
  • The FDA approval of Busulfan continues to expand our portfolio of difficult to manufacture injectables, in addition to becoming our second oncology generic drug, said Omair Ahmed, Chief Commercial Officer, Nexus Pharmaceuticals.
  • Busulfan is currently on American Society of Health System Pharmacists drug shortage list.
  • Busulfan is expected to launch in the United States shortly in cartons of eight single-dose vials, each containing 60 mg of busulfan in 10 mL of clear sterile solution.