by Peter Ciszewski | Dec 20, 2019
Sen Zhuang, MD, PhD of Janssen Pharmaceuticals explains what a Breakthrough Therapy Designation means in terms of drug and clinical trial development. A Breakthrough Therapy Designation is given to a drug by the U.S. Food and Drug Administration (FDA) if the...
by Peter Ciszewski | Dec 19, 2019
The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted unanimously (11 – 0) in favor of approving tazemetostat to treat patients with epithelioid sarcoma. The FDA is scheduled to make its decision for market approval on or...
by Peter Ciszewski | Dec 19, 2019
Tadeusz Robak, MD of the Poznań University of Medical Sciences in Poland provides a summary of a phase II clinical trial assessing rozanolixizumab to treat people with primary immune thrombocytopenia. Rozanolixizumab is an anti-Fc receptor antibody and results...
by Peter Ciszewski | Dec 18, 2019
Timothy Craig, DO of the Penn State Milton S. Hershey Medical Center talks about the need for clinicians to be educated about the pros and cons of entering a clinical trial. Clinical trials, especially those for rare diseases, are excellent opportunities for...
by Peter Ciszewski | Dec 17, 2019
Jonathan Sorof, MD of Global Blood Therapeutics (GBT) explains the mechanism of action of Oxbryta (voxelotor) to treat persons with sickle cell disease. Voxelotor blocks deoxygenated sickle hemoglobin polymerization and attenuates red blood cells from...
