Author name: druganddevicedigest

Week of October 16, 2017 YESCARTA™ (axicabtagene ciloleucel) suspension for intravenous infusion Kite Pharma, Inc. (Gilead company) INDICATION: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising […]

Drug and Device Development Clinical Pharmacology Cards: JADENU, SYNJARDY September 13, 2016September 13, 2016 skg2787Leave a comment CLINICAL PHARMACOLOGY CARDS     Mechanism of Action   Orally active chelator that is selective for iron (as Fe3+) for the treatment of chronic iron overload due to blood transfusions. Pharmacodynamics (PD)         Deferasirox (10, 20,and

FDA BRIEF: Week of October 3, 2016 ILARIS (canakinumab) injection Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA INDICATIONS: Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) ILARIS is indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients. Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) ILARIS

FDA BRIEF: Week of  June 6, 2016 VAXCHORA (Cholera Vaccine, Live, Oral) Suspension for Oral Administration PaxVax Bermuda Ltd., Hamilton, BERMUDA. INDICATION:  Active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas UNMET NEED: Cholera, caused by Vibrio cholerae bacteria, acquired by ingesting contaminated

FDA BRIEF: WEEK OF MAY 2, 2016   NUPLAZID (pimavanserin) tablets Acadia Pharmaceuticals, San Diego, California, USA INDICATION:  Treatment of hallucinations and delusions associated with Parkinson’s  disease psychosis UNMET NEED:  ~ 50,000 Americans diagnosed with Parkinson’s disease each year Hallucinations or delusions can occur ~in as many as 50 percent of patients Can be profoundly disturbing and disabling REG

WHAT: Total prohibition on the current and future sales, distribution, and manufacturing of a medical device WHY:  Analyzing and weighing the risks and benefits the device poses to individuals. Can ban a device without actual proof of illness or injury, and only needs to find that a device has the potential to present the required

FDA News and Views: Orphan Drug Act, Continuous Manufacturing, Priority Therapeutic Areas Drug & Device Advisory Group 3 years ago FDA BRIEF: Week of September 11, 2017 FDA is Advancing the Goals of the Orphan Drug Act By: Scott Gottlieb, M.D., FDA Commissioner Orphan Drug Modernization Plan eliminate a backlog of about 200 orphan drug