Author name: druganddevicedigest

Drug and Device Approvals: YESCARTA, IMPELLA RP – Drug and Device Digest

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 …

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Drug and Device Development – Drug and Device Digest

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 …

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FDA News: AAMI Technical Information Report, Fraudulent Cancer Products

May 1, 2017 Drug & Device Advisory Group FDA Briefs FDA News: AAMI Technical Information Report, Fraudulent Cancer Products FDA BRIEF: Week of April 24, 2017 AAMI Technical Information Report on “Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems.” FDA + Association for the Advancement of Medical Instrumentation (AAMI) report Applies to medical …

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FDA Approval, Classification: ILARIS, EPIC CLEARVIEW – Drug and Device Digest

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 …

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FDA Approvals and Reviews: VAXCHORA vaccine, LIFESTENT vascular system – Drug and Device Digest

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 …

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FDA APPROVAL: NUPLAZID, KRYPTOR, – Drug and Device Digest

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 …

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Drug Safety Podcasts for Healthcare Professionals

August 11, 2015August 11, 2015 Drug & Device Advisory Group Link and Learn Drug Safety Podcasts for Healthcare Professionals Division of Drug Information has posted new Drug Safety Podcasts for Healthcare Professionals. Click on the following links to read transcripts and listen to podcasts. FDA evaluating the potential risks of using codeine cough-and-cold medicines in …

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Cures Web Page

July 10, 2017 Drug & Device Advisory Group Link and Learn Cures Web Page Cures Web Page The 21st Century Cures Act (Cures Act) signed into law on December 13, 2016 Help accelerate medical product development Bring new innovations to patients faster and more efficiently Incorporate patient perspectives into the development of medical products Modernize …

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FDA News and Views: Orphan Drug Act, Continuous Manufacturing, Priority Therapeutic Areas

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 …

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