Drugs

FDA Accepts Adamas Pharma NDA for Parkinson’s

FDA has accepted for review an Adamas Pharmaceuticals NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules for treating levodopa-induced dyskinesia in patients with Parkinson’s disease. The submission has been given a user fee review target date of 8/24. “Over time, 90% of patients on levodopa therapy suffer from levodopa-induced dyskinesia,” the company says. “Currently, there is no FDA approved medicine for levodopa-induced dyskinesia for patients with Parkinson’s disease.”

ADS-5102 is a chrono-synchronous amantadine therapy. In 2015, the FDA granted orphan status for the drug and its use for this indication. Adamas is also investigating ADS-5102 for other indications earlier in the Parkinson’s treatment cycle, as well as for walking impairment in multiple sclerosis.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome