Drugs

FDA ‘Complete Response’ on Sunovion Parkinson’s Drug

FDA has issued Sunovion Pharmaceuticals a complete response letter on its NDA for apomorphine sublingual film for use in treating “off episodes” (the re-emergence or worsening of symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease. In the letter, FDA requested additional information and analyses, but said no new clinical studies are required, according to the company.

The novel formulation of apomorphine and a dopamine agonist is being developed for the on-demand management of off episodes associated with Parkinson’s. It is currently FDA approved for the acute, intermittent treatment of hypomobility, “end-of-dose wearing off” and unpredictable “on/off” episodes associated with advanced Parkinson’s. It is currently available in the U.S. as a subcutaneous injection.

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