Drugs

Acadia Parkinson’s Psychosis Drug Doesn’t Worsen Disease: FDA

FDA reviewers say an Acadia Pharmaceuticals pivotal study, which supports an NDA for Nuplazid (pimavanserin) and its use in treating psychosis associated with Parkinson’s Disease (PDP), “established statistical evidence” and does not worsen Parkinson’s Disease status. In a briefing document released in advance of a 3/29 Psychopharmacologic Drugs Advisory Committee meeting, the reviewers say pimavanserin 40 mg has been shown to be more efficacious than placebo for an acute treatment of PDP.

The primary efficacy endpoint in the study was the change from baseline to week six in the SAPS-PD (Scale for the Assessment of Positive Symptoms for Parkinson’s Disease) score. The briefing document notes that the advisory committee will be asked for input on the SAPS-PD instrument and whether the treatment effect observed in this study, “three points in SAPS-PD as an observed effect (a difference of pimavanserin from placebo in least square mean estimate), is clinically meaningful.”

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