Drugs

FDA Sets PDUFA Target Date for Acadia Nuplazid sNDA

FDA has set 8/4 as the PDUFA target action date for an Acadia Pharmaceuticals resubmitted sNDA for a new indication for its Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. The company says it was told by the CDER Division of Psychiatry that it will be convening an advisory committee to consider the sNDA.

FDA issued a complete response letter to the firm’s original sNDA in 4/2021 raising questions about the pivotal Phase 3 HARMONY study design and citing a lack of statistical significance in some of the subgroups of dementia and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval.

Pimavanserin is described as a selective serotonin inverse agonist and antagonist preferentially targeting receptors that are thought to play an important role in neuropsychiatric disorders. FDA approved it in 4/2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

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