Drugs

Breakthrough Status for Sunovion Schizophrenia Drug

FDA has granted Sunovion Pharmaceuticals and PsychoGenics a breakthrough therapy designation for SEP-363856, a novel agent for treating people with schizophrenia. The companies say that SEP-363856 does not bind to dopamine 2 or serotonin 2A receptors, which are thought to mediate the effects of currently available antipsychotic medicines. Although the exact mechanism of action is unknown, SEP-363856 is believed to activate trace amine-associated receptor 1 in addition to serotonin 1A receptors, they say.

The designation was based on pivotal, Phase 2 data from Study SEP361-201, as well as data from Study SEP361-202, a six-month, open-label, safety and tolerability extension study. The companies say the Phase 2 study showed statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale total score compared to placebo after four weeks of treatment. Investigational studies to further evaluate the therapy’s clinical benefit are underway.

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