Drugs

Neurocrine Bio Stops 2 Develoment Programs

Neurocrine Biosciences says it is stopping the development of two drugs being evaluated for treating focal onset seizures and anhedonia after reporting what it called were “disappointing results” from Phase 2 studies.

The investigational selective NaV 1.6 inhibitor, NBI-921352, licensed from Xenon Pharmaceuticals, did not demonstrate a meaningful reduction in seizure frequency during a Phase 2 dose-finding study, Neurocrine Bio says. The company is reviewing the data from the focal onset seizure study study to determine if there is any potential implication for its ongoing study in SCN8A-developmental epileptic encephalopathy.

The collaborative Phase 2 TERPSIS study with Takeda Pharmaceutical Co. that was evaluating the efficacy of investigational NBI-1065846 compared to placebo in patients with anhedonia in major depressive disorder did not meet its primary endpoint, Neurocrine Bio says. As a result, no further development with NBI-1065846 is planned at this time. Despite the setback, Neurocrine says it and Takeda are maintaining their collaboration on several ongoing programs in clinical development. These include NBI-1065845 as a treatment in major depressive disorder (Phase 2), luvadaxistat for treating cognitive impairment associated with schizophrenia (Phase 2), and NBI-1070770 for treating major depressive disorder (Phase 1).

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