Drugs

Bayer Files NDA for Menopause Drug

FDA has accepted a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause. The submission is based on the positive results from the OASIS Phase 3 studies evaluating elinzanetant versus placebo. Bayer says the findings showed a significant reduction in VMS for those taking elinzanetant compared to placebo. “In addition, improvements were seen in measures of sleep disturbances and menopause-related quality of life with elinzanetant use over 52 weeks,” according to the company.

Elinzanetant is described as the first dual neurokinin-1 and 3 receptor antagonist that works by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons). When the neurons experience a decrease in estrogen,they “become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS, Bayer says.

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