Drugs

Menlo Gains Breakthrough Status for Pruritus Therapy

FDA has granted Menlo Therapeutics a breakthrough therapy designation for serlopitant for treating pruritus associated with prurigo nodularis (PN). The designation is based on data from a Phase 2 clinical trial in pruritus associated with PN, according to the company. In the 127-patient trial, serlopitant met its primary and multiple secondary efficacy endpoints, it says. At week eight, the serlopitant 5 mg group showed a 36 mm improvement from baseline in average itch (measured by the itch visual analog scale) compared with a 19 mm improvement for the placebo group, Menlo says. Currently, patients are enrolling in two Phase 3 clinical trials (one in the U.S. and one in Europe) to evaluate the indication, with data expected by the first quarter of 2020. Serlopitant is a once-daily oral NK1 receptor antagonist being developed for the treatment of pruritus associated with various conditions such as prurigo nodularis, psoriasis and chronic pruritus of unknown origin.

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