Drugs

RedHill Plans Study in Irritable Bowel Patients

RedHill Biopharma has submitted to FDA a Phase 2 study protocol for Bekinda (ondansetron) 12 mg for its use in treating diarrhea-predominant irritable bowel syndrome. The company says it recently concluded a “successful” first-in-man pharmacokinetic study to support the planned Phase2I study. A Phase 3 study with Bekinda 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S., with top-line results expected in the second half of this year. Bekinda is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, that is being studied in multiple gastrointestinal indications.

The randomized, double-blind, two-arm parallel Phase 2 study will be conducted in 12 clinical sites in the U.S. and is expected to enroll 120 patients who will be randomized 60:40 to receive either Bekinda 12 mg or a placebo once daily for eight weeks, RedHill says. The primary endpoint for the study is the proportion of patients in each treatment group with response in stool consistency as compared to baseline.

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