Drugs

Oramed Reports ‘Positive’ Results on Oral Insulin Study

Oramed Pharmaceuticals has announced “positive top-line results” from its Phase 2b study that was designed to evaluate the safety and efficacy of its oral insulin capsule (ORMD-0801) in patients with Type 2 diabetes. The study’s primary endpoint, a significant reduction in weighted mean night-time glucose, was successfully achieved, the company says. A Phase 3 trial is now being planned.

The double blind, 28 day, randomized study of 180 adult Type 2 diabetic patients showed a night-time glucose mean percentage change of 6.47% from run-in, between placebo and active cohorts, it says, adding that the study demonstrated a good safety profile with no drug related serious adverse events.

“RMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications,” Oramed says. “Orally administered insulin is expected to enhance patient compliance. In addition, intestinally absorbed-oral insulin mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.”

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