Drugs

FDA Clears BioVie for Parkinson’s Trial

FDA has given BioVie approval to begin its Phase 2 SUNRISE-PD trial in Parkinson’s disease patients. The company says the agency reviewed its clinical trial and provided a single, actionable comment recommending the inclusion of the Part II score from the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale as a primary endpoint for potential future registrational filings. “As this metric is already included as a secondary endpoint within the current trial design, BioVie believes it can proceed with the SUNRISE-PD trial as planned without protocol amendments,” a company release says.

“The SUNRISE-PD trial focuses on the second of two objectives we have in developing bezisterim for Parkinson’s disease, which is to improve upon the motor experiences in patients’ daily living,” the company says. “Our Phase 2a trial demonstrated that bezisterim in conjunction with levodopa may dramatically improve motor control for patients with moderate to severe symptoms of Parkinson’s disease.”

The Phase 2 SUNRISE-PD trial is designed to evaluate bezisterim’s impact on symptoms of Parkinson’s disease in patients who need medication for the first time. “This Phase 2 study intends to address the newly diagnosed patient population, which in conjunction with our earlier trial, could establish bezisterim’s applicability for the total Parkinson’s patient population and provide a foundation for a disease progression study, which is the ultimate objective of the PD program,” BioVie says, adding that patient screening is on track for the fourth quarter of this year.

Bezisterim is described as an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. It is also being studied as a treatment in Alzheimer’s patients.

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