Drugs

Revive Therapeutics Amends Protocol on Covid Therapy

Revive Therapeutics says it has finalized an amended protocol for the company’s Phase 3 clinical trial designed to evaluate the safety and efficacy of bucillamine, an oral drug with anti-inflammatory and antiviral properties for treating patients with mild to moderate Covid-19.

The amended protocol includes a new primary efficacy endpoint — “assessing the difference in the proportion of participants with improvement in at least two Covid-19 related clinical symptoms on or before Day 14 compared with baseline between bucillamine versus placebo,” according to the company. It adds that additional secondary endpoints may include the time to polymerase chain reaction resolution, clinical outcome (death or hospitalization), disease severity, supplemental oxygen use, and progression of Covid-19.

“Should the FDA agree with the revised protocol, the data safety monitoring board (DSMB) will review the completed post-dose selection data of approximately 500 subjects in the context of the new primary endpoint,” Revive says. “The DSMB may recommend continuing the study if there is a trend toward achieving statistical significance, halting the study early due to statistical significance likely not going to be met, or halting the study early due to positive efficacy showing statistical significance.”

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