Biologics

Submit Long Covid Drug as IND: FDA

FDA has recommended that Toronto, Canada’s Revive Therapeutics submit an IND for agency evaluation of the company’s bucillamine, described as an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for Long Covid. In a Type C meeting with company executives, FDA officials said the new IND may cross-reference applicable sections from Revive’s current IND that evaluated in a Phase 3 trial bucillamine’s safety and effectiveness in treating patients with mild to moderate Covid-19.

Revive says that during the meeting FDA also provided feedback on the appropriate design, study population, and safety and efficacy measures for assessing a therapeutic benefit in patients with Long Covid.

In 7/2023, the company released positive results from the Phase 3 trial in patients with mild to moderate Covid-19.

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

Read more

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