Drugs

Complete Response Letter for Plinabulin

FDA has issued a complete response letter for the BeyondSpring Pharmaceuticals NDA seeking approval of plinabulin in combination with granulocyte colony-stimulating factor to prevent chemotherapy-induced neutropenia (CIN). The company says the agency indicated the NDA cannot be approved at this time because the results of the single registrational Phase 3 trial were not sufficiently robust to demonstrate benefit. FDA said a second well-controlled trial would be required to satisfy the substantial evidence requirement for approval.

Company officials said they plan to seek a meeting with FDA “to consider the possible future clinical pathway for CIN, which may include a second study.”

BeyondSpring says plinabulin, its lead asset, is a selective immunomodulating microtubule-binding agent that is a potent antigen-presenting cell inducer.

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