Drugs

Argenx Buys Priority Review Voucher from Bluebird for $102 Mil.

Argenx has agreed to purchase a Priority Review Voucher from Bluebird Bio for $102 million, which Argenx plans to use for a planned BLA for efgartigimod, its first-in-class neonatal Fc receptor blocker that is being studied in autoimmune diseases. A year ago, FDA approved Argenx’s Vyvgart (intravenous efgartigimod) for treating generalized myasthenia gravis in adults who are anti-AChR antibody positive.

The company says it has demonstrated proof-of-concept with efgartigimod in four autoimmune diseases, and it is planning to be active in 15 disease targets by 2025. “With a priority review voucher available, we hope to expedite the approval process for one of our current or future indications to more quickly reach the patients who are in serious need of a new treatment option,” it says.

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