Biologics

FDA Rejects Pharming Expanded Use for Ruconest

FDA has issued Pharming Group a complete response letter on its supplemental BLA for Ruconest [C1 esterase inhibitor (recombinant)] to expand the current indication to include prophylaxis in patients with hereditary angioedema. Based on the agency review, FDA has requested an additional clinical trial to further evaluate the effectiveness of Ruconest for the proposed indication. The 11/2017-submitted application included data from two Phase 2 studies, an open-label study and a randomized, double-blind, placebo-controlled trial with 4-8 week treatment periods, which the company says showed consistent efficacy and safety results.

Ruconest, the first recombinant C1-esterase inhibitor product for treating acute attacks in adult and adolescent patients with hereditary angioedema, was originally approved in 2014. The therapy is purified from the milk of genetically modified (transgenic) rabbits, according to an agency news release. “Ruconest is intended to restore the level of functional C1-esterase inhibitor in a patient’s plasma, thereby treating the acute attack of swelling.”

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