Drugs

FibroGen, FDA Agree on Roxadustat Phase 3 Elements

FibroGen and FDA have reached an agreement on important design elements for a pivotal Phase 3 trial of the company’s roxadustat to treat anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell burden. A company statement says it will submit the Phase 3 protocol in the fourth quarter.

The planned trial will assess the safety and efficacy of roxadustat in some 200 patients with LR-MDS. The company says agreement was reached in a meeting with FDA on the patient population, dose regimen, and management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria.

Roxadustat is described as the first in a new class of medicines that are HIF-PH inhibitors that promote red blood cell production through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. It is in clinical development for chemotherapy-induced anemia, FibroGen 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