Drugs

FDA Lifts Marker Therapeutics Trial Hold

FDA has lifted its clinical hold on a Marker Therapeutics planned clinical trial investigating the safety and efficacy of its novel MultiTAA T-cell therapy in patients with post-transplant acute myeloid leukemia. The hold was initiated 11/12/19 when FDA requested additional information and technical specifications for two legacy reagents supplied by third parties used in the MultiTAA-specific T-cell manufacturing process. Marker says the technical specifications and data requested by the agency could not be produced by the original suppliers. The company identified alternative suppliers and FDA permitted it to initiate its trial and then placed a partial clinical hold on the trial for the use of the MultiTAA-specific T-cell product manufactured using one of the reagents supplied by the alternative supplier until the final data and certificate of analysis for the reagent are reviewed and accepted by FDA.

Marker says it estimates that the alternative supplier will deliver the final reagent, along with the final data and certificate of analysis required by FDA, by the end of the second quarter of 2020.

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