Drugs

Juno Sends Complete Response for JCAR015 Clinical Hold

Juno Therapeutics has submitted a complete response to FDA to address concerns after a clinical hold was ordered on a Phase 2 clinical trial (ROCKET) involving JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The agency placed the hold on the trila after three patient deaths, with two occurring this month after a recent addition of fludarabine to the pre-conditioning regimen. Juno says it has proposed to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone. The complete response included a revised patient informed consent form, a revised investigator brochure, and a revised trial protocol. Juno says its trials and plans for other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected.

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