Drugs

FDA OKs I-Mab Biopharma IND for Cancer Immunotherapy

FDA has approved an I-Mab Biopharma IND for TJC4, a human anti-CD47 monoclonal antibody for cancer immunotherapy. TJC4 is the third candidate from I-Mab’s proprietary discovery pipeline to be approved for clinical trials by the agency. Unlike other known CD47 antibodies under development, TJC4 works by binding to a “unique epitope on CD47 that leads to minimal red blood cell binding,” the company says. It has also shown efficacy in animal models of hematological malignancies and solid tumors as monotherapy and combination therapies, it adds. The IND enables I-Mab to initiate Phase 1/1b clinical trials to assess safety, tolerability, and efficacy in patients with solid tumors and lymphoma as monotherapy and combination therapies. It expects to initiate the study in several clinical sites across the U.S. in the second quarter.

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