Drugs

Clinical Hold on 3 CARsgen CAR T-cell Therapies

FDA has placed a clinical hold on three CARsgen Therapeutics clinical trials due to chemistry, manufacturing and controls questions. As a result, trials evaluating CT053, CT041, and CT071 are on hold “pending resolution of the findings following an inspection of the manufacturing site located in Durham, NC,” a company release says.

CARsgen says it plans to conduct a comprehensive review and improvement on GMPs at the site, and it is “committed to working closely with the FDA to address the findings to ensure the smooth progress and production quality for clinical trials.”

CT041 is described as an autologous CAR T-cell product candidate against the protein Claudin18.2, and it targets the treatment of Claudin18.2 positive solid tumors with a primary focus on gastric/gastroesophageal junction cancer and pancreatic cancer. CT053 is an autologous BCMA CAR T-cell product candidate for treating refractory or relapsed multiple myeloma, according to the company. And,it says, CT071 is an autologous CAR T-cell therapy candidate targeting G protein-coupled receptor Class C group 5 member D for treating relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.

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