Biologics

Erytech Scraps Plans for Leukemia BLA

Erytech Pharma says it is no longer seeking approval for Graspa (L-asparaginase encapsulated in red blood cells) in hypersensitive acute lymphoblastic leukemia (ALL) following FDA feedback that requested additional clinical data. “In multiple clinical trials, Graspa showed promising results for patients, and we were encouraged by the dialog with the FDA and the fast track designation that we received for this indication last year,” the company says.

Erytech had been in discussions with FDA for seeking approval of Graspa in treating ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. In 2021, the company confirmed its intention to submit a BLA, subject to the submission of additional requested information and agreement on an Initial Pediatric Study Plan (iPSP).

“The company recently received feedback from the FDA on its iPSP, submitted in July 2022,” it says. “After thorough evaluation of this feedback, which included a new request for additional data, and taking into account the changing competitive landscape in the treatment of hypersensitive ALL, the company has determined that it is in the best interests of the company and its shareholders to no longer seek approval for Graspa in ALL and to focus its resources on its preclinical programs and strategic partnering activities.”

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