Biologics

Marks Wants ‘Project Orbis’ for Cell/Gene Therapies

CBER director Peter Marks told the Biopharma Congress on 2/13 that he wants to see something similar to the agency’s Project Orbis cancer program developed for cell and gene therapies as the involvement of other “high-income countries” could help attract developers. The FDA Oncology Center of Excellence launched Project Orbis in 2019 to provide applicants with a framework for concurrent submissions and review of oncology products with other regulators, according to a Regulatory Affairs Professionals Society post on the conference.

Marks said that to spur the development of cell and gene therapies, it may be best to pool resources and expertise from other regulators in reviewing and approving projects such as Project Orbis has done.

“A lot of these gene therapies have such small populations that are applicable to the U.S. that if we can expand those markets to other high-income countries, you would attract more developers and cover more diseases,” he said.

In other comments, Marks said FDA would soon announce a new pilot program that would be akin to Operation Warp Speed for rare diseases.

Asked whether CBER is tightening its approval standards for cell and gene therapies, as reflected in an increasing number of clinical holds on the products, he said that some INDs are “missing major pieces” and that “there are cases where we have bona fide companies coming in” that have problems with their submissions that could be resolved by a simple interactive meeting. But, he said, the Center doesn’t have the “bandwidth” to support such discussions.

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