Drugs

FDA Lifts Partial Hold on Lymphoma Trial

FDA has lifted a partial clinical hold against an Innate Pharma Phase 2 clinical trial (TELLOMAK) that is evaluating the efficacy and safety of lacutamab (formerly IPH4102) in patients with advanced T-cell lymphomas. FDA’s action is based on a quality assessment of a new GMP-certified batch that has been successfully manufactured for the lacutamab clinical development program, the company says. Innate adds it will now resume recruitment of new patients in the U.S. with relapsed/refractory Sézary syndrome and mycosis fungoides who have received at least two prior systemic therapies.

The partial hold was based on GMP deficiencies at the company’s manufacturing subcontractor site that managed the fill and finish operations of the lacutamab clinical vials for TELLOMAK, Innate says. In Europe, regulatory authorities in Spain, Italy and Germany temporarily halted the trial whereas the French and UK regulatory authorities agreed to resume trial recruitment in those respective countries earlier this year. It says it is consulting the regulatory authorities in Germany, Italy and Spain in order to resume the trial in those countries soon.

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