Drugs

FDA Lifts Hold on Medivation’s Pidilizumab

FDA has lifted a partial clinical hold against a Medivation IND for pidilizumab (MDV9300) in hematological malignancies and confirmed that a Phase 2 clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma, as well as other studies that cross reference the IND, may now proceed. The company says the hold was not related to any safety concerns.

“The investigator brochure, protocols, and informed consent documents related to the Phase 2 trial have satisfactorily been revised to reflect the company’s understanding that PD-1 (Programmed Death-1) is not the target of pidilizumab,” Medivation says. “Patients who were receiving pidilizumab through investigator-sponsored trials have continued to receive treatment and those investigators have been informed to update their protocols and informed consent documents to state that pidilizumab is not an anti-PD-1 antibody.”

Additionally, the company intends to submit an amendment to the chemistry, manufacturing and controls section of the IND in the second quarter to provide for larger manufacturing lot sizes to better support the current and planned clinical activities in other hematologic malignancies, such as multiple myeloma.

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