Biologics

Coherus Refiles Udenyca Onbody BLA Supplement

Coherus BioSciences has resubmitted a BLA supplement for Udenyca Onbody, the company's on-body injector presentation of Udenyca (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta that is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

Last month, FDA issued Coherus a complete response letter on the supplement due to an ongoing review of inspection findings at a third-party filler, according to the company. It added that no issues about clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were raised, and no additional data or trials had been requested.

Coherus says the submission follows the completion and satisfactory resolution of the FDA’s review of the inspection findings.

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