Drugs

Fresenius Kabi BLA for Neulasta Biosimilar

FDA has accepted for review a Fresenius Kabi BLA for a pegfilgrastim biosimilar candidate (MSB11455) that references Amgen’s Neulasta, indicated for reducing the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy. The drug works by stimulating the body’s own production of white blood cells to fight infection, according to the company. The submission includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data. It also includes the results of two pivotal clinical trials that showed equivalent pharmacokinetic and pharmacodynamic profiles to the originator Neulasta, as well as similar immunogenicity in healthy volunteers, the company says, adding that the therapy’s safety was also comparable to Neulasta.

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