Biologics

Biogen sBLA OKd for Plegridy Intramuscular Injection

FDA has approved a Biogen supplemental BLA for an intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a), indicated for treating relapsing forms of multiple sclerosis. A subcutaneous (SC) formulation of Plegridy was originally approved in 2014. Plegridy uses pegylated interferon beta-1a to extend its half-life and prolong its exposure in the body. Combining interferon beta-1a with pegylation is intended to enable less frequent dosing, Biogen says.

Approval is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. “Bioequivalence between the two dosing regimens was confirmed and data show that participants receiving Plegridy through IM administration experienced fewer injection site reactions in comparison to participants receiving SC administration (14.4% vs. 32.1%),” the company says, adding that the overall safety profiles were generally similar and there were no new safety signals observed.

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