Biologics

FDA Extends Review of BLA for Herceptin Biosimilar

FDA has extended by three months a Biocon BLA for a proposed trastuzumab biosimilar product (Roche’s Herceptin), indicated for HER2-positive breast cancer and gastric cancer. The company said that the agency “has notified our partner Mylan that they will extend the target action date” to 12/3 in order to review clarification information submitted as part of the application review process. Last month, FDA’s Oncologic Drugs Advisory Committee voted 16-0 to recommend approval for the biosimilar.

Meanwhile, Biocon recently withdrew its filings for both its trastuzumab product and its pegfilgrastim candidate from the European Medicines Agency due to manufacturing concerns after an inspection of its facility in Bangalore, India. Presumably, the agency has similar concerns based on a Form 483 posted (see story) after an agency inspection in May.

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