Drugs

FDA Releases Form 483 Citing Biocon on Manufacturing

FDA has released a seven-item Form 483 following a 5/1 inspection of Biocon’s Bangalore, India drug substance and drug product manufacturing facility. For example, FDA investigators cited the firm for not adequately demonstrating its disinfection efficacy. The firm was also cited for a deficient environmental monitoring effort and inadequate cleaning procedures. Additionally, the investigators noted that they observed inadequate behaviors to prevent contamination of raw materials.

Biocon has struggled with certain manufacturing issues over the past few years. Last year, it and Mylan were issued a complete response letter on a BLA for a proposed trastuzumab biosimilar product (Roche’s Herceptin) due to chemistry, manufacturing and controls concerns. Biocon also 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. And a year ago, FDA released a Form 483 issued following a 5/2017 inspection at Biocon’s Bangalore sterile drug manufacturing facility that cited 10 inspection observations (see story).

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