Drugs

Wockhardt Grappling with FDA Issues

India’s LiveMint online media reports that Wockhardt posted a bigger loss in the first quarter of this year due to expenses for remedial measures at plants facing regulatory issues. “Wockhardt has been grappling with quality control issues raised by the U.S. FDA for the past four years,” the report says. The company’s formulations units at Chikalthana and Waluj have been under an FDA import alert since 2013 for manufacturing standards violations. And a bulk drug plant at Ankleswahr was placed on import alert in 2016.

The company’s U.S. step-down unit, Morton Grove Pharmaceuticals, was issued an FDA Warning Letter in March and a UK indirect subsidiary received a Warning Letter for its Wrexham facility.

“While clear focus on cost containments and rationalization gave positive impact, ongoing expenses on remedial measures for U.S. FDA-related issues impacted profitability,” Workhardt said. “In the U.S., genericization of some of the products of the company also impacted business.”

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