Drugs

Support for Biosimilar Legislation

Representing 39 additional health advocacy organizations, the Association for Accessible Medicines has written to the Republican and Democratic leaders of the Senate HELP Committee and the House Energy and Commerce Committee to voice support for S. 1954, the Biosimilar Red Tape Elimination Act. The letter says the bill would remove the distinction between biosimilars and interchangeable biosimilars and thus increase patient access to essential biosimilar medications and reduce healthcare costs.

“The statutory distinction between biosimilars and interchangeable biosimilars continues to generate confusion and misinformation about the safety of biosimilar medicines,” the groups say. “FDA has consistently affirmed that there is no scientific difference between biosimilar and interchangeable biologics and has recommended that Congress remove the outdated distinction. The Biosimilar Red Tape Elimination Act is consistent with FDA’s science-based recommendation and represents an important step toward building confidence and streamlining patient access to biosimilar medicines.”

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