Drugs

Pass PASTEUR Act Before Congress Ends: 165 Groups

Some 165 organizations representing healthcare providers, public health professionals, scientists, patients, and the biotech and diagnostics industries are urging lawmakers to advance the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (H.R. 3932) before the 117th Congress ends 1/3/23. “With its power to jump-start the development of desperately needed antimicrobials, the PASTEUR Act is a vital next step in the global fight to address the increasing threat of antimicrobial resistance,” the groups say in a statement.

The organizations say they believe the legislation would transform the broken antimicrobial pipeline by delivering the novel, medically significant therapeutics that patients need to stave off lethal infections and avert a devastating pandemic.

“PASTEUR would also safeguard U.S. investment in antibiotic development by funding antimicrobial stewardship programs that guide optimal antibiotic use and preserve antibiotic efficacy,” the statement says. “The time for action is now…. We urge Congress to enact the PASTEUR Act and invigorate a new era of antimicrobial research and development to avert another devastating pandemic.”

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