Drugs

Too Few Antibiotics in Development: Pew Report

An analysis by the Pew Charitable Trusts finds that “it is clear that there are too few [antibiotic] drugs in development to meet current and anticipated patient needs.” The Pew issue brief shows 42 new antibiotics currently in development.

“These drugs would potentially address many, but not all, resistant bacteria,” the report says. “However, given the inevitability that some of these antibiotics will fail to win approval, and that resistance will eventually develop to those that are approved,” more new antibiotics are needed.

Of the 42 antibiotics in development, Pew says, 11 were in Phase 1 clinical trials, 13 in Phase 2, 13 in Phase 3, four have had new drug and/or marketing authorization applications submitted, and one received a complete response letter. Pew says that historically, about 60% of drugs entering Phase 3 are approved.

At least 17 of the antibiotics in clinical development have the potential to treat infections caused by Gram-negative ESKAPE pathogens, a critical area of unmet need, according to the report.

The report also includes potential solutions to the problem supported by Pew.

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