Drugs

BIO September Congressional Priorities

The Biotechnology Innovation Organization (BIO) says its priorities for when Congress returns in September are reauthorization of the FDA Pediatric Priority Review Voucher (PPRV) program and the Small Business Innovation Research/ Small Business Technology Transfer (SBIR/STTR) seed-funding program. An online statement says patients and innovators have been relying on PPRV to enable treatments for rare diseases affecting children for 15 years. It had been renewed with bipartisan support until it sunset last year, it says.

“It costs taxpayers nothing, and it’s hanging in limbo right now,” the statement says. “Congress needs to understand the urgency and what is truly at stake. For the rare disease community, PPRV means hope.”

BIO says SBIR/STTR provides $4 billion for thousands of small and medium-sized companies each year, driving 12% of all FDA-approved drugs. It says that for years, Congress has reauthorized the program with bipartisan support.

The association says it will also be working to educate the administration and Congress about the impact that policies like Most Favored Nation pricing and tariffs would have on America’s economic and national security and how such policies would disrupt the country’s ability to develop future treatments and cures.

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