Drugs

Bipartisan Bill on Provisional FDA Approvals

Senators Mike Braun (R-IN), Kirsten Gillibrand (D-NY), Lisa Murkowski (R-AK), Kevin Cramer (R-ND) and Roger Wicker (R-MS) have introduced the Promising Pathway Act, a bill to help Americans with amyotrophic lateral sclerosis (ALS/Lou Gehrig’s Disease) and other life-threatening diseases receive early access to promising unapproved treatments.

The bill would allow early access to treatments under a provisional approval while research continues for full FDA approval, the lawmakers say in a release. “Treatments eligible for provisional approval under PPA must have substantial evidence of safety and early evidence of positive therapeutic outcomes,” they say.

Under the Promising Pathway Act, FDA would be required to establish a rolling, real-time, priority review pathway for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions, according to the release. “Under this pathway, FDA would grant time-limited, provisional approval to drugs that demonstrate substantial evidence of safety, and relevant, early evidence of efficacy. Drug sponsors would be allowed to incorporate scientifically substantiated surrogate endpoints and real-world data to demonstrate the efficacy of the drugs under review. The period of provisional approval is time-limited and effective for a two-year period.”

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