Drugs

Breakthrough Drugs See Shorter Development Times: Analysis

Cancer therapies are reaping rewards under FDA’s breakthrough therapy program. According to a new analysis released by Friends of Cancer Research (FOCR), drugs with breakthrough designations gained approval more quickly than those without the designation and they experienced faster pre-market development and review times. “We also found that considerably more breakthrough-designated drugs were approved via the accelerated approval pathway than non-designated drugs, and that breakthrough-designated drugs were more often approved on the basis of Phase 1 or Phase 2 trials,” FOCR says. “We also conclude that, owing to the large number of accelerated approvals among breakthrough-designated drugs, the FDA is more willing to take measured risks in approving drugs that show early evidence of substantial improvement over available therapy.”

Breakthrough drugs typically were approved about three months before their user fee goal dates compared with those without the designation,” the group says. “Pre-market development time, calculated as the number of years from submission of an investigational new drug application (IND) to submission of a new drug application (NDA) or biologics license application (BLA), was considerably shorter among approved breakthrough-designated drugs (median 5.2 years) than non-designated drugs (median 7.4 years), a difference of 2.2 years,” it says.

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