Drugs

Drug and Bio Development Times Similar: Analysis

Researchers from Harvard Medical School and the University of Calgary say there are similar development times for small molecules and biologic drugs, leading to questions about the longer patent period under the Biologics Price Competition and Innovation Act. “Our study reviewed pre-market times for all new drugs approved by CDER over the past decade,” the authors write. “Although new laws are being considered by policymakers around the world to further expand market exclusivities for biologics, we found no evidence that developing biologic drugs was more time-intensive than developing traditional small-molecule drugs. In addition, biologic drugs appear to be associated with higher probabilities of success during clinical testing and regulatory approval than small-molecule drugs.”

The analysis suggests policymakers should prioritize eliminating barriers to biosimilar competition and continue to monitor the potential impact of varying exclusivity protections on biologic versus small-molecule drug development.

The study was published online in the journal Nature.

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