Drugs

Author Encouraged by Decade of FDA Drug Approvals

Writing in a Science blog, Derek Lowe says a report on FDA drug approvals over the last 10 years is “a pretty encouraging read.” The analysis of drug approvals was prepared by two Jnana Therapeutics employees and published in the Journal of Medicinal Chemistry.

The authors found that 378 novel drugs and 27 biosimilars were approved by FDA between 2010 and 2019. Oncology remained the top therapeutic area (25%), followed by infection (15%), and central nervous system disorders (11%).

“Regulatory incentives have been effective as evidenced by an increase in orphan drugs as well as antibacterial drugs approved under the GAIN (Generating Antibiotic Incentives Now) act,” the authors wrote.

Lowe says the review points out that first-in-class approvals seem to have surged over the period, compared to the previous 10 years. An average of 37% of approvals was in that category, and the number never went below 32%. He said he expects that trend to continue given the number of unusual mechanisms and targets that seem to be available.

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