Drugs

Change Antibiotic Development Incentives: Study

Harvard Medical School researchers say policymakers should consider new incentives for developing new antibiotics since many new antibiotics developed in the last five years lacked efficacy evidence on clinical endpoints. Writing in an open-source BMJ article, the researchers say most antibiotics introduced in the U.S. between 2016 and 2019 were approved by FDA based on trials with a non-inferiority design that evaluated changes in surrogate outcome measures. “These new antibiotics were often found to be non-inferior and more costly than the older effective comparator drugs,” the researchers write.

They say policymakers should take these trends into account when considering new incentives for developing antibiotics. “Incentives for the development of antibiotics should balance the need for a strong antibiotic development pipeline with ensuring that new drugs show added value for patients by, for example, improving patient outcomes in patients with antimicrobial-resistant infections,” the researchers conclude.

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

Read more

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