Drugs

FDAers Find Increases in Tropical Disease Drug Development

Three FDA researchers writing in the online PLOS journal have found a significant increase in the development of new tropical disease drugs after Congress enacted the priority review voucher legislation. They note data showing increases for both high- and low- prevalence conditions. In the post-voucher period, development has centered on three diseases: dengue, malaria, and tuberculosis. This is not surprising, given that these are very high-prevalence conditions, which will therefore have large markets for approved drugs, the researchers write. “However, the results of the statistical analysis indicate that only the increase in development of drugs for low-prevalence tropical diseases is statistically significant. Therefore, while the total number of development programs is larger for high-prevalence conditions, the proportional increase has been much higher for low-prevalence conditions as a group.”

The researcher also note that while there have been many drug development programs begun for such diseases, the rate of failure remains high. “Most tropical disease drug development programs begun between 2007–2013 have already failed, many without even reaching clinical development,” they write. “This level of failure is not unusual in drug development. However, because the [voucher] is a prize awarded only after successful development and provides no compensation if development fails, it is possible that if failure rates remain high, companies will determine that the cost of development is not worth the potential prize, and drug development starts will return to pre-voucher levels.”

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