Drugs

Personalized Drug Development is Faster: Study

A review of cancer drugs approved by FDA between 1998 and 2014 found that a personalized approach for drug development was associated with faster clinical development, according to an online study report in Impact Journals. Researchers also reported no differences in access to FDA expedited review programs between personalized and non-personalized drugs.

The study says that one of the biggest oncology challenges is to deliver more efficient and safer drugs in a shorter time frame to patients with cancer. The review showed, the researchers say, that drugs developed under a biomarker-based strategy (also known as personalized or precision oncology) were associated with a significantly shorter clinical phase of development (a median of 58.5 months compared with 93.5 months for non-personalized drugs).

“Targeted drugs that were developed for a molecularly selected population had some of the shortest clinical development timelines,” the report says. “Aiming to obtain a large difference in a small patient group was an important driver of their success. It is possible that a higher clinical activity of biomarker driven drugs … could also explain their faster clinical development. It is also interesting to note that we could not detect differences in total approval time if the drug approval was based on a randomized or non-randomized trial.”

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