On the road this week left little time for posting, though some interesting things happened. And meanwhile, back in Washington, D.C., the last vestiges of snow have departed and on my dog walk, I spotted blooming purple crocuses which was nothing short of thrilling. Daffodil spikes also appeared quite robust. My mood lightened considerably.
And here is some of the important stuff:
- FDA Approves First Therapy for High Risk Neuroblastoma – Neurobalstoma is a rare, but tragic cancer primarily affecting children under the age of five years. Despite aggressive therapy, patients have only a 40-50 percent chance of long-term survival. FDA announced this week the first approval for a therapy against it. Unituxin (dinutuximab) is an antibody that binds to the surface of neuroblastoma cells and is being approved to use as part of a multimodality regimen that includes surgery, chemotherapy and radiation therapy who have achieved at least a partial response to prior first-line multiagent, multimodality therapy. The approval is yet another in a recent stream of medical treatments that are directed to rare conditions and had orphan product designation along with priority review. The company press release is here.
- Reusable Medical Device Guidance – A final industry guidance was announced by FDA this week aimed at reducing the risk of spreading infectious conditions through the use of reusable medical devices entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling“. The guidance lists criteria for the instructions that come from manufacturers to ensure that end users understand how to reprocess durable medical equipment for reuse. The guidance also recommends that manufacturers consider reprocessing challenges early in device design. In its press release, FDA emphasizes that the risk of acquiring an infection from a reprocessed device is low though within the same release refer to an upcoming meeting of the Gastroenterology and Urology Devices Panel to discuss recent reports and investigations into transmission of infections with particular device use.
- FDA Sets Up Biosimilars Page – It probably happened before this week, but as noted last week, the first biosimilar was approved. Also as noted last week, the new era of biosimilar availability demands an effort aimed at educating both patients and practitioners. FDA is doing its part by setting up a new web page that provides some information on biosimilars, what they are and what they are not, though it is rather contained. You can check it out here.
- FDA Tweets – This also happened a while back, but only came to my attention this week – the Office of Minority Health opened up a Twitter feed, making a total of 15 feeds now run by the agency by my count. The Eye on FDA Twitter feed has created a list of the feeds where you can observe all of FDA’s feeds together at once.
That’s it for me this week. Hope to be more freed up next week. In the meantime, have a good weekend – the first on Daylight Savings Time!
