publication date: May. 1, 2015

FDA Grants Orphan Designation To Reolysin for Malignant Glioma

 

FDA granted an Orphan Drug Designation to Reolysin for the treatment of malignant glioma.

Oncolytics Biotech Inc. applied for an ODD for pediatric high grade gliomas, however the FDA granted an ODD for the broader indication of malignant glioma in patients of all ages. In three previous brain cancer studies including gliomas, Reolysin was shown to infect a variety of brain tumors when delivered intravenously.

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time.

 

Paclical received market authorization in the Russian Federation by the Russian Ministry of Health, and is planned for launch in the second half of 2015.

Paclical, a novel formulation of paclitaxel based on XR-17 technology developed by Oasmia Pharmaceutical AB, was approved for treatment of epithelial ovarian cancer in combination with carboplatin. XR-17 is non-toxic and forms water soluble nanoparticles with paclitaxel.

The Russia-based company Pharmasyntez holds the distribution rights to Paclical in Russia and will be responsible for marketing the product in Russia and the CIS countries, including Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Ukraine, Georgia, Turkmenistan and Uzbekistan.

 

Celgene International II Sàrl entered into a strategic collaboration with MedImmune Limited, a wholly owned subsidiary … Continue reading 41-17 FDA Grants Orphan Designation To Reolysin for Malignant Glioma

To access this members-only content, please log in.
Institutional subscribers, please log in with your IP.
If you're not a subscriber why not join today?
To gain access to the members only content click here to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2020 The Cancer Letter Inc.