Regeneron rilonacept grabs priority status
This article was originally published in Pharmaceutical Approvals Monthly
Regeneron's BLA for its "Interleukin-1 Trap" agent rilonacept will reach its user fee goal "by the end of November 2007" following FDA's decision to grant priority review status to Regeneron's application, the firm reported Aug. 8. The company announced completion of its rolling BLA for rilonacept for treatment of Cryopyrin-Associated Periodic Syndromes, a spectrum of rare inherited inflammatory conditions, on June 8. Rilonacept was previously granted fast track and orphan drug designations; Regeneron estimates that there are 200 to 500 patients with CAPS in the U.S...
You may also be interested in...
As Amneal’s generics segment sees significant growth, the company has revealed plans to launch new products and expand in new markets. “We are extremely proud of the progress our company has made since we re-joined as leaders of Amneal,” said Chirag and Chintu Patel, co-CEOs of Amneal.
Schemes and funding to support growth in the life sciences and medtech sectors featured in the UK government’s spring budget on 3 March.
Entries are now open for the Global Generics & Biosimilars Awards 2021, which will take place in Milan, Italy on 10 November.