FDA has accepted Biological License Application submitted by Kite for its CAR-T cell therapy- KTE-X19, for relapsed or refractory mantle cell lymphoma (MCL)
The drug– KTE-X19, which is an investigational chimeric antigen receptor (CAR) T cell therapy treatment method for curing relapsed or refractory mantle cell lymphoma (MCL), has received a Priority Review designation.
The recommendation came after the data from the single arm, open-label, Phase 2 ZUMA-2 trial, which revealed 93 percent of patients responded to a single infusion of KTE-X19, including 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee.
A subsidiary of Gilead Sciences, Kite pharma, focusing on the development of Cancer therapies, already has one therapy marketed- Yescarta (axicabtagene ciloleucel), for curing diffuse large B-cell lymphoma; and if the FDA rules in favour of the recent one, Gilead would be able to occupy the major Gene therapy market share.
The US FDA has accepted Aquestive Therapeutics’ NDA for Libervant (diazepam) Buccal Film for seizure clusters.
Libervant is a soluble film of formulation of diazepam, is administered on the inner side of the cheek. It is designed as a fast treatment to provide relief from acute uncontrolled seizures in refractory patients with epilepsy on stable anti-epileptic drugs (AEDs).
With Orphan drug designation granted in 2016, and target action date of September 27, 2020, if the therapy gets FDA approval, it would be the first oral diazepam-based therapy approved for seizure clusters.
The submission of the NDA was backed by the results from the study that supported the administration of Libervant for the treatment of Epileptic patents.
ReForm Biologics LLC and MilliporeSigma have announced a global license agreement and collaboration for the development and commercialization of excipients.
Under the agreement, MilliporeSigma and ReForm Biologics- a US-based pharma tech company- will carry out research, and develop ReForm Biologics’ excipients for pharmaceutical use.
On the other hand, MilliporeSigma will fund the research and development and will manage the global commercialization, GMP manufacturing, and sale of ReForm Biologics’ excipients to MilliporeSigma’s customers for use in biologic formulations.
ReForm Biologics will receive revenues from MilliporeSigma for sublicensing ReForm Biologics’ technology to MilliporeSigma’s customers in biologic formulations.