Roche gets Japanese approval for personalised medicine Rozlytrek
Rozlytrek is the first tumour-agnostic medicine to be approved in Japan that targets NTRK gene fusions, which have been identified in a range of hard-to-treat solid tumour types,
ImmunityBio has received approval from the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region, China, for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for bladder cancer.
Sustained efficacy of ULTOMIRIS was observed on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase (LDH) levels and the secondary endpoints of LDH level reduction
Under the agreement, Dr. Reddy’s will receive U.S.$70 million as upfront consideration, U.S.$40.5 million in near term milestones and additional financial considerations including existing contractual obligation and inventory.
The program is intended to assist drug supply chain stakeholders, including FDA, in developing the electronic, interoperable system that will identify and trace certain prescription drugs as they