Celgene said the US FDA issued a refuse-to-file letter for ozanimod in multiple sclerosis because "the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a review." It's yet another big blow for a company whose value has been falling since October.
Celgene Corp. revealed more bad news it didn't need on Feb. 27 when the company said it received a refuse-to-file letter from the US FDA for the new drug application (NDA) for ozanimod in multiple sclerosis, which generally was seen as a sure thing based on Phase III data.
Celgene does not expect an extremely long delay in FDA approval, because the agency's refuse-to-file (RTF) decision was based on...
UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.
The Belgian drugmaker is boosting its biologics capacity over the pond.
Deal Snapshot: Including its internal efforts with bimagrumab, Lilly has been seeking a muscle-sparing therapy to complement GLP-1 obesity drugs, such as Zepbound.
Plus deals involving BioAge/JiKang, Sanyou/Medicovestor, AriBio/Acino, Intragrand/Transpire, Kaken/Twocells, Sumitomo/Novo Nordisk, NIBEC/Undisclosed, Formosa/Adalvo, Drug Farm/Amoytop, Lupin/SteinCares and Lupin/Honeywell.
After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.
Public Company Edition: Insmed raised $750m after reporting positive Phase IIb data in PAH, Cogent accessed up to $400m in new debt, Kelun-Biotech netted $250m in a placement of shares and ADC revealed a $100m private placement. In strategic updates, Recursion cut 20% of its jobs.
Deal Snapshot: Including its internal efforts with bimagrumab, Lilly has been seeking a muscle-sparing therapy to complement GLP-1 obesity drugs, such as Zepbound.
