Showing an overall survival improvement in the especially hard to treat FLT3-ITD mutated patients is a significant achievement in AML, analysts say.
Daiichi Sankyo Co. Ltd.'s quizartinib has demonstrated an overall survival benefit as a single agent compared with chemotherapy in the pivotal QuANTUM-R study of relapsed/refractory acute myeloid leukemia patients with FLT3-ITD mutations, giving the company a potential foot in the door for the indication.
Full results for the FLT3 inhibitor in the QuANTUM-R study were presented at the European Hematology Association meeting in Stockholm on June 16, following a positive topline release in May
The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.
The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.
The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.
InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.
The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.
The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
