Italfarmaco To Seek Givinostat Approvals After Phase III Success In DMD
Capricor Reported Long-Term Data For Its Cell Therapy
Executive Summary
Italfarmaco’s HDAC inhibitor helped ambulatory Duchenne muscular dystrophy patients climb stairs faster than non-treated boys while Capricor’s cell therapy improved upper limb function in non-ambulatory patients.
You may also be interested in...
Keeping Track: First-In-Class Candidates In COPD, Cancer Join US FDA Review Queue
Recent applications for approval also include another DMD therapy, another hemophilia B gene therapy, and a new antibiotic.
With Duchenne Filing Due, Santhera Moves Vamorolone Into Becker Muscular Dystrophy
Santhera is bouncing back after a Duchenne drug failure two years ago with idebenone, and is looking to gain approval of vamorolone in this indication as well as the much rarer Becker muscular dystrophy.
Capricor's DMD Cell Therapy Has HOPE, But Market Is Unsure
Capricor will start a Phase II trial in the first quarter of 2018 for its regenerative cell therapy CAP-1002 in Duchenne muscular dystrophy following positive results in an early-stage trial – the stem cell product was dropped by Capricor's big pharma partner Johnson & Johnson earlier this year.