Latest from Joseph Haas
Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.
Plus deals involving Novartis/Sironax, Neuraxpharm/Dizlin, Recursion/RallyBio, MaaT/Clinigen, Future Pak/Theratechnologies, BerGenBio/Oncoinvent, Xoma/Turnstone and more.
With China’s Hengrui reporting successful Phase III data for its dual GLP-1/GIP agonist, licensee Kailera is readying plans to demonstrate better efficacy than current obesity drugs.
New US approval in heart failure with preserved or mildly reduced ejection fraction should add to Kerendia’s earning power on top of chronic kidney disease indication.
Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.