Sanofi’s multiple sclerosis therapy gains breakthrough therapy status from FDA
The designation is supported by the positive outcomes from the double-blind Phase III HERCULES trial, where the therapy showed a 31% delay in the time to onset of
The European Commission (EC) has adopted a positive decision for designating Agios Pharmaceuticals’ oral, small molecule pyruvate kinase (PK) activator, mitapivat, as an orphan medicinal product (OMP) for treating sickle cell disease.
This move grants Theratechnologies the ‘rights’ to potentially introduce treatments for familial chylomicronaemia syndrome (FCS), hereditary angioedema (HAE), and severe hypertriglyceridemia (sHTG) within the Canadian market. Under the
The single-asset focused partnership leverages Tubulis’ platforms, Tubutecan and Alco5, to create an ADC with stability and reduced off-target toxicity, addressing present treatment challenges. Under the agreement terms,