News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
New data from the QWINT clinical trial may get Eli Lilly closer to bringing a once-weekly insulin injection to the US, following the FDA’s rejection of Novo Nordisk’s own weekly insulin formulation earlier this year.
Clinical trials are becoming increasingly complex as emerging technologies such as immunotherapy enter the mainstream.
Rare disease biotech Rezolute recently announced that the FDA has lifted the partial clinical hold on RZ358 (ersodetug), a novel therapy in development for the treatment of low blood sugar (hypoglycemia) resulting from congenital hyperinsulinism.