Alexion's Kanuma held back due to US FDA's CMC data demands
Review of Alexion’s enzyme replacement therapy Kanuma (sebelipase alfa) has been pushed back after the US FDA requested more Chemistry, Manufacturing and Controls (CMC) information.
Archives for September 7, 2015
Gain-of-function study finding may accelerate flu vaccine production
Influenza research completed just before the US banned ‘gain-of-function’ studies could help vaccine makers boost virus yields and accelerate production say scientists.
Novo Nordisk and MIT on the hunt for oral peptide route
Novo Nordisk is collaborating with MIT on new ways to deliver peptides.
Roche's haemophilia A bispecific antibody granted USFDA breakthrough status
A bispecific antibody developed by Roche subsidiary Chugai has been granted Breakthrough Therapy Designation by the US FDA for the treatment of haemophilia A.
Sanofi blames manufacturing costs for end of snake bite cure
Sanofi’s decision to stop manufacturing an anti-venom will contribute to “needless death and disability” for snake bite victims, according to Médecins Sans Frontières.