Updated on 15 January 2013
· Iniparib: Headline results from the phase III in first-line squamous non-small-cell lung cancer are expected in Q2 2013.
Key regulatory milestones expected in the next six months
· Zaltrap (aflibercept, collaboration with Regeneron): The European Commission decision in second-line metastatic colorectal cancer is targeted in Q1 2013.
· Lyxumia (lixisenatide, licensed from Zealand Pharma): The European Commission decision in type 2 diabetes is targeted in Q1 2013. The FDA decision on file acceptance in type 2 diabetes in the US is expected in Q1 2013.
· Aubagio (teriflunomide): The CHMP opinion for the treatment of relapsing multiple sclerosis is expected in Q1 2013.
· Lemtrada1 (alemtuzumab): The CHMP opinion for the treatment of relapsing multiple sclerosis is expected in Q2 2013. The FDA decision on file acceptance is expected in Q1 2013.
· Kynamro (mipomersen sodium, development partnership with Isis Pharmaceuticals): The FDA decision for the treatment of patients with Homozygous Familial Hypercholesterolemia is expected in Q1 2013. In December, the CHMP adopted a negative opinion for its marketing authorization application for the treatment patients with Homozygous Familial Hypercholesterolaemia. Genzyme has requested a re-examination of the CHMP Opinion.
Vaxigrip QIV IM (quadrivalent inactivated flu vaccine, intramuscular): The submission of regulatory file in the EU is expected in Q1 2013.
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