On the basis of its experience with Halaven, Eisai is predicting that its kidney cancer drug Kisplyx will face a difficult journey getting the OK from NICE, England's health technology appraisal institute.
NICE, the health technology appraisal body for England and Wales, has finally okayed Eisai Europe Ltd.'s breast cancer drug Halaven (eribulin), five years after it was first launched in the UK.
While the company will of course welcome the move, it says that in light of Halaven's long journey to routine commissioning, another of its products, Kisplyx (lenvatinib) for kidney cancer,...
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
