NICE has not recommended Shire's Onivyde in draft guidance as it is not cost effective, the HTA body for England and Wales said. The pancreatic cancer treatment has also struggled to make its mark on the US market where it is being commercialized by Merrimack Pharmaceuticals.
NICE has issued draft guidance that does not recommend Shire PLC's Onivyde, a liposomal injectable formulation of irinotecan (Pfizer Inc.'s Camptosar and generics),
The product obtained FDA approval in October 2015 as a treatment in combination with fluorouracil (5-FU) and leucovorin for patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based (
Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.
Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.
The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.
