Vismodegib hard capsule 150 mg product-specific bioequivalence guidance
AstraZeneca’s selumetinib flops in thyroid cancer, adding to list of failures
Roche’s Erivedge could be removed from the Cancer Drugs Fund within months after the National Institute for Health and Care Excellence ruled that the drug was not a cost-effective treatment for skin cancer.
Sun PharmaBSE -0.36 %, Dr. Reddy’s, GlenmarkBSE -0.33 %, Zydus Cadila, AurobindoBSE 1.03 % and their ilk are embracing a new life. Deploying investments to bolster indigenous research and lapping up late clinical stage drugs or new brands is heralding a seismic shift from churning copies of drugs to the daunting world of innovative or differentiated brands.
Erivedge was originally granted ‘conditional approval’ in July, 2013 in the European Union (EU) and the authorization has now been converted from ‘conditional’ to ‘full approval’ based on the results from the STEVIE study that included 1215 patients with advanced BCC. STEVIE (MO25616) is a single-arm, open-label, Phase II, multicenter study that was conducted by Roche to assess the safety of vismodegib in patients with locally advanced and metastatic BCC. The safety and efficacy results of the STEVIE trial were consistent with the results of the pivotal study ERIVANCE BCC (SHH4476g) that supported the initial conditional approval of the drug in the EU.