Amgen Amps Up T-VEC Story At ASCO With Filing Plans And Combos
This article was originally published in The Pink Sheet Daily
Amgen will file the cancer immunotherapy talimogene laherparepvec for the treatment of metastatic melanoma later this year, although the product’s larger commercial potential likely lies om combination with other immunotherapies.
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FDA’s Oncologic Drugs and Cellular, Tissue and Gene Therapies advisory committees will weigh in on a new molecular entity in a nascent field of cancer vaccines April 29; could set precedent for other intralesional drug reviews.
Three 2015 filings play a key role in the big biotech offsetting expected revenue declines for four legacy products. The biggest test will be the showdown between its PCSK9 inhibitor evolocumab and Sanofi/Regeneron’s competing alirocumab, which is expected to reach market first.
European Notebook: EC Pharma Policy Reorganized; Early Access To Medicines Scheme Starts; U.K. Changing Merger Regs
Changes in responsibilities in new European Commission were welcomed by industry but not by health activists; and a brain cancer vaccine being developed by American biotech is selected to pioneer new early access scheme for innovative drugs being set up in the U.K.