Phase II Study Opens Window For Sellas' NeuVax In Triple-Negative Breast Cancer
Sellas is pursuing accelerated approval for NeuVax in triple-negative breast cancer based on Phase II data, but that may be a tough sell with the FDA.
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Preparing to meet with FDA in December to plan next steps for NeuVax in triple-negative breast cancer, Sellas reveals 26-month data that show further clinical benefit compared with a 19-month interim look. Firm still hopes to out-license the vaccine candidate.
Cancer vaccine development is a tricky undertaking, but Galena may be grasping at last straws with a third-party review of a recently halted study of NeuVax, hoping to discover operational reasons for cancer vaccine's poor performance.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.