Regulatory news was at the forefront of comment in the past week, notably Celgene getting a major setback on its multiple sclerosis drug candidate ozanimod with a refusal-to-file letter from the US Food and Drug Administration, as well as positive news for Sorrento Therapeutics’ with FDA approval for its non-opioid post-shingles pain drug ZTlido. AstraZeneca attracted interest with its spin out of certain inflammatory and autoimmune products into a new company – Viela Bio, as did Mylan, with the announcement of a deal with Revance Therapeutics to develop a Botox biosimilar.
Celgene's ozanimod snafu adds insult to injury
Celgene probably thought things could not get any worse, but they just did. Tuesday’s US Food and Drug Administration’s refusal-to-file letter for ozanimod puts at risk the company’s brightest near-term hope, which analysts had seen as one of the biggest potential launches of 2018, comments EP Vantage, the editorial arm of the Evaluate group.
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