The US FDA has surprised no-one with a Complete Response Letter for Amgen and UCB's novel osteoporosis treatment Evenity but, with luck, analysts say the product might still reach the market in 2018-19 and garner sales over £500m.
Amgen Inc./UCB SA's investigational therapy for osteoporosis Evenity (romosozumab) could still bring in sales of more than half a billion dollars despite delays to market and concerns over its adverse event profile, say analysts as the product received a Complete Response Letter from the US FDA.
Hopes for a swift approval for the first-in-class sclerostin inhibitor died when a cardiovascular safety signal overshadowed positive efficacy data...
The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.
Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.
