Questions from FDA may delay progress to US approval of Takeda's more convenient formulation of blockbuster Entyvio.
Takeda Pharmaceutical Co. Ltd. has received a Complete Response Letter from the US Food and Drug Administration (FDA) on a Biologics License Application for a new subcutaneous (SC) formulation of its blockbuster inflammatory bowel disease drug Entyvio (vedolizumab).
The Japanese firm is seeking approval of the alpha4beta7 integrin antagonist antibody as a maintenance therapy in adults with moderate...
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.
