Outlook Pulls Bevacizumab BLA As Filing Falls Short
Plans To Submit Revised US Application With FDA In Q3
Pinning its hopes on its proposed bevacizumab product for ophthalmic indications, Outlook Therapeutics has been told to give more information to the US FDA ahead of an approval. However, one analyst remained upbeat for the company’s prospects.
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The European Medicines Agency has been asked to re-examine its rejection of the EU marketing application for Ipique, which, if approved, could become the first drug containing bevacizumab to be authorized for use in neovascular (wet) macular degeneration.
Going toe-to-toe with Amgen on its Neulasta Onpro on-body injector device is a key strategic goal for Coherus BioSciences, although news will be kept concealed until the company’s proposed biosimilar is approved or launched.