Tags : Development Program

Biosimilars

Xbrane to Initiate New Biosimilar Development Program Annually

Shots: Xbrane to initiate a new biosimilar development program annually and planning to generate positive operating cash flow monthly on the back of expected Xlucane net-income by late 2023/early 2024 Xlucane (biosimilar, ranibizumab) referencing Lucentis is currently in the P-III trial with expected results in mid-2021, regulatory submissions are underway in the EU in Q3 […]Read More

Biosimilars

Revance and Mylan to Advance Development Program for a Proposed

Shots: The two companies will advance the development program of a proposed biosimilar to BOTOX and BOTOX Cosmetic (onabotulinumtoxinA), under 351(k) pathways. The US FDA’s feedback during BIAM indicated that the 351(k) regulatory pathways for an onabotulinumtoxinA product is viable Following the advancement of the program, Revance will receive $30M as milestones and is eligible […]Read More