Roche/Genentech: A Defensive Play On Follow-on Biologics
This article was originally published in The Pink Sheet Daily
Roche’s takeover move may be about gaining a platform to make “me-better” large-molecule drugs.
You may also be interested in...
An abbreviated pathway for follow-on biologics just missed getting tacked onto the FDA user fee/drug reform legislation. It will be years before proponents get another shot at creating an abbreviated approval pathway for the biotech copycats. So who won and who lost?
Surge of interest prompts US FDA to consider how to adjust feedback, including potentially creating a separate team to answer more basic questions.
When the closest you can get to US FDA staff is Webex, the meeting minutes and interactions with the review team project manager take on increased importance, consultants suggest during an Informa-sponsored webinar.