Will Velphoro’s Convenience Advantage Be Enough In Crowded ESRD Field?
This article was originally published in The Pink Sheet Daily
Executive Summary
With the field going generic and a new brand competitor with additional advantages on the way, Vifor Pharma is counting on lower pill burden to propel hyperphosphatemia drug Velphoro.
You may also be interested in...
Zerenex To Be Positioned As Cost-Saving, Oral Alternative In ESRD Setting
Keryx plans to file an NDA for phosphate binder Zerenex during the second quarter, with an EU filing to follow by mid-year. In a long-term Phase III study, the candidate met its primary efficacy endpoint as well as several secondary endpoints.
Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length
Recently retired US FDA Principal Deputy Commissioner Janet Woodcock will be advising the Haystack Project, with the goal of helping rare disease organizations encourage creativity in drug development programs without jeopardizing regulatory success, Woodcock told the Pink Sheet in an interview.
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.