Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From Covis Pharma
Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More
Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.
Supplemental Filings: Pink Sheet Notebook On Disease Lobbying, Dan Leonard’s Next Act, And More
Quick takes on Ultragenyx’s CEO lobbing the US FDA for rare disease policy changes, the agency naming a new deputy assistant commissioner for media affairs, the former CEO of AAM starting a consulting firm, and more.
Intarcia, CDER Tussle Over Advisory Cmte. Process For Hearing On Denial Of Diabetes Combo Product
Seeking to reverse CDER’s proposal to reject the NDA, Intarcia wants a say in formulating issues to be presented to the committee and questions inclusion of device experts as ad hoc members that will consider the fate of ITCA 650, a subdermal pump which delivers the GLP-1 agonist exenatide.
Makena Vs. Avastin: No Contest When It Came To Withdrawal Process Duration
Approximately 41 months passed from the initial advisory committee meeting in October 2019 on Makena’s potential withdrawal to the 5 April 2023 final decision by FDA's commissioner and chief scientist - more than double the length of the same interval in the accelerated approval withdrawal proceeding involving the breast cancer claim for Genentech's Avastin.
All set! This article has been sent to firstname.lastname@example.org.
All fields are required. For multiple recipients, separate email addresses with a semicolon.