Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Adventrx hopes to find a new pathway for ANX-530

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Adventrx will meet with FDA April 20 to discuss the agency's refuse-to-file letter for its chemotherapy drug, ANX-530. The sponsor submitted its NDA in December 2009, but announced March 1 that FDA rejected the application because the data included in the submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. This chemistry, manufacturing and controls issue was the only reason for the RTF letter, FDA said. Adventrx is hoping to position ANX-530 as a safer therapeutic option to the currently marketed Navelbine and Taxotere

You may also be interested in...

Warning Letter Close-Outs – September 2020

The US FDA released two device-related close-out letters in September. One of the letters carries a January 2020 date, but previously was not publicly available.

COVID-19 Lessons: Experts Predict Shift Toward Intermittent Hemodialysis In ICUs

The pandemic may accelerate a move toward versatile, single-solution renal replacement therapy in intensive care.

COVID-19: FDA Schedules 4 More Virtual Town Halls Through October

The US agency has announced another month of webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the novel coronavirus.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts