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

UsernamePublicRestriction
UsernamePublicRestriction

Advexin gets rolling?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Introgen is requesting clearance for a rolling BLA submission for Advexin, the firm announces Dec. 23. Submission would begin immediately and complete before the end of 2005. Introgen is seeking accelerated approval for the orphan head and neck cancer therapy, which also has fast track status. Two Phase III studies are underway. Introgen recently released Phase II data in a sub-population of recurrent, unresectable head and neck cancer showing tumor growth control in 41% of patients, with an objective response rate of 15%. Median survival was 13.5 months for patiens with tumor growth control and 31.4 months for patients with objective responses...

You may also be interested in...



Why Is Congress Targeting These Six Medicines In Drug Price Hearing?

Revlimid, Copaxone, Sensipar, Enbrel, Acthar Gel and Gleevec will be the subject of a US House Committee on Oversight and Reform in an upcoming drug price hearing.

Why Value-Based Health Care Is Here To Stay

COVID-19 has disrupted the operational schedules of health care and technology providers alike to unparalleled levels in 2020. But scratch the surface, and outcomes-oriented, value-based health care targets remains a priority – albeit competing a little harder for attention at present.

VC View: Deal-Making During A Pandemic And 2021 Expectations

In the latest instalment of VC Playbook, In Vivo gets to know Arix Bioscience, a relatively young venture capital firm that went public in 2016. Arix has “has many similarities yet some key differences from a typical venture capital firm,” says the management team.

Topics

UsernamePublicRestriction

Register

PS142970

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

Cancel