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

Marqibo Clears FDA Despite Advisory Committee Concerns About Confirmatory Trial

This article was originally published in The Pink Sheet Daily

Executive Summary

Talon’s liposomal vincristine receives accelerated approval for refractory Ph- acute lymphoblastic leukemia, with a requirement for a confirmatory trial. The firm has a first-line trial under way for that purpose, but it wasn’t well received by the Oncologic Drugs Advisory Committee.

You may also be interested in...



Spectrum Bets On Marqibo In NHL With Low-Priced Talon Acquisition

Spectrum gains an approved drug with the deal and aims for label expansion. Talon’s high-profile investors are counting on an increase in Spectrum share price and post-acquisition milestones to break even.

Talon Marqibo’s Confirmatory Trial Plan May Need To Be Reworked

FDA advisory committee members express concern about the toxicity of Marqibo in the elderly patients expected to enroll in the Phase III confirmatory study for advanced acute lymphoblastic leukemia.

Purell Battling Class Actions Over Disease Claims While World Scrambles To Increase Hand Sanitizer Supplies

Leading chemical firms, beauty and consumer health companies, even distilleries and medical marijuana cultivators are adapting operations to meet global demand for hand sanitizers amid the COVID-19 pandemic. Meanwhile, plaintiff’s attorneys are busy with multiple class actions against Purell manufacturer GOJO Industries for alleged false advertising following a January warning letter to the firm from the US FDA.

Topics

Related Companies

UsernamePublicRestriction

Register

PS074616

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