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

Genta withdraws Genasense NDA

Executive Summary

Genta is withdrawing its NDA for melanoma therapy Genasense, the company said May 13. The firm is requesting a meeting with FDA; co-developer Aventis plans to participate. FDA's Oncologic Drugs Advisory Committee voted 12 to 4 that Genta's pivotal trial for Genasense (oblimersen) did not show a "real effect" on progression-free survival (1"The Pink Sheet" May 10, 2004, p. 9)...

You may also be interested in...



Genasense Progression-Free Survival Data Do Not Show “Real Effect,” Cmte.

Genta/Aventis Genasense appears to have a "real effect" on response rates in metastatic melanoma patients but not on progression-free survival or survival, FDA's Oncologic Drugs Advisory Committee concluded at its May 3 meeting

India To Scrap Intellectual Property Appellate Board: Should Pharma Worry?

Legal experts tell the Pink Sheet why India’s plans to abolish the Intellectual Property Appellate Board and shift its powers to courts may be problematic for stakeholders, including those pursuing infringement charges. The transition could mean a significant burden on courts both in terms of capability and capacity, and IPR cases will now conflate into all other pending commercial matters, some experts said, though others cheered the proposed change.

QUOTED. 5 March 2021. Dedi Gilad.

Tyto Care’s remote monitoring and telehealth platform has seen rising demand since the start of the pandemic and the company continues to expand. This week, it announced it raised $50m in a series D financing round. See what Dedi Gilad, CEO of Tyto Care, said about it here.

UsernamePublicRestriction

Register

OM007466

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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