Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Genasense gets standard review for CLL
Genta's Genasense (oblimersen) has a standard review PDUFA date of Oct. 28 for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL), Genta says March 1. The review designation comes despite Genta's request for a priority review of its NDA, which it submitted Dec. 29, 2005 (1Pharmaceutical Approvals Monthly January 2006, p. 26). The firm highlighted the submission as "the first NDA for a drug that promotes chemotherapy-induced apoptosis in hematologic oncology." Genasense is a first-in-class Bcl-2 protein inhibitor. One of Genta's long-term goals for Genasense is to expand the agent's indications into first-line CLL...
More from Archive
• By
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
• By
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
• By
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
• By
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
• By
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
• By
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
• By
New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.