news010
FDA Says Additional Pixuvri Trial Needed, CTI Opens Drug to Expanded Access
Cell Therapeutics (CTI) has decided to pursue an expanded access program for its non-Hodgkin’s lymphoma drug Pixuvri, while conducting an additional trial needed for approval. CTI plans to request a meeting with the FDA to discuss the expanded access program and design of the follow-on study. The company said it received a complete response letter from the agency citing concerns with trial data raised at a meeting of the Oncologic Drugs Advisory Committee last month.
Drug Industry Daily
News & Events
- New Class of Brain-Protecting Drugs Emerging Researchers have identified a compound that mim... Read more>>
- FDA Requests More Information on Certriad LONDON (AP) - AstraZeneca PLC and Abbott Laborator... Read more>>
- Proximagen Signs Deal With Upsher-Smith Proximagen Neuroscience plc, a biotechnology company... Read more>>
- Statins May Slow Progression Of Multiple Sclerosis, New Study Finds A UCSF-led study exa... Read more>>
- Food and Drug Administration NOTICES Meetings: Internationa... Read more>>
- Key Protein Aids In DNA Repair Scientists have shown in multiple contexts that DNA damage ov... Read more>>
- Mapping Technique Speeds Finding Specific Genes A Purdue University scientist was part of a... Read more>>
- Pending Litigation to Delay Launch of Generic Asacol Boehringer Ingelheim’s Roxane Laboratori... Read more>>
- Novozymes Partnering With ProMetic Life Sciences Inc.Drug Discovery & Development - April 0... Read more>>
- GSK Receives EMEA Approval for Duodart LONDON (AP) - Pharmaceutical company GlaxoSmithKline... Read more>>
- FDA Says Additional Pixuvri Trial Needed, CTI Opens Drug to Expanded Access Cell Therapeutics... Read more>>
- in vivo Pharmacodynamic Assay Trevigen offers a validated assay with higher sensitivity and... Read more>>