House Erbitux probe
Executive Summary
Hearings stemming from the House Energy & Commerce investigation of ImClone and its BLA for Erbitux are not likely to happen this year, Health Subcommittee Chairman Michael Bilirakis (R-Fl.) told reporters April 16. Committee Chairman Billy Tauzin (R-La.) added: "Staff has been meeting with FDA and stakeholders, but there has been no decision made as of yet." The House investigation is focusing on ImClone's representations to shareholders regarding the oncologic product and may include FDA review policies (1"The Pink Sheet" March 25, p. 20)...
You may also be interested in...
FDA Refuse-To-File Policy Records Requested Under House ImClone Probe
The House Commerce/Oversight Subcommittee is asking FDA to provide records relating to its policy on refuse-to-file letters, as part of its broadening investigation into ImClone
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.