Chiron Halts Menjugate Meningococcal Vaccine Program After Pivotal Trials
This article was originally published in The Pink Sheet Daily
Executive Summary
Phase III trials were “successfully concluded,” but there are no plans to file a BLA for the meningococcal C conjugate vaccine due to limited commercial viability, Chiron says. The company plans to begin Phase III trials for its quadravalent meningococcal vaccine in 2005.
You may also be interested in...
Three Congressional Flu Hearings Planned For Next Week
The Senate Special Committee on Aging and the House Energy & Commerce and Government Reform Committees will hold hearings to discuss flu vaccine supply. FDA Acting Commissioner Lester Crawford and NIAID Director Anthony Fauci are expected to be among the witnesses.
Menactra Approval Awaits Final Manufacturing Clearance
Sanofi-Aventis says it is prepared to produce a limited supply of the meningococcal conjugate vaccine soon after licensure. To meet expanded demand, the company is constructing a new Menactra manufacturing facility that will be fully operational in two to three years.
NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter
DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter