BC Week In Review | May 2, 2011
Clinical News

Menactra regulatory update

FDA approved an sBLA to expand the label for Menactra to include the prevention of invasive meningococcal disease caused by serogroups A, C, Y and W-135 in infants and toddlers as young as 9 months....
BioCentury | Jan 10, 2011
Finance

Buyside View XIX: Commercial Risk

Michael Flanagan Senior Writer  BioCentury's 19th Annual Buyside View finds money managers entering 2011 cautiously optimistic about biotech's prospects, particularly as some of the high-profile compounds have already reported some data, lowering risk. Amidst the...
BC Week In Review | Sep 13, 2010
Clinical News

Menactra regulatory update

FDA accepted an sBLA for Menactra to immunize infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135. The PDUFA date is in 1H11. sanofi's Sanofi Pasteur...
BC Week In Review | Nov 9, 2009
Clinical News

Menactra: Phase III data

An open-label, U.S. Phase III trial in 1,351 healthy infants showed that a 2-dose schedule of Menactra was well tolerated. The most common side effects were injection site pain, redness, swelling and irritability. Subjects received...
BC Extra | Aug 29, 2008
Politics & Policy

CDC releases pre-teen vaccine PSAs

The U.S. Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Disease released new public service announcements to encourage pre-teen vaccinations. The PSAs target the parents of 11- and 12-year-olds and recommend...
BC Week In Review | May 12, 2008
Clinical News

Menveo: Phase III data

Novartis reported data on one of three primary endpoints in a U.S. Phase III trial comparing single injections of Menveo with Menactra in about 3,500 volunteers aged 11-55. Menveo met the co-primary endpoint of non-inferiority...
BioCentury | May 12, 2008
Product Development

Eye of the beholder

Novartis AG says its Menveo quadrivalent meningitis vaccine showed a superior immune response in a head-to-head study vs. Menactra from sanofi-aventis Group . But the French pharma says it's impossible to discern a meaningful difference because...
BC Extra | May 7, 2008
Clinical News

Novartis reports Menveo data

Novartis (NYSE:NVS; SWX:NOVN) reported data on one of three co-primary endpoints in a U.S. Phase III meningococcal meningitis trial comparing single injections of Menveo with Menactra in about 3,500 volunteers aged 11-55. Menveo met the...
BC Week In Review | Oct 22, 2007
Clinical News

Menactra regulatory update

FDA approved an expanded label for SAN's Menactra meningococcal vaccine to include children 2 through 10 years of age. sanofi-aventis Group (Euronext:SAN; SNY), Paris, France   Product: Menactra   Business: Infectious  ...
BC Week In Review | Aug 20, 2007
Clinical News

Gardasil regulatory update

The not-for-profit National Vaccine Information Center (NVIC) released a follow-up analysis of reports from the federal Vaccine Adverse Event Reporting System (VAERS) of health problems following HPV vaccination with Gardasil in conjunction with vaccination with...
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