07:00 , Oct 3, 2016 |  BC Week In Review  |  Clinical News

Afluria Quadrivalent: Phase III data

CSL’s Seqirus unit reported data from a double-blind, U.S. Phase III trial in 3,484 adults ages >=18 showing that intramuscular Afluria Quadrivalent met the primary endpoint of non-inferiority to Afluria trivalent influenza vaccine and a...
07:00 , Oct 3, 2016 |  BC Week In Review  |  Clinical News

Afluria Quadrivalent: Phase III data

CSL’s Seqirus unit reported data from a double-blind, U.S. Phase III trial in 2,278 children ages 5-17 showing that intramuscular Afluria Quadrivalent met the primary endpoint of non-inferior immunogenicity to Fluarix Quadrivalent as assessed...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Afluria Quadrivalent regulatory update

FDA approved an sBLA from CSL’s Seqirus unit for Afluria Quadrivalent to prevent infection from 2 influenza subtypes A and 2 influenza type B viruses contained in the vaccine in people ages >=18. Seqirus said...
07:00 , Sep 15, 2014 |  BC Week In Review  |  Clinical News

Afluria regulatory update

CSL's bioCSL Inc. (formerly CSL Biotherapies) subsidiary and PharmaJet Inc. (Golden, Colo.) said FDA approved the PharmaJet Stratis 0.5 mL Needle-Free Jet Injector from PharmaJet for delivery of bioCSL's Afluria seasonal influenza vaccine in...
07:00 , Oct 31, 2011 |  BC Week In Review  |  Clinical News

Influenza vaccines infectious data

Researchers at the university and colleagues reported data from a meta-analysis of 17 randomized controlled trials and 14 observational studies of approved influenza vaccines suggesting that the vaccines can provide moderate protection against virologically-confirmed influenza....
07:00 , Jul 4, 2011 |  BC Week In Review  |  Clinical News

Afluria regulatory update

CSL received a warning letter from FDA relating to deviations in cGMP practices in the manufacture of Afluria seasonal influenza vaccine and monovalent influenza bulks observed during a March inspection of the company's Parkville, Australia,...
07:00 , Aug 9, 2010 |  BC Week In Review  |  Clinical News

Afluria regulatory update

FDA updated the label for CSL's Afluria to warn that the trivalent inactivated seasonal influenza vaccine has been associated with an increased incidence of fever and febrile seizure in Australian children, mainly under the age...
08:00 , Nov 16, 2009 |  BC Week In Review  |  Clinical News

Afluria regulatory update

FDA granted accelerated approval to expand the label for CSL's Afluria trivalent inactivated seasonal influenza vaccine and Influenza A/H1N1 2009 vaccine to include use in persons aged 6 months and older. Both vaccines are already...
07:00 , Oct 5, 2009 |  BC Week In Review  |  Company News

CSL, Merck sales and marketing update

Merck received an exclusive license to market CSL's seasonal influenza H1N1 vaccine Afluria in the U.S. The trivalent inactivated influenza vaccine was approved in July for active immunization of people age 18 years and...
07:00 , Jul 27, 2009 |  BioCentury  |  Regulation

Licensed influenza vaccines

Licensed influenza vaccines Company Product Type Approved population CSL Ltd. (ASX:CSL) Afluria Inactivated >=18 years GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) Fluarix FluLaval (A) Inactivated Inactivated...