07:00 , Apr 25, 2011 |  BC Week In Review  |  Clinical News

Aflunov regulatory update

In November, the European Commission approved Aflunov vaccine from Novartis to prevent influenza A (H5N1) virus infection in adults. In 2008, Novartis withdrew an MAA for the adjuvanted pre- pandemic influenza vaccine following CHMP's request...
07:00 , Oct 4, 2010 |  BC Week In Review  |  Clinical News

Aflunov regulatory update

CHMP issued a positive opinion recommending approval of an MAA from Novartis for Aflunov H5N1 pre-pandemic avian influenza vaccine to prevent influenza A (H5N1) virus infection in adults. In 2008, Novartis withdrew an MAA for...
07:00 , May 4, 2009 |  BioCentury  |  Product Development

Opportunity in Crisis

The scramble to create and mass produce vaccines to combat the outbreak of H1N1 swine influenza is exposing the limitations of global pandemic preparedness and, in the process, highlighting scientific, technological and commercial opportunities for...
08:00 , Jan 26, 2009 |  BC Week In Review  |  Company News

Novartis, U.S. Department of Health and Human Services infectious news

HHS's Biomedical Advanced Research and Development Authority (BARDA) awarded Novartis a $486.6 million contract over eight years to build a facility in North Carolina to manufacture seasonal and pandemic influenza vaccines. Novartis will provide two...
07:00 , Sep 29, 2008 |  BC Week In Review  |  Clinical News

MF59: Phase I data

An open-label Phase I study in 54 healthy adults showed that a prime with MF59-adjuvanted H5N3 vaccine resulted in significantly higher antibody response than a prime with unadjuvanted H5N3 vaccine. Specifically, in 24 patients who...
07:00 , Jul 7, 2008 |  BioCentury  |  Finance

2Q approvals

2Q approvals Selected second quarter product approvals. The list does not include an FDA approvable letter for Zentase pancrealipase capsules to treat exocrine pancreatic insufficiency from Eurand (NASDAQ:EURX). While not a full approval, the...
07:00 , Jun 23, 2008 |  BC Week In Review  |  Clinical News

Aflunov regulatory update

EMEA said Novartis withdrew an MAA for Aflunov H5N1 pre- pandemic influenza vaccine to prevent H5N1 influenza infection. The company told the agency that it withdrew the application following a CHMP request for additional clinical...
01:46 , Jun 17, 2008 |  BC Extra  |  Company News

Novartis withdraws Aflunov MAA

The EMEA said Novartis (NYSE:NVS; SWX:NOVN) withdrew an MAA for Aflunov H5N1 pre-pandemic influenza vaccine to prevent H5N1 influenza infection. The company told the agency that it withdrew the application following a CHMP request for...
08:00 , Jan 7, 2008 |  BioCentury  |  Finance

Approval watch

Approval watch Company Product Indication Event Milestone Adolor (NASDAQ:ADLR)/ Entereg alvimopan (ADL 8-2698) Post-operative ileus (POI) FDA panel mtg; 1/23/08 (mtg); GlaxoSmithKline (LSE:GSK; NYSE:GSK) PDUFA date 2/10/08 (PDUFA) Advanced Medical (LSE:AMS) Liquiband Adhesive...