07:00 , May 17, 2010 |  BioCentury  |  Regulation

Adventitious Detection

Now that an academic researcher using new sequencing technology has detected foreign viral DNA in a live attenuated rotavirus vaccine, vaccine developers would be smart - and may eventually be required - to test all...
08:00 , Jan 11, 2010 |  BioCentury  |  Finance

New Products to Watch

New Products to Watch...
08:00 , Jan 4, 2010 |  BioCentury  |  Finance

4Q approvals

4Q approvals...
08:00 , Dec 7, 2009 |  BC Week In Review  |  Clinical News

Focetria regulatory update

After a review of additional clinical data for the three approved pandemic swine influenza A (H1N1) vaccines, EMEA's CHMP said sufficient protection is provided by a single dose of Focetria adjuvanted vaccine from Novartis AG...
08:00 , Nov 2, 2009 |  BC Week In Review  |  Clinical News

Pandemrix regulatory update

After reviewing clinical data for the three approved pandemic swine influenza A (H1N1) vaccines, EMEA's CHMP maintained its previous recommendation that the vaccines be administered in two doses given at least three weeks apart. The...
23:51 , Oct 30, 2009 |  BC Extra  |  Politics & Policy

WHO recommends single dose of H1N1 vaccine

The World Health Organization's Strategic Advisory Group of Experts (SAGE) on Immunization on Friday recommended the use of a single dose of swine influenza A (H1N1) vaccine in adults and children 10 and up. For...
07:00 , Oct 12, 2009 |  BC Week In Review  |  Clinical News

Celvapan regulatory update

The EC approved Baxter's Celvapan H1N1 pandemic influenza vaccine . The dosing schedule consists of two 7.5 µg doses given 21 days apart. Earlier this month, EMEA's CHMP issued a positive opinion to grant marketing...
23:39 , Oct 7, 2009 |  BC Extra  |  Company News

EC approves Celvapan H1N1

The European Commission approved Celvapan H1N1 pandemic vaccine from Baxter International Inc. (NYSE:BAX). The whole virion, non-adjuvanted swine influenza A (H1N1) vaccine uses Baxter's Vero cell technology....
07:00 , Oct 5, 2009 |  BC Week In Review  |  Clinical News

Celvapan H1N1 regulatory update

EMEA's CHMP issued a positive opinion to grant marketing approval for Baxter's Celvapan H1N1 pandemic influenza vaccine. CHMP recommended a 2-dose vaccination schedule, with a 3-week interval, for adults, including pregnant women, and children ages...
00:29 , Oct 3, 2009 |  BC Extra  |  Company News

CHMP backs Celvapan H1N1

EMEA's CHMP issued a positive opinion recommending approval of Celvapan H1N1 pandemic vaccine from Baxter International Inc. (NYSE:BAX). The whole virion, non-adjuvanted swine influenza A (H1N1) vaccine uses Baxter's Vero cell technology....