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 Selected drugs that received regulatory approval in 2009. Company Product Indication 2009 approval Allergan Inc. (NYSE:AGN) Ozurdex dexamethasone Macular edema U.S. Allos Therapeutics...
08:00 , Jan 4, 2010 |  BioCentury  |  Finance

4Q approvals

4Q approvals Company Approval Amylin Pharmaceuticals Inc. (NASDAQ:AMLN)/ Eli Lilly and Co. (NYSE:LLY) FDA approves Byetta exenatide to include monotherapy in Type II diabetes AstraZeneca plc (LSE:AZN; NYSE:AZN) FDA approves...
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....