BioCentury | May 17, 2010
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 of their...
BioCentury | Jan 11, 2010
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 Inc. (NASDAQ:ALTH) Folotyn pralatrexate Relapsed or refractory peripheral...
BioCentury | Jan 4, 2010
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 once-daily Seroquel XR quetiapine as...
BC Week In Review | Dec 7, 2009
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...
BC Week In Review | Nov 2, 2009
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...
BC Extra | Oct 30, 2009
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...
BC Week In Review | Oct 12, 2009
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 approval...
BC Extra | Oct 7, 2009
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....
BC Week In Review | Oct 5, 2009
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...
BC Extra | Oct 3, 2009
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....
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