BioMed Updates: JNJ, DYAX, HEB, SNTS, PLX, PFE, CVM, GILD, ENDP, TEVA, AMGN Print E-mail
Tuesday, 01 December 2009 19:58

Click here to follow me on twitter / mikehavrilla and check out the FDA Calendar service, which includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.



$JNJ / Johnson + Johnson New FDA Filing for Tapentadol ER (pain drug) / IR forumation already approved (Nucynta)


$DYAX / Dyax Corp. Up Big AH / Receives FDA Approval for Kalbitor (ecallantide) for acute attacks HAE


$HEB / Hemispherx Tanks AH / FDA Complete Response Letter for Ampligen


$SNTS / Santarus Up Big AH / FDA Approval for Zegerid OTC


$PLX $PFE $GENZ $SHPGY / Protalix / trading lower after Pfizer pact (but no buyout) for Gaucher disease drug


$CVM / Cel-Sci / Retains CRO for pending Phase 3 pivotal trial of experimental cancer vaccine Multikine


$SNTS / Santarus / Dual Pending FDA Decisions for OTC Zegerid (9-Dec), Zegerid tablet reformulation (4-Dec)


$GILD / Gilead Sciences FDA Panel Review 10-Dec / aztreonam inhalation anti-infective for cystic fibrosis patients


$ENDP / Expected FDA Decision 2-Dec / Nebido (long-lasting testosterone injection)


$TEVA $AMGN Teva FDA Filing XM02 (G-CSF) Bio-Generic Amgen's Neupogen


Disclosure: No positions

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit!! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus