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 BioMedReports.com 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




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