StreetInsider.com News Articles http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2010, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Fri, 12 Mar 2010 13:12:43 -0500 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif StreetInsider.com News Articles http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday Sanofi-aventis (SNY) and Bristol-Myers Squibb (BMY) Update on PLAVIX Revisions http://www.streetinsider.com/FDA/Sanofi-aventis+%28SNY%29+and+Bristol-Myers+Squibb+%28BMY%29+Update+on+PLAVIX+Revisions/5434145.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Sanofi-aventis+%28SNY%29+and+Bristol-Myers+Squibb+%28BMY%29+Update+on+PLAVIX+Revisions/5434145.html for the full story. http://www.streetinsider.com/FDA/Sanofi-aventis+%28SNY%29+and+Bristol-Myers+Squibb+%28BMY%29+Update+on+PLAVIX+Revisions/5434145.html Fri, 12 Mar 2010 13:12:43 -0500 BMY SNY Ligand Pharma (LGND) Announces that Glaxo (GSK) was Approved for Revolade Marketing in Europe http://www.streetinsider.com/FDA/Ligand+Pharma+%28LGND%29+Announces+that+Glaxo+%28GSK%29+was+Approved+for+Revolade+Marketing+in+Europe/5433977.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Ligand+Pharma+%28LGND%29+Announces+that+Glaxo+%28GSK%29+was+Approved+for+Revolade+Marketing+in+Europe/5433977.html for the full story. http://www.streetinsider.com/FDA/Ligand+Pharma+%28LGND%29+Announces+that+Glaxo+%28GSK%29+was+Approved+for+Revolade+Marketing+in+Europe/5433977.html Fri, 12 Mar 2010 12:22:15 -0500 GSK LGND Medtronic (MDT) Initiates CoreValve Transcatheter Aortic Valve System International Clinical Program http://www.streetinsider.com/FDA/Medtronic+%28MDT%29+Initiates+CoreValve+Transcatheter+Aortic+Valve+System+International+Clinical+Program/5433732.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Medtronic+%28MDT%29+Initiates+CoreValve+Transcatheter+Aortic+Valve+System+International+Clinical+Program/5433732.html for the full story. http://www.streetinsider.com/FDA/Medtronic+%28MDT%29+Initiates+CoreValve+Transcatheter+Aortic+Valve+System+International+Clinical+Program/5433732.html Fri, 12 Mar 2010 11:13:00 -0500 MDT Amylin (AMLN) Falls On Reports of Inappropriate Quality Control at Ohio Plant http://www.streetinsider.com/FDA/Amylin+%28AMLN%29+Falls+On+Reports+of+Inappropriate+Quality+Control+at+Ohio+Plant/5433629.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Amylin+%28AMLN%29+Falls+On+Reports+of+Inappropriate+Quality+Control+at+Ohio+Plant/5433629.html for the full story. http://www.streetinsider.com/FDA/Amylin+%28AMLN%29+Falls+On+Reports+of+Inappropriate+Quality+Control+at+Ohio+Plant/5433629.html Fri, 12 Mar 2010 10:46:14 -0500 AMLN Progenics Pharma (PGNX) to Commence Phase 2b/3 on Methylnaltrexone OIC Treatment http://www.streetinsider.com/FDA/Progenics+Pharma+%28PGNX%29+to+Commence+Phase+2b3+on+Methylnaltrexone+OIC+Treatment/5433004.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Progenics+Pharma+%28PGNX%29+to+Commence+Phase+2b3+on+Methylnaltrexone+OIC+Treatment/5433004.html for the full story. http://www.streetinsider.com/FDA/Progenics+Pharma+%28PGNX%29+to+Commence+Phase+2b3+on+Methylnaltrexone+OIC+Treatment/5433004.html Fri, 12 Mar 2010 08:17:01 -0500 PGNX ADVENTRX Pharma (ANX) ANX-530 Name 'Exelbine' Accepted by U.S. FDA http://www.streetinsider.com/FDA/ADVENTRX+Pharma+%28ANX%29+ANX-530+Name+%27Exelbine%27+Accepted+by+U.S.+FDA/5432986.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/ADVENTRX+Pharma+%28ANX%29+ANX-530+Name+%27Exelbine%27+Accepted+by+U.S.+FDA/5432986.html for the full story. http://www.streetinsider.com/FDA/ADVENTRX+Pharma+%28ANX%29+ANX-530+Name+%27Exelbine%27+Accepted+by+U.S.+FDA/5432986.html Fri, 12 Mar 2010 08:10:02 -0500 ANX Bovie Medical Corp. (BVX) Get Marketing Clearance for ICON VS from U.S. FDA http://www.streetinsider.com/FDA/Bovie+Medical+Corp.+%28BVX%29+Get+Marketing+Clearance+for+ICON+VS+from+U.S.+FDA/5432840.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Bovie+Medical+Corp.+%28BVX%29+Get+Marketing+Clearance+for+ICON+VS+from+U.S.+FDA/5432840.html for the full story. http://www.streetinsider.com/FDA/Bovie+Medical+Corp.+%28BVX%29+Get+Marketing+Clearance+for+ICON+VS+from+U.S.+FDA/5432840.html Fri, 12 Mar 2010 07:24:26 -0500 AstraZeneca (AZN) Comments on LABA Advisory Meetings; Confident in SYMBICORT http://www.streetinsider.com/FDA/AstraZeneca+%28AZN%29+Comments+on+LABA+Advisory+Meetings%3B+Confident+in+SYMBICORT/5431816.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/AstraZeneca+%28AZN%29+Comments+on+LABA+Advisory+Meetings%3B+Confident+in+SYMBICORT/5431816.html for the full story. http://www.streetinsider.com/FDA/AstraZeneca+%28AZN%29+Comments+on+LABA+Advisory+Meetings%3B+Confident+in+SYMBICORT/5431816.html Thu, 11 Mar 2010 17:08:32 -0500 AZN Pfizer (PFE) Anounces Two Phase 3's of Sutent Miss End-Points http://www.streetinsider.com/FDA/Pfizer+%28PFE%29+Anounces+Two+Phase+3%27s+of+Sutent+Miss+End-Points/5431766.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Pfizer+%28PFE%29+Anounces+Two+Phase+3%27s+of+Sutent+Miss+End-Points/5431766.html for the full story. http://www.streetinsider.com/FDA/Pfizer+%28PFE%29+Anounces+Two+Phase+3%27s+of+Sutent+Miss+End-Points/5431766.html Thu, 11 Mar 2010 17:04:02 -0500 PFE Watson Pharma (WPI) Gets U.S. FDA Approval for TRELSTAR 22.5-mg Prostate Cancer Treatment http://www.streetinsider.com/FDA/Watson+Pharma+%28WPI%29+Gets+U.S.+FDA+Approval+for+TRELSTAR+22.5-mg+Prostate+Cancer+Treatment/5431571.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Watson+Pharma+%28WPI%29+Gets+U.S.+FDA+Approval+for+TRELSTAR+22.5-mg+Prostate+Cancer+Treatment/5431571.html for the full story. http://www.streetinsider.com/FDA/Watson+Pharma+%28WPI%29+Gets+U.S.+FDA+Approval+for+TRELSTAR+22.5-mg+Prostate+Cancer+Treatment/5431571.html Thu, 11 Mar 2010 16:44:13 -0500 WPI Neoprobe Corp (NEOP) Announces Meeting with U.S. FDA Regarding Lymphoseek Phase 3 http://www.streetinsider.com/FDA/Neoprobe+Corp+%28NEOP%29+Announces+Meeting+with+U.S.+FDA+Regarding+Lymphoseek+Phase+3/5431409.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Neoprobe+Corp+%28NEOP%29+Announces+Meeting+with+U.S.+FDA+Regarding+Lymphoseek+Phase+3/5431409.html for the full story. http://www.streetinsider.com/FDA/Neoprobe+Corp+%28NEOP%29+Announces+Meeting+with+U.S.+FDA+Regarding+Lymphoseek+Phase+3/5431409.html Thu, 11 Mar 2010 16:26:32 -0500 NEOP Abbott (ABT) Seeks U.S. FDA Approval for Lupron Six-Month 45-mg Formulation Prostate Cancer Treatment http://www.streetinsider.com/FDA/Abbott+%28ABT%29+Seeks+U.S.+FDA+Approval+for+Lupron+Six-Month+45-mg+Formulation+Prostate+Cancer+Treatment/5430968.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Abbott+%28ABT%29+Seeks+U.S.+FDA+Approval+for+Lupron+Six-Month+45-mg+Formulation+Prostate+Cancer+Treatment/5430968.html for the full story. http://www.streetinsider.com/FDA/Abbott+%28ABT%29+Seeks+U.S.+FDA+Approval+for+Lupron+Six-Month+45-mg+Formulation+Prostate+Cancer+Treatment/5430968.html Thu, 11 Mar 2010 15:21:39 -0500 ABT Caraco Pharma (CPD) Lauches Oxaliplatin Injections; Equivalent to Sanofi's Eloxatin http://www.streetinsider.com/FDA/Caraco+Pharma+%28CPD%29+Lauches+Oxaliplatin+Injections%3B+Equivalent+to+Sanofi%27s+Eloxatin/5429814.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Caraco+Pharma+%28CPD%29+Lauches+Oxaliplatin+Injections%3B+Equivalent+to+Sanofi%27s+Eloxatin/5429814.html for the full story. http://www.streetinsider.com/FDA/Caraco+Pharma+%28CPD%29+Lauches+Oxaliplatin+Injections%3B+Equivalent+to+Sanofi%27s+Eloxatin/5429814.html Thu, 11 Mar 2010 10:18:32 -0500 CPD SNY Bayer HealthCare Pharmaceuticals (BAY) Receives FDA Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler http://www.streetinsider.com/FDA/Bayer+HealthCare+Pharmaceuticals+%28BAY%29+Receives+FDA+Orphan+Drug+Designation+for+Investigational+Ciprofloxacin+Dry+Powder+Inhaler+/5429387.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Bayer+HealthCare+Pharmaceuticals+%28BAY%29+Receives+FDA+Orphan+Drug+Designation+for+Investigational+Ciprofloxacin+Dry+Powder+Inhaler+/5429387.html for the full story. http://www.streetinsider.com/FDA/Bayer+HealthCare+Pharmaceuticals+%28BAY%29+Receives+FDA+Orphan+Drug+Designation+for+Investigational+Ciprofloxacin+Dry+Powder+Inhaler+/5429387.html Thu, 11 Mar 2010 09:05:13 -0500 BAY Boston Scientific (BSX) Receives FDA Approval for Express LD Iliac Stent System http://www.streetinsider.com/FDA/Boston+Scientific+%28BSX%29+Receives+FDA+Approval+for+Express+LD+Iliac+Stent+System/5429225.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Boston+Scientific+%28BSX%29+Receives+FDA+Approval+for+Express+LD+Iliac+Stent+System/5429225.html for the full story. http://www.streetinsider.com/FDA/Boston+Scientific+%28BSX%29+Receives+FDA+Approval+for+Express+LD+Iliac+Stent+System/5429225.html Thu, 11 Mar 2010 08:34:41 -0500 BSX BioSante Pharma (BPAX) Announces Positive Results from Gleevec Study http://www.streetinsider.com/FDA/BioSante+Pharma+%28BPAX%29+Announces+Positive+Results+from+Gleevec+Study/5428951.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/BioSante+Pharma+%28BPAX%29+Announces+Positive+Results+from+Gleevec+Study/5428951.html for the full story. http://www.streetinsider.com/FDA/BioSante+Pharma+%28BPAX%29+Announces+Positive+Results+from+Gleevec+Study/5428951.html Thu, 11 Mar 2010 07:58:19 -0500 BPAX Auxilium Pharma (AUXL) Announces Managed Distribution Network Partners for XIAFLEX http://www.streetinsider.com/FDA/Auxilium+Pharma+%28AUXL%29+Announces+Managed+Distribution+Network+Partners+for+XIAFLEX/5428934.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Auxilium+Pharma+%28AUXL%29+Announces+Managed+Distribution+Network+Partners+for+XIAFLEX/5428934.html for the full story. http://www.streetinsider.com/FDA/Auxilium+Pharma+%28AUXL%29+Announces+Managed+Distribution+Network+Partners+for+XIAFLEX/5428934.html Thu, 11 Mar 2010 07:49:56 -0500 AUXL St. Jude Medical (STJ) Receives U.S. FDA Clearance and European CE Mark for Engage and Engage TR http://www.streetinsider.com/FDA/St.+Jude+Medical+%28STJ%29+Receives+U.S.+FDA+Clearance+and+European+CE+Mark+for+Engage+and+Engage+TR/5428755.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/St.+Jude+Medical+%28STJ%29+Receives+U.S.+FDA+Clearance+and+European+CE+Mark+for+Engage+and+Engage+TR/5428755.html for the full story. http://www.streetinsider.com/FDA/St.+Jude+Medical+%28STJ%29+Receives+U.S.+FDA+Clearance+and+European+CE+Mark+for+Engage+and+Engage+TR/5428755.html Thu, 11 Mar 2010 07:01:16 -0500 STJ Affymax (AFFY) Receives $5M Milestone for Hematide Phase 3 Initiation http://www.streetinsider.com/FDA/Affymax+%28AFFY%29+Receives+%245M+Milestone+for+Hematide+Phase+3+Initiation/5425135.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Affymax+%28AFFY%29+Receives+%245M+Milestone+for+Hematide+Phase+3+Initiation/5425135.html for the full story. http://www.streetinsider.com/FDA/Affymax+%28AFFY%29+Receives+%245M+Milestone+for+Hematide+Phase+3+Initiation/5425135.html Wed, 10 Mar 2010 08:15:36 -0500 AFFY Oculus Innovative Sciences (OCLS) Receives U.S. FDA 501(k) Clearance for Microcyn Skin and Wound HydroGel http://www.streetinsider.com/FDA/Oculus+Innovative+Sciences+%28OCLS%29+Receives+U.S.+FDA+501%28k%29+Clearance+for+Microcyn+Skin+and+Wound+HydroGel/5425127.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Oculus+Innovative+Sciences+%28OCLS%29+Receives+U.S.+FDA+501%28k%29+Clearance+for+Microcyn+Skin+and+Wound+HydroGel/5425127.html for the full story. http://www.streetinsider.com/FDA/Oculus+Innovative+Sciences+%28OCLS%29+Receives+U.S.+FDA+501%28k%29+Clearance+for+Microcyn+Skin+and+Wound+HydroGel/5425127.html Wed, 10 Mar 2010 08:13:21 -0500 OCLS Cytokinetics, Inc.'s (CYTK) CK-2017357 Granted Orphan-Drug Designation by U.S. FDA http://www.streetinsider.com/FDA/Cytokinetics%2C+Inc.%27s+%28CYTK%29+CK-2017357+Granted+Orphan-Drug+Designation+by+U.S.+FDA/5424853.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Cytokinetics%2C+Inc.%27s+%28CYTK%29+CK-2017357+Granted+Orphan-Drug+Designation+by+U.S.+FDA/5424853.html for the full story. http://www.streetinsider.com/FDA/Cytokinetics%2C+Inc.%27s+%28CYTK%29+CK-2017357+Granted+Orphan-Drug+Designation+by+U.S.+FDA/5424853.html Wed, 10 Mar 2010 07:34:31 -0500 CYTK Abbott (ABT) Get U.S. FDA Approval for TECNIS Multifocal 1-Piece Intraocular Lens http://www.streetinsider.com/FDA/Abbott+%28ABT%29+Get+U.S.+FDA+Approval+for+TECNIS+Multifocal+1-Piece+Intraocular+Lens/5424765.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Abbott+%28ABT%29+Get+U.S.+FDA+Approval+for+TECNIS+Multifocal+1-Piece+Intraocular+Lens/5424765.html for the full story. http://www.streetinsider.com/FDA/Abbott+%28ABT%29+Get+U.S.+FDA+Approval+for+TECNIS+Multifocal+1-Piece+Intraocular+Lens/5424765.html Wed, 10 Mar 2010 07:03:44 -0500 ABT FDA Approves Allergan's (AGN) Botox to Treat Spasticity in Flexor Muscles http://www.streetinsider.com/FDA/FDA+Approves+Allergan%27s+%28AGN%29+Botox+to+Treat+Spasticity+in+Flexor+Muscles+/5423679.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/FDA+Approves+Allergan%27s+%28AGN%29+Botox+to+Treat+Spasticity+in+Flexor+Muscles+/5423679.html for the full story. http://www.streetinsider.com/FDA/FDA+Approves+Allergan%27s+%28AGN%29+Botox+to+Treat+Spasticity+in+Flexor+Muscles+/5423679.html Tue, 09 Mar 2010 16:58:45 -0500 AGN InterMune (ITMN) Re-Opens 60% Higher After FDA Panel Recommends Approval of Pirfenidone http://www.streetinsider.com/FDA/InterMune+%28ITMN%29+Re-Opens+60%25+Higher+After+FDA+Panel+Recommends+Approval+of+Pirfenidone/5423674.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/InterMune+%28ITMN%29+Re-Opens+60%25+Higher+After+FDA+Panel+Recommends+Approval+of+Pirfenidone/5423674.html for the full story. http://www.streetinsider.com/FDA/InterMune+%28ITMN%29+Re-Opens+60%25+Higher+After+FDA+Panel+Recommends+Approval+of+Pirfenidone/5423674.html Tue, 09 Mar 2010 16:58:05 -0500 ITMN Allergan (AGN) Receives FDA Approval for Botox Spasticity Treatment -Bloomberg http://www.streetinsider.com/FDA/Allergan+%28AGN%29+Receives+FDA+Approval+for+Botox+Spasticity+Treatment+-Bloomberg/5423474.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Allergan+%28AGN%29+Receives+FDA+Approval+for+Botox+Spasticity+Treatment+-Bloomberg/5423474.html for the full story. http://www.streetinsider.com/FDA/Allergan+%28AGN%29+Receives+FDA+Approval+for+Botox+Spasticity+Treatment+-Bloomberg/5423474.html Tue, 09 Mar 2010 16:36:40 -0500 AGN FDA Panel Recommends Approval of Intermune's (ITMN) Pirfenidone in 9-3 Vote http://www.streetinsider.com/FDA/FDA+Panel+Recommends+Approval+of+Intermune%27s+%28ITMN%29+Pirfenidone+in+9-3+Vote/5422855.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/FDA+Panel+Recommends+Approval+of+Intermune%27s+%28ITMN%29+Pirfenidone+in+9-3+Vote/5422855.html for the full story. http://www.streetinsider.com/FDA/FDA+Panel+Recommends+Approval+of+Intermune%27s+%28ITMN%29+Pirfenidone+in+9-3+Vote/5422855.html Tue, 09 Mar 2010 15:24:46 -0500 ITMN FDA Panel Votes 9-3 That Intermune's (ITMN) Pirfenidone is Safe; Waiting Final Vote for Approval http://www.streetinsider.com/FDA/FDA+Panel+Votes+9-3+That+Intermune%27s+%28ITMN%29+Pirfenidone+is+Safe%3B+Waiting+Final+Vote+for+Approval/5422827.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/FDA+Panel+Votes+9-3+That+Intermune%27s+%28ITMN%29+Pirfenidone+is+Safe%3B+Waiting+Final+Vote+for+Approval/5422827.html for the full story. http://www.streetinsider.com/FDA/FDA+Panel+Votes+9-3+That+Intermune%27s+%28ITMN%29+Pirfenidone+is+Safe%3B+Waiting+Final+Vote+for+Approval/5422827.html Tue, 09 Mar 2010 15:16:18 -0500 ITMN FDA Panel Says Intermune's (ITMN) Pirfenidone Has 'Clinically Meaningful' Benefit, No Further Data Needed; Panel Still Needs to Vote on Approval http://www.streetinsider.com/FDA/FDA+Panel+Says+Intermune%27s+%28ITMN%29+Pirfenidone+Has+%27Clinically+Meaningful%27+Benefit%2C+No+Further+Data+Needed%3B+Panel+Still+Needs+to+Vote+on+Approval/5422795.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/FDA+Panel+Says+Intermune%27s+%28ITMN%29+Pirfenidone+Has+%27Clinically+Meaningful%27+Benefit%2C+No+Further+Data+Needed%3B+Panel+Still+Needs+to+Vote+on+Approval/5422795.html for the full story. http://www.streetinsider.com/FDA/FDA+Panel+Says+Intermune%27s+%28ITMN%29+Pirfenidone+Has+%27Clinically+Meaningful%27+Benefit%2C+No+Further+Data+Needed%3B+Panel+Still+Needs+to+Vote+on+Approval/5422795.html Tue, 09 Mar 2010 15:09:28 -0500 ITMN EDAP TMS (EDAP) Gets Marketing Approval for Sonolith I-Sys from Japanese Administration http://www.streetinsider.com/FDA/EDAP+TMS+%28EDAP%29+Gets+Marketing+Approval+for+Sonolith+I-Sys+from+Japanese+Administration/5421233.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/EDAP+TMS+%28EDAP%29+Gets+Marketing+Approval+for+Sonolith+I-Sys+from+Japanese+Administration/5421233.html for the full story. http://www.streetinsider.com/FDA/EDAP+TMS+%28EDAP%29+Gets+Marketing+Approval+for+Sonolith+I-Sys+from+Japanese+Administration/5421233.html Tue, 09 Mar 2010 09:19:18 -0500 EDAP Smith & Nephew (SNN) Introduces TIGEN SURESHOT Distal Targeting System http://www.streetinsider.com/FDA/Smith+%26+Nephew+%28SNN%29+Introduces+TIGEN+SURESHOT+Distal+Targeting+System/5420905.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Smith+%26+Nephew+%28SNN%29+Introduces+TIGEN+SURESHOT+Distal+Targeting+System/5420905.html for the full story. http://www.streetinsider.com/FDA/Smith+%26+Nephew+%28SNN%29+Introduces+TIGEN+SURESHOT+Distal+Targeting+System/5420905.html Tue, 09 Mar 2010 08:48:58 -0500 SNN