StreetInsider.com News Articles http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2009, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Fri, 20 Nov 2009 15:42:35 -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 Cornerstone Therapeutics (CRTX) Receives Warning Letter From FDA http://www.streetinsider.com/FDA/Cornerstone+Therapeutics+%28CRTX%29+Receives+Warning+Letter+From+FDA/5130672.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Cornerstone+Therapeutics+%28CRTX%29+Receives+Warning+Letter+From+FDA/5130672.html for the full story. http://www.streetinsider.com/FDA/Cornerstone+Therapeutics+%28CRTX%29+Receives+Warning+Letter+From+FDA/5130672.html Fri, 20 Nov 2009 15:42:35 -0500 CRTX Pfizer (PFE) Gets Okay for Bipolar Treatment Geodon from U.S. FDA http://www.streetinsider.com/FDA/Pfizer+%28PFE%29+Gets+Okay+for+Bipolar+Treatment+Geodon+from+U.S.+FDA/5130187.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Pfizer+%28PFE%29+Gets+Okay+for+Bipolar+Treatment+Geodon+from+U.S.+FDA/5130187.html for the full story. http://www.streetinsider.com/FDA/Pfizer+%28PFE%29+Gets+Okay+for+Bipolar+Treatment+Geodon+from+U.S.+FDA/5130187.html Fri, 20 Nov 2009 13:22:53 -0500 Intuitive Surgical (ISRG) Receives Japanese Approval for da Vinci http://www.streetinsider.com/FDA/Intuitive+Surgical+%28ISRG%29+Receives+Japanese+Approval+for+da+Vinci/5130182.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Intuitive+Surgical+%28ISRG%29+Receives+Japanese+Approval+for+da+Vinci/5130182.html for the full story. http://www.streetinsider.com/FDA/Intuitive+Surgical+%28ISRG%29+Receives+Japanese+Approval+for+da+Vinci/5130182.html Fri, 20 Nov 2009 13:21:14 -0500 ISRG Dendreon Corp. (DNDN) Receives U.S. FDA Complete Response for PROVENGE CRPC Treatment http://www.streetinsider.com/FDA/Dendreon+Corp.+%28DNDN%29+Receives+U.S.+FDA+Complete+Response+for+PROVENGE+CRPC+Treatment/5129277.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Dendreon+Corp.+%28DNDN%29+Receives+U.S.+FDA+Complete+Response+for+PROVENGE+CRPC+Treatment/5129277.html for the full story. http://www.streetinsider.com/FDA/Dendreon+Corp.+%28DNDN%29+Receives+U.S.+FDA+Complete+Response+for+PROVENGE+CRPC+Treatment/5129277.html Fri, 20 Nov 2009 08:36:36 -0500 DNDN Boston Scientific (BSX) Receives 510(k) Clearance and CE Mark on WallFlex http://www.streetinsider.com/FDA/Boston+Scientific+%28BSX%29+Receives+510%28k%29+Clearance+and+CE+Mark+on+WallFlex/5129273.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Boston+Scientific+%28BSX%29+Receives+510%28k%29+Clearance+and+CE+Mark+on+WallFlex/5129273.html for the full story. http://www.streetinsider.com/FDA/Boston+Scientific+%28BSX%29+Receives+510%28k%29+Clearance+and+CE+Mark+on+WallFlex/5129273.html Fri, 20 Nov 2009 08:33:13 -0500 BSX Covidien (COV) Announces FDA Extends Review of NDA for Exalgo http://www.streetinsider.com/FDA/Covidien+%28COV%29+Announces+FDA+Extends+Review+of+NDA+for+Exalgo/5129077.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Covidien+%28COV%29+Announces+FDA+Extends+Review+of+NDA+for+Exalgo/5129077.html for the full story. http://www.streetinsider.com/FDA/Covidien+%28COV%29+Announces+FDA+Extends+Review+of+NDA+for+Exalgo/5129077.html Fri, 20 Nov 2009 07:32:49 -0500 COV Matrixx Initiatives (MTXX) Files Response with FDA on Zicam http://www.streetinsider.com/FDA/Matrixx+Initiatives+%28MTXX%29+Files+Response+with+FDA+on+Zicam/5128039.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Matrixx+Initiatives+%28MTXX%29+Files+Response+with+FDA+on+Zicam/5128039.html for the full story. http://www.streetinsider.com/FDA/Matrixx+Initiatives+%28MTXX%29+Files+Response+with+FDA+on+Zicam/5128039.html Thu, 19 Nov 2009 16:40:13 -0500 MTXX Salix (SLXP) December volatility at 56, January at 68, April at 73 into PDUFA http://www.streetinsider.com/FDA/Salix+%28SLXP%29+December+volatility+at+56%2C+January+at+68%2C+April+at+73+into+PDUFA/5126565.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Salix+%28SLXP%29+December+volatility+at+56%2C+January+at+68%2C+April+at+73+into+PDUFA/5126565.html for the full story. http://www.streetinsider.com/FDA/Salix+%28SLXP%29+December+volatility+at+56%2C+January+at+68%2C+April+at+73+into+PDUFA/5126565.html Thu, 19 Nov 2009 11:17:59 -0500 SLXP UnitedHealth's (UNH) Prescription Solutions Releases Study Finding No Significant Differences Between Ezetimibe/Simvastatin and Statin Alone http://www.streetinsider.com/FDA/UnitedHealth%27s+%28UNH%29+Prescription+Solutions+Releases+Study+Finding+No+Significant+Differences+Between+EzetimibeSimvastatin+and+Statin+Alone/5122778.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/UnitedHealth%27s+%28UNH%29+Prescription+Solutions+Releases+Study+Finding+No+Significant+Differences+Between+EzetimibeSimvastatin+and+Statin+Alone/5122778.html for the full story. http://www.streetinsider.com/FDA/UnitedHealth%27s+%28UNH%29+Prescription+Solutions+Releases+Study+Finding+No+Significant+Differences+Between+EzetimibeSimvastatin+and+Statin+Alone/5122778.html Wed, 18 Nov 2009 11:36:16 -0500 UNH BSD Medical (BSDM) Provides Update on FDA's Review of Company's BSD-2000 Hyperthermia System http://www.streetinsider.com/FDA/BSD+Medical+%28BSDM%29+Provides+Update+on+FDA%27s+Review+of+Company%27s+BSD-2000+Hyperthermia+System/5122669.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/BSD+Medical+%28BSDM%29+Provides+Update+on+FDA%27s+Review+of+Company%27s+BSD-2000+Hyperthermia+System/5122669.html for the full story. http://www.streetinsider.com/FDA/BSD+Medical+%28BSDM%29+Provides+Update+on+FDA%27s+Review+of+Company%27s+BSD-2000+Hyperthermia+System/5122669.html Wed, 18 Nov 2009 11:06:46 -0500 BSDM Medtronic (MDT) Receives FDA Warning Letter Following Inspection of Its Minnesota Facility http://www.streetinsider.com/FDA/Medtronic+%28MDT%29+Receives+FDA+Warning+Letter+Following+Inspection+of+Its+Minnesota+Facility/5121824.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Medtronic+%28MDT%29+Receives+FDA+Warning+Letter+Following+Inspection+of+Its+Minnesota+Facility/5121824.html for the full story. http://www.streetinsider.com/FDA/Medtronic+%28MDT%29+Receives+FDA+Warning+Letter+Following+Inspection+of+Its+Minnesota+Facility/5121824.html Wed, 18 Nov 2009 09:01:03 -0500 MDT VIVUS (VVUS) Will Announces Phase 3 Results of Avanafil Before The Market Opens http://www.streetinsider.com/FDA/VIVUS+%28VVUS%29+Will+Announces+Phase+3+Results+of+Avanafil+Before+The+Market+Opens/5120149.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/VIVUS+%28VVUS%29+Will+Announces+Phase+3+Results+of+Avanafil+Before+The+Market+Opens/5120149.html for the full story. http://www.streetinsider.com/FDA/VIVUS+%28VVUS%29+Will+Announces+Phase+3+Results+of+Avanafil+Before+The+Market+Opens/5120149.html Tue, 17 Nov 2009 16:55:52 -0500 VVUS NeurogesX (NGSX) Higher On FDA Approval of Qutenza http://www.streetinsider.com/FDA/NeurogesX+%28NGSX%29+Higher+On+FDA+Approval+of+Qutenza/5117388.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/NeurogesX+%28NGSX%29+Higher+On+FDA+Approval+of+Qutenza/5117388.html for the full story. http://www.streetinsider.com/FDA/NeurogesX+%28NGSX%29+Higher+On+FDA+Approval+of+Qutenza/5117388.html Tue, 17 Nov 2009 08:59:38 -0500 NGSX Merck (MRK) Announces Results of COZAAR Study; Increased Dose Reduced Death or Hospitalization from Heart Failure http://www.streetinsider.com/FDA/Merck+%28MRK%29+Announces+Results+of+COZAAR+Study%3B+Increased+Dose+Reduced+Death+or+Hospitalization+from+Heart+Failure/5117335.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Merck+%28MRK%29+Announces+Results+of+COZAAR+Study%3B+Increased+Dose+Reduced+Death+or+Hospitalization+from+Heart+Failure/5117335.html for the full story. http://www.streetinsider.com/FDA/Merck+%28MRK%29+Announces+Results+of+COZAAR+Study%3B+Increased+Dose+Reduced+Death+or+Hospitalization+from+Heart+Failure/5117335.html Tue, 17 Nov 2009 08:45:53 -0500 MRK InterMune (ITMN) Modifies On-Going Phase 2b Study of ITMN-191 http://www.streetinsider.com/FDA/InterMune+%28ITMN%29+Modifies+On-Going+Phase+2b+Study+of+ITMN-191/5117334.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/InterMune+%28ITMN%29+Modifies+On-Going+Phase+2b+Study+of+ITMN-191/5117334.html for the full story. http://www.streetinsider.com/FDA/InterMune+%28ITMN%29+Modifies+On-Going+Phase+2b+Study+of+ITMN-191/5117334.html Tue, 17 Nov 2009 08:45:34 -0500 ITMN Discovery Laboratories (DSCO) Submits Propsed Protocol for Surfaxin Clinical to U.S. FDA http://www.streetinsider.com/FDA/Discovery+Laboratories+%28DSCO%29+Submits+Propsed+Protocol+for+Surfaxin+Clinical+to+U.S.+FDA/5116739.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Discovery+Laboratories+%28DSCO%29+Submits+Propsed+Protocol+for+Surfaxin+Clinical+to+U.S.+FDA/5116739.html for the full story. http://www.streetinsider.com/FDA/Discovery+Laboratories+%28DSCO%29+Submits+Propsed+Protocol+for+Surfaxin+Clinical+to+U.S.+FDA/5116739.html Tue, 17 Nov 2009 07:31:31 -0500 DSCO Kinetic Concepts (KCI) Losses Bid To Halt Sales of Smith & Nephew Wound Kits - Bloomberg http://www.streetinsider.com/FDA/Kinetic+Concepts+%28KCI%29+Losses+Bid+To+Halt+Sales+of+Smith+%26+Nephew+Wound+Kits+-+Bloomberg/5113368.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Kinetic+Concepts+%28KCI%29+Losses+Bid+To+Halt+Sales+of+Smith+%26+Nephew+Wound+Kits+-+Bloomberg/5113368.html for the full story. http://www.streetinsider.com/FDA/Kinetic+Concepts+%28KCI%29+Losses+Bid+To+Halt+Sales+of+Smith+%26+Nephew+Wound+Kits+-+Bloomberg/5113368.html Mon, 16 Nov 2009 14:49:08 -0500 KCI SNN Cerus (CERS) Halted As FDA To Review Proposed Phase III Clinical Trial Design for the INTERCEPT Blood System http://www.streetinsider.com/FDA/Cerus+%28CERS%29+Halted+As+FDA+To+Review+Proposed+Phase+III+Clinical+Trial+Design+for+the+INTERCEPT+Blood+System/5113140.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Cerus+%28CERS%29+Halted+As+FDA+To+Review+Proposed+Phase+III+Clinical+Trial+Design+for+the+INTERCEPT+Blood+System/5113140.html for the full story. http://www.streetinsider.com/FDA/Cerus+%28CERS%29+Halted+As+FDA+To+Review+Proposed+Phase+III+Clinical+Trial+Design+for+the+INTERCEPT+Blood+System/5113140.html Mon, 16 Nov 2009 14:21:50 -0500 CERS ODAC to Review Using OSI Pharma's (OSIP) Tarceva as First-Line Therapy for Patients with Advanced Non-Small Cell Lung Cancer http://www.streetinsider.com/FDA/ODAC+to+Review+Using+OSI+Pharma%27s+%28OSIP%29+Tarceva+as+First-Line+Therapy+for+Patients+with+Advanced+Non-Small+Cell+Lung+Cancer/5112051.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/ODAC+to+Review+Using+OSI+Pharma%27s+%28OSIP%29+Tarceva+as+First-Line+Therapy+for+Patients+with+Advanced+Non-Small+Cell+Lung+Cancer/5112051.html for the full story. http://www.streetinsider.com/FDA/ODAC+to+Review+Using+OSI+Pharma%27s+%28OSIP%29+Tarceva+as+First-Line+Therapy+for+Patients+with+Advanced+Non-Small+Cell+Lung+Cancer/5112051.html Mon, 16 Nov 2009 11:37:33 -0500 OSIP NovaDel Pharma (NVD) to Enter into Exclusive License and Distribution Agreement with ECR Pharma for ZolpiMist http://www.streetinsider.com/FDA/NovaDel+Pharma+%28NVD%29+to+Enter+into+Exclusive+License+and+Distribution+Agreement+with+ECR+Pharma+for+ZolpiMist/5111139.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/NovaDel+Pharma+%28NVD%29+to+Enter+into+Exclusive+License+and+Distribution+Agreement+with+ECR+Pharma+for+ZolpiMist/5111139.html for the full story. http://www.streetinsider.com/FDA/NovaDel+Pharma+%28NVD%29+to+Enter+into+Exclusive+License+and+Distribution+Agreement+with+ECR+Pharma+for+ZolpiMist/5111139.html Mon, 16 Nov 2009 09:28:26 -0500 NVD Genzyme (GENZ) Receives FDA Complete Response Letter Regarding Application to Market Lumizyme http://www.streetinsider.com/FDA/Genzyme+%28GENZ%29+Receives+FDA+Complete+Response+Letter+Regarding+Application+to+Market+Lumizyme/5111088.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Genzyme+%28GENZ%29+Receives+FDA+Complete+Response+Letter+Regarding+Application+to+Market+Lumizyme/5111088.html for the full story. http://www.streetinsider.com/FDA/Genzyme+%28GENZ%29+Receives+FDA+Complete+Response+Letter+Regarding+Application+to+Market+Lumizyme/5111088.html Mon, 16 Nov 2009 09:19:19 -0500 GENZ Biotech Movers: SPEX, NABI, ALKS Up; PARD, CRXX Down http://www.streetinsider.com/FDA/Biotech+Movers%3A+SPEX%2C+NABI%2C+ALKS+Up%3B+PARD%2C+CRXX+Down/5111025.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Biotech+Movers%3A+SPEX%2C+NABI%2C+ALKS+Up%3B+PARD%2C+CRXX+Down/5111025.html for the full story. http://www.streetinsider.com/FDA/Biotech+Movers%3A+SPEX%2C+NABI%2C+ALKS+Up%3B+PARD%2C+CRXX+Down/5111025.html Mon, 16 Nov 2009 09:11:04 -0500 ALKS CRXX NABI PARD SPEX Par Pharma (PRX) Receives Final U.S. FDA Approval for Tramadol ER Doses http://www.streetinsider.com/FDA/Par+Pharma+%28PRX%29+Receives+Final+U.S.+FDA+Approval+for+Tramadol+ER+Doses/5110530.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Par+Pharma+%28PRX%29+Receives+Final+U.S.+FDA+Approval+for+Tramadol+ER+Doses/5110530.html for the full story. http://www.streetinsider.com/FDA/Par+Pharma+%28PRX%29+Receives+Final+U.S.+FDA+Approval+for+Tramadol+ER+Doses/5110530.html Mon, 16 Nov 2009 08:31:37 -0500 PRX Alkermes (ALKS) Reports Positive Preliminary Results from Phase 3 Trial of Naltrexone http://www.streetinsider.com/FDA/Alkermes+%28ALKS%29+Reports+Positive+Preliminary+Results+from+Phase+3+Trial+of+Naltrexone/5110362.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Alkermes+%28ALKS%29+Reports+Positive+Preliminary+Results+from+Phase+3+Trial+of+Naltrexone/5110362.html for the full story. http://www.streetinsider.com/FDA/Alkermes+%28ALKS%29+Reports+Positive+Preliminary+Results+from+Phase+3+Trial+of+Naltrexone/5110362.html Mon, 16 Nov 2009 08:06:47 -0500 ALKS Covidien (COV) Announces Neuromed Representatives Discuss Pending NDA for ExalgoTM http://www.streetinsider.com/FDA/Covidien+%28COV%29+Announces+Neuromed+Representatives+Discuss+Pending+NDA+for+ExalgoTM/5110127.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Covidien+%28COV%29+Announces+Neuromed+Representatives+Discuss+Pending+NDA+for+ExalgoTM/5110127.html for the full story. http://www.streetinsider.com/FDA/Covidien+%28COV%29+Announces+Neuromed+Representatives+Discuss+Pending+NDA+for+ExalgoTM/5110127.html Mon, 16 Nov 2009 07:42:03 -0500 COV CombinatoRx (CRXX) Receives FDA Feedback on NDA for Exalgo ER Tablets http://www.streetinsider.com/FDA/CombinatoRx+%28CRXX%29+Receives+FDA+Feedback+on+NDA+for+Exalgo+ER+Tablets/5110104.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/CombinatoRx+%28CRXX%29+Receives+FDA+Feedback+on+NDA+for+Exalgo+ER+Tablets/5110104.html for the full story. http://www.streetinsider.com/FDA/CombinatoRx+%28CRXX%29+Receives+FDA+Feedback+on+NDA+for+Exalgo+ER+Tablets/5110104.html Mon, 16 Nov 2009 07:33:52 -0500 CRXX Human Genome (HGSI) Receives U.S. FDA Response Letter for Anthrax Treatment Raxibacumab http://www.streetinsider.com/FDA/Human+Genome+%28HGSI%29+Receives+U.S.+FDA+Response+Letter+for+Anthrax+Treatment+Raxibacumab/5110041.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Human+Genome+%28HGSI%29+Receives+U.S.+FDA+Response+Letter+for+Anthrax+Treatment+Raxibacumab/5110041.html for the full story. http://www.streetinsider.com/FDA/Human+Genome+%28HGSI%29+Receives+U.S.+FDA+Response+Letter+for+Anthrax+Treatment+Raxibacumab/5110041.html Mon, 16 Nov 2009 07:24:59 -0500 HGSI Poniard Pharma (PARD) SPEAR Phase III of Picoplatin Did Not Meet Survival Endpoint http://www.streetinsider.com/FDA/Poniard+Pharma+%28PARD%29+SPEAR+Phase+III+of+Picoplatin+Did+Not+Meet+Survival+Endpoint/5110026.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Poniard+Pharma+%28PARD%29+SPEAR+Phase+III+of+Picoplatin+Did+Not+Meet+Survival+Endpoint/5110026.html for the full story. http://www.streetinsider.com/FDA/Poniard+Pharma+%28PARD%29+SPEAR+Phase+III+of+Picoplatin+Did+Not+Meet+Survival+Endpoint/5110026.html Mon, 16 Nov 2009 07:16:18 -0500 PARD GLAXO (GSK) and Nabi BioPharma (NABI) Announce Option and Licensing Agreement for NicVAX http://www.streetinsider.com/FDA/GLAXO+%28GSK%29+and+Nabi+BioPharma+%28NABI%29+Announce+Option+and+Licensing+Agreement+for+NicVAX/5109860.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/GLAXO+%28GSK%29+and+Nabi+BioPharma+%28NABI%29+Announce+Option+and+Licensing+Agreement+for+NicVAX/5109860.html for the full story. http://www.streetinsider.com/FDA/GLAXO+%28GSK%29+and+Nabi+BioPharma+%28NABI%29+Announce+Option+and+Licensing+Agreement+for+NicVAX/5109860.html Mon, 16 Nov 2009 06:45:03 -0500 GSK GSK NABI Genzyme's (GENZ) Quality Control Detects Foreign Particles in Five Enzyme Replacement Products; Issues Letters to U.S. Healthcare Providers http://www.streetinsider.com/FDA/Genzyme%27s+%28GENZ%29+Quality+Control+Detects+Foreign+Particles+in+Five+Enzyme+Replacement+Products%3B+Issues+Letters+to+U.S.+Healthcare+Providers/5109246.html Visit StreetInsider.com at http://www.streetinsider.com/FDA/Genzyme%27s+%28GENZ%29+Quality+Control+Detects+Foreign+Particles+in+Five+Enzyme+Replacement+Products%3B+Issues+Letters+to+U.S.+Healthcare+Providers/5109246.html for the full story. http://www.streetinsider.com/FDA/Genzyme%27s+%28GENZ%29+Quality+Control+Detects+Foreign+Particles+in+Five+Enzyme+Replacement+Products%3B+Issues+Letters+to+U.S.+Healthcare+Providers/5109246.html Fri, 13 Nov 2009 19:20:01 -0500 GENZ