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  • Celgene Officially Notified of ANDA Filing for REVLIMID®
    SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). The application requests authorization to manufacture and market generic versions of REVLIMID® (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States. Celgene intends to vigorously enforce its extens
  • Stentys appoints Stanislas Piot as Chief Financial Officer
    PRINCETON, N.J. & PARIS--(BUSINESS WIRE)--Stentys appoints new Chief Financial Officer
  • Long Term Data Presented at ESC 2010 Shed Further Light on the Benefit of the CYPHER® Sirolimus Drug-Eluting Stent Compared to the ENDEAVOR® Zotarolimus-Eluting Stent in Important High-Risk Subgroups
    BRIDGEWATER, N.J.--(BUSINESS WIRE)--Three new analyses of subgroups from the SORT OUT III study presented at the European Society of Cardiology (ESC) meeting in Stockholm, Sweden, provide additional detail on longer-term follow-up subgroup safety and efficacy outcomes in the SORT OUT III trial in three high-risk subgroups. These important data add detail to those already published in the March, 2010 issue of the Lancet on the clinical outcomes for the primary endpoint in the total population and
  • Saint Barnabas Medical Center Implements ZOLL AutoPulse
    CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that Saint Barnabas Medical Center, one of the largest non-profit, non-sectarian hospitals in New Jersey, has installed the AutoPulse® Non-Invasive Cardiac Support Pump for resuscitative capabilities in the hospital’s emergency department. The AutoPulse is the only automated chest compression device that uses an easy-to-use, load-distrib
  • BRINAVESS™ (vernakalant) for Infusion Approved in the European Union for Rapid Conversion of Recent Onset Atrial Fibrillation
    WHITEHOUSE STATION, N.J. & VANCOUVER, British Columbia--(BUSINESS WIRE)--Merck (known as MSD outside the United States and Canada) (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) today announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults: for non-surgery patients with AF of seven days or
  • Sentrx to Exhibit at the 4th Annual Pacific Drug Safety Summit September 23-24, 2010 in Burlingame, CA
    LITTLE FALLS, N.J.--(BUSINESS WIRE)--Sentrx to Exhibit at the 4th Annual Pacific Drug Safety Summit, September 23-24, 2010 in Burlingame, CA
  • PacificHealth Laboratories Promotes Fred Duffner, Current President, to CEO and President
    MATAWAN, N.J.--(BUSINESS WIRE)--PacificHealth Laboratories, Inc. (OTCBB: PHLI), a nutrition technology company, today announced that Fred Duffner has been promoted to CEO and President reporting directly to the Board of Directors. Mr. Duffner had previously been named President in January 2010. Fred Duffner, CEO and President of PacificHealth Laboratories said, “We have made great progress this year refocusing the company on its core brands in sports nutrition, reducing expenses and in building
  • Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate
    WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010. The extension is a result of the agency c