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Clinical Trial Begins for Innovative Drug-Eluting Stent with Unique Reservoir Technology Mar 27, 2008 |
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Warren, NJ (March 27, 2008) - A randomized clinical trial comparing the Conor Sirolimus-eluting Coronary Stent, a new cobalt chromium reservoir-base stent design, to the Taxus Liberte Paclitaxel-eluting Coronary Stent has begun according to Conor Medsystems, LLC and Cordis Corporation, the sponsors of the study. "We a... |
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Ethicon Endo-Surgery Submits Application to FDA for Approval of the Sedasys™ System - The First Computer-Assisted Personalized Sedation System Mar 27, 2008 |
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Cincinnati, OH (March 27, 2008) - Ethicon Endo-Surgery announced today that the company has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEDASYS™ System, the first computer-assisted personalized sedation (CAPS) system. The SEDASYS™ System is intended ... |
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Relief "In Sight" For Allergy Sufferers Mar 21, 2008 |
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Doctor says single use lens is healthy contact lens option for wearers prone to ocular allergies; ACUVUE® Offers Free Trial Pair Certificate* for 1?DAY ACUVUE® MOIST Brand Contact Lenses JACKSONVILLE, Fla. (March 21, 2008) - For many of the nation's 40 million contact lens wearers, seasonal ocular allergy symptoms such as itching, tear... |
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Centocor, Inc. And Schering-Plough Submit Application Requesting Approval Of Golimumab In Europe For The Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis Mar 19, 2008 |
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HORSHAM, PA, and KENILWORTH, N.J., March 18, 2008 - Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP) announced today that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with... |
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FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections Mar 18, 2008 |
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RARITAN, N.J., March 18, 2008 /PRNewswire via COMTEX News Network/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and ski... |
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Cordis Corporation Receives U.S. Food and Drug Administration Clearance for S.M.A.R.T. Nitinol Stent Transhepatic Biliary System for 120 mm and 150 mm Lengths Mar 17, 2008 |
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WASHINGTON, Mar 17, 2008 (BUSINESS WIRE) -- Cordis Corporation announced today at the 33rd Annual Scientific Meeting of the Society of Interventional Radiology meeting it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the S.M.A.R.T.(R) Nitinol Stent Transhepatic Biliary System for lengths of 120 mm and 150 mm... |
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Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote Mar 17, 2008 |
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GAITHERSBURG, MD (March 13, 2008) -- Ortho Biotech is concerned by the Advisory Committee's recommendations to restrict access to erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia (CIA) in patients with metastatic breast and head and neck cancer, and patients treated with curative intent. The company beli... |
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Johnson & Johnson to Participate in the 28th Annual Cowen & Company Health Care Conference Mar 13, 2008 |
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NEW BRUNSWICK, N.J., March 13, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Johnson & Johnson will participate in the 28th Annual Cowen & Company Health Care Conference on Thursday, March 20th at the Boston Marriott Copley Place Hotel in Boston, Massachusetts. Colleen Goggins, Worldwide Chairman, Consumer Group will represent the Company ... |
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Totality of Available Data Reaffirms PROCRIT® (Epoetin alfa) Safe and Effective When Used Appropriately As Labeled to Treat Chemotherapy-Induced Anemia Mar 11, 2008 |
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BRIDGEWATER, NJ (March 11, 2008) -- The totality of scientific data submitted in recent months to the U.S. Food and Drug Administration (FDA) in preparation for the March 13th Oncologic Drugs Advisory Committee Meeting (ODAC) reaffirms that erythropoiesis-stimulating agents (ESAs) are safe and effective when used according to th... |
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Johnson & Johnson to Participate in Lehman Brothers Eleventh Annual Global Healthcare Conference Mar 11, 2008 |
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NEW BRUNSWICK, N.J., March 11, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Johnson & Johnson will participate in the Eleventh Annual Lehman Brothers Global Healthcare Conference on Tuesday, March 18th at the Loews Miami Beach Hotel in Miami, Florida. Dominic Caruso, Vice President, Finance and Chief Financial Officer, will represent the ... |
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Ortho Biotech Modifies Prescribing Information for PROCRIT® (Epoetin alfa) Mar 7, 2008 |
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BRIDGEWATER, N.J. (March 7, 2007) - Ortho Biotech Products, L.P. today modified prescribing information for PROCRIT® (Epoetin alfa), following guidance from the U.S. Food and Drug Administration (FDA) to revise labeling for all drugs within the erythropoiesis-stimulating agent (ESA) class. Modifications to the label were based... |
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FDA Extends Review Timeline for Additional Indication for Antibiotic DORIBAX(TM) Mar 6, 2008 |
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RARITAN, N.J., March 6, 2008 /PRNewswire via COMTEX News Network/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the second New Drug Application for the antibiotic DORIBAX(TM) (doripenem for injection). The application, submitt... |
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FDA CLEARS CELLSEARCH™ CIRCULATING TUMOR CELL TEST Feb 27, 2008 |
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RARITAN, N.J., Feb. 27, 2008 - Veridex, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic prostate cancer (MPC) patients. The CellSearch™ S... |
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DePuy to Host Analyst Meeting Feb 27, 2008 |
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NEW BRUNSWICK, N.J., Feb 27, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- DePuy, Inc., a Johnson & Johnson company, will sponsor an analyst meeting and webcast for financial analysts on Wednesday, March 5, from 2:00 p.m.-3:00 p.m. (Pacific Standard Time) to coincide with the American Academy of Orthopaedic Surgeons (AAOS) conference in Sa... |
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PRICARA™ RECALLS 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII PAIN PATCHES Feb 12, 2008 |
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Raritan, NJ (February 12, 2008) - PriCara,™ Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being v... |
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New 48-Week Efficacy and Safety Data Presented for Intelencetm (Etravirine) As Part of HIV Combination Therapy Feb 7, 2008 |
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[Boston, February 7, 2008] - New data showed that at 48 weeks, significantly more treatment-experienced adults with HIV-1 with documented resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) had an undetectable viral load (defined as less than 50 HIV-1 RNA copies/mL) with INTELENCE... |
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Promising Phase 3 Data for Ustekinumab (Cnto 1275) in Long-Term Improvement of Chronic Plaque Psoriasis Feb 4, 2008 |
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San Antonio, TX (February 4, 2008) - One-year data from the second double blind, placebo-controlled Phase 3 study PHOENIX 1 showed therapy with ustekinumab given every 12 weeks provided sustained, clinically meaningful improvement in the treatment of moderate to severe plaque psoriasis through one year. According to findings pr... |
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Centocor Announces Ustekinumab Biologic License Application Accepted For Filing By FDA Feb 4, 2008 |
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HORSHAM, Pa., (February 4, 2008) -- Centocor, Inc. announced today that the Biologics License Application (BLA) for ustekinumab (CNTO 1275) has been accepted for review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Ustekinumab is a new, human monoclonal antibo... |
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Study Suggests Risperidone Long-Acting Injection Combined with Standard Treatment Helped Delay Time to Relapse in Patients with Bipolar Disorder Feb 4, 2008 |
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MONTREUX, Switzerland, Feb 04, 2008 /PRNewswire via COMTEX News Network/ -- Patients with frequently relapsing bipolar disorder had a significant delay in the time to an initial relapse when risperidone long-acting injection (RLAI) was combined with standard treatment, according to a new study. The study compared patients who received RLAI and stan... |
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New Drug Application Submitted to FDA for Investigational Analgesic Tapentadol Immediate Release Tablets Jan 23, 2008 |
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RARITAN, N.J., Jan 23, 2008 /PRNewswire-USNewswire via COMTEX News Network/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol hydrochloride immediate release (IR) tablets, an investigational oral analgesic for ... |
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