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First Patient Enrolled in CYPRESS, a Dual Antiplatelet Therapy Trial with the CYPHER(R) Sirolimus-Eluting Coronary Stent Aug 31, 2009 |
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BRIDGEWATER, N.J., Aug 31, 2009 (BUSINESS WIRE) -- Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today that the first patient has been enrolled in the CYPRESS study, which will assess clinical outcomes in a broad range of patients with coronary ... |
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FDA Issues Complete Response Letter for Carisbamate Aug 21, 2009 |
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TITUSVILLE, N.J., Aug 21, 2009 /PRNewswire via COMTEX News Network/ -- The U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for carisbamate, an anti-epileptic drug in development, announced Ortho-McNeil-Janssen Pharmaceuticals, Inc. The NDA, filed in October 2008 by Johnson & Johnso... |
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DePuy receives FDA Advisory Panel Recommendation for Pinnacle( R) CoMplete( TM) Acetabular Hip System Aug 19, 2009 |
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WARSAW, IN - August 18, 2009 - DePuy Orthopaedics, Inc., a global leader in devices for joint replacement, today announced that the Orthopaedic and Rehabilitation Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) has unanimously recommended FDA approval of the Pinnacle® CoMplete™ Acetabular Hip System, the fir... |
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Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia Aug 3, 2009 |
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TITUSVILLE, N.J., Aug 03, 2009 /PRNewswire via COMTEX News Network/ -- The U.S. Food and Drug Administration approved INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults on Friday, July 31, 2009. It is the first once-monthly, long-acting, injectabl... |
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FDA Approves INVEGA( R) SUSTENNA( TM) for the Acute and Maintenance Treatment of Schizophrenia Jul 31, 2009 |
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Titusville, N.J., July 31, 2009 - The U.S. Food and Drug Administration today approved INVEGA® SUSTENNA™ (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults. It is the first once-monthly, long-actin... |
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INVEGA( R) Approved as the First and Only Treatment for Schizoaffective Disorder Jul 31, 2009 |
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Titusville, N.J., July 31, 2009 -The U.S. Food and Drug Administration (FDA) today approved the first and only antipsychotic for the acute treatment of schizoaffective disorder. INVEGA® (paliperidone) extended-release tablets were approved for the acute treatment of schizoaffective disorder either as monother... |
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FDA Approves Vitros( R) Anti-HCV Assay For Use On Vitros 5600( R) Integrated And Vitros 3600( R) Immunodiagnostic Systems Jul 21, 2009 |
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RARITAN, N.J. (July 21, 2009) - Ortho Clinical Diagnostics today announced the U.S. Food and Drug Administration (FDA) approval of the VITROS® Anti-HCV assay for use on the VITROS 5600® Integrated and 3600® Immunodiagnostic Systems. This approval marks a major milestone in the successful ... |
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Ortho Clinical Diagnostics Launches 24-Hour Remote Monitoring Center Jul 21, 2009 |
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RARITAN, N.J. (July 21, 2009) - Ortho Clinical Diagnostics today announced the launch of its Remote Monitoring Center, the first 24-7 central command center in the in vitro diagnostic industry that continuously tracks the condition of laboratory instrument performance. Using proprietary remote diagnostic tools leveraging more than 3... |
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New HIV Study Shows That Large Numbers of Women and People of Color can be Successfully Enrolled in U.S. HIV Clinical Studies Jul 20, 2009 |
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[Bridgewater, NJ, July 20] - Data from a historic HIV study demonstrate that it is possible to recruit large numbers of women, African Americans and Latinos into U.S.-based HIV-1 treatment studies. The study, known as GRACE, is the largest study to date in treatment-experienced adult women with HIV-1 to examine gender and race diffe... |
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96-Week Safety and Efficacy Findings Presented for Intelencetm (Etravirine) as Part of HIV Combination Therapy Jul 20, 2009 |
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Bridgewater, NJ, [July 20, 2009]-Ninety-six week pooled results from two Phase 3 studies (DUET-1 and DUET-2) showed that significantly more treatment-experienced HIV-1-infected adults with non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI) resistance had an undetectable viral load (<50 HIV-1 RNA copies/mL... |
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Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada® with Gilead Sciences Jul 16, 2009 |
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Cork, Ireland, July 16, 2009 - Tibotec Pharmaceuticals today announced that it has entered into a license and collaboration agreement with Gilead Sciences, Inc. for the development and commercialization of a new once-daily fixed-dose antiretroviral product containing Tibotec's investigational non-nucleoside reverse transcripta... |
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Centocor Ortho Biotech Statement on FDA ODAC Opinion Regarding Doxil( R) for Treatment of Advanced Breast Cancer Jul 15, 2009 |
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Horsham, Pa., July 15, 2009 - Based on the data presented today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of DOXIL® (doxorubicin HCI liposome injection) and docetaxel did not provide a sufficient benefit-risk profile for first-line treatment of locally... |
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Centocor Ortho Biotech Statement on the FDA ODAC Opinion Regarding Trabectedin for Relapsed Ovarian Cancer
Jul 15, 2009 |
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Horsham, Pa., July 15, 2009 - Based on the data presented today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of trabectedin when administered with DOXIL® (doxorubicin HCI liposome injection) did not provide a sufficient benefit-risk profile for the t... |
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Johnson & Johnson Reports 2009 Second-Quarter Results: Jul 14, 2009 |
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NEW BRUNSWICK, N.J., July 14, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Johnson & Johnson (NYSE: JNJ) today announced sales of $15.2 billion for the second quarter of 2009, a decrease of 7.4% as compared to the second quarter of 2008. Operational results declined 1.4% and the negative impact of currency was 6.0%. Domestic sales declin... |
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Johnson & Johnson Completes Acquisition of Cougar Biotechnology Jul 10, 2009 |
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NEW BRUNSWICK, N.J., July 10, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Johnson & Johnson (NYSE: JNJ) today announced it has successfully completed its acquisition of Cougar Biotechnology, Inc., a development stage biopharmaceutical company with a specific focus on oncology. Johnson & Johnson's tender offer for shares of Cougar Biotec... |
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Johnson & Johnson to Host Analyst Conference Call on Second-Quarter Results Jul 7, 2009 |
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NEW BRUNSWICK, N.J., July 7, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Johnson & Johnson will host a conference call for financial analysts at 8:30 a.m. (Eastern Time) on Tuesday, July 14, 2009, to review second-quarter results. Dominic Caruso, Vice President, Finance and Chief Financial Officer, and Louise Mehrotra, Vice President, I... |
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Johnson & Johnson Completes Initial Tender Offer for Cougar Biotechnology Jul 3, 2009 |
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NEW BRUNSWICK, N.J., July 3, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Johnson & Johnson (NYSE: JNJ) today announced that the initial offering period of its tender offer for all outstanding shares of common stock of Cougar Biotechnology, Inc. (Nasdaq: CGRB) expired at midnight (Eastern time) on July 2, 2009. The offer was conducted th... |
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Johnson & Johnson and Elan Corporation plc Announce Definitive Agreement for Alzheimer's Immunotherapy Program and Equity Investment Jul 2, 2009 |
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New Brunswick, N.J., and Dublin, Ireland, July 2, 2009 - Johnson & Johnson (NYSE: JNJ) and Elan Corporation plc (NYSE: ELN) today announced a definitive agreement whereby Johnson & Johnson will acquire substantially all of the assets and rights of Elan related to its Alzheimer's Immunotherapy Program (AIP Program), through a newly formed company... |
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Centocor Ortho Biotech Inc. Awarded $1.67 Billion Patent Jury Verdict from Abbott Laboratories Jun 29, 2009 |
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HORSHAM, Pa., June 29, 2009 /PRNewswire via COMTEX News Network/ -- Centocor Ortho Biotech Inc. announced today that a federal jury has returned a verdict of $1.67 billion against Abbott Laboratories in a patent infringement suit. "We are pleased that the jury has ruled in our favor in the patent litigation case against Abbott," said Kim Taylor, P... |
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Simponi™ (Golimumab) Receives Positive Opinion From CHMP For Once-Monthly Subcutaneous Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis Jun 26, 2009 |
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HORSHAM, Pa. and KENILWORTH, N.J., June 26, 2009 - Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending the approval of SIMPONI™ (golimumab) as a once-monthl... |
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