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Velcade® (Bortezomib) Findings Reinforce Efficacy And Survival Across Multiple Patient Populations Dec 9, 2008 |
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Beerse, BELGIUM - (9 December, 2008) - Janssen-Cilag today announced preliminary results from a prospective, international, multicenter, open-label, phase II study showing re-treatment with VELCADE® (bortezomib) is an effective and well-tolerated treatment option for patients with relapsed multiple myeloma (MM) who had previously resp... |
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Rivaroxaban Reduces Symptomatic VTE & Death Following Knee or Hip Replacement Surgery by More Than 50% Compared to Enoxaparin in Pooled Analysis of the RECORD Clinical Trial Program Dec 7, 2008 |
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San Francisco (December 7, 2008) -- Results from a pre-specified pooled analysis of the RECORD clinical trial program showed that the novel, investigational, oral anticoagulant rivaroxaban was superior to enoxaparin treatment regimens for the prevention of venous thromboembolism (VTE) after total knee or hip replacement surgery. The data also show ... |
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Phase III Data Demonstrates Efficacy and Tolerability of Carisbamate as an Adjunctive Therapy for Partial Onset Seizures Dec 6, 2008 |
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Seattle, WA (December 6, 2008) – Phase III data on carisbamate, an investigational compound recently filed with the FDA for the adjunctive treatment of partial onset seizures (POS) in patients 16 years of age and older, was presented today during the poster sessions of the 32nd Annual Meeting of the American Epilepsy Society.Result... |
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Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-stimulating Agents Associated with Increased Need for Blood Transfusion Dec 6, 2008 |
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OBSERVATIONAL STUDY FINDS CHANGES IN MEDICARE REIMBURSEMENT FOR ERYTHROPOIESIS-STIMULATING AGENTS ASSOCIATED WITH INCREASED NEED FOR BLOOD TRANSFUSIONSAN FRANCISCO (December 6, 2008) – Researchers today report that after the implementation of Medicare coverage limitations for erythropoiesis-stimulating agents (ESAs), a significan... |
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Tibotec and Emcure Collaborate on Access to Darunavir for India Dec 3, 2008 |
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County Cork, Ireland (December 3, 2008) - Tibotec Pharmaceuticals today announced that it has signed a royalty-free, non-exclusive license agreement with Emcure Pharmaceuticals Limited of India to distribute the protease inhibitor darunavir (DRV) in India.Tibotec is committed to ensuring access to innovative HIV/AIDS therapies and has c... |
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Prezista® (Darunavir) Receives Expanded Marketing Authorisation In The European Union For Treatment-Experienced Adults With HIV-1 Dec 3, 2008 |
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Cork, Ireland - 3 December 2008 - Tibotec Pharmaceuticals, announced today that the European Commission adopted the decision to broaden the indication for PREZISTA® (darunavir), a protease inhibitor, in combination with ritonavir and other antiretroviral medicinal products to the treatment of HIV-1 infection in all treatment-experienced a... |
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ETHICON Completes Divestiture of Professional Wound Care Business to One Equity Partners Dec 1, 2008 |
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SOMERVILLE, N.J., Dec. 1 /PRNewswire/ -- ETHICON, Inc., a Johnson & Johnson company, announced today that it has completed the divestiture of its Professional Wound Care business to One Equity Partners. Financial terms of the transaction are not being disclosed. Under the terms of the transaction, One Equity Partners has acquired the... |
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Johnson & Johnson Announces Definitive Agreement to Acquire Mentor Corporation Dec 1, 2008 |
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NEW BRUNSWICK, N.J. and SANTA BARBARA, Calif., Dec 01, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Mentor's Aesthetic and Reconstructive Medical Products Complement Ethicon's Industry-Leading Surgery Portfolio Johnson & Johnson (NYSE: JNJ) and Mentor Corporation (NYSE: MNT), a leading supplier of medical products for the global aestheti... |
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European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion For Once-Daily PREZISTA® (darunavir) as Part of Combination Therapy for Treatment-Naïve Adults With HIV-1 Nov 27, 2008 |
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Cork, Ireland (November 27, 2008) - The Committee for Human Medicinal Products (CHMP) has issued a positive opinion recommending approval for once-daily dosing of 800 mg PREZISTA® (darunavir) with low-dose ritonavir as part of combination therapy in treatment-naïve adults (those who have never taken HIV medication before). Darunavir, a proteas... |
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FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections Nov 26, 2008 |
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RARITAN, N.J., Nov 26, 2008 /PRNewswire via COMTEX News Network/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received a Complete Response 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... |
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Johnson & Johnson Begins Tender Offer to Acquire Omrix Nov 25, 2008 |
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NEW BRUNSWICK, N.J., Nov 25, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Johnson & Johnson (NYSE: JNJ) is commencing today, through a new wholly-owned subsidiary, Binder Merger Sub, Inc., a cash tender offer to purchase all outstanding shares of common stock of Omrix Biopharmaceuticals, Inc. (Nasdaq: OMRI). Johnson & Johnson reported on... |
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Johnson & Johnson Announces Definitive Agreement to Acquire Omrix Nov 24, 2008 |
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New Brunswick, N.J. and New York (Nov. 24, 2008) -- Johnson & Johnson (NYSE: JNJ) and Omrix Biopharmaceuticals, Inc. (NASDAQ: OMRI), a fully integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, today announced a definitive agreement whereby Omrix will be acquired for approximately $438 millio... |
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New Antibiotic Against Serious Infections Nov 21, 2008 |
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Beerse, Belgium (November 21, 2008) - The Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the antibiotic, ZEVTERA™ (ceftobiprole medocaril) for the treatment of complicated skin and soft tissue infections. The CHMP's positive opinion is now referred for final action ... |
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FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain Nov 21, 2008 |
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Raritan, NJ - November 21, 2008 - Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Today, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD), announced that the U.S. Food and Drug Administration (FDA) approved tapentadol immediate-re... |
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European Agency for the Evaluation of Medicinal Products Recommends Suspension of Marketing Authorisation for IONSYS® Nov 20, 2008 |
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Beerse, Belgium (November 20, 2008) - Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended suspension of the marketing authorisation for IONSYS® (fentanyl iontophoretic transdermal system), indicated for the management of acute mo... |
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FDA Advisory Panel Unanimously Recommends Approval of NAVISTAR® THERMOCOOL® Catheter for Atrial Fibrillation Nov 20, 2008 |
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GAITHERSBURG, Md., Nov 20, 2008 (BUSINESS WIRE) -- SOURCE: Biosense Webster, Inc. Biosense Webster, Inc.Christopher Allman, 305-586-6024 Copyright Business Wire 2008 News Provided by COMTEX... |
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Tibotec Begins Enrollment in Europe for Phase III Trial of Telaprevir in HCV Patients who Failed Prior Treatment Nov 20, 2008 |
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CORK, Ireland, November 20 /PRNewswire/ -- Tibotec BVBA today announced that it has begun enrolling patients in its phase III study of telaprevir (VX-950), an investigational protease inhibitor (PI), in patients with chronic genotype 1 hepatitis C virus (HCV) for whom the current standard treatment has not been successful. Tibotec is managing th... |
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Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008 Nov 20, 2008 |
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SAN FRANCISCO, Nov. 1 /PRNewswire/ -- New clinical data show antiviral activity of TMC435, an investigational protease inhibitor (PI) being developed by Tibotec BVBA for the treatment of chronic hepatitis C virus (HCV) infection. Tibotec will present findings from three TMC435 studies, including a late-breaker poster on the proof-of-principle ph... |
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Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer Nov 20, 2008 |
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Bridgewater, N.J. (November 20, 2008) - Ortho Biotech Products, L.P. today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL® (doxorubicin HCI liposome injection) for the treatment of women with r... |
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Long-Term Titan Study Evaluates Prezista®/Ritonavir vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Experienced Adults Nov 18, 2008 |
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[Bridgewater, NJ, November 18, 2008] - Tibotec recently announced long-term study results from a phase 3 clinical trial, which compared PREZISTA® (darunavir) /ritonavir to lopinavir/ritonavir, as part of HIV combination therapy, in lopinavir/r-naïve, treatment-experienced HIV-1 infected adults. A 96-week resistance analysis from the ... |
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