Actualités de Lexington/Massachusetts

18.05.2017 – 13:01
Shire Pharmaceuticals Group Plc
Shire's Investigational Treatment Lanadelumab Reduces Hereditary Angioedema Monthly Attack Rate by 87% Versus Placebo in Phase 3 26-week Pivotal Trial
Lexington, Massachusetts (ots/PRNewswire) - - Significant reduction in monthly Hereditary Angioedema (HAE) attack rate with infrequent subcutaneous administration - Data to serve as basis for U.S. BLA filing expected in Q4 2017 to Q1 2018 - Shire to host Investor Call today at 10 a.m. ET; details below Shire plc ...
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01.05.2017 – 13:01
Shire Pharmaceuticals Group Plc
Shire and Parion Sciences Enter into a Collaborative License Agreement to Advance P-321 for Ophthalmic Indications
Lexington, Massachusetts and Durham, North Carolina (ots/PRNewswire) - Demonstrates ongoing commitment to innovation in ophthalmics for Shire P-321 is a Phase 2 investigational topical treatment for dry eye disease Shire plc (LSE: SHP, NASDAQ: SHPG) and Parion Sciences, Inc. today announced they have entered into an ...
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12.11.2016 – 13:01
Shire Pharmaceuticals Group Plc
Tolerability Data for Shire's CUVITRU Accepted for Oral Presentation at the American College Of Allergy, Asthma & Immunology Annual Meeting
Lexington, Massachusetts (ots/PRNewswire) - Data reveals key findings on the tolerability of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] for patients, regardless of treatment infusion volume and rates Shire plc (LSE: SHP, NASDAQ: SHPG) will present additional data supporting the tolerability of ...
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17.10.2016 – 13:02
Shire Pharmaceuticals Group Plc
Shire Announces Update to Vyvanse® (lisdexamfetamine dimesylate) U.S. Labeling to Include New Longer-Term Maintenance of Efficacy Data in Adults with Moderate to Severe Binge Eating Disorder
Lexington, Massachusetts (ots/PRNewswire) - Labeling Update Based on Maintenance of Efficacy Data from a 38-Week Phase 3 Study For U.S. Audiences Only - Shire plc (LSE: SHP, NASDAQ: SHPG) announces an update to the Vyvanse® (lisdexamfetamine dimesylate) labeling to include information regarding the approval of a ...
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06.10.2016 – 00:09
Shire Pharmaceuticals Group Plc
Patent Trial and Appeal Board Upholds the Validity of LIALDA® Patent
Lexington, Massachusetts (ots/PRNewswire) - Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Patent & Trademark Office's Patent Trial and Appeal Board (PTAB) has issued their decision upholding the validity of U.S. Patent No. 6,773,720, related to Shire's LIALDA® (mesalamine) product. The petition seeking to institute inter partes review (IPR) was ...
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29.08.2016 – 16:49
Shire Pharmaceuticals Group Plc
Shire's First Prescription Eye Drop, Xiidra(TM) (lifitegrast ophthalmic solution) 5% is Now Available in the U.S.
Lexington, Massachusetts (ots/PRNewswire) - - Xiidra is the only prescription eye drop approved by the U.S. FDA for the treatment of both signs and symptoms of dry eye disease - Resources are available to support patients seeking information regarding coverage and savings offers - Xiidra is the first medication in a ...
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25.08.2016 – 13:03
Shire Pharmaceuticals Group Plc
Shire and Jennifer Aniston Want to Inspire People to Show Their Eyes Some Love and Help Raise Awareness of Chronic Dry Eye
Lexington, Massachusetts (ots/PRNewswire) - Jennifer Aniston Opens Up about Personal Experience with Dry Eye Symptoms, Which Have Been Reported by Nearly 30 Million Americans Jennifer Aniston is one of the millions of Americans who experience symptoms consistent with Chronic Dry Eye. Commonly referred to as Dry Eye, ...
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12.07.2016 – 01:10
Shire Pharmaceuticals Group Plc
Regulatory Approval - FDA Approves Shire's Xiidra(TM) (lifitegrast ophthalmic solution) 5% - The Only Treatment Indicated for the Signs and Symptoms of Dry Eye Disease
Lexington, Massachusetts (ots/PRNewswire) - - An estimated 16 million people in the U.S. are diagnosed with dry eye disease - Xiidra is the first prescription eye drop FDA-approved to treat both the signs and symptoms of dry eye disease - U.S. launch of Xiidra planned for third quarter 2016 Shire plc (LSE: SHP, ...
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30.06.2016 – 13:01
Shire Pharmaceuticals Group Plc
Shire Announces Top-Line Results for Phase 2 Trial of SHP607 in Extremely Premature Infants
Lexington, Massachusetts (ots/PRNewswire) - - Top-line SHP607 study results in extremely premature infants showed no impact on primary endpoint of reducing the severity of Retinopathy of Prematurity - Top-line analysis of secondary endpoints showed clinically relevant effects on severe complications related to lung and brain damage - These data support further ...
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29.03.2016 – 13:20
Shire Pharmaceuticals Group Plc
Shire Wins Patent Trial Against Watson Concerning LIALDA®
Lexington, Massachusetts (ots/PRNewswire) - LIALDA Patent Upheld and Extends through June 8, 2020 Shire plc (LSE: SHP, NASDAQ: SHPG) and its subsidiary, Shire Development LLC, announced today that the United States District Court for Southern Florida has upheld its patent for LIALDA® (mesalamine) delayed release tablets for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the ...
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10.02.2016 – 23:26
Shire Pharmaceuticals Group Plc
Shire Partner, Shionogi, Submits New Drug Application in Japan for ADHD Treatment for Children
Lexington, Massachusetts (ots/PRNewswire) - This press release is intended for U.S. and EU audiences only. A separate press release has been prepared for use in Japan. With submission, Shire continues to strengthen its presence in Japan Shire plc (LSE: SHP, NASDAQ: SHPG) and Shionogi & Co., Ltd. recently announced that Shionogi submitted a New Drug Application (NDA) ...
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27.10.2015 – 12:50
Shire Pharmaceuticals Group Plc
Shire's OPUS-3 Phase 3 Trial with Lifitegrast Meets Primary and Key Secondary Endpoints, Significantly Reducing Patient-Reported Symptoms for Dry Eye Disease
Lexington, Massachusetts (ots/PRNewswire) - Data to support lifitegrast FDA resubmission in Q1 2016; plans on track for potential 2016 launch - The topline data showed OPUS-3, a phase 3 trial, met primary endpoint, demonstrating significant improvement in patient-reported symptoms from baseline to day 84 in ...
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07.04.2015 – 08:01
Shire Pharmaceuticals Group Plc
Shire Announces Clear Regulatory Path Forward for SHP465, an Investigational Treatment for Adults with ADHD
Lexington, Massachusetts (ots/PRNewswire) - - Potential Launch of SHP465 Anticipated in Second Half of 2017 - Exclusivity for Shire's Overall ADHD Product Portfolio Extends to 2029 Shire plc today announces that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a clear regulatory path ...
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06.04.2015 – 14:01
Shire Pharmaceuticals Group Plc
Shire Comments on USPTO Petitions Related to LIALDA and GATTEX
Lexington, Massachusetts (ots/PRNewswire) - Shire plc acknowledges the two petitions filed with the U.S. Patent and Trademark Office (USPTO) on April 2nd by Hayman Capital Management regarding LIALDA(R) (mesalamine) and GATTEX(R) (teduglutide [rDNA origin]). The patents listed in the FDA Orange Book for LIALDA and GATTEX protect the innovation and value Shire brings to patients who benefit from these important medicines. ...
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31.01.2015 – 00:26
Shire Pharmaceuticals Group Plc
Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) Becomes First and Only Treatment Approved by the FDA for Adults with Moderate to Severe Binge Eating Disorder
Lexington, Massachusetts (ots/PRNewswire) - Shire plc announced today that the U.S. Food and Drug Administration (FDA) approved Vyvanse(R) (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults, shown to ...
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21.01.2015 – 22:36
Shire Pharmaceuticals Group Plc
Shire Added to Global 100 Sustainability Index
Lexington, Massachusetts And Zug, Switzerland (ots/PRNewswire) - Shire plc announces that it has for the first time placed in the Global 100 Sustainability Index. Shire was ranked 62nd in the index, which is being revealed during the World Economic Forum in Davos this week. The Global 100 Index is a global ranking by Canada-based media and investment advisory company, Corporate Knights, of the top sustainability ...
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25.06.2014 – 08:46
Shire Pharmaceuticals Group Plc
Vyvanse® Patents Found to Be Infringed and Valid by U.S. District Court
Lexington, Massachusetts (ots/PRNewswire) - Shire plc announces that Judge Stanley R. Chesler of the U.S. District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse(R) (lisdexamfetamine dimesylate) were both infringed and valid. The ruling prevents ...
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28.02.2014 – 08:01
Shire Pharmaceuticals Group Plc
Shire Recognizes Rare Disease Day 2014
Lexington, Massachusetts (ots/PRNewswire) - Global Initiatives Underscore Shire's Long-term Commitment to the Rare Disease Community Shire plc today announced its support of Rare Disease Day and invites others to join them in its continued commitment to the rare disease community. Observed annually on the last day of February, Rare Disease Day is coordinated at the international level by the European Organisation for Rare ...
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14.02.2014 – 15:02
Shire Pharmaceuticals Group Plc
Shire Announces FDA Approval of Manufacturing Facility for VPRIV® (Velaglucerase Alfa for Injection) Drug Substance
Lexington, Massachusetts (ots/PRNewswire) - Shire plc , the global specialty biopharmaceutical company, announced today that the US Food & Drug Administration (FDA) has approved the production of VPRIV(R) drug substance (velaglucerase alfa for injection) in Shire's manufacturing facility at 400 Shire Way, Lexington, ...
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25.03.2013 – 13:15
Shire Pharmaceuticals Group Plc
Shire to Acquire SARcode Bioscience, Expands Presence in Ophthalmology
Lexington, Massachusetts (ots/PRNewswire) - Acquisition brings Shire a new phase 3 compound being investigated for the signs and symptoms of Dry Eye Disease Shire plc today announced that it will acquire SARcode Bioscience Inc., a privately held biopharmaceutical company based in Brisbane, California. This acquisition continues to build Shire's presence in the ...
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12.03.2013 – 13:03
Shire Pharmaceuticals Group Plc
Shire Acquires Premacure AB
Lexington, Massachusetts (ots/PRNewswire) - Deal Enhances Shire's Late-Stage Pipeline with the Acquisition of a Phase II Protein Replacement Therapy Being Investigated for the Prevention of Retinopathy of Prematurity Shire plc announces that it has acquired Premacure AB of Uppsala, Sweden, a privately held biotechnology company developing a protein replacement therapy, currently in Phase II development, for the prevention of retinopathy of prematurity (ROP). ROP is a rare ...
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28.02.2013 – 08:01
Shire Pharmaceuticals Group Plc
Shire Supports Rare Disease Day 2013
Lexington, Massachusetts (ots/PRNewswire) - - Global Initiatives Underscore Company's Long-Term Commitment to the Rare Disease Community Shire plc today announced its support of Rare Disease Day, joining patients, healthcare providers, and patient organizations around the world to support a day that focuses attention on rare diseases as a public health issue, and highlights the need for more understanding and awareness ...
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08.01.2013 – 13:01
Shire Pharmaceuticals Group Plc
Shire Acquires Lotus Tissue Repair, Inc.
Lexington, Massachusetts (ots/PRNewswire) - - HGT Pipeline Enhanced with Protein Replacement Therapy Being Investigated for the Treatment of Dystrophic Epidermolysis Bullosa Shire plc , announces that it has signed an agreement to acquire Lotus Tissue Repair, Inc. of Cambridge, MA, a privately held biotechnology company developing the first and only protein replacement therapy currently being investigated for the ...
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20.11.2012 – 13:03
Shire Pharmaceuticals Group Plc
Shire and Boston Children's Hospital Enter Into Broad Research Collaboration
Lexington, Massachusetts (ots/PRNewswire) - Shire plc and Boston Children's Hospital today announced a three-year, broad research collaboration in rare diseases. The goal of the collaboration is to develop novel therapies to treat a number of rare pediatric diseases with high unmet medical need, thereby leveraging Boston Children's research expertise and Shire's ...
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