Zug, Switzerland (ots/PRNewswire) - VEYVONDI is the first and only recombinant von Willebrand factor treatment for adults with von Willebrand disease, the most common inherited bleeding disorder[1],[2],[3] Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving individuals with rare ...
Zug, Switzerland (ots/PRNewswire) - New clinical and real-life data in chronic hypoparathyroidism, to advance understanding of this rare disease and improve patients' lives Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, announced today new research to be presented on rhPTH(1-84) and on the ...
Dublin (ots/PRNewswire) - - Study met primary endpoint demonstrating significantly greater remission rates in patients receiving anti-MAdCAM antibody (SHP647) compared to placebo in three of four tested dose groups - First study to investigate the potential role of anti-MAdCAM antibody in the management of ...
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 ...
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 ...
Zug, Switzerland (ots/PRNewswire) - Natpar is the first and only licensed recombinant human parathyroid hormone therapy for chronic hypoparathyroidism Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the European Commission (EC) has granted Conditional Marketing Authorisation for Natpar (rhPTH[1-84]), the ...
Zug, Switzerland (ots/PRNewswire) - Shire launches campaign to raise global awareness during World PI Week Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, is launching #PIPostsThanks, a social campaign to spotlight the unsung heroes who make a difference in the lives of people living with primary immunodeficiency (PI). PI is a group of nearly ...
Zug, Switzerland (ots/PRNewswire) - On World Hemophilia Day 2017, Shire challenges the community to collectively improve global standards of care for rare bleeding disorders Shire plc (LSE: SHP, NASDAQ: SHPG), a leading biotechnology company focused on serving individuals with rare diseases, joins the global ...
Zug, Switzerland (ots/PRNewswire) - A New Non-stimulant Clinical Option for Children and Adolescents From 6 to 17 Years old With ADHD Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that its partner in Japan, Shionogi & Co., Ltd, has received the approval of the Japanese Ministry of Health, Labor and Welfare to ...
Zug, Switzerland (ots/PRNewswire) - CINRYZE is now the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the European Commission (EC) has approved a label extension granting three new indications for CINRYZE® (C1 inhibitor ...
Zug, Switzerland (ots/PRNewswire) - This Press Release is intended for Global Use If approved, Natpar would be the first licensed recombinant parathyroid hormone in Europe for the management of chronic hypoparathyroidism, the only endocrine-deficiency disorder with no hormone treatment[1] Shire plc (LSE: SHP, ...
Zug, Switzerland (ots/PRNewswire) - Shire presentations at EAHAD 2017 underscore the company's leadership in improving global standards of care Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving individuals with rare diseases, presented its new estimate of the Global Annual Bleed Rate (GABR), an effort to build on current global ...
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 ...
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 ...
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 ...
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 ...
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, ...
Zug, Switzerland (ots/PRNewswire) - The positive opinion is based on a pivotal Phase 3 study showing that ONIVYDE combined with chemotherapy significantly increased overall survival (OS) in patients with metastatic pancreatic cancer after previous gemcitabine based therapy Shire plc (LSE: SHP, NASDAQ: SHPG) today ...
Zug, Switzerland (ots/PRNewswire) - HyQvia (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase) is the only subcutaneous IG treatment for primary and certain secondary immunodeficiencies that can be administered in one site, once a month (up to every four weeks) Shire plc (LSE: SHP, NASDAQ: SHPG) is launching a pediatric indication for HyQvia (Human ...
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, ...
Zug, Switzerland (ots/PRNewswire) - This press release is intended for a global audience. First therapy indicated in the EU for use in patients aged one year and above with SBS, a rare gastrointestinal condition Shire (LSE: SHP, NASDAQ: SHPG) today announced that the European Commission has granted extension of ...
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 ...
Zug, Switzerland (ots/PRNewswire) - - Cuvitru (IG 20mg/ml solution for subcutaneous injection) builds on company's broad portfolio of IG treatments gained through combination with Baxalta - New option to treat primary and certain secondary immunodeficiencies can help meet patient needs related to number of infusion ...
Zug, Switzerland (ots/PRNewswire) - Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of the approval of Revestive[®*] (teduglutide) 5 mg powder and solvent for ...
Dublin (ots/PRNewswire) - NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF THAT JURISDICTION. PLEASE SEE THE IMPORTANT NOTICE WITHIN THIS ANNOUNCEMENT. Publication of Circular, Notice and Prospectus ...
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 ...
Dublin (ots/PRNewswire) - Shire plc (LSE: SHP, NASDAQ: SHPG) (the "Company") reminds shareholders of important developments relating to the Company's Income Access Share arrangements ("IAS Arrangements"). All shareholders who wish to receive, or continue to receive, UK sourced dividends via the IAS Arrangements (and ...
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) ...
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 ...
Zug, Switzerland (ots/PRNewswire) - Shire plc is pleased to announce the winner and runner up of the Spotlight on Gaucher film contest on the occasion of International Gaucher Day (IGD). The film contest, which was supported by the European Gaucher Alliance (EGA), encouraged people whose lives have been touched by Gaucher disease to share a video to raise awareness of ...