Zug, Switzerland (ots/PRNewswire) - The first selective alpha-2A adrenergic receptor agonist licensed for the treatment of ADHD in the EU Shire today announced that the European Commission granted Marketing Authorisation for once-daily, non-stimulant INTUNIV(R) (guanfacine hydrochloride prolonged release ...
Zug, Switzerland (ots/PRNewswire) - For Release in Europe Only - Resolor was approved in 2009 in Europe for use in women for the symptomatic treatment of chronic constipation in whom laxatives fail to provide adequate relief[1] Shire plc announced today that Resolor (prucalopride) has been approved by the European ...
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 ...
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. ...
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 ...
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 ...
Dublin (ots/PRNewswire) - - Increases Non GAAP diluted earnings per ADS growth guidance to the high thirty percent range for the full year (2014). Shire announces unaudited results for the three months to September 30, 2014. Financial Highlights Q3 2014 Growth[1] $1,552 Product sales million +33%[2] $1,597 Total ...
Dublin (ots/PRNewswire) - Shire plc ("Shire" or the "Company") announces that its Canadian subsidiary(1) has received assessments from the Canadian revenue authorities, entitling it to total cash refunds equivalent to US$410 million(2). Following receipt of the assessments(3), the Company has recorded a net credit ...
Dublin, Ireland (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 SUCH JURISDICTION. Shire plc ("Shire" or the "Company") notes today's announcement by AbbVie Inc. ("AbbVie") repeating its proposal of May 30, 2014, which comprised GBP20.44 in cash and 0.7988 AbbVie shares per Shire ...
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 ...
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 SUCH JURISDICTION. Presentation for analysts and investors to be held at 13:00 British Summer Time today The management of Shire plc ("Shire" or the "Company") has transformed the Company over the last year, creating the platform ...
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 SUCH JURISDICTION. Shire plc ("Shire" or the "Company") will today host a call for investors at 1pm BST / 8am EDT, as announced on Friday June 20th. A further press release will be issued today at midday BST / 7am EDT with highlights related to the presentation at 1pm BST. The ...
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 ...
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, ...
Dublin (ots/PRNewswire) - Honor extraordinary carers who sacrifice for others The BRAVE Awards, an international awards initiative that recognizes the courage and dedication of non-professional caregivers, is seeking nominations through June 30, 2013. Developed and implemented by Shire plc, the global biopharmaceutical company, the BRAVE Awards honor unpaid, ...
Philadelphia (ots/PRNewswire) - Shire LLC has settled its litigation against Teva Pharmaceuticals USA Inc. ("Teva") in connection with Teva's Abbreviated New Drug Application ("ANDA") for a generic version of Shire's INTUNIV (guanfacince) Extended Release Tablets for the treatment of Attention Deficit Hyperactivity Disorder. The settlement provides Teva with a license ...
Philadelphia (ots/PRNewswire) - Research explores data on treatments for psychiatric disorders; health economics and outcomes research also to be presented Shire plc , the global specialty biopharmaceutical company, announces that it will present scientific data in 7 poster presentations at the American Psychiatric ...
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 ...
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 ...
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 ...
Philadelphia (ots/PRNewswire) - Shire plc , announces that its subsidiary, Shire LLC, has settled all pending litigation with Impax Laboratories, Inc. ("Impax") over Shire's supply of an authorized generic version of Adderall XR. Shire has been supplying Impax with authorized generic Adderall XR since October 2009 pursuant to a supply agreement between the parties. In ...
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 ...
Nyon, Switzerland (ots/PRNewswire) - Shire plc today announces a positive outcome from the European Decentralised Procedure (DCP) for Elvanse(R) (to be known as Tyvense(R) in Ireland). Elvanse is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children ...
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 ...
Dublin (ots/PRNewswire) - - Fifteen everyday heroes who selflessly care for others in the face of adversity honored by Shire in annual international awards program They inspire with their determination, selflessness, courage and hope. Fifteen caregivers from around the world have been announced today as Recipients or Distinguished Honorees in the 2nd Annual Shire BRAVE Awards, an international program that honors the bravery and devotion of non-professional caregivers. ...
Nyon, Switzerland (ots/PRNewswire) - Shire plc , today announced a long-term, broad based, multi-indication research collaboration in rare diseases with Fondazione Telethon, a major Italian biomedical charitable foundation, for research carried out at the Telethon Institute of Genetics and Medicine (TIGEM). This ...
Amsterdam (ots/PRNewswire) - The results of an international survey to assess patients' and healthcare professionals' (HCPs') differing perceptions of ulcerative colitis have been presented at a Shire organised press briefing during the 20th United European Gastroenterology Week (UEGW) meeting in Amsterdam today. ...
Nyon, Switzerland (ots/PRNewswire) - - In a head-to-head trial between VPRIV and Cerezyme(R) (imiglucerase), only patients treated with VPRIV experienced statistically significant improvement in lumbar spine bone mineral density at 9 months Shire plc , the global specialty biopharmaceutical company, today presented ...
Nyon, Switzerland (ots/PRNewswire) - Significantly lower proportion of subjects experiencing treatment failure whilst receiving LDX in the randomised withdrawal period, compared to those subjects receiving placebo.[1] Today, at the EUNETHYDIS 2nd International ADHD Conference, Shire AG , the global specialty ...
Philadelphia (ots/PRNewswire) - - Company Plans to Conduct Additional Analyses of These Preliminary Data Shire plc [http://www.shire.com/shireplc/en/home ] , the global specialty biopharmaceutical company, today announced positive top-line results from a Phase 2 study to evaluate the safety and efficacy of ...