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News Shire Reports Positive Signal Finding Study of Investigative Use of Vyvanse (lisdexamfetamine dimesylate) Capsules CII in Excessive Daytime Sleepiness Model
Shire , the global specialty biopharmaceutical company, announced results from a study of Vyvanse® (lisdexamfetamine dimesylate), assessing its effect in a model for Excessive Daytime Sleepiness (EDS). |
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News VPRIV (velaglucerase alfa) Approved in Canada for the Treatment of Type I Gaucher Disease
Shire plc, the global specialty biopharmaceutical company, announces that Health Canada has approved VPRIV (velaglucerase alfa), an enzyme replacement therapy (ERT) for long-term use in pediatric and adult type 1 Gaucher disease. |
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News FDA Approves Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents
Shire plc the global specialty biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents ages 13 to 17. |
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News Shire Presents Positive New Data at the 60th Annual American Society of Human Genetics (ASHG) for Patients with Type 1 Gaucher Disease
Shire plc , the global specialty biopharmaceutical company, today presented positive new data from a Phase III clinical trial (study 039) designed to evaluate the efficacy of VPRIV® (velaglucerase alfa for injection) compared with imiglucerase in patients with type 1 Gaucher disease at the 2010 Annual American Society of Human Genetics (ASHG) in Washington D.C. |
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News Shire Receives INTUNIV Paragraph IV Notice Letter
Shire plc , the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Watson Laboratories, Inc. (“Watson”) advising of the filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of Shire’s 4 mg guanfacine hydrochloride extended release tablet, INTUNIV. |
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News Shire Announces Support for Inflammatory Bowel Disease (IBD) Fellowships at Leading Medical Institutions Nationwide
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced its support for inflammatory bowel disease (IBD) fellowships at leading medical institutions across the country. |
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News Shire agrees to divest Daytrana® (methylphenidate transdermal system) CII to Noven Pharmaceuticals, Inc.; Shire’s 2010 earnings outlook unchanged
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced the divestiture of Daytrana® (methylphenidate transdermal system) to Noven Pharmaceuticals, Inc. Daytrana, which is approved and marketed in the US for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents, will continue to be available for patients through Noven. |
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News Lialda® - Shire Files Suit against Cadila Healthcare Limited, doing business as Zydus Cadila and Zydus Pharmaceuticals
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiaries Shire Development Inc. and Shire Pharmaceutical Development Inc. have filed a lawsuit in the U.S. District Court for the District of Delaware against Cadila Healthcare Limited, doing business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc. (collectively “Zydus”) for the infringement of U.S. Patent No. 6,773,720 (the ’720 patent). |
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News FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. |
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News Shire Receives CHMP Positive Opinion for VPRIV (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease in the European Union
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion on the marketing authorisation for VPRIV™ (velaglucerase alfa), the company’s enzyme replacement therapy (ERT) for the treatment of type 1 Gaucher disease. |
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Leaflet Drug Xagrid
Xagrid is a medicine that contains the active substance anagrelide. It is available as white capsules (0.5 mg). |
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News Shire Receives LIALDA Paragraph IV Notice Letter from Zydus Pharmaceuticals
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter today from Zydus Pharmaceuticals USA, Inc. (“Zydus”) advising of the filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of Shire’s 1.2g mesalamine delayed release tablets, LIALDA®. |
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News INTUNIV - Shire Files Suit against Anchen Pharmaceuticals, Inc. and Anchen, Inc.
Dublin, Ireland and Philadelphia, US – June 3, 2010 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Delaware against Anchen Pharmaceuticals, |
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News Study Evaluated Vyvanse (lisdexamfetamine dimesylate) Capsules CII Efficacy and Safety in Adolescents with ADHD
Data Showed Vyvanse Significantly Improved ADHD Symptoms of Inattention, Hyperactivity and Impulsivity in Adolescents Aged 13 to 17 |
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News INTUNIV - Shire Files Suit against Actavis Elizabeth LLC and Actavis Inc.
Dublin, Ireland and Philadelphia, US – May 13, 2010 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, |
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News Shire Receives INTUNIV Paragraph IV Notice Letter from Anchen
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc. (“Anchen”) advising of the filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of Shire’s 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV™. |
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News Shire Receives Second INTUNIV Paragraph IV Notice Letter
Shire plc (LSE: SHP, NASDAQ; SHPGY), announces that it has received a second Paragraph IV Notice Letter this time from Actavis Elizabeth LLC (“Actavis”) advising of the filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of Shire’s 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV™. |
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News Shire Presents Positive Data for Patients with Type 1 Gaucher Disease Who Switched to VPRIV
Cambridge, MA, US – March 25, 2010 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase. |
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Article Shire Pharmaceuticals
As one of the world’s leading specialty biopharmaceutical companies, Shire has emerged as a company fully focused on a single purpose: to enable people with life-altering conditions to lead better lives. |
