Shire plc

Shire Submits European Marketing Authorization Application (MAA) For Velaglucerase Alfa For The Treatment Of Type 1 Gaucher Disease

Medical News Today (Free subscription) | 11/25/2009

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has submitted a MAA to the European Medicines Agency for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. This is the third marketing application for velaglucerase alfa that has been submitted, with previous submissions...

• Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease - PR News Wire

Shire moves to advance Gaucher drug

The Boston Business Journal (Free subscription) | 11/24/2009

Shire plc has submitted an application for approval to European regulators of its drug target velaglucerase alfa. The drug candidate, for Gaucher disease, is an alternative to Genzyme’s Cerezyme. Regulators in both the U.S. and Canada have already fast-tracked the drug to help head off a shortage of Cerezyme, due to the temporary closure of a Genzyme plant in Allston, Mass. (SHPGY)

Shire Announces Publication of Open-Label Study on Coadministration of INTUNIV(TM) (guanfacine) Extended-Release Tablets with Stimulants

PR News Wire (Free subscription) | 11/16/2009

PHILADELPHIA, Nov. 16 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced new study results on INTUNIV(TM) (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV...

Shire Reports Analysis Examining Emotional Lability In Children With ADHD Taking Vyvanse

Medical News Today (Free subscription) | 11/14/2009

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®.

• Shire Reports Analysis Examining Emotional Lability In Children With ADHD Taking Vyvanse - Red Orbit
• Shire Reports Findings From An Analysis Examining Emotional Lability In Children With ADHD Taking Vyvanse(R) (lisdexamfetamine Dimesylate) Capsules - Medical News Today

Shire Reports Findings From an Analysis Examining Emotional Lability in Children With ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII

PR News Wire (Free subscription) | 11/12/2009

PHILADELPHIA, Nov. 12 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale...

Shire Re-Launches FOCUS, an Online, Personalized Patient Support Program for Adults with ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII

Red Orbit (Free subscription) | 11/11/2009

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced the re-launch of FOCUS (http://www.vyvanseFOCUS.com), a free, online patient support program for adults taking once-daily Vyvanse®

• Shire Re-Launches FOCUS, an Online, Personalized Patient Support Program for Adults with ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII - PR News Wire

ADHD: Once-Daily INTUNIV (Guanfacine) Extended Release Tablets Now Available In US Pharmacies

Medical News Today (Free subscription) | 11/11/2009

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company,has announced the availability of INTUNIV™ (guanfacine) Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17.

Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Now Available in Pharmacies Nationwide

PR News Wire (Free subscription) | 11/09/2009

PHILADELPHIA, Nov. 9 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced the availability of INTUNIV(TM) (guanfacine) Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17. INTUNIV, a once-daily formulation...

Shire Extends Agreement with Medidata Solutions for Trial Planning Products

Business Wire (Free subscription) | 11/04/2009

NEW YORK--(BUSINESS WIRE)--Medidata Solutions (NASDAQ: MDSO), a leading global provider of hosted clinical development solutions, today announced a multi-year contract extension with Shire plc (LSE: SHP, NASDAQ: SHPGY) for use of Medidata Grants Manager™ and CRO Contractor™ benchmarking and analysis tools for investigator site and contract research organization (CRO) trial budget planning...

FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease

PR News Wire (Free subscription) | 11/04/2009

CAMBRIDGE, Massachusetts, November 4 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher...

New Shire Board Member

PR News Wire (Free subscription) | 11/02/2009

DUBLIN, Ireland, November 2 /PRNewswire-FirstCall/ -- The Board of Directors of Shire plc (LSE: SHP, NASDAQ: SHPGY) announces that Mr David Stout joined the Board as a Non Executive Director with effect from 31 October 2009.

Shire plc Q3 2009 Earnings Call Transcript

SeekingAlpha.com (Free subscription) | 11/01/2009

Shire plc ( SHPGY ) Q3 2009 Earnings Call Transcript October 30, 2009 10:00 am ET Complete Story »

Shire Reports Tolerability And Clinical Effects Results Of Daytrana(R) (methylphenidate Transdermal System) From Study In Adolescents With ADHD

Medical News Today (Free subscription) | 10/31/2009

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana® (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). In addition, data regarding the pharmacokinetic profile...

• Shire Reports Tolerability and Clinical Effects Results of Daytrana(R) (methylphenidate transdermal system) from Study in Adolescents with ADHD - PR News Wire
• Study Findings On ADHD Treatments Presented At Psychiatric Meeting - Medical News Today

Shire Plc (SHPGY) NewsBite - SHPGY Rises On Earnings

MarketIntelligenceCenter.com (Free subscription) | 10/30/2009

Shire Plc (NasdaqNM: SHPGY) opened at $53.03. So far today, the stock has hit a low of $52.56 and a high of $54.06. SHPGY is now trading at $53.79, up $2.70 (5.28%). Over the last 52 weeks the stock has ranged from a low of $31.66 to a high of $53.85. SHPGY reported earnings this morning, posting a third-quarter profit of $59.6 million, or 33 cents per share. SHPGY's adjusted profit of 49 cents per...

Shire Continues to Deliver Excellent Growth From Core Products

PR News Wire (Free subscription) | 10/30/2009

DUBLIN, October 30 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.