NewsInferno (Free subscription) | 17/11/2009
News media are reporting that the U.S. Food and Drug Administration (FDA) has issued warning letters to Shire PLC and Eisai Co Ltd about drug promotions for Dacogen and Fosrenol. The warning letters state that the Dacogen (Eisai) and Fosrenol (Shire) promotions understate the risk and overstate the benefits of the medications. The FDA said that [...]
Health - The Post Chronicle (Free subscription) | 16/11/2009
U.S. regulators have warned Shire PLC and Eisai Co Ltd about drug promotions that minimized the medicines' risks and overstated benefits....
Eurekalert (Free subscription) | 16/11/2009
Shire plc announced new study results on INTUNIV 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 and amphetamine or methylphenidate relative to what was observed with either medication alone. The open-label study also assessed improvement of ADHD symptoms using...
Medical News Today (Free subscription) | 14/11/2009
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®.
Reuters UK (Free subscription) | 13/11/2009
WASHINGTON (Reuters) - U.S. regulators have warned Shire PLC and Eisai Co Ltd about drug promotions that minimized the medicines' risks and overstated benefits, letters released on Friday said.
Medical News Today (Free subscription) | 13/11/2009
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®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating...
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®
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.
Eurekalert (Free subscription) | 09/11/2009
( Porter Novelli ) Shire PLC announced the availability of INTUNIV in pharmacies nationwide for the treatment of ADHD in children and adolescents ages 6-17. INTUNIV, a once-daily formulation of guanfacine, is the first and only nonscheduled alpha-2A receptor agonist approved for the treatment of ADHD. In clinical trials, INTUNIV provided significant efficacy across the spectrum of ADHD symptoms that...
Business Wire (Free subscription) | 04/11/2009
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...
PR News Wire (Free subscription) | 04/11/2009
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...
PR News Wire (Free subscription) | 02/11/2009
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.
SeekingAlpha.com (Free subscription) | 01/11/2009
Shire plc ( SHPGY ) Q3 2009 Earnings Call Transcript October 30, 2009 10:00 am ET Complete Story »
Medical News Today (Free subscription) | 31/10/2009
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...
Miami Herald (Free subscription) | 30/10/2009
Shares of biotechnology company Amicus Therapeutics Inc. fell Friday after the company said it ended a partnership with Shire PLC to jointly develop treatments for genetic disorders, while cutting jobs amid the resignation of its chief financial officer.
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