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Medical News Today (Free subscription) | 25/11/2009
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...
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The Boston Business Journal (Free subscription) | 24/11/2009
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)
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Market Watch (Free subscription) | 24/11/2009
BOSTON (MarketWatch) -- Drug stocks were sluggish in early action Tuesday as shares of Shire plc gained on news that it has applied for European market approval for its new treatment for the rare disorder Gaucher disease. The NYSE Arca Pharmaceutical Index was virtually flat at 306.99 and the NYSE Arca Biotechnology Index was up marginally at 869.09. Shire shares were up almost 1% at $58.23. Market...
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Market Watch (Free subscription) | 24/11/2009
BOSTON (MarketWatch) -- Shire plc said early Tuesday that it has applied for European marketing approval of its drug velaglucerase alfa, a treatment for the rare genetic disorder Gaucher disease. The product is also awaiting approval in the U.S. If approved, the drug would compete against Genzyme Corp.'s flagship product Cerezyme. A third company, Israel's Protalix BioTherapeutics is also finishing...
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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 [...]
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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....
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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...
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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®.
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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.
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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...
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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®
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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.
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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...
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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...
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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...
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