Thursday Dec 3 | BioSpace
Shire plc: Non-Safety-Related Voluntary Recall of a Limited Portion...
Shire plc, the global specialty biopharmaceutical company, today announced a voluntary recall of five lots and voluntary market withdrawal of one lot of the Attention-Deficit/Hyperactivity Disorder patch DaytranaA .
Drug stocks sluggish; Shire gains in early action
The NYSE Arca Pharmaceutical Index /quotes/comstock/10t!drg.x was virtually flat at 306.99 and the NYSE Arca Biotechnology Index /quotes/comstock/10t!btk.x was up marginally at 869.09. Shire shares were up almost 1% at $58.23. /quotes/comstock/15*!shpg.y Shire PLC /marketstate/country/ The market is open The market is closed $ 57.70 Change +1.27 ...
Shire submits a MAA for velaglucerase alfa in Europe
Shire plc , 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 .
FDA Says Shire, Eisai Drug Promotions Misleading
News media are reporting that the U.S. Food and Drug Administration has issued warning letters to Shire PLC and Eisai Co Ltd about drug promotions for Dacogen and Fosrenol.
Shire announces publication of open-label study on coadministration of INTUNIV with stimulants
November 16, 2009 - Shire plc , the global specialty biopharmaceutical company, announced new study results on INTUNIV Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology .
FDA Warns Shire, Eisai on Promotions
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.
Shire plc , the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse .
Once-Daily INTUNIVa (guanfacine) Extended Release Tablets Now Available in Pharmacies Nationwide
" Shire plc , the global specialty biopharmaceutical company, today announced the availability of INTUNIVTM Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder in children and adolescents ages 6 to 17.
Once-daily INTUNIV (guanfacine) extended release tablets now available in US pharmacies
November 9, 2009 A- Shire plc , the global specialty biopharmaceutical company, today announced the availability of INTUNIVA Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder in children and adolescents ages 6 to 17.
Genzyme Could Get 'ERT' as Pharma Makes Gaucher Bids
As Shire plc gears up for an early 2010 PDUFA date for its enzyme replacement therapy velaglucerase alfa in Gaucher's disease, potential competitor Protalix BioTherapeutics Inc.
News and FDA Updates for Medidata
A complete list of all headlines and biomedical stock developments can be found on BioMedReports.Com On 11/04/09, Medidata Solutions , a leading global provider of hosted clinical development solutions, announced a multi-year contract extension with Shire plc for use of Medidata Grants Manager and CRO Contractor benchmarking and analysis tools for ...
Shire Extends Agreement with Medidata Solutions for Trial Planning Products
Medidata Solutions multiyear contract with Shire plc has been extended for use of Medidata Grants Manager and CRO Contractor benchmarking and analysis tools for investigator site and contract research organization trial budget planning and forecasting.
FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease
Shire plc, a global specialty biopharmaceutical company, today announced that the FDA has granted Priority Review for the New Drug Application for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.
DUBLIN, Ireland, November 2 Shire-plc DUBLIN, Ireland , November 2 /PRNewswire-FirstCall/ -- The Board of Directors of Shire plc 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
Shire plc October 30, 2009 10:00 am ET Executives Eric Rojas a ' IR Angus Russell a ' CEO Graham Hetherington a ' CFO Analysts Tom Russo a ' Robert W. Baird & Co.
Shire Reports Tolerability And Clinical Effects Results Of...
Shire plc , the global specialty biopharmaceutical company, announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder .
Shire announces third quarter 2009 financial results
Shire plc the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.
Amicus shares fall on closed partnership, job cuts
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.
INTUNIV demonstrated symptom reduction on oppositional subscale Conners' ADHD rating scale
October 29, 2009 - Shire plc , the global specialty biopharmaceutical company, announced new study results on INTUNIV Extended Release Tablets, at a major psychiatric medical meeting today.
Shire Secures European Wide Label Extension for FOSRENOL(R) in Chronic Kidney Disease
Shire plc today announced it has received approval through the European Mutual Recognition Procedure for an extension to the current indication for FOSRENOL , paving the way to make the non-calcium, non-resin phosphate binder available throughout the EU to control hyperphosphataemia in chronic kidney disease patients who are not on dialysis with a ...
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