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Shire plc News Editors

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Shire plc News

News on Shire plc continually updated from thousands of sources around the net.

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 .

Comment?

Related Topix: Biotech, Medicine, ADHD, Noven Pharmaceuticals, Food and Drug Administration, Ritalin, Methylphenidate (generic), Medication

Wed Nov 25, 2009

Market Watch

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 ...

Comment?

Related Topix: Biotech

Tue Nov 24, 2009

Medical News

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 .

Comment?

Related Topix: Biotech, Marketing, Health

Tue Nov 17, 2009

Personal Injury Law News

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.

Comment?

Related Topix: Food and Drug Administration, Biotech

Mon Nov 16, 2009

EurekAlert!

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 .

Comment?

Related Topix: Biotech, Ritalin, Methylphenidate (generic), Medicine, Medication, University of Florida, Sarasota Metro, Bradenton, FL

Fri Nov 13, 2009

ABC News

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.

Comment?

Related Topix: Food and Drug Administration, Biotech

Thu Nov 12, 2009

Freshnews

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

Shire plc , the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse .

Comment?

Related Topix: Medicine, Health, ADHD, Biotech

Tue Nov 10, 2009

Health News Digest

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.

Comment?

Related Topix: Medicine, ADHD, Health, Biotech, Food and Drug Administration

Mon Nov 09, 2009

Bioscience Technology

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.

Comment?

Related Topix: Biotech, Healthcare Law, Law, Food and Drug Administration

Sun Nov 08, 2009

BioWorld

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.

Comment?

Related Topix: Biotech, Plains Resources, Energy, Oil & Gas, Pfizer, Medicine, Healthcare Industry, Cerezyme, Imiglucerase (generic), Medication

Fri Nov 06, 2009

American Chronicle

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 ...

Comment?

Related Topix: Healthcare Law, Law, Food and Drug Administration, Healthcare Technologies, Biotech, Healthcare Services Group, Medicine, Apparel, Healthcare Industry, Opexa Therapeutics, Opinion

Wed Nov 04, 2009

Applied Clinical Trials

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.

Comment?

Related Topix: Biotech, Computers, IT Services, Software

Pharmaceutical Processing

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.

Comment?

Related Topix: Biotech, Food and Drug Administration, Drugs

Tue Nov 03, 2009

Earth Times

New Shire Board Member

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 .

Comment?

Related Topix: Biotech, Ireland, World News, Medicine, ADHD, Health

Sun Nov 01, 2009

The Biotech Stock Blog

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.

Comment?

Related Topix: Biotech, Financial Services, Investment Services

Sat Oct 31, 2009

MediLexicon

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 .

Comment?

Related Topix: Biotech, Ritalin, Methylphenidate (generic), Medicine, Medication, Food and Drug Administration, Health

Medical News

Shire announces third quarter 2009 financial results

Shire plc the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

Comment?

Related Topix: Biotech, Medicine, Health, ADHD

Fri Oct 30, 2009

Seattle Post-Intelligencer

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.

Comment?

Related Topix: Amicus, Startups, Biotech, Cranbury, NJ

EurekAlert!

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.

Comment?

Related Topix: Medicine, ADHD, Health, Biotech, Centers for Disease Control and Prevention, Cincinnati, OH Metro, University of Cincinnati, Healthcare Law, Law

Wed Oct 28, 2009

Pharmaceutical Processing

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 ...

Comment?

Related Topix: Biotech, Dialysis, Medicine, Health, Marketing

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