News: Shire

01.09.2010 | NCBI PubMed: Single- and Multiple-Dose Pharmacokinetics of Methylphenidate Administered as Methylphenidate Transdermal System or Osmotic-Release Oral System Methylphenidate to Children and Adolescents With Attention Deficit Hyperactivity Disorder.

This was a 1-month, multicenter, open-label, randomized study to determine single- and multiple-dose pharmacokinetics of d,l-methylphenidate (MPH) after MPH transdermal system (MTS) and osmotic-release oral system MPH (OROS MPH) dosing in children (6-12 years) and adolescents (…)

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[Source: NCBI PubMed]

09.09.2010 | BioSpace: Acceleron Pharma Announces Joint Development and Commercialization Agreement with Shire plc on Novel Muscle Therapeutics for Orphan Diseases in Deal Worth up to $498 Million

CAMBRIDGE, Mass.-(BUSINESS WIRE)-Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, and Shire plc (LSE: SHP, NASDAQ: SHPGY), the (…)

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[Source: BioSpace]

09.09.2010 | BioSpace: Garheng Kong, M.D., Ph.D. Joins Sofinnova Ventures as General Partner

MENLO PARK, Calif. September 8, 2010 Sofinnova Ventures, a venture capital firm based in Silicon Valley, today announced that Garheng Kong, M.D., Ph.D. has joined the firm as General Partner. He will actively invest in biopharmaceutical companies from the firm s current fund, (…)

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[Source: BioSpace]

07.09.2010 | BioSpace: FDA Relents from Midodrine Withdrawal Plan

AP - NEW YORK Federal regulators have backed off a plan to remove a Shire PLC low blood-pressure treatment from the market after warning in August that the drug has not been proven effective.

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[Source: BioSpace]

01.09.2010 | BioSpace: EUSA Pharma Announces the Appointment of Stephen A. Stamp to Its Board of Directors

Oxford, UK and Langhorne, PA, USA 1 September 2010 EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, today announced the appointment of Stephen A. Stamp to the company s Board as an independent Non-Executive (…)

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[Source: BioSpace]

30.08.2010 | Bionity.com: Shire Announces European Approval of VPRIV (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease

30.08.2010 - Shire plc announced that the European Commission has granted marketing authorisation for VPRIV(R) (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease. VPRIV has been authorized as an (…)

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[Source: Bionity.com]

27.08.2010 | Medical News Today: Shire Announces European Approval Of VPRIV(R) (velaglucerase Alfa) For The Treatment Of Type 1 Gaucher Disease

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced that the European Commission has granted marketing authorisation for VPRIV(R) (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term (…)

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[Source: Medical News Today]

27.08.2010 | BioSpace: Shire plc Announces European Approval of VPRIV(R) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease

Cambridge, MA, US August, 27th 2010 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that the European Commission has granted marketing authorisation for VPRIV (velaglucerase alfa), a human cell line derived enzyme replacement (…)

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[Source: BioSpace]

25.08.2010 | BioSpace: Shire plc Gets Mixed FDA Response On Pentasa

DUBLIN and PHILADELPHIA, August 24, 2010 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire Pharmaceuticals Inc. received a ruling from the FDA on its Citizen's Petition relating to (…)

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[Source: BioSpace]

19.08.2010 | Business Wire: Oceana Therapeutics Announces John T. Spitznagel Named to PharmaVOICE s 100 Most Inspiring People in the Life Sciences | Business Wire

EDISON, N.J.-(BUSINESS WIRE)-Oceana Therapeutics, a forward-thinking global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, today announced that John T. Spitznagel, Chairman & CEO, has been featured in PharmaVOICE s 2010 (…)

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[Source: Business Wire]

19.08.2010 | Business Wire: Four Keynote Speakers to Headline at BioFlorida s Annual Conference | Business Wire

FORT LAUDERDALE, Fla.-(BUSINESS WIRE)-BioFlorida today announced an impressive roster of keynote speakers for its 13th Annual Conference that includes the former Secretary of the U.S. Department of Health and Human Services, biotechnology entrepreneurs, executives and medical (…)

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[Source: Business Wire]

18.08.2010 | BioSpace: Shire Pharmaceuticals (SHPGY) to Pull Low Blood Pressure Drug from Market

PHILADELPHIA, Pennsylvania, August 17, 2010 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY) acquired ProAmatine as a part of the acquisition of Roberts Pharma in 1999 and Shire conducted and completed the post marketing trials that the FDA required. The FDA, (…)

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[Source: BioSpace]

18.08.2010 | BioSpace: Blood Pressure Drug To Be Pulled From Market Effective September 30

AP - Shire PLC said Tuesday it will pull a blood-pressure drug off the market following warnings from federal regulators who said the drug has not been proven effective.

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[Source: BioSpace]

10.08.2010 | Business Wire: Noven to Acquire Daytrana Methylphenidate Transdermal System from Shire | Business Wire

MIAMI-(BUSINESS WIRE)-Noven Pharmaceuticals, Inc. today announced that it has entered into a Product and Trademark Acquisition Agreement (the œAgreement ) with affiliates of Shire plc ( œShire ) pursuant to which Noven will acquire global rights to Daytrana (…)

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[Source: Business Wire]

09.08.2010 | Business Wire: Research and Markets: Controlled-Release: Players, Products & Prospects - The Key Companies to Generate Additional Sales of Over US$5.1 Billion by 2018 | Business Wire

DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/4ac227/controlledrelease) has announced the addition of the "Controlled-release: Players, products & prospects to 2018 (Volume I)" report to their offering. Controlled-release: Players, (…)

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[Source: Business Wire]

29.07.2010 | Business Wire: Shire and Philabundance Announce First Region-Wide High School Food Drive | Business Wire

PHILADELPHIA-(BUSINESS WIRE)-High schools throughout Southeastern Pennsylvania are invited to join Shire s The Great Food Fight!, the first regional student food drive to fight hunger. The goal: to collect 25 tons of food the equivalent of 50,000 meals for Philabundance and (…)

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[Source: Business Wire]

01.01.2010 | NCBI PubMed: Absorption of lisdexamfetamine dimesylate and its enzymatic conversion to d-amphetamine.

These studies investigated the absorption and metabolic conversion of lisdexamfetamine dimesylate (LDX), a prodrug stimulant that requires conversion to d-amphetamine for activity. Oral absorption of LDX was assessed in rat portal and jugular blood, and perfusion of LDX into (…)

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[Source: NCBI PubMed]

20.07.2010 | Marketwire: Join Pharmaceutical Industry Leaders at iiBIG's Next Generation Pharma Sales & Marketing Summit

Highlighted Links Conference Overview To Register NEW YORK, NY-(Marketwire - July 20, 2010) - iiBIG presents the Next Generation Pharma Sales & Marketing Summit, to be held November 16-17, 2010 at the Inner Harbor Marriott Hotel in Baltimore, MD. This networking and (…)

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[Source: Marketwire]

16.07.2010 | BioSpace: Shire plc Files Suit against Cadila Healthcare Limited, Doing Business As Zydus Cadila and Zydus Pharmaceuticals (USA) Inc.

Lainate, Italy 12 July 2010 Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today reports that Shire plc (LSE: SHP, NASDAQ: SHPGY) announced on July 8, 2010 that it has filed a law suit in the U.S. District Court of Delaware against Cadila Healthcare limited, doing business as Zydus (…)

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[Source: BioSpace]

14.07.2010 | Medical News Today: FDA Approves Daytrana (methylphenidate Transdermal System) CII For The Treatment Of ADHD In Adolescents

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in (…)

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[Source: Medical News Today]

12.07.2010 | Marketwire: New Report Forecasts HIV/AIDS Market to Reach $13.7 Billion by 2016

ROCKVILLE, MD-(Marketwire - July 12, 2010) - MarketResearch.com has announced the addition of GlobalData's new report "HIV-AIDS - Pipeline Assessment and Market Forecasts to 2016," to their collection of Diseases & Conditions market reports. For more information, visit (…)

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[Source: Marketwire]

07.07.2010 | BioSpace: FDA Approves Daytrana(R) (Methylphenidate Transdermal System) CII for the Treatment of ADHD in Adolescents

Dublin, Ireland and Philadelphia, US July 6, 2010 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana (methylphenidate transdermal system) for the treatment of Attention (…)

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[Source: BioSpace]

29.06.2010 | Business Wire: Research and Markets: ADHD Therapeutics - Global Strategic Business Report | Business Wire

DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/db9383/adhd_therapeutics) has announced the addition of the "ADHD Therapeutics - Global Strategic Business Report" report to their offering. ADHD Therapeutics - Global Strategic Business (…)

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[Source: Business Wire]

28.06.2010 | BioSpace: Shire plc Named Company of the Year at Mediscience Awards

28 June 2010 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, was named Company of the Year at the European Mediscience Awards 2010. All quoted European mediscience companies are eligible for the European Mediscience Awards, provided that the (…)

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[Source: BioSpace]

18.06.2010 | NCBI PubMed: IEF pattern classification-derived criteria for the identification of epoetin-delta in urine.

Epoetin-delta (Dynepo Shire Pharmaceuticals, Basing stoke, UK) is a synthetic form of erythropoietin (EPO) whose resemblance with endogenous EPO makes it hard to identify using the classical identification criteria. Urine samples collected from six healthy volunteers treated (…)

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[Source: NCBI PubMed]

17.06.2010 | BioSpace: Shire plc Release: Two New Board Directors Appointed

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that Dr David Ginsburg and Ms Anne Minto OBE, have been appointed to the Shire Board of Directors with immediate effect. Dr Ginsburg, MD is currently Professor of Internal Medicine & (…)

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[Source: BioSpace]

01.06.2010 | BioSpace: Cosmo Pharmaceuticals S.p.A. Reports Shire Pharmaceuticals (SHPGY) Receives LIALDA(R) Paragraph IV Notice Letter from Zydus Pharmaceuticals (USA) Inc.

Lainate, Italy 31 May 2010 Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today reports that Shire plc (LSE: SHP, NASDAQ: SHPGY) announced on 28 May 2010 that it has received a Paragraph IV Notice Letter from Zydus Pharmaceuticals USA, Inc. ( œZydus ) advising of the filing of an (…)

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[Source: BioSpace]

29.05.2010 | Medical News Today: Shire Announces FDA Approval Of VPRIV(TM) (velaglucerase Alfa For Injection) For The Treatment Of Type 1 Gaucher Disease

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of (…)

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[Source: Medical News Today]

28.05.2010 | Business Wire: Research and Markets: Inflammatory Bowel Disease Therapeutics - Global Strategic Business Report | Business Wire

DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/194007/inflammatory_bowel) has announced the addition of the "Inflammatory Bowel Disease Therapeutics - Global Strategic Business Report" report to their offering. Inflammatory Bowel (…)

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[Source: Business Wire]

28.05.2010 | BioSpace: Shire Pharmaceuticals (SHPGY) Pays $200M For Lab Buildings

Boston Globe - Drug maker Shire Pharmaceuticals is buying four buildings in Raytheon s former Lexington campus along Route 2 for more than $200 million, marking a major move forward for the recovering commercial real estate market.

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[Source: BioSpace]

26.05.2010 | Medical News Today: Study Evaluated Vyvanse (lisdexamfetamine Dimesylate) Capsules CII Efficacy And Safety In Adolescents With ADHD

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (…)

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[Source: Medical News Today]

25.05.2010 | Business Wire: Oceana Therapeutics Announces David S. Tierney, MD, Featured in the Inaugural Irish Life Science 50; Honor Presented by the President of Ireland | Business Wire

EDISON, N.J.-(BUSINESS WIRE)-Oceana Therapeutics today announced that the Company s President and COO, David S. Tierney, MD, has been featured in the first ever listing of the Irish Life Science 50. I have known David for years and am pleased to call him a friend as well as (…)

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[Source: Business Wire]

21.05.2010 | Business Wire: 12th Annual C21 BioVentures Presenter Profiles | Business Wire

NAPA, Calif.-(BUSINESS WIRE)-The 12th Annual C21 BioVentures Conference takes place May 25-27, 2010 at The Meritage Resort in Napa, CA. Links to important information: Overview Participants Program Business Wire is the official newswire service for the 12th Annual C21 (…)

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[Source: Business Wire]

19.05.2010 | Business Wire: Research and Markets: Neurodegenerative Drugs: Global Strategic Business Report - Alzheimers Disease, Parkinsons Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis and Others | Business Wire

DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/d5a60b/neurodegenerative) has announced the addition of the "Neurodegenerative Drugs - Global Strategic Business Report" report to their offering. Neurodegenerative Drugs - Global (…)

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[Source: Business Wire]

06.05.2010 | BioSpace: US Warns Roche Holding AG (RHHBF.PK), Shire plc on Misleading Drug Promotions

Reuters - U.S. regulators have warned Roche Holding AG unit Genentech and Shire Plc about misleading promotions for cancer and bowel drugs, letters released on Wednesday said.

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[Source: BioSpace]

29.04.2010 | BioSpace: Shire plc's Replenished Portfolio Drives Excellent Quarterly Performance

DUBLIN, April 29, 2010 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company, announces results for the three months to March 31, 2010.

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[Source: BioSpace]

28.04.2010 | Medical News Today: Santaris Pharma A/S Advances RNA-Targeted Drug Development Candidate Against PCSK9, An Important New Target For The Treatment Of High Cholesterol

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, announced that it has advanced into drug development a discovery research candidate directed against PCSK9 (proprotein convertase subtilisin/kexin (…)

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[Source: Medical News Today]

27.04.2010 | BioSpace: Shire plc Receives INTUNIV(TM) Paragraph IV Notice Letter From Anchen Pharmaceuticals(USA), Inc.

DUBLIN, April 27, 2010 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc. ("Anchen") advising of the filing of an (…)

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[Source: BioSpace]

23.04.2010 | Business Wire: ShareFEST 2010 Conference by NextDocs Highlights Content Management and Collaboration in Life Sciences | Business Wire

KING OF PRUSSIA, Pa.-(BUSINESS WIRE)-The drive to share information across boundaries has helped make SharePoint the fastest growing product in Microsoft history. Steve Aylward, General Manager, U.S. Healthcare and Life Sciences Group for Microsoft, told this to more than 350 (…)

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[Source: Business Wire]

23.04.2010 | BioSpace: Shire plc Files Suit Against TEVA Pharmaceuticals USA (TEVA) and Teva Pharmaceutical Industries Limited (TEVA)

DUBLIN and PHILADELPHIA, April 23, 2010 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Delaware against (…)

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[Source: BioSpace]

14.04.2010 | BioSpace: Shire plc Selects IDBS for Virtualized Drug Research Collaboration Platform

GUILDFORD, UK and BURLINGTON, MA-(Marketwire - April 14, 2010) - IDBS, the leading worldwide provider of research data management and analytics solutions to R&D organizations, today announced that Shire plc, the global specialty biopharmaceutical company, has selected IDBS to (…)

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[Source: BioSpace]

13.04.2010 | BioSpace: KV Pharmaceutical Company (KV-A) Appoints New Chief Financial Officer

ST. LOUIS, April 13 /PRNewswire-FirstCall/ - K-V Pharmaceutical Company (the "Company") today announced it has appointed Stephen A. Stamp as Chief Financial Officer and Treasurer, effective April 7, 2010. Mr. Stamp will report directly to David Van Vliet, interim CEO of the (…)

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[Source: BioSpace]