Regulation - Shire


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Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD

Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD


Ireland-headquartered drugmaker Shire says it has agreed to a written request by the US Food and Drug…


Shire plans NDA filing with FDA for Lifitegrast in 1st-qtr 2015


Following a May 15, 2014, meeting with the US Food and Drug Administration, Ireland-headquartered drugmaker…


UK’s MHRA accepts Shire’s Elvanse filing for ADHD in adults

UK’s MHRA accepts Shire’s Elvanse filing for ADHD in adults


Ireland-headquartered drugmaker Shire has had an application for its once-daily attention deficit/hyperactivity…


Added benefit of lisdexamfetamine not proven, says German watchdog


Ireland-headquartered Shire's (LSE: SHP) Elvanse (lisdexamfetamine dimesylate) demonstrated no added…

ElvanseEuropelisdexamfetamine dimesylateNeurologicalPharmaceuticalPricingRegulationShireVyvanse

US FDA adds new indication for Shire's ADHD drug Vyvanse; 1st-qtr results


Ireland-headquartered Shire (LSE: SHP) says that the US Food and Drug Administration has approved its…

FinancialNeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

Positive response from European regulatory procedure supports Shire's Elvanse for ADHD


Ireland headquartered Shire (LSE: SHP) yesterday announced a positive outcome from the European Decentralized…

ElvanseEuropelisdexamfetamine dimesylateNeurologicalPharmaceuticalRegulationShireTyvenseVyvanse

FDA accepts Shire's sNDA for Vyvanse as maintenance treatment


Ireland-headquartered drugmaker Shire (LSE: SHP) that the US Food and Drug Administration has accepted…

NeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

US FDA approves generics for Actavis and Lupin


Switzerland-based generic drugmaker Actavis Group, now owned by US firm Watson Pharmaceuticals (NYSE:…

ActavisGenericsIntunivLupinLyricaNeurologicalNorth AmericaPfizerRegulationShireWatson Pharmaceuticals

Shire to face generic competition for Adderall XR from Actavis


Shares in UK drugmaker Shire (LSE: SHP) fell around 9% to £17.82 in early trading this morning,…

ActavisAdderall XRGenericsNeurologicalNorth AmericaPharmaceuticalRegulationShireWatson Pharmaceuticals

Shire to acquire FerroKin BioSciences; drops Replagal BLA


Ireland-headquartered Shire (LSE: SHP) said yesterday that it has signed an agreement to acquire privately-held…

FerroKin BioSciencesMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRare diseasesRegulationReplagalShire

EMA approves Shire Vpriv plant in USA


Ireland-headquartered biopharma firm Shire (LSE: SHP) says that the European Medicines Agency's Committee…

BiotechnologyFinancialNorth AmericaPharmaceuticalRare diseasesRegulationReplagalShireVpriv

Shire forecasts strong 2012 EPS growth on record 2011 sales; Vyvanse news


Shire (LSE: SHP), the UK’s third-largest drugmaker, posted a pleasing set of financial for full-year…

FinancialNeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

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