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

18-05-2014

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

LifitegrastManagementOphthalmicsPharmaceuticalRegulationShire

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

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

19-02-2014

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

ElvanseNeurologicalPharmaceuticalRegulationShire

Added benefit of lisdexamfetamine not proven, says German watchdog

03-09-2013

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

02-05-2013

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

18-12-2012

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

12-09-2012

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

06-07-2012

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

25-06-2012

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

16-03-2012

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

23-02-2012

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

10-02-2012

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

FinancialNeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

US FDA approves Shire’s Firazyr to treat acute attacks of hereditary angioedema

26-08-2011

After a near unanimous recommendation from an advisory panel earlier this year (The Pharma Letter June…

FirazyrNorth AmericaPharmaceuticalRare diseasesRegulationShire

Shire drops Dermagraft for venous leg ulcers, after Ph III failure

25-08-2011

Ireland-headquartered drugmaker Shire (LSE: SHP) says that Advanced BioHealing (ABH), the USA-based regenerative…

Advanced BioHealingBiotechnologyDermagraftDermatologicalsPharmaceuticalRegulationResearchShire

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