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Health Canada backs pediatric Humira for Crohn's

27-08-2013

US drugmaker AbbVie (NYSE: ABBV) says that Health Canada has approved its blockbuster rheumatoid arthritis…

AbbVieBiotechnologyGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA

22-05-2013

Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday (May 21) presented the results of two pivotal…

Anti-viralsAstraZenecaBiotechnologyEuropeGastro-intestinalsGilead SciencesnaloxegolNektar TherapeuticsPharmaceuticalRegulationResearchsofosbuvir

US FDA approves Janssen's Simponi to treat ulcerative colitis

16-05-2013

The US Food and Drug Administration late yesterday (May 15) approved a new use for Johnson & Johnson…

BiotechnologyGastro-intestinalsInflammatory diseasesJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

US gastroenterologists increasingly using biologics to treat Crohn's patients in remission

06-03-2013

Although there have been no significant changes with regard to biologic treatment and Crohn's disease…

AbbVieBiotechnologyCimziaGastro-intestinalsHumiraJanssenMarkets & MarketingNorth AmericaPharmaceuticalRemicadeUCB

FDA approvals for Gattex, Adasuve, Varizig and Tamiflu

27-12-2012

Ahead of the Christmas holiday period, the US Food and Drug Administration announced a number of regulatory…

Anti-viralsBiotechnologyGastro-intestinalsNeurologicalNorth AmericaPharmaceuticalRegulation

EU approvals for Viread and Constella; EMA accepts vintafolide MAA

29-11-2012

Among a batch of European Union regulatory news in the last day or two, US biotech firm Gilead Sciences…

AlmirallAnti-viralsBiotechnologyConstellaEndocyteetarfolatideEuropeGastro-intestinalsGilead SciencesIronwood PharmaceuticalsMerck & CoOncologyPharmaceuticalRegulationvintafolideViread

Study finds potential use of ustekinumab for Crohn's disease

18-10-2012

Ustekinumab, an antibody proven to treat the skin condition psoriasis, has now shown positive results…

BiotechnologyGastro-intestinalsJanssenJohnson & JohnsonPharmaceuticalResearchStelara Injectionustekinumab

Theravance in up to $63.5 million deal with Alfa Wassermann for velusetrag; RuiYi links with arGEN-X on MAb

05-10-2012

USA-based Theravance (Nasdaq: THRX) and Italy headquartered Alfa Wassermann have entered into an exclusive…

Alfa WassermannarGEN-XARGX-109BiotechnologyGastro-intestinalsInflammatory diseasesLicensingOncologyPharmaceuticalRuiYiTheravancevelusetrag

Abbott's Humira cleared for Crohn's disease in EU

31-08-2012

The European Commission has approved US health care major Abbott Laboratories' (NYSE: ABT) blockbuster…

Abbott LaboratoriesAnti-Arthritics/RheumaticsBiotechnologyEuropeGastro-intestinalsHumiraPharmaceuticalRegulation

Abbott's Humira gains FDA panel backing for wider use

29-08-2012

The US Food and Drug Administration's Gastrointestinal Drugs Advisory Committee yesterday voted by 15…

Abbott LaboratoriesAnti-Arthritics/RheumaticsBiotechnologyGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

Ferring Pharma gains rights for elobixibat from Albireo

05-07-2012

Swiss drugmaker Ferring Pharmaceuticals has entered into a licensing agreement with Albireo AB, a Sweden-based…

AlbireoBiotechnologyelobixibatFerring PharmaceuticalsGastro-intestinalsLicensingPharmaceutical

EMA advisory backs Humira for UC and expanded use of Byetta

20-02-2012

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday…

Abbott LaboratoriesAmylinAnti-Arthritics/RheumaticsBiotechnologyByettaDiabetesEli LillyEuropeGastro-intestinalsHumiraPharmaceuticalRegulation

US gastroenterologists see significant growth for Abbott/Eisai’s Humira in ulcerative colitis once indication is approved

29-11-2011

In a recent survey of US gastroenterologists (n=99), BioTrends Research (a Decision Resources company)…

Abbott LaboratoriesBiotechnologyEisaiGastro-intestinalsHumiraMarkets & MarketingNorth AmericaPharmaceuticalRemicade

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