Pharmaceutical - Pharmaceutical, North America, Gastro-intestinals

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Health Canada clears AbbVie’s Humira for UC

Health Canada clears AbbVie’s Humira for UC

28-11-2013

In what is now the eighth indication in Canada for its top-selling drug Humira (adalimumab), US drugmaker…

AbbVieAnti-Arthritics/RheumaticsGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

US FDA accepts AstraZeneca’s NDA for naloxegol

US FDA accepts AstraZeneca’s NDA for naloxegol

19-11-2013

The US Food and Drug Administration has accepted the New Drug Application for naloxegol, an investigational…

AstraZenecaGastro-intestinalsnaloxegolNektar TherapeuticsNorth AmericaPharmaceuticalRegulation

GA and PhRMA partner on pilot scheme to enhance patient engagement in three therapy areas

05-11-2013

The USA’s Genetic Alliance and the Pharmaceutical Research and Manufacturers of America have announced…

Gastro-intestinalsHealthcareHematologyNorth AmericaPharmaceuticalRespiratory and Pulmonary

Coronado reports disappointing results from its Crohn’s disease trial

15-10-2013

Coronado Biosciences has announced that TSO (Trichuris suis ova or CNDO-201) did not meet its primary…

Coronado BiosciencesGastro-intestinalsNorth AmericaPharmaceuticalResearch

Opioid-induced constipation market expected to see rapid growth by 2017

Opioid-induced constipation market expected to see rapid growth by 2017

13-10-2013

The global market for opioid-induced constipation will increase significantly from $144.42 million in…

AstraZenecabevenopranCubist PharmaceuticalsEuropeGastro-intestinalsMarkets & MarketingnaloxegolNorth AmericaPharmaceuticalRelistorSalix Pharmaceuticals

US Appeals Court lifts temporary injunction on Hanmi Nexium generic NDA

03-10-2013

AstraZeneca said that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction…

AstraZenecaEsomeprazole MagnesiumGastro-intestinalsHanmi PharmaceuticalLegalNexiumNorth AmericaPharmaceuticalRegulation

GlaxoSmithKline returns rights to vercirnon

19-09-2013

US drug developer ChemoCentryx (Nasdaq: CCXI) says that partner GlaxoSmithKline (LSE: GSK), the UK’s…

ChemoCentryxGastro-intestinalsGlaxoSmithKlineLicensingNorth AmericaPharmaceuticalvercirnon

US Priority Review for Takeda's vedolizumab for ulcerative colitis

05-09-2013

Japan's largest drugmaker, Takeda Pharmaceutical (TYO: 4502) says that the US Food and Drug Administration…

Gastro-intestinalsNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticalsvedolizumab

Sanofi US in deal to commercialize PA8140/PA32540

04-09-2013

The US subsidiary of French drug major Sanofi (Euronext: SAN) has entered into a deal with US drugmaker…

AspirinCardio-vascularGastro-intestinalsLicensingNorth AmericaOmeprazolePharmaceuticalPozenSanofi

Resubmission expected for Orexigen's obesity drug Contrave

29-08-2013

US biopharma company Orexigen Therapeutics (Nasdaq: OREX) has announced that the Light Study independent…

Arena PharmaceuticalsBelviqContraveGastro-intestinalsNorth AmericaOrexigen TherapeuticsPharmaceuticalQnexaRegulationVivus

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

$10 million milestone for Sucampo, as Takeda starts US selling of Amitiza for OIC

27-06-2013

USA-based Sucampo Pharmaceuticals (Nasdaq: SCMP) says that it has received a $10 million milestone payment…

AmitizaFinancialGastro-intestinalsMarkets & MarketingNorth AmericaPharmaceuticalSucampoTakeda Pharmaceuticals

Takeda files BLA for vedolizumab for Crohn's and ulcerative colitis in USA

21-06-2013

The US subsidiary of Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) has submitted a Biologics…

Gastro-intestinalsNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticalsvedolizumab

Pfizer in $2.15 billion settlement from Teva and Sun for infringement of Protonix patent

12-06-2013

Global pharma behemoth Pfizer (NYSE: PFE) today (June 12) said it has reached a $2.15 billion settlement…

Gastro-intestinalsGenericsLegalNorth AmericaPatentsPfizerPharmaceuticalProtonixSun Pharmaceutical IndustriesTeva Pharmaceutical Industries

AstraZeneca settles with Hanmi and Amneal over Nexium; Prepares for olaparib regulatory filing

03-06-2013

Anglo-Swedish drug major AstraZeneca (LSE: AZN) today (May 3) said it has entered into an agreement with…

Amneal PharmaAstraZenecaGastro-intestinalsGenericsHanmi PharmaceuticalLegalNexiumNorth AmericaolaparibOncologyPatentsPharmaceuticalRegulationResearch

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

Shire prevails in US Lialda patent dispute with Watson

10-05-2013

Ireland-headquartered drugmaker Shire's (LSE: SHP) subsidiary Shire Development has prevailed in its…

ActavisGastro-intestinalsGenericsLegalLialdaNorth AmericaPatentsPharmaceuticalShireWatson Pharmaceuticals

Vedolizumab has potential to offer improvement over infliximab in UC

30-04-2013

Surveyed US and EU5 gastroenterologists agree that new moderate to severe ulcerative colitis (UC) therapies…

EuropeGastro-intestinalsinfliximabJanssenMarkets & MarketingMerck & CoNorth AmericaPharmaceuticalRemicadeTakeda Pharmaceuticalsvedolizumab

FDA approves Eisai's Aciphex Sprinkle for GERD in children; Inovelon OKed in Japan

28-03-2013

Japanese drug major Eisai (TYO: 4523) says that the US Food and Drug Administration has approved Aciphex…

AciphexAsia-PacificEisaiGastro-intestinalsInovelonNeurologicalNorth AmericaPharmaceuticalRegulation

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 approves first anti-diarrheal drug for HIV/AIDS patient, Salix Pharma's Fulyzaq

02-01-2013

Continuing the flurry of 2012 year-end drug approvals, the US Food and Drug Administration on Monday…

crofelemerFulyzaqGastro-intestinalsNapo PharmaceuticalsNorth AmericaPharmaceuticalRegulationSalix Pharmaceuticals

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

Pfizer agrees $55 million settlement for off-label promotion of Protonix by Wyeth; strikes deal over Zyvox and Lyrica

13-12-2012

USA-based Pfizer (NYSE: PFE), the world's largest drugmaker by sales, has agreed to pay $55 million plus…

Antibiotics and Infectious diseasesFinancialGastro-intestinalsLegalLyricaMarkets & MarketingNeurologicalNorth AmericaPfizerPharmaceuticalProtonixWyethZyvox

Prescription drug costs: USA versus UK

04-11-2012

In the USA, the cost paid for statins (drugs to lower cholesterol) in people under the age of 65 who…

Cardio-vascularEuropeGastro-intestinalsGenericsNorth AmericaPharmaceuticalPricing

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