Regulation - 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

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

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

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

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

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

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

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

Unanimous FDA advisory panel backing for NPS Pharma's Gattex

17-10-2012

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

Gastro-intestinalsGattexNorth AmericaNPS PharmaceuticalsPharmaceuticalRegulationteduglutide

FDA posts briefing papers for review of NPS Pharma's Gattex for SBS

15-10-2012

The USA Food and Drug Administration has posted briefing materials for the October 16 Gastrointestinal…

Gastro-intestinalsGattexNorth AmericaNPS PharmaceuticalsPharmaceuticalRegulation

Abbott's Humira gets FDA backing for new use

30-09-2012

US health care major Abbott Laboratories (NYSE: ABT) says that the US Food and Drug Administration has…

Abbott LaboratoriesGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

EMA backs Almirall's Constella; Bayer's Eylea recommended by CHMP

24-09-2012

The European Medicines Agency last Friday issued a batch of recommendations relating to marketing authorization…

AlmirallBayerConstellaEuropeEyleaGastro-intestinalsIronwood PharmaceuticalsNorth AmericaOphthalmicsPharmaceuticalRegeneronRegulation

FDA action on Salix' crofelemer delayed until 2013

05-09-2012

There was disappointing news for Salix Pharmaceuticals (Nasdaq: SLXP) with the Food and Drug Administration…

crofelemerGastro-intestinalsNorth AmericaPharmaceuticalRegulationSalix Pharmaceuticals

FDA nod for use of Ironwood and Forest's Linzess in certain cases of IBS and constipation

03-09-2012

The US Food and Drug Administration last week approved Linzess (linaclotide), co-marketed by US drugmakers…

Forest LaboratoriesGastro-intestinalsIronwood PharmaceuticalslinaclotideLinzessNorth AmericaPharmaceuticalRegulation

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

Watson debuts generic Nexium in Europe; Mylan launches Amidate copy in USA

08-08-2012

US generics firm Watson Pharmaceuticals (NYSE: WPI) said yesterday that its third-party business Specifar…

AmidateAstraZenecaEuropeGastro-intestinalsGenericsHospiraMarkets & MarketingMylan LaboratoriesNeurologicalNexiumNorth AmericaRegulationWatson Pharmaceuticals

Disappointing FDA views for Bayer's Xarelto and Pozen ulcer drug

22-06-2012

Bayer HealthCare, a unit of Germany's Bayer (BAYN: DE) says that it has received a complete response…

BayerCardio-vascularGastro-intestinalsJohnson & JohnsonNorth AmericaPA32540PharmaceuticalPozenRegulationXarelto

US FDA delays Salix' Crofelemer approval

01-05-2012

US drugmaker Salix Pharmaceuticals (Nasdaq: SLXP) revealed yesterday that the Food and Drug Administration…

crofelemerGastro-intestinalsNorth AmericaPharmaceuticalRegulationSalix Pharmaceuticals

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