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US FDA accepts AstraZeneca’s NDA for naloxegol

US FDA accepts AstraZeneca’s NDA for naloxegol


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

AstraZenecaGastro-intestinalsnaloxegolNektar TherapeuticsNorth AmericaPharmaceuticalRegulation

Eisai expands marketing and supply agreement for Belviq worldwide

Eisai expands marketing and supply agreement for Belviq worldwide


Japanese drug major Eisai (TYO: 4523) has expanded the marketing and supply agreement between its US…


Salix Pharma moves into diabetes with $2.6 billion buy of Santarus

Salix Pharma moves into diabetes with $2.6 billion buy of Santarus


Salix Pharmaceuticals has entered into a definitive merger agreement to acquire all the outstanding common…

DiabetesGastro-intestinalsGlumetzaMergers & AcquisitionsPharmaceuticalRare diseasesRuconestSalix PharmaceuticalsSantarus

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


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

Gastro-intestinalsHealthcareHematologyNorth AmericaPharmaceuticalRespiratory and Pulmonary

Abraaj sells stake in Opalia Pharma to Recordati


The Dubai-based Abraaj Group, an investor operating in global growth markets, has announced its full…

Abraaj GroupDermatologicalsGastro-intestinalsGenericsMergers & AcquisitionsOpalia PharmaRecordatiRespiratory and PulmonaryRest of the World

AstraZeneca reveals new safety data for naloxegol in OIC

AstraZeneca reveals new safety data for naloxegol in OIC


AstraZeneca has released results of a Phase III long-term safety and tolerability study of the once-daily…


Coronado reports disappointing results from its Crohn’s disease trial


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

Coronado BiosciencesGastro-intestinalsNorth AmericaPharmaceuticalResearch

PeptiDream and Ipsen expand their peptide drug collaboration to treat endocrinologic disease


PeptiDream and Ipsen have expanded the scope of their April 2013 research collaboration and license option…


US Appeals Court lifts temporary injunction on Hanmi Nexium generic NDA


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

AstraZenecaEsomeprazole MagnesiumGastro-intestinalsHanmi PharmaceuticalLegalNexiumNorth AmericaPharmaceuticalRegulation

Roche highlights late-stage pipeline beyond cancer


Swiss drug major Roche has provided an update from its leading late-stage pipeline comprising 10 new…


AstraZeneca’s naloxegol marketing application accepted by EMA

AstraZeneca’s naloxegol marketing application accepted by EMA


The European Medicines Agency has accepted AstraZeneca’s Marketing Authorization Application for naloxegol…

AstraZenecaEuropeGastro-intestinalsMarkets & MarketingnaloxegolNektar TherapeuticsPharmaceuticalRegulation

GlaxoSmithKline returns rights to vercirnon


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

ChemoCentryxGastro-intestinalsGlaxoSmithKlineLicensingNorth AmericaPharmaceuticalvercirnon

Eli Lilly and Oxford University to fund three-year study into IBD


US drug major Eli Lilly (NYSE: LLY) has entered a partnership with Oxford University, UK, to fund a three-year…

Eli LillyEuropeGastro-intestinalsPharmaceuticalResearch

Italy's Recordati to acquire Spanish drugmaker


In a second takeover deal this year, Italian drugmaker Recordati (RC: MI) says it has signed agreements…

CitrafleetGastro-intestinalsLab Casen FleetMergers & AcquisitionsPharmaceuticalRecordatiWomen's Health

US Priority Review for Takeda's vedolizumab for ulcerative colitis


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


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


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


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

AbbVieBiotechnologyGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

ChemoCentryx plunges as partnered drug candidate fails to meet endpoints


US drug developer ChemoCentryx (Nasdaq: CCXI) saw its shares plummet 31.6% to $7.99 last Friday (August…


Takeda's vedolizumab shows efficacy in colitis and Crohn's disease


A new investigational antibody - vedolizumab - from Japan's largest drugmaker, Takeda Pharmaceuticals…

Gastro-intestinalsPharmaceuticalResearchTakeda Pharmaceuticalsvedolizumab

Astellas gains marketing approval for Irribow


Japanese drug major Astellas Pharma (TYO: 4503) has gained marketing approval in Japan for Irribow (ramosetron…

Asia-PacificAstellas PharmaGastro-intestinalsIrribowMarkets & MarketingPharmaceutical

Nektar hedges bets on deal with AstraZeneca


Along with presenting second-quarter financial results, Howard Robin, president and chief executive of…

AstraZenecaFinancialGastro-intestinalsLicensingnaloxegolNektar TherapeuticsPharmaceutical

IQWiG finds no added benefit proven for Constella in IBS


In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

AlmirallConstellaEuropeGastro-intestinalsIronwood PharmaceuticalsPharmaceuticalPricingRegulation

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