Regulation - Pharmaceutical, Gastro-intestinals

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US DEA de-schedules AstraZeneca’s Movantik

07-02-2015

The USA’s Drug Enforcement Administration (DEA) has de-scheduled UK pharma major AstraZeneca’s Movantik…

AstraZenecaGastro-intestinalsMovantiknaloxegolNektar TherapeuticsPharmaceuticalRegulationUSA

AstraZeneca files marketing authorization application with EMA for lesinurad

AstraZeneca files marketing authorization application with EMA for lesinurad

22-01-2015

The European Medicines Agency has accepted the marketing authorization application by AstraZeneca for…

AstraZenecaGastro-intestinalslesinuradPharmaceuticalRegulation

FDA committee votes to not recommend Ferring’s desmopressin

FDA committee votes to not recommend Ferring’s desmopressin

15-01-2015

The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has…

desmopressinFerring PharmaceuticalsGastro-intestinalsPharmaceuticalRegulationUSA

Takeda gains approval for Takecab in Japan; files MS drug NDA

Takeda gains approval for Takecab in Japan; files MS drug NDA

29-12-2014

Japan’s largest drugmaker Takeda Pharmaceutical and partner Otsuka Pharmaceuticals have been granted…

Gastro-intestinalsGlatiramer AcetateJapanNeurologicalOtsuka PharmaceuticalsPharmaceuticalRegulationTakecabTakeda PharmaceuticalTeva Pharmaceuticals Industriesvonoprazan

NICE says ‘yes’ to Remicade, Humira and Simponi for ulcerative colitis

NICE says ‘yes’ to Remicade, Humira and Simponi for ulcerative colitis

12-12-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued…

AbbVieGastro-intestinalsHumiraMerck & CoPharmaceuticalPricingRegulationRemicadeSimponi InjectionUK

AstraZeneca’s Moventig gains EU approval for OIC

09-12-2014

The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s…

AstraZenecaEuropeGastro-intestinalsMoventigNektar TherapeuticsPharmaceuticalRegulation

FDA responds to Public Citizen antacid petition from 2011

FDA responds to Public Citizen antacid petition from 2011

05-11-2014

The US Food and Drug Administration has responded to a 2011 petition from consumer rights advocacy group…

Gastro-intestinalsNexiumPharmaceuticalPrevacidPrilosecRegulationUSA

Added benefit of Takeda’s Entyvio is not proven, says IQWiG

Added benefit of Takeda’s Entyvio is not proven, says IQWiG

04-11-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products,…

EntyvioGastro-intestinalsGermanyPharmaceuticalPricingRegulationTakeda Pharmaceutical

Russian approval for Norgine/Takeda’s MoviPrep

28-10-2014

Netherlands-headquartered independent drugmaker Norgine says that its partner, Japan’s largest pharma…

Gastro-intestinalsMoviPrepNorginePharmaceuticalRegulationRussiaTakeda Pharmaceutical

Ferring Pharma’s Cortiment gains EU approval

Ferring Pharma’s Cortiment gains EU approval

23-10-2014

Privately-held Switzerland-headquartered Ferring Pharmaceuticals says its Cortiment (budesonide) treatment…

CortimentCosmo PharmaceuticalsEuropeFerring PharmaceuticalsGastro-intestinalsPentasaPharmaceuticalRegulation

Salix and Progenics receive FDA approval for Relistor injection for opioid-induced constipation

Salix and Progenics receive FDA approval for Relistor injection for opioid-induced constipation

01-10-2014

Gastrointestinal specialist Salix Pharmaceuticals and Progenix Pharmaceuticals have had their Relistor…

Gastro-intestinalsPharmaceuticalProgenics PharmaceuticalsRegulationRelistorSalix PharmaceuticalsUSA

AbbVie's Humira gains added indication from US FDA

AbbVie's Humira gains added indication from US FDA

25-09-2014

The US Food and Drug Administration has approved US drugmaker AbbVie’s Humira (adalimumab) for reducing…

AbbVieGastro-intestinalsHumiraInflammatory diseasesPharmaceuticalRegulationUSA

NICE opens consultation on three drugs for chronic bowel condition

NICE opens consultation on three drugs for chronic bowel condition

24-09-2014

Three drugs to treat ulcerative colitis, a chronic bowel condition, have not been proven to be more cost…

AbbVieGastro-intestinalsHumiraMerck & CoPharmaceuticalPricingRegulationRemicadeSimponi InjectionUK

OxThera’s Oxabact gains orphan drug designation in EU

OxThera’s Oxabact gains orphan drug designation in EU

23-09-2014

Privately-held Swedish biopharmaceutical company OxThera AB’s product Oxabact (oxalobacter formigenes)…

EUGastro-intestinalsOxabactOxTheraPharmaceuticalRegulationSweden

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

FDA approves AstraZeneca’s Movantik for opioid-induced constipation

17-09-2014

The US Food and Drug Administration yesterday approved Movantik (naloxegol), an oral treatment for opioid-induced…

AstraZenecaGastro-intestinalsMovantikNektar TherapeuticsPharmaceuticalRegulationUSA

FDA accepts Actavis NDA for eluxadoline

FDA accepts Actavis NDA for eluxadoline

03-09-2014

Ireland-headquartered generic drug major Actavis says that the US Food and Drug Administration has accepted…

ActaviseluxadolineForest LaboratoriesFuriex PharmaceuticalsGastro-intestinalsPharmaceuticalRegulationUSA

Takeda launches first gut-selective treatment for inflammatory bowel disease in the UK

Takeda launches first gut-selective treatment for inflammatory bowel disease in the UK

28-08-2014

The first gut-selective treatment for ulcerative colitis and Crohn’s Disease is now available in the…

Crohn's diseaseEntyvioGastro-intestinalsInflammatory bowel diseasePharmaceuticalRegulationTakeda PharmaceuticalUKUlcerative colitis

Insys submits Dronabinol oral solution New Drug Application

Insys submits Dronabinol oral solution New Drug Application

13-08-2014

Supportive care specialist Insys Therapeutics has made a New Drug Application submission to the US Food…

CannabinoidsDronabinolEntheogensGastro-intestinalsInsys TherapeuticsPharmaceuticalRegulationTetrahydrocannabinolUSA

NICE recommends Amitiza to treat long-term, painful constipation

NICE recommends Amitiza to treat long-term, painful constipation

23-07-2014

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Amitiza (lubiprostone)…

AmitizaGastro-intestinalsGastroenterologyPharmaceuticalRegulationSucampoUK

Astellas submits sNDA for Irribow/Irribow OD in Japan

Astellas submits sNDA for Irribow/Irribow OD in Japan

14-07-2014

Japanese drug major Astellas Pharma has submitted a supplemental New Drug Application for the indication…

Astellas PharmaGastro-intestinalsIrribowJapanPharmaceuticalRegulation

Swissmedic approves Amitiza for opioid-induced constipation

Swissmedic approves Amitiza for opioid-induced constipation

08-07-2014

US biopharma firm Sucampo Pharmaceuticals has received approval from Swissmedic, Switzerland’s Agency…

AmitizaEuropeGastro-intestinalsPharmaceuticalRegulationSucampo

UK’s NICE recommends Sucampo’s Amitiza for CIC

UK’s NICE recommends Sucampo’s Amitiza for CIC

18-06-2014

The UK health care watchdog the National Institute of Health and Care Excellence (NICE) has released…

AmitizaGastro-intestinalsPharmaceuticalPricingRegulationSucampoUK

Positive US FDA advisory panel view on PAMORAs

Positive US FDA advisory panel view on PAMORAs

13-06-2014

The majority of US Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee…

AstraZenecaGastro-intestinalsMovantiknaloxegolPharmaceuticalRegulationUSA

EU approval for Takeda’s Entyvio for UC and Crohn’s disease

27-05-2014

Takeda Pharmaceutical, Japan’s largest drugmaker has received marketing approval from the European…

EntyvioEuropeGastro-intestinalsPharmaceuticalRegulationTakeda Pharmaceutical

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