Regulation - Pharmaceutical, Gastro-intestinals

Filter

Popular Filters

1 to 25 of 62 results

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

US FDA thumbs up for Takeda’s Entyvio for ulcerative colitis and Crohn's disease

US FDA thumbs up for Takeda’s Entyvio for ulcerative colitis and Crohn's disease

21-05-2014

The US Food and Drug Administration yesterday approved Entyvio (vedolizumab) injection, from Japan’s…

EntyvioGastro-intestinalsPharmaceuticalRegulationTakeda PharmaceuticalsUSA

Takeda gets positive CHMP opinion for Entyvio for UC and Crohn’s disease

21-03-2014

Takeda Pharmaceutical, Japan’s largest drugmaker, today received a positive opinion form the European…

EntyvioEuropeGastro-intestinalsPharmaceuticalRegulationTakeda Pharmaceuticals

Highlights from the Pharmacovigilance Risk Assessment Committee meeting

Highlights from the Pharmacovigilance Risk Assessment Committee meeting

09-03-2014

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations…

diacereindomperidoneEuropeGastro-intestinalsNeurologicalPharmaceuticalRegulationzolpidem

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

Takeda stops development of diabetes candidate fasiglifam; PDUFA date for vedolizumab extended

27-12-2013

Japan’s largest drugmaker Takeda Pharmaceutical has decided voluntarily to terminate the development…

DiabetesfasiglifamGastro-intestinalsNorth AmericaPharmaceuticalRegulationResearchTakeda PharmaceuticalsUSAvedolizumab

FDA advisory panel backs approval of Takeda’s vedolizumab

FDA advisory panel backs approval of Takeda’s vedolizumab

10-12-2013

A US Food and Drug Administration advisory committee has recommended approval of vedolizumab from Japan’s…

Gastro-intestinalsPharmaceuticalRegulationTakeda PharmaceuticalsUSAvedolizumab

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

AstraZeneca’s naloxegol marketing application accepted by EMA

AstraZeneca’s naloxegol marketing application accepted by EMA

27-09-2013

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

AstraZenecaEuropeGastro-intestinalsMarkets & MarketingnaloxegolNektar TherapeuticsPharmaceuticalRegulation

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

IQWiG finds no added benefit proven for Constella in IBS

07-08-2013

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

AlmirallConstellaEuropeGastro-intestinalsIronwood PharmaceuticalsPharmaceuticalPricingRegulation

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

First approved new class of IBS-C therapy, Constella, now available in Europe

13-06-2013

Spain's largest drugmaker Almirall (ALM: MC) and US partner Ironwood Pharmaceuticals, (Nasdaq: IRWD)…

AlmirallConstellaEuropeGastro-intestinalsIronwood PharmaceuticalsMarkets & MarketingPharmaceuticalRegulation

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

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

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

1 to 25 of 62 results

Company Spotlight

Eleven Biotherapeutics

Eleven Biotherapeutics

Back to top