Simponi(Janssen Biotech) filed at FDA and EMA for Ulcerative Colitis treatment - 19-Jul-2012
Janssen Biotech and Janssen Biologics have requested the FDAand European Medicines Agency to approve Simponi(golimumab) a treatment for "adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy." Simponi ,a once-monthly subcutaneously administered drug , received approvals in the United States, Europe and Canada in 2009 for the treatment of moderately to severely-active rheumatoid arthritis and, in combination with methotrexate, for active psoriatic arthritis and for active ankylosing spondylitis.
Related News
FDA approves Uceris (Santarus) for mild to moderate Ulcerative Colitis
FDA approve Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis
FDA approves Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis
FDA Advisory Panel recommends Humira (Abbott Labs) for treatment of Ulcerative Colitis
Tofacitinib (Pfizer) success in Phase II study for Ulcerative Colitis
Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis
Simponi(Janssen Biotech) filed at FDA and EMA for Ulcerative Colitis treatment
Simponi (Janssen Biotech) shows positive results in Phase III trial for Ulcerative Colitis
Related Gastroenterology Information
Gastroenterology Clinical Guidelines
Dyspepsia: Managing dyspepsia in adults in primary care
NICEEating disorders, Core interventions in the treatment and management of anorexia nervosa, bulimia nervosa and related eating disorders
NICEGastroenterology Clinical Trials
Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
Clinicaltrials.gov 09 April 2013Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)
Clinicaltrials.gov 04 April 2013Gastroenterology Medical Journal Abstracts
Prospective antibody case finding of coeliac disease in type-1 diabetes children: need of biopsy revisited
Acta Paediatrica 04 January 2013Placental Transfer of Anti-Tumor Necrosis Factor Agents in Pregnant Patients with Inflammatory Bowel Disease
Clinical Gastroenterology and Hepatology 29 November 2012Gastroenterology Medical Apps
DigAlmanac
£13.99
GI Monitor
Free
Related Gastroenterology Drugs
- FYBOGEL MEBEVERINE
- ZANTAC 75 TABLETS
- PANCREX V FORTE TABLETS
- CONSTELLA 290 MICROGRAMS HARD CAPSULES
- HYDROTALCITE SUSPENSION (GENERIC)
- ASACOL SUPPOSITORIES
- PARIET
- ZANTAC INJECTION 50MG/2ML
- MESTINON TABLETS
- IMODIUM PLUS CAPLETS GSL
- RESOLOR 2MG FILM-COATED TABLETS
- CO-DANTHRAMER CAPSULES AND STRONG CO-DANTHRAMER CAPSULES
- FAMOTIDINE (GENERIC)
- MAXOLON 10MG TABLETS
- DESERIL
- QUESTRAN LIGHT (DIARRHOEA)
- ASACOL FOAM ENEMA
- ANACAL
- DOMPERIDONE (DYSPEPSIA) (GENERIC)
- SUCRALFATE (GENERIC)
- KOLANTICON
- TOPAL
- PROTIUM SOLUTION FOR INJECTION
- MICOLETTE MICRO-ENEMA
- ORIGINAL ANDREWS SALTS
- METOCLOPRAMIDE 5 MG/ML INJECTION
- COLIFOAM
- CIMETIDINE 200MG/5ML ORAL SOLUTION
- BUSCOPAN TABLETS
- HIDRASEC 100 MG HARD CAPSULES
- PROCTOSEDYL
- HIDRASEC CHILDREN 30MG GRANULES FOR ORAL SUSPENSION
- CELEVAC TABLETS 500MG
- SENOKOT
- SALOFALK
- ENO
- ANUGESIC HC CREAM
- EPIRUBICIN HYDROCHLORIDE 2 MG/ML SOLUTION FOR INJECTION OR INFUSION
- MYOTONINE
- OILY PHENOL BP (GENERIC)
- NORMAX
- ESOMEPRAZOLE 40MG GASTRO RESISTANT TABLETS
- GASTROCOTE LIQUID
- AXID CAPSULES
- METOCLOPRAMIDE 10MG TABLETS
- PICOLAX
- DESTOLIT
- ATROPINE (GENERIC-GASTROINTESTINAL)
- OMEPRAZOLE 20MG CAPSULES
- PYLORID
- NORMACOL PLUS
- PEPCID 20 AND 40 MG TABLETS
- PYROGASTRONE
- MANEVAC
- INFACOL
- COLAZIDE 750MG CAPSULES
- PEPTO-BISMOL, 17.5MG/ML ORAL SUSPENSION
- KAOLIN AND MORPHINE MIXTURE BP
- PEPTO-BISMOL CHEWABLE TABLETS
- FLETCHERS' ARACHIS OIL
- LOSEC INFUSION 40MG
- PROCTOFOAM HC
- RESOLOR 1MG FILM-COATED TABLETS
- LOSEC I.V. INJECTION 40MG
- BUDENOFALK
- LOSEC CAPSULES 10MG, 20MG & 40MG
- PREPULSID
- FLEET PHOSPHO-SODA
- UNIROID-HC
- COLOFAC TABLETS 135MG
- RANITIDINE 150MG/10ML ORAL SOLUTION
- PROTIUM 40 MG TABLET
- HIDRASEC INFANT 10MG GRANULES FOR ORAL SUSPENSION
- GLYCERIN [GLYCEROL] SUPPOSITORIES
- SENNA TABLETS
- MICRALAX
- COMPOUND MACROGOL ORAL POWDER SUGAR FREE.
- COLOFAC MR
- DE-NOLTAB
- KLEAN-PREP
- DULCOLAX TABLETS, 5MG
- ASACOL MR TABLETS
- BUSCOPAN IBS RELIEF
- TROPERGEN
- FLEET ENEMA
- OMEPRAZOLE 10MG CAPSULES
- CYTOTEC TABLETS
- UBRETID
- LACTUGAL
- LOMOTIL TABLETS
- NORIMODE
- PERINAL
- NORMACOL
- LOPERAMIDE HYDROCHLORIDE
- NORGALAX
- ENTOCORT CR 3MG CAPSULES
- REMICADE
- PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION
- MESALAZINE (GENERIC)
- LOPERAGEN
- URSODEOXYCHOLIC ACID
- ENTOCORT ENEMA
- FYBOGEL ORANGE
- SALAZOPYRIN
- PANCREASE
- MAALOX PLUS
- URDOX 300MG FILM-COATED TABLETS, URSODEOXYCHOLIC ACID 300MG FILM-COATED TABLETS
- PROTIUM 20 MG TABLET
- ALTACITE PLUS
- MUCOGEL
- ELECTROLADE (DIARRHOEA)
- PRO-BANTHINE
- DIORALYTE RELIEF (DIARRHOEA)
- SCHERIPROCT OINTMENT
- MERBENTYL
- RENNIE DUO
- XYLOPROCT 5%/0.275% OINTMENT
- REGULAN LEMON/LIME FLAVOUR
- DIOCTYL 100 MG CAPSULES
- CIMETIDINE 200 MG TABLETS BP
- COLPERMIN IBS RELIEF CAPSULES
- TAGAMET
- ANUSOL CREAM
- MINTEC OR 0.2ML GASTRO-RESISTANT CAPSULES
- DUPHALAC
- ALU-CAP
- MOTILIUM 30MG SUPPOSITORIES
- MAALOX SUSPENSION
- CLIPPER 5MG SUSTAINED RELEASE TABLETS
- CREON 10000 CAPSULES
- URSOFALK SUSPENSION
- ZOTON FASTAB
- XIFAXANTA 200 MG FILM-COATED TABLETS
- PENTASA SLOW RELEASE TABLETS 1G
- NUTRIZYM GR
- MAALOX PLUS TABLETS
- ANTEPSIN TABLETS
Advert for Healthcare Professionals only