Regulation - Simponi Injection

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German pharma watch dog finds benefits for biologicals in RA

30-08-2013

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined nine biotechnologically…

Anti-Arthritics/RheumaticsBiotechnologyCimziaEnbrelEuropeHumiraKineretMabTheraOrenciaPharmaceuticalPricingRegulationRemicadeRoActemraSimponi Injection

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

Janssen files BLA for IV form of Simponi for moderate-to-severe RA

20-09-2012

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech has submitted a Biologics…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

Janssen Biotech gets FDA delay for new Simponi indication

12-09-2011

The US Food and Drug Administration has issued a Complete Response letter (CRL) to Janssen Biotech, a…

Anti-Arthritics/RheumaticsBiotechnologyJanssen PharmaceuticaJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

UK’s NICE recommends Merck & Co’s Simponi but not B-MS’s Orencia

26-08-2011

There was mixed news for US drug majors Merck & Co (NYSE: MRK) and Bristol-Myers Squibb (NYSE: BMY) this…

Anti-Arthritics/RheumaticsBristol-Myers SquibbEuropeMerck & CoOrenciaPharmaceuticalPricingRegulationSimponi Injection

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