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Janssen files for EU approval of Stelara in pediatric plaque psoriasis

13-10-2014

Janssen-Cilag International says that a Type II Variation has been filed with the European Medicines…

BiotechnologyDermatologicalsEuropeInflammatory diseasesJanssen-CilagJohnson & JohnsonRegulationStelara

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

Lilly’s ixekizumab shows superiority over etanercept and placebo in Ph III

Lilly’s ixekizumab shows superiority over etanercept and placebo in Ph III

21-08-2014

US pharma major Eli Lilly’s investigational medicine ixekizumab was superior to etanercept and placebo…

Eli LillyInflammatory diseasesixekizumabPharmaceuticalRegulationResearch

Celltrion files for US FDA approval of Remsima biosimilar

Celltrion files for US FDA approval of Remsima biosimilar

13-08-2014

South Korean biopharmaceutical firm Celltrion says it has completed the filing procedure to obtain US…

BiosimilarsBiotechnologyCellTrionClinical researchInflammatory diseasesinfliximabJanssen BiotechJohnson & JohnsonPatentsRegulationRemicadeRemsimaUSA

Review of ibuprofen medicines started by EMA Pharmacovigilance unit

Review of ibuprofen medicines started by EMA Pharmacovigilance unit

16-06-2014

At its June 2014 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee…

EuropeibuprofenInflammatory diseasesNeurologicalPharmaceuticalRegulation

NICE gives negative guidance on Janssen’s Stelara for psoriatic arthritis

NICE gives negative guidance on Janssen’s Stelara for psoriatic arthritis

28-05-2014

US health care giant Johnson & Johnson subsidiary Janssen today received a negative opinion from UK watchdog…

DermatologicalsInflammatory diseasesJanssenJohnson & JohnsonPharmaceuticalPricingRegulationStelaraUK

Insmed’s mixed results from Ph II trial for treatment resistant NTM lung infections

27-03-2014

US-based Insmed has reported mixed results from its Phase II clinical trial of Arikayce, for the treatment…

Inflammatory diseasesInsmedPharmaceuticalRegulationRespiratory and PulmonaryUSA

Report: Approval of first biosimilar MAb in Europe has major implications for 2014 and beyond

Report: Approval of first biosimilar MAb in Europe has major implications for 2014 and beyond

07-12-2013

Key clinical, corporate and regulatory events affecting the biosimilar industry have been identified…

Anti-Arthritics/RheumaticsBiosimilarsCellTrionEuropeGenericsHospiraInflammatory diseasesInflectraMarkets & MarketingRegulationRemsima

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