Regulation - Inflammatory diseases


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Celltrion files for US FDA approval of Remsima biosimilar

Celltrion files for US FDA approval of Remsima biosimilar


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


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


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


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

Inflammatory diseasesInsmedPharmaceuticalRegulationRespiratory and PulmonaryUSA

Novartis gains breakthrough therapy designation for sIBM drug from US FDA


Swiss drug major Novartis (NOVN: VX) has gained US Food and Drug Administration breakthrough therapy…

bimagrumabInflammatory diseasesNorth AmericaNovartisPharmaceuticalRegulation

US FDA approves Janssen's Simponi to treat ulcerative colitis


The US Food and Drug Administration late yesterday (May 15) approved a new use for Johnson & Johnson…

BiotechnologyGastro-intestinalsInflammatory diseasesJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi Injection

Positive opinions for Novartis' Jetrea and Ilaris from EMA advisory panel


Among a number of positive recommendations last Friday from the European Medicines Agency's Committee…

Anti-Arthritics/RheumaticsEuropeIlarisInflammatory diseasesJetreaNovartisOphthalmicsPharmaceuticalRegulationThromboGenics

Savient's Krystexxa gets final EU approval for chronic tophaceous gout


US drugmaker Savient Pharmaceuticals (Nasdaq: SVNT) says that the European Commission has granted a marketing…

EuropeInflammatory diseasesKrystexxaPharmaceuticalRegulationSavient Pharmaceuticals

FDA approves SOBI's Kineret for the treatment of NOMID


Biotech firm Swedish Orphan Biovitrum (STO: SOBI) today announced that the US Food and Drug Administration…

AmgenBiotechnologyInflammatory diseasesKineretNorth AmericaRegulationSobiSwedish Orphan Biovitrum

Abbott's Humira OKed for new ulcerative colitis indication in EU


Following a previous favorable advisory committee recommendation, US health care major Abbott Laboratories…

Abbott LaboratoriesEuropeGastro-intestinalsHumiraInflammatory diseasesPharmaceuticalRegulation

Actelion drops setipiprant, gets miglustat approval in Japan


Switzerland-based Actelion Ltd (SIX: ATLN) announced says that it will re-direct its development efforts…

ActelionAsia-PacificBiotechnologyBrazavesInflammatory diseasesMiglustatRare diseasesRegulationResearchsetipiprantZavesca

Germany’s IQWiG finds no added benefit for Pfizer’s Xiapex


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

EuropeInflammatory diseasesPfizerPharmaceuticalRegulationXiapex

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