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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

Novartis gains breakthrough therapy designation for sIBM drug from US FDA

20-08-2013

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

bimagrumabInflammatory diseasesNorth AmericaNovartisPharmaceuticalRegulation

SOBI gets FDA approval to manufacture substance for Kineret with partner Boehringer Ingelheim

11-06-2013

Swedish Orphan Biovitrum (STO: SOBI) said today (June 11) that it has received approval from the US Food…

Boehringer IngelheimInflammatory diseasesKineretNorth AmericaPharmaceuticalProductionRegulationSavient PharmaceuticalsSwedish Orphan Biovitrum

In Japan, Mitsubishi Tanabe files for canagliflozin approval; Eisai/AbbVie's Humira gets new indication

28-05-2013

Japanese drug major Mitsubishi Tanabe Pharma (TYO: 4508) said yesterday (May 27) that it has submitted…

AbbVieAsia-PacificBiotechnologycanagliflozinDiabetesEisaiHumiraInflammatory diseasesInvokanaMitsubishi TanabePharmaceuticalRegulation

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

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

21-01-2013

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

10-01-2013

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

08-01-2013

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

AmgenBiotechnologyInflammatory diseasesKineretNorth AmericaRegulationSobiSwedish Orphan Biovitrum

EMA reviews hypothesis on Pandemrix hypothesis; finalizes on NSAIDs and CV events

21-10-2012

The European Medicines Agency's Committee on Human Medicinal Products (CHMP) said Friday that it has…

Anti-Arthritics/RheumaticsdiclofenacGlaxoSmithKlineibuprofenInflammatory diseasesNaproxenNeurologicalPandemrixPharmaceuticalRegulationVaccines

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

12-04-2012

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

04-04-2012

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

14-02-2012

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

EuropeInflammatory diseasesPfizerPharmaceuticalRegulationXiapex

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