Regulation - Gilenya

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FDA investigating rare brain infection in patient taking Gilenya

30-08-2013

In a safety communication issued on Thursday (August 29), the US Food and Drug Administration is alerting…

GilenyaNeurologicalNorth AmericaNovartisPharmaceuticalRegulation

Scotland denies access to Roche skin cancer drug Zelboraf, but OKs Novartis' Gilenya

11-09-2012

Swiss drug major Roche (ROG SIX) says it is "extremely disappointed" that the Scottish Medicines Consortium…

EuropeGilenyaHealthcareNeurologicalNovartisOncologyPharmaceuticalPricingRegulationRocheZelboraf

EMA confirms positive benefit-risk profile for Novartis' Gilenya, but with label change; updated US label

23-04-2012

Novartis said on Friday that the European Medicines Agency's Committee for Medicinal Products for Human…

EuropeGilenyaNeurologicalNorth AmericaNovartisPharmaceuticalRegulation

Novartis makes Tekturna label change, updates on Gilenya and stops alisporivir trial

20-04-2012

In a day of mixed news for the Swiss drug major, Novartis (NOVN: VX) said yesterday that it has updated…

alisporivirAnti-viralsCardio-vascularGilenyaNeurologicalNovartisPharmaceuticalRegulationResearchTekturna

Positive NICE news for Gilenya for MS and Incivo for hep C

16-03-2012

There was good news from the UK drugs watchdog the Institute for Health and Clinical Excellence (NICE)…

Anti-viralsEuropeGilenyaIncivoJanssen-CilagJohnson & JohnsonNeurologicalNovartisPharmaceuticalPricingRegulation

Germany’s IQWiG finds “hint” of advantage for Novartis’ Gilenya

30-01-2012

The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed whether Swiss drug…

EuropeGilenyaNeurologicalNovartisPharmaceuticalPricingRegulation

EMA starts review of Gilenya; guidance on biosimilar interferon beta

23-01-2012

The European Medicines Agency has begun a review of the benefits and risks of Swiss drug major Novartis’…

BiotechnologyEuropeGenericsGilenyainterferon betaNeurologicalNovartisPharmaceuticalRegulation

Erbitux and Gilenya added to Australia’s PBS listing

02-09-2011

More than 400,000 Australians will benefit from new subsidized medicines, effective September 1, as Minister…

Asia-PacificErbituxGilenyaMerck KGaANeurologicalNovartisOncologyPharmaceuticalPricingRegulation

UK’s NICE turns down Novartis MS drug Gilenya in draft guidance

07-08-2011

In provisional draft guidance published last Friday, UK drugs watchdog the National Institute for Health…

EuropeGilenyaNeurologicalNovartisPharmaceuticalPricingRegulation

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