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Novartis

 

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FDA approves Novartis’ biosimilar to treat multiple inflammatory diseases

1 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The FDA approval is based on analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis...

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Novartis’ phase III MS study successfully meets endpoints

25 August 2016 | By Novartis

The study included 1,651 people with SPMS randomised to receive either 2mg BAF312 or placebo in a 2:1 ratio respectively, the primary endpoint being an improvement in the time to three-month confirmed disability progression, as measured by the expanded disability status scale (EDSS), versus placebo...

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NICE says Novartis’ and Janssen’s cancer drugs are not cost effective

18 August 2016 | By The National Institute for Health and Care Excellence (NICE)

In new draft guidance, the National Institute for Health and Care Excellence (NICE) has advised that everolimus, for treating advanced breast cancer after endocrine therapy, and ibrutinib, for treating relapsed or refractory mantle cell lymphoma, two drugs on the Cancer Drugs Fund are not cost effective.