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FDA approves IDE study for bone graft substitute, Cerament G

10 August 2016 | By Niamh Louise Marriott, Digital Content Producer

Bonesupport’s Fortify study will evaluate the safety and efficacy of Cerament G as part of surgical repair of open diaphyseal tibial fractures. The trial will enrol up to 230 patients at up to 30 centres globally, with the aim of having at least 50% of the study data coming from…

MSD’s Hepatitis C drug given green light for EU market

9 August 2016 | By MSD

Following successful phase 3 clinical trials, in which MSD’s new Hepatitis C drug, Zepatier, performed well, achieving high virologic cure rates across the study, the European Commission has licensed the drug for sale in the European market, specifically for the treatment of chronic hepatitis C virus (HCV) in adults with…

NHS Scotland approves Novo Nordisk’s diabetes drug

9 August 2016 | By Novo Nordisk

The drug was approved using evidence from three phase III studies in adults with type 1 diabetes mellitus and five phase III studies in adults with type 2 diabetes mellitus. The researchers discovered that insulin degludec was non-inferior to other long-acting insulin analogues, assessed by the mean change in glycosylated…

Pfizer’s Vyndaqel a success for rare disease

8 August 2016 | By Pfizer

Treatement over varying periods of up to 5.5 years, showed that early stage treatment with Vyndaqel resulted in minimal neurological disease progression, and in preservation of body weight, which often declines as the disease progresses...

FDA approves Merck’s head and neck cancer drug

8 August 2016 | By Merck

Under the FDA’s accelerated approval regulations, Keytruda, a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells, is approved based on tumour response rate and durability of response. However, continued approval for the drug may be contingent upon…

SMC ‘U-turn’ offers lifeline to Scottish skin cancer patients

8 August 2016 | By Bristol-Myers Squibb

The SMC initially refused access to nivolumab for Scottish patients, having taken a different view to the National Institute for Health and Care Excellence (NICE), which approved it to treat patients in England and Wales. However, following a review of additional evidence, the SMC decision has been reversed, bringing access…

NICE recommends secukinumab for people with ankylosing spondylitis

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

The National Institute for Health and Care Excellence (NICE) has recommended innovative new drug secukinumab for treating ankylosing spondylitis, a type of arthritis that mainly affects the back....

ReNeuron Group publishes stroke clinical data

4 August 2016 | By Niamh Louise Marriott, Digital Content Producer

The PISCES I study was the first clinical trial of ReNeuron’s CTX cell therapy candidate for patients with motor disability as a consequence of ischaemic stroke. The data, collated over two years relates to the eleven stroke patients treated in the study...