NICE approves UCB’s treatment for Psoriasis but disapproved Almirall’s

The public body has recommended in draft guidance that UCB’s Certolizumab pegol receives regular NHS funding for plaque psoriasis, although NICE decided that Almirall’s rival Tildrakizumab is not cost effective. Certolizumab pegol has been previously approved in Europe in the new indication of plaque psoriasis, thereby adding to a list of uses including rheumatoid arthritis,

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CHMP recommend Shire’s rare disease treatment for use in EU

EMA’s CHMP committee has recommended Shire’s Lanadelumab, a new rare disease treatment which has blockbuster potential. Lanadelumab has been endorsed for prevention of recurrent attacks of hereditary angioedema (HAE) a rare, genetic disorder that results in recurring attacks of oedema in parts of the body, including the abdomen, face, feet, genitals, hands and throat. Laryngeal

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NHS approves combination skin cancer therapy from Novartis

NHS has three months to ensure that Novartis’ combination therapy dabrafenib/trametinib is routinely available to eligible skin cancer patients, after cost regulators published guidance backing funds for the treatment. NICE recommended the combination for use in patients with stage III BRAF V600 mutation-positive melanoma that has spread to lymph vessels, or lymph glands close to

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Regulatory Affairs: In an ever changing industry – what are you doing to stand out?

Regulatory Professionals, part of the Clinical Professionals Group, have compiled a report that utilises results from our salary survey along with our specialist industry knowledge, which outlines significant changes within Regulatory Affairs, and can be used as a guide to business development. Divisional Manager, Kirsty Calow, elaborates on the findings and the current state of

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