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The public body has recommended in draft guidance that UCB’s Certolizumab pegol receives regular NHS funding for plaque psoriasis, although NICE decided that Almirall’s rival Tildrakizumab is not cost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,

Continue Reading

Novartis seeks approval for Multiple Sclerosis drug in EU and US

Novartis is seeking approval from EU and US for use of experimental multiple sclerosis therapy, siponimod, to treat secondary progressive forms of MS. Secondary progressive multiple sclerosis (SPMS) is where the disease causes continuous worsening of neurological function over time, independent of relapses. Most people with relapsing remitting forms of MS will eventually go on

Continue Reading

Regulatory Professionals to attend TOPRA 2018 Symposium in Sweden

Regulatory Professionals employees Sarah Goddard, Divisional Director and Kirsty Calow, Divisional Manager will be exhibiting at the 2018 TOPRA Symposium, which is taking place in Sweden October 1-3rd. The Symposium features the following: Information on the latest regulatory developments Insight provided directly from Regulatory experts Opportunity for delegates to expand on their existing knowledge of

Continue Reading

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

Continue Reading

European Medicines Agency backs strengthened regulatory measures for valproate

An announcement from the EMA has endorsed strengthened regulatory measures for prescribing valproate to women who are pregnant and of child-bearing age. The agency’s Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed strengthened measures to avoid pregnant women being exposed to the drug. Under the new measures proposed by the

Continue Reading