The public body has recommended in draft guidance that UCB’s Certolizumab pegol receives regular NHS funding for plaque psoriasis, although NICE decided that Almirall’s rival Tildrakizumab is not cost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,
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
This month’s report specifically looks at the Regulatory Affairs sector and notes many interesting occurrences within the levels of vacancies available over the past 12 months and focuses on any noteworthy changes that has occurred.
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
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
The FDA has confirmed its approval of AbbVie and Neurocrine Biosciences’ Orilissa, a nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist, to help patients manage the moderate to severe pain of endometriosis. It has been noted that the drug is the first and only of its kind that is specifically developed for women suffering from
Rigel Pharmaceuticals has obtained its first FDA approval, with a green light to market Tavalisse for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have failed to respond to previous treatment. Chronic ITP is a rare autoimmune disease where the immune system destroys platelets, which are necessary for normal blood
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
NICE has stated that Eisai’s breast cancer drug Halaven should not be funded by the NHS, citing uncertainty in the clinical evidence submitted. Eisai already has a strained relationship with NICE which led to two years to review thyroid cancer drug Lenvima due to changes in its procedures, before rejecting it last month. NICE had
Bayer has received approval from the European Commission for its haemophilia A drug, Kovaltry (octocog alfa) in patients of all age groups. Thereby allowing it to market the product in all 28 EU member states.