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NICE recommends bimekizumab for severe plaque psoriasis treatment
Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.
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Bimzelx® receives EC approval for plaque psoriasis treatment
The European Commission (EC) have approved UCB’s Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis.
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EC approves treatment for severe osteoporosis postmenopausal women
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
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Creating a modern business landscape in biopharma
There are many business challenges to developing a biologics drug, one of which is effective data management. In this article, Unjulie Bhanot focuses on efficient data management policies and systems, and how they could improve biologics product development processes.
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FDA approves Briviact for partial-onset seizures in paediatric epilepsy
The approval provides paediatric epilepsy patients a treatment option which can be initiated at a therapeutic dose from day one...
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EMA accepts MAA for romosozumab in the treatment of osteoporosis
The EMA has accepted the Marketing Authorization Application for romosozumab in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture...
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Improving patient access, the UCB way
UCB’s ambition, according to its website, is to transform the lives of people living with severe diseases. The company’s Head of Global Clinical Development and Medical Affairs Stuart Dollow believes that making its clinical trial design more patient-centred and creating the right partnerships are key steps toward improving access to…
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FDA approves Vimpat for partial-onset seizures in paediatric epilepsy
FDA approves Vimpat for partial-onset seizures in paediatric epilepsy patients as an oral solution or a convenient tablet...
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UCB receives EU approval for paediatric anti-epileptic drug
UCB has announced that the EC has approved the use of its anti-epileptic drug Vimpatas in the treatment of partial-onset seizures...
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UCB and Amgen’s Osteoporosis study shows bone mineral density gains
18 November 2016 | By Niamh Louise Marriott, Digital Content Producer
The BRIDGE study involved 245 men with osteoporosis randomised 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once monthly for 1 year...
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UCB and Amgen submit FDA application for Osteoporosis drug
22 July 2016 | By Niamh Louise Marriott, Digital Content Producer
UCB and Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab, an investigational, monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture...
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NICE recommends certolizumab pegol in draft guidance
12 July 2016 | By Victoria White, Digital Content Producer
Certolizumab pegol is recommended as an option for people with severe rheumatoid arthritis when other drugs haven’t worked or aren’t suitable...
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SMC accepts five new medicines for use in NHS Scotland
11 July 2016 | By Victoria White, Digital Content Producer
The SMC has accepted five new medicines for routine use in NHS Scotland including lung cancer treatments nivolumab and crizotinib...
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Bimekizumab demonstrates positive results in patients with psoriatic arthritis
10 June 2016 | By Victoria White, Digital Content Producer
In a Phase Ib study, bimekizumab showed fast and sustained efficacy on disease activity measures in both skin and joints and was well-tolerated...
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Positive top-line results from Phase III study of romosozumab in osteoporosis
21 March 2016 | By Victoria White
The study demonstrated a statistically significant increase in bone mineral density at the lumbar spine in men with osteoporosis treated with romosozumab...