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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.
The approval provides paediatric epilepsy patients a treatment option which can be initiated at a therapeutic dose from day one...
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...
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…
FDA approves Vimpat for partial-onset seizures in paediatric epilepsy patients as an oral solution or a convenient tablet...
UCB has announced that the EC has approved the use of its anti-epileptic drug Vimpatas in the treatment of partial-onset seizures...
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...
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...
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...
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...
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...
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...
29 February 2016 | By Victoria White
UCB’s Briviact (brivaracetam) has been authorised in the UK as an add-on treatment for partial onset seizures with or without secondary generalised seizures...
23 February 2016 | By Victoria White
The Phase III FRAME study evaluated UCB and Amgen's romosozumab in postmenopausal women with osteoporosis...
26 January 2016 | By Victoria White
NICE recommends the seven biological disease modifying drugs as options for treating severe rheumatoid arthritis which has not responded to intensive therapy with a combination of conventional DMARDs...
