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New Phase III data for hidradenitis suppurativa biologic released
The IL-17A and IL–17F inhibitor demonstrated positive efficacy and safety in adults with moderate-to-severe hidradenitis suppurativa, new data shows.
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Digitalisation of the clinical trial landscape
UCB Pharma's Chief Medical Officer Iris Loew-Friedrich, shares her perspective on digital innovation in clinical trials plus current challenges in clinical data management and how it could evolve in the future.
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Potential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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CHMP recommends fenfluramine for LGS-associated seizures
Positive Phase III study data has prompted the CHMP to recommend FINTEPLA ®▼ (fenfluramine) for seizures associated with Lennox-Gastaut syndrome (LGS).
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New collaboration could advance small molecule epilepsy therapy
UCB and Praxis Precision Medicines, Inc. will collaborate to advance Praxis’ PRAX-020 small molecule programme for KCNT1 related epilepsies.
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Fenfluramine found effective in preventing drop seizures from LGS
Phase III trial shows fenfluramine as an adjunct to existing anti-epileptic treatment is effective in reducing the frequency of drop seizures from Lennox-Gastaut Syndrome (LGS).
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Bimekizumab achieves sustained levels of skin clearance over two years
Interim results from the BE BRIGHT study shows that bimekizumab is effective and safe for the treatment of moderate to severe psoriasis.
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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...
