Alfasigma sets stage for Jyseleca in axSpA after Phase III win
Alfasigma plans to engage with regulators to seek approval for Jyseleca (filgotinib) in active axial spondyloarthritis (axSpA) following a successful…
Musculoskeletal Disorders
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Roche extends SMA market lead with Evrysdi tablet approval in Europe
Roche has won approval in Europe for a tablet formulation of its spinal muscular atrophy (SMA) treatment Evrysdi (risdiplam), as…
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Biogen’s higher dose Spinraza under review by US and EU regulators
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Biogen’s applications for a higher dose…
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Santhera launches DMD therapy in the UK following NICE nod
Swiss biotech Santhera Pharmaceuticals has started launch preparations for its Duchenne muscular dystrophy (DMD) drug Agamree (vamorolone) in the UK,…
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Santhera’s DMD therapy Agamree approved for NHS use after new price deal
England’s National Institute for Health and Care Excellence (NICE) has recommended Santhera Pharmaceuticals’ treatment for Duchenne muscular dystrophy (DMD) Agamree…
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FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy trial
The US Food and Drug Administration (FDA) has lifted the partial clinical hold on Avidity Biosciences’ investigational drug, delpacibart etedesiran…
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Modalis wins FDA rare paediatric designation for CMD CRISPR therapy
Modalis Therapeutics has been awarded a rare paediatric disease designation by the US Food and Drug Administration (FDA) for its…
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Coherus offloads Humira biosimilar Yusimry for $40m
Coherus Biosciences has divested Yusimry (adalimumab-aqvh), a biosimilar to AbbVie’s rheumatoid arthritis therapy Humira, to Hong Kong King-Friend Industrial (HKF)…
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Midland Pharmaceuticals launches to advance spinal injury therapeutics
Scientists from the universities of Birmingham and Sheffield have partnered with NLC Health Ventures for the launch of Midland Pharmaceuticals…
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EC approves Sandoz’s biosimilars for bone-related ailments
The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilars Wyost (denosumab) and Jubbonti (denosumab) for bone-related ailments. Wyost…
