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Novo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
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Drug Development
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Drug development In-Depth Focus 2025
This in-depth focus features articles on cell and gene therapy in Europe and enhancing drug delivery with cost-effective solutions.
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Biogen wins European first for depression drug Zurzuvae
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
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Roche pays $3.5bn for 89bio and its potential best-in-disease treatment MASH drug
The deal with the US biopharma could help address metabolic dysfunction-associated steatohepatitis, one of the most prevalent comorbidities of obesity.
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Novartis builds on Monte Rosa collaboration with $5.7 billion deal
Expanding its collaboration with the US biotech will add novel molecular glue degrader-based medicines to the pharma company’s pipeline.
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Novartis expands in cardiovascular disease with $1.4bn Tourmaline Bio acquisition
Gains access to potential breakthrough atherosclerotic cardiovascular disease biologic therapy pacibekitug.
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FDA to modernise review process for developers of ultra-rare diseases
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
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Roche en route to first continuous delivery treatment for nAMD in Europe
CE mark for Contivue platform supports its ambitions for Susvimo in age-related macular degeneration (AMD).
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Amgen to build $600m science and innovation centre in the US
The new Thousand Oaks, California facility will incorporate advanced automation and digital capabilities.
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Merck’s health business gains new Global Head of R&D
David Weinreich will also serve as its Chief Medical Officer and arrives at the German pharmaceutical group with experience from Amgen, Bayer and Regeneron.
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FDA waives trial requirement for Stelera biosimilar, easing the copycat’s path
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
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Teva wins US obesity approval for its GLP-1 generic liraglutide
And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
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Pharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
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Late-stage trial boost for Argenx’s myasthenia gravis drug Vyvgart
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
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Nanoscope gene therapy data signals potential retinal disease advancement
Further to its potential in Stargardt disease, if approved, the one-time gene therapy could become standard of care for retinitis pigmentosa, alongside other retinal degenerative diseases.
