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J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
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UK first country to secure zero-tariff US pharmaceuticals deal
New trade deal to “ignite economic growth” and help boost the UK’s position as a superpower in life sciences.
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European Commission calls for bio-based innovation in new EU Bioeconomy Strategy
Changes proposed in the EU body’s regulatory framework aim to create a competitive and sustainable European bioeconomy.
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Novartis adjusts manufacturing strategy in Switzerland to secure competitiveness
Swiss pharma company to trim production of oral medicines and packaging in Stein, while boosting productivity in Schweizerhalle.
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Dupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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First biosimilar version of J&J’s Simponi approved in Europe
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
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Medicines manufacturing in the UK to receive £54m sustainability boost
R&D projects supported by the Centre for Process Innovation (CPI) aim to shape a sustainable, resilient and competitive future for pharma manufacturing.
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Insmed wins first EU approval for non-cystic fibrosis bronchiectasis treatment
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
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Moderna strengthens US mRNA manufacturing capabilities with over $140m investment
The expansion places the pharma company’s full manufacturing loop in the US under one roof.
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FDA hits Sarepta with liver warning labelling for its DMD drug Elevidys
As well as the new safety warnings for the Duchenne muscular dystrophy gene therapy, the biopharma company also faced a new, more restrictive licence for the treatment.
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Policy reform call to secure Europe’s antibiotics supply
Supply crisis of antibiotics in Europe adds burden to regional efforts to overcome antimicrobial resistance (AMR), says a new report.
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MHRA set to overhaul the UK’s rare disease drug regulatory pathway
The medicines regulator will aim to take a more flexible licensing approach for the research and manufacture of rare disease therapies in the UK.
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Pfizer and Novo Nordisk battle for obesity market dominance
Novo Nordisk’s “bold” $6.5 billion bid subject to a final verdict by Metsera’s board of directors.
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J&J’s Tremfya secures two paediatric psoriasis approvals from FDA
The US FDA approvals make the drug the first IL-23 inhibitor to be licensed for two common skin conditions.
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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.
