WuXi Biologics granted novel authorisation for commercial biologic manufacturing in Ireland
The EMA’s decision permits WuXi Biologics to progress with commercial manufacturing of a global client’s innovative biologic.
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The EMA’s decision permits WuXi Biologics to progress with commercial manufacturing of a global client’s innovative biologic.
In this article, Miguel Angel Ortega Sánchez of ROIS explores how the industry is adapting to new delivery formats, device bottlenecks, and strategic partnership models — and why flexibility, compliance, and tech transfer agility are now critical to success.
Becomes the first monoclonal antibody for the condition to be approved by the MHRA and advances the pharma company’s ambitions in diabetes.
In this article, Michal Nitka, Senior Vice President, Head of Generics Europe & Global Head OTC, Teva Pharmaceuticals, outlines how policy reform, digital innovation, and manufacturing resilience can secure sustainable access to essential treatments - ensuring generic medicines remain a cornerstone of equitable, reliable care.
The pharma company will add to its existing Chicago site, boosting its active pharmaceutical ingredient production capacity.
Sven Dethlefs will be tasked with driving its deupirfenidone programme in idiopathic pulmonary fibrosis.
Amid intensifying market competition, the next-generation therapies could shape the future of oncology.
Amid shifting global dynamics, continued resilience in UK healthcare M&A deal activity is expected in H2 2025, forecasting predicts.
The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market more quickly.
In this article, Patrice Navarro, Tech Partner (Healthcare & Life Sciences Sector), Clifford Chance, discusses the AI Act and the related compliance considerations for pharmaceutical companies in the EU.
Regulatory pressures and demand for trained operators is expected to hinder growth of the rapid microbiological testing market into the next decade, research suggests.
The novel approach could reduce the industry’s reliance on fossil fuels by offering a sustainable production alternative for pharmaceuticals.
The proposed transaction means Just-Evotec Biologics’ Toulouse site would be used to develop and manufacture Sandoz biosimilars.
Alongside Phase III data demonstrating significant efficacy in the rare disease, the FDA’s decision could position the small molecule as a future standard of care.
The new findings support a limited duration dosing approach and highlight the consistent safety profile for Eli Lilly’s antibody drug.