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FDA to pilot faster review of generic drugs manufactured in the US
Sets bioequivalence and active pharmaceutical ingredient (API) requirements for its new ANDA prioritisation programme.
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Dominic Tyer (European Pharmaceutical Review)
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Europe unveils science strategy as it looks to become an ‘AI continent’
Establishes Resource for AI Science in Europe and eyes frontier AI models and autonomous agentic AI for pharma.
![Eli Lilly logo sign [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Eli-Lilly-300x278.jpg)
![Eli Lilly logo sign [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Eli-Lilly-e1629971959212.jpg)
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Lilly outlines $1bn India manufacturing expansion
The investment will cover CMO collaborations and a new manufacturing and quality hub in Hyderabad.
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Boehringer’s Jascayd becomes first new IPF treatment in US for a decade
FDA approval for the idiopathic pulmonary fibrosis drug supported by the pharma company’s FIBRONEER phase III clinical trials.
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CDMO Wheeler Bio appoints Jay Benson as chief operating officer
He joins the US company with over two decades of experience in pharma operations, supply chain and manufacturing.
![Close up view of the Merck logo on the top corner of a glass building [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Merck-aquisition-300x278.jpg)
![Close up view of the Merck logo on the top corner of a glass building [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Merck-aquisition-scaled-e1605009301887.jpg)
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Merck & Co starts phase IIb study of tulisokibart in rheumatoid arthritis
The study is one of three to start, along with those in hidradenitis suppurativa and radiographic axial spondyloarthritis.
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AstraZeneca and Daiichi’s Datroway gets phase III breast cancer boost
Companies’ first-line ambitions for the antibody drug conjugate buoyed by the TROPION-Breast02 clinical trial.
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Manufacturing roundup: Symbiosis, BioGrad, Abzena, Eschbach and more
This update includes sterile manufacturing, bio-manufacturing, cell line development and radiopharmaceuticals.
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Teva closes in on sale of API business TAPI
The pharma company’s plan to divest its active pharmaceutical ingredient interests was first announced in 2024.
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Bassem Saleh joins Netherlands CRO Julius Clinical as its new CEO
He arrives at the Netherlands-based contract research organisation from TFS HealthScience.
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Polpharma Biologics splits into biosimilars and CDMO businesses
Contract development and manufacturing services will be provided as Rezon Bio from Poland, with the biosimilars company operating from Switzerland.
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Kai Beckmann to take over from Belén Garijo as Merck CEO
The planned succession will also see him become Chair of the German pharma company’s Executive Board in May 2026.
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GSK’s Emma Walmsley to step down as CEO
In a surprise announcement, she will be replaced at the UK pharma company by its Chief Commercial Officer Luke Miels.
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Trump upends drug import policy with 100 percent tariff threat
Pharma manufacturing facility construction placed at the heart of a policy announcement made on social media.
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Moderna opens UK’s first mRNA vaccine manufacturing facility
As other pharma companies reconsider their investments, Moderna’s focus insulates it from the UK’s drug pricing row.
