news
In-line pharma monitoring system developed for tablet quality inspection
The novel approach could enhance quality testing applications in pharmaceutical manufacturing.
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Research & Development (R&D)
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FDA approves first-of-a-kind intravesical drug delivery system for bladder cancer
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
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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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Demand for AI-integration propelling mass spectrometry growth
Significant investment in advanced technologies Is expected to support global adoption of mass spectrometry in the next five years.
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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.
webinar
The Future of Sterility Testing: One-Day Results with Advanced RT-rt PCR Technology
2 September 2025 | By FUJIFILM Wako Europe GmbH
Join this webinar to find out how RT-rt PCR is revolutionising sterility testing and discover a unique approach that provides reliable one-day results and enhanced sensitivity and detection capabilities.
![Roche logo sign lit up [Credit: testing/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Roche-3-300x278.jpg)
![Roche logo sign lit up [Credit: testing/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Roche-3-e1652444508201.jpg)
news
Roche touts ‘best-in-disease’ potential for anti-hypertensive zilebesiran
While AstraZeneca’s first-in-class candidate baxdrostat marks phase III hypertension win at ESC 2025.
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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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MHRA pilot to prepare sponsors for clinical trial regulation changes
The Route B notification pilot will expand the MHRA’s risk-proportionate approach and help prepare for a new modifications process under upcoming regulations.
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Understanding European regulatory requirements for low-GWP propellant transition
The paper explores recent guidance by the EMA and aims to help companies ensure their developments are efficient and effective for the forthcoming transition.
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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.
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Sanofi’s Tzield type 1 diabetes immunotherapy wins UK first
Becomes the first monoclonal antibody for the condition to be approved by the MHRA and advances the pharma company’s ambitions in diabetes.
