news
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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Clinical Trials
webinar
The Future of Sterility Testing: One-Day Results with Advanced RT-rt PCR Technology
2 September 2025 | By FUJIFILM Wako Europe GmbH
Watch 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.
news
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.
news
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.
news
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.
news
UK yet to agree on VPAG scheme following accelerated review
While no other country has an identical scheme, analysis of the 2025 payment rate shows the UK is significantly behind comparable countries.
news
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.
news
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.
webinar
The future of contamination control in pharma: from compliance to innovation
15 August 2025 | By Bruker Microbiology & Infection Diagnostics
This webinar explores the benefits of accelerated microbial identification using MALDI-TOF in pharmaceutical contamination control strategies.
whitepaper
TCS revolutionize clinical trial monitoring and data analysis with AR/VR-driven immersive analytics
12 August 2025 | By
AR/VR solution for visualizing multi-dimensional data in 3D. Explore sites on a 3D globe to detect trends and anomalies with ease.
![Novartis logo Novartis building in Stein, Switzerland [Credit: Taljat David shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/novartis-image-300x278.jpg)
![Novartis logo Novartis building in Stein, Switzerland [Credit: Taljat David shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/novartis-image-scaled-e1594985022657.jpg)
news
Novartis scores Phase III wins for two ianalumab indications
Late-stage trials in Sjögren’s disease and primary immune thrombocytopenia met primary endpoints.
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New AbbVie data highlights Rinvoq promise in alopecia areata
The trial is the first pivotal clinical programme to have met the standard of complete scalp hair regrowth, suggesting potential in immune-mediated diseases.
news
Broad label FDA approval for phenylketonuria drug
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.
news
Extension trial demonstrates long-term benefit for Lilly Alzheimer’s drug
The new findings support a limited duration dosing approach and highlight the consistent safety profile for Eli Lilly’s antibody drug.
