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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Research & Development (R&D)
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.
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
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.
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.
news
Daewoong’s microneedle patch marks semaglutide first in obesity
Pharmacokinetic study of the novel drug delivery method shows high relative bioavailability in a once-weekly regimen.
news
PureTech taps ex-Teva CEO to run its new respiratory unit Celea
Sven Dethlefs will be tasked with driving its deupirfenidone programme in idiopathic pulmonary fibrosis.
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.
webinar
Best practices for PUPSIT assembly design and operation
11 August 2025 | By Entegris
This webinar explores the design and implementation of pre use post sterilisation integrity test assemblies (PUPSIT) in sterile filtration processes to ensure regulatory compliance while minimising operational risk.
news
AI driving automated microbiological testing market growth to 2033
Regulatory pressures and demand for trained operators is expected to hinder growth of the rapid microbiological testing market into the next decade, research suggests.
