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Clinical Trials

FDA approves first-of-a-kind intravesical drug delivery system for bladder cancer

10 September 2025 | By Catherine Eckford (European Pharmaceutical Review)

The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.

news

Novartis expands in cardiovascular disease with $1.4bn Tourmaline Bio acquisition

9 September 2025 | By Catherine Eckford (European Pharmaceutical Review)

Gains access to potential breakthrough atherosclerotic cardiovascular disease biologic therapy pacibekitug.

news

FDA to modernise review process for developers of ultra-rare diseases

5 September 2025 | By Catherine Eckford (European Pharmaceutical Review)

The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.

news

FDA waives trial requirement for Stelera biosimilar, easing the copycat’s path

2 September 2025 | By Catherine Eckford (European Pharmaceutical Review)

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.

news

Roche touts ‘best-in-disease’ potential for anti-hypertensive zilebesiran

1 September 2025 | By Dominic Tyer (European Pharmaceutical Review)

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

29 August 2025 | By Catherine Eckford (European Pharmaceutical Review)

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

28 August 2025 | By Catherine Eckford (European Pharmaceutical Review)

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

26 August 2025 | By Catherine Eckford (European Pharmaceutical Review)

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

25 August 2025 | By Catherine Eckford (European Pharmaceutical 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

18 August 2025 | By Catherine Eckford (European Pharmaceutical Review)

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

15 August 2025 | By Catherine Eckford (European Pharmaceutical Review)

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.

news

Novartis scores Phase III wins for two ianalumab indications

12 August 2025 | By Dominic Tyer (European Pharmaceutical Review)

Late-stage trials in Sjögren’s disease and primary immune thrombocytopenia met primary endpoints.

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Clinical Trials