news
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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Drug Development
news
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).
news
Amgen to build $600m science and innovation centre in the US
The new Thousand Oaks, California facility will incorporate advanced automation and digital capabilities.
news
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.
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.
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
Pharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
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
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.
article
Scaling for the GLP-1 revolution – meeting global injectable demand
In this article, Miguel Angel Ortega Sánchez of ROIS explores how the industry is adapting to new delivery formats, device bottlenecks, and strategic partnership models — and why flexibility, compliance, and tech transfer agility are now critical to success.
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.
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.
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.
