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).
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Regulation & Legislation
news
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.
news
Critical Medicines Act ‘must prioritise’ EU pharmaceutical manufacturing competitiveness
European Parliament's SANT Committee urges for greater control on medicine provisions to help strengthen security of supply.
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
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
FDA starts publishing daily adverse event data
US regulator says the move to open up the FAERS database will help modernise its safety monitoring.
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
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
Merck’s SpringWorks Therapeutics gains European approval for Ogsiveo
The drug is the first treatment for desmoid tumours to be approved in the region.
news
Pharma cautious about rushing towards direct-to-consumer drug sales
Disruption to traditional distribution channels is anticipated to hinder widespread adoption of the channel.
news
WuXi Biologics granted novel authorisation for commercial biologic manufacturing in Ireland
The EMA’s decision permits WuXi Biologics to progress with commercial manufacturing of a global client’s innovative biologic.
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.
