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.
List view / Grid view
Therapeutics
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.
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
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
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
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
Johnson & Johnson builds on US manufacturing pledge with $2bn Fujifilm investment
Contracts to use a facility at Fujifilm’s North Carolina site as part of moves to onshore its manufacturing.
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Eli Lilly neuroscience executive Anne White to retire
Her leadership experience spans three decades with Lilly, across multiple therapeutic areas including oncology, neuroscience and infectious disease.
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
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.
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.
