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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First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
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.
While AstraZeneca’s first-in-class candidate baxdrostat marks phase III hypertension win at ESC 2025.
And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
The Route B notification pilot will expand the MHRA’s risk-proportionate approach and help prepare for a new modifications process under upcoming regulations.
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
While no other country has an identical scheme, analysis of the 2025 payment rate shows the UK is significantly behind comparable countries.
22 August 2025 | By US Pharmacopeia
Join our live webinar with USP as they explore new approaches for impurity profiling - unveiling new frameworks, analytical tools, and regulatory insights that are reshaping pharmaceutical quality standards.
Her leadership experience spans three decades with Lilly, across multiple therapeutic areas including oncology, neuroscience and infectious disease.
The paper explores recent guidance by the EMA and aims to help companies ensure their developments are efficient and effective for the forthcoming transition.
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.
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.
Becomes the first monoclonal antibody for the condition to be approved by the MHRA and advances the pharma company’s ambitions in diabetes.
Pharmacokinetic study of the novel drug delivery method shows high relative bioavailability in a once-weekly regimen.
Sven Dethlefs will be tasked with driving its deupirfenidone programme in idiopathic pulmonary fibrosis.