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AI in pharmaceutical development: hype or panacea?
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
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EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
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Novo Nordisk gains rights to novel small molecule inhibitor
As part of the agreement with Novo Nordisk, Lexicon Pharmaceuticals is eligible for total of $1 billion in upfront and potential milestone payments, alongside royalties.
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Pharma Horizons: Artificial Intelligence
EPR's latest Pharma Horizons report explores the latest advances in artificial intelligence (AI) for drug and clinical development, regulation and more.
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FDA approves first-in-class oral antibiotic
The drug is the first in a new class of oral antibiotics for uncomplicated urinary tract infections in nearly three decades.
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MSD to advance investigational Lp(a) inhibitor in nearly $2b deal
The new license agreement will support development of a potential additional treatment option for patients at risk of atherosclerosis.
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European Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
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Novo Nordisk industry membership reinstated
The company now has ABPI membership after a two-year suspension involving concerns relating to its compliance with the industry body’s code of conduct.
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Investigational plaque psoriasis treatments show promise in late-stage trials
With the Phase III trials demonstrating sustained skin clearance in plaque psoriasis, this could lead to patients accessing more treatment options to manage the autoimmune inflammatory disease.
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Preparing for a new era in the rare disease sector
To mark Rare Disease Day 2025, EPR interviewed Christina Gkousgkouni, Head of Rare Diseases for Central South Europe, Sanofi.
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Stabilising Europe’s generic medicine supply
Ahead of the Critical Medicines Act anticipated in 2025, Teva’s report offers policy recommendations to mitigate the economic pressures risking generic medicine availability in Europe.
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Pharmaceutical training boost: how the growth and skills levy could shape industry development
A major overhaul of the UK’s Apprenticeship Levy promises to deliver greater flexibility for pharmaceutical workforce training, helping to address critical skills shortages.
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AstraZeneca cancels £450m Liverpool vaccine facility expansion
Under growing global competition, this development highlights potential challenges for the UK to uphold large-scale pharmaceutical investments.
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Moderna reports record for UK clinical trials in 2023/24
The announcement follows the completed construction of Moderna’s MITC and progress in its long-term partnership with the UK government.
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MHRA approves SARCLISA for newly diagnosed multiple myeloma
SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.
