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Bavarian Nordic has announced it will supply 110,000 doses of its MVA-BN smallpox/monkeypox vaccine to the European Health Emergency Preparedness and Response Authority (HERA) over the coming months.
The pandemic has been a game-changer for the pharmaceutical industry, sending the seemingly inexorable globalisation trends into reverse, with Big Pharma increasingly seeking more domestic supply chain options. Here, Karen Winterhalter of Onyx Health shares her expert insights on the impact of this emerging trend on the industry.
Pharma industry calls for support as restrictive pricing measures and rising costs of goods/inflation could undermine the availability of medicines.
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
How will a new regulatory landscape impact the EU and UK pharma industries? Early 2022 will see major new clinical trial legislation come into effect, with proposals for an entirely new regulatory regime promised by the end of the year. Paul Ranson, Consultant at Morgan Lewis, reflects on this and…
Lorviqua® monotherapy approved as first-line advanced non-small cell lung cancer therapy based on promising Phase III trial results.
The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.
Children with cystic fibrosis aged six to11 years could benefit from Kaftrio® in combination with ivacaftor, as a treatment targeting the underlying cause of the disease.
Amgen’s Lumykras® (sotorasib) has been approved for adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
When the pandemic broke out in 2020, pharmaceutical supply chains showed signs of potential failure across the continent. Now, with COVID-19 cases rising once more, and an end to the problem not yet in sight, we discuss with Medicines for Europe how these supply chains are faring, almost two years…
The European Medicines Agency (EMA)'s pilot project will support not-for-profit organisations and academia in gathering evidence for the use of a drug in a new indication.
A microneedle patch, which can be stored for >30 days at room temperature, safely delivered a DNA-based COVID-19 vaccine in mice.
Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) gives her take on the industry response to the pandemic; highlighting the benefits of focused effort and what can be achieved through unified collaboration.
The COVID-19 pandemic spotlighted drug repurposing as a key strategy to support traditional novel chemical entity development; yet repurposing is just one example of how off-patent molecules can be further developed to provide patients with more treatment options. Here, Arun Narayan, Chairman of the Value Added Medicines Sector Group at…
Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
