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FDA grants priority review to omalizumab for food allergies
If approved, monoclonal antibody omalizumab would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.
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Research & Development (R&D)
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EU pharmaceutical legislation revisions: what are the implications for biopharma?
Anne Dhulesia and Sean Dyson, Partners at L.E.K. Consulting, discuss the proposed revisions to EU pharma legislation and potential implications for biopharma companies operating in Europe.
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The imperative of fridge-free vaccines
Bruce Roser of Stablepharma gives an overview of efforts to develop thermostable vaccines. Could ‘fridge-free’ formulations improve the cost-effectiveness and accessibility of vaccination?
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The nitty gritty of biotherapeutics production
Caroline Peachey chats with Mahesh Bhalgat, COO at Syngene International Limited about the role of new technology in biotherapeutics production.
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Otsuka to commercialise hereditary angioedema drug in Europe
Japanese company Otsuka Pharmaceutical will pay $65 million is to commercialise Ionis’ hereditary angioedema candidate in Europe.
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European regulators prepare for AI in pharma
A coordinated workplan, which runs to 2028 will help European regulators embrace opportunities for artificial intelligence.
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$260 million funding injection for Danish vaccines initiative
The Novo Nordisk Foundation is investing up to $260 million in a vaccines research and development initiative focused on respiratory diseases.
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Year in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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Psilocybin-assisted therapy reduces depressive symptoms in cancer patients
Results from a Phase II clinical trial indicate that psilocybin-assisted therapy could benefit individuals with cancer and major depression.
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CHMP issues positive option for first gene-editing medicine
If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.
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Alkermes to sell Irish manufacturing facility to Novo Nordisk
The facility in Athlone, Ireland, will give Novo Nordisk additional capacity to manufacture oral products.
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Astellas secures EC approval for VMS treatment, fezolinetant
Approval of fezolinetant gives patients in Europe a new nonhormonal treatment option to control hot flashes or night sweats associated with menopause.
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New approach for synthesis of oligonucleotide conjugates
Researchers from Aarhus University and Novo Nordisk have discovered a new synthesis method for oligonucleotide conjugates, marking a step forward in development of more targeted RNA medicines.
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EC approves treatment for rare haematological disorder
The European Commission has approved Europe's first treatment for adults with indolent systemic mastocytosis, a rare haematological disorder.
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NK cell immunotherapy: what’s next in clinical development?
In this interview, Innate Pharma’s Yannis Morel, Executive Vice President of product portfolio strategy and business development, delves into the unique advantages of using multi-specific antibodies capable of engaging NK cells against tumours for oncology indications, and shares key data from the company’s ongoing and recent clinical trials.
