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Draft regulatory guidance on personalised cancer therapies published
The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
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mRNA
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The year ahead for RNA therapeutic development and manufacturing
As the industry prepares for a new year, Dr Kate Broderick, PhD, Chief Innovation Officer of Maravai Life Sciences and TriLink Biotechnologies, shares her thoughts on what the RNA therapeutics landscape of 2024 can tell us about what may be on the horizon in 2025.
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Innovating LNP design to improve mRNA therapeutics
The new approach involving refinement and optimisation of ionisable lipids could accelerate the development of mRNA therapies, research suggests.
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Personalised mRNA cancer therapy shown to boost immune response
The individualised neoantigen therapy could enable a precise, durable immune response, based on study findings in melanoma and lung cancers.
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mRNA cancer vaccine granted world-first approval
Once commercialised, the mRNA therapeutic cancer vaccine will offer a new option to treat advanced Epstein–Barr virus-positive solid tumours and haematologic malignancies.
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European Pharmaceutical Review Issue 1 2024
EPR Issue 1 includes articles on separation & purification, process analytical technology and drug delivery. Register your details now to download this exclusive content.
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Boehringer Ingelheim agrees $2bn siRNA therapeutic collaboration
The collaboration seeks to develop new siRNA treatments for the liver diseases nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH).
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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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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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Continuous flow chemistry: from mRNA to small molecules
In this video, experts from Curia discuss trends in the pharmaceutical industry, including move to adopt continuous flow chemistry processes for both mRNA and small molecule manufacturing.
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mRNA therapies: a new frontier
Nicolas Chornet, Senior Vice President of International Manufacturing at Moderna, speaks to EPR about the future of mRNA therapies and offers an update on the company’s international expansion plans.
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European Pharmaceutical Review Issue 5 2023
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
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Moderna reveals optimistic data for influenza-COVID-19 vaccine
Strong influenza and COVID-19 immunogenicity compared to approved standalone vaccines has been demonstrated in Moderna’s combination vaccine, interim Phase I/II trial data shows.
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mRNA researchers awarded 2023 Nobel Prize
The Nobel Prize in Physiology or Medicine 2023 has been awarded to two researchers who were instrumental in helping to curb the COVID-19 pandemic, through their discoveries in mRNA base modifications.
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Bioprocessing & Bioproduction In-Depth Focus 2023
In this in-depth focus are articles on reducing production time for allogenic CAR T-cell therapies and the complexities of mRNA development, from design intricacies to scalability.
