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The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
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The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
This article discusses the impact of the recent mpox emergency following the outbreak of the virus in 2022, highlights the industry’s response, potential vaccine candidates and key recommendations for international management of the disease.
Once commercialised, the mRNA therapeutic cancer vaccine will offer a new option to treat advanced Epstein–Barr virus-positive solid tumours and haematologic malignancies.
Researchers from Queen's University Belfast, Garry Laverty, Sreekanth Pentlavalli and Yuming An, delve into the potential of an innovative ‘hydrogel’ version of the HIV drug zidovudine.
Here, Sherene Min, Vice President and Head of Global Clinical Development at ViiV Healthcare, explains how the HIV treatment landscape is changing, with moves towards long acting and self‑administered treatments.
The fluid management for mRNA, LNPs, pDNA and viral vectors for cryopreservation are often prone to inefficiencies. SUT optimizes the manufacturing process.
UK scientists have unlocked the potential of bioengineering vaccine adjuvants, based on a study of the molecule QS-21.
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?
The Novo Nordisk Foundation is investing up to $260 million in a vaccines research and development initiative focused on respiratory diseases.
The European Commission has authorised the first protein-based adapted vaccine for COVID-19.
Dr Neil Murray, Chief Executive of ReNewVax, explores the importance of new bacterial vaccines in the context of antimicrobial resistance and examines how the principle of reverse vaccinology could help to create more accessible and cost-effective vaccines.
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.
A potential first-in-class extraintestinal pathogenic E. coli (ExPEC) vaccine set to be jointly developed by Sanofi and Janssen, could help to abate a pathogen that is key in driving global antimicrobial resistance (AMR).
Recent breakthroughs in anti-Abeta immunotherapy for Alzheimer's have shown disease-modifying potential, with vaccination emerging as a promising approach, as AC Immune’s Marija Vukicevic, Yves Kremer, Marie Kosco-Vilbois and Andrea Pfeifer explain.