CHMP meeting highlights – June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
New findings from a Phase II study suggest the curative potential of a combination treatment for chronic hepatitis delta virus, according to Gilead Sciences.
Dr Maria Escolar, Chief Medical Officer, Forge Biologics, explores the advantages of the company’s novel AAV gene therapy for Krabbe disease, which could help to overcome some of the immune and safety challenges the gene therapy sector is facing.
Once commercialised, the mRNA therapeutic cancer vaccine will offer a new option to treat advanced Epstein–Barr virus-positive solid tumours and haematologic malignancies.
Considering reduced global demand for COVID vaccines, AstraZeneca has deemed there is no long-term value in investing in manufacturing the adenovirus-based vaccine.
Key drivers of the global injectable drug market include technological advancement and an increase in chronic diseases such as cancer, due to treatments utilising this drug delivery method.
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.
Phase III data shows that mRNA-1283 has a similar safety profile to Moderna's approved COVID-19 vaccines, the company states.
UK scientists have unlocked the potential of bioengineering vaccine adjuvants, based on a study of the molecule QS-21.
CIM® Monolithic Well Plates combine the advantages of monolithic chromatography with the convenience of a standard well plate format. They ensure robustness and reliable results, making them ideal for screening multiple chromatographic conditions simultaneously.
If biotech Berlin Cures’ larger Phase III study of its Long COVID drug candidate goes ahead, the findings will support the treatment’s potential future regulatory approval.
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
Vaccitech’s Chief Business Officer, Graham Griffiths, discusses key learnings in vaccine and drug development, the challenges of preparing for the unknown, and how strategic collaboration is imperative to achieve faster and more equitable outcomes - if and when another pandemic strikes.
This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
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.