news
Downstream process shows potential for oncolytic virus purification
The paper presents an “efficient and scalable GMP-compliant process” for purifying a fusogenic oncolytic virus (rVSV-NDV).
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Biopharma
news
Sanofi plant to help secure EU insulin supply
The planned €1.3 billion investment will result in the new German facility replacing the company’s existing insulin production plants.
news
FDA approves innovative engineered cell therapy
The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
article
Alzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
news
Achieving VLP continuous production with digital twins
Utilising a digital twin for an advanced process control strategy facilitates additional productivity gains of 20 percent at 99.9 percent reliability, the authors shared.
news
From biologics to small molecules – the shift in biopharma’s revenue growth
Biopharma companies that experienced strong revenue growth due to COVID-19 drug sales have been overtaken by companies that developed obesity drugs in 2023, GlobalData suggests.
news
Eco HPLC-based method shows promise for Z-alkene synthesis
The innovative method, which utilises continuous closed-loop recycling of samples, could lead to a more environmentally-friendly approach to developing pharmaceuticals.
webinar
Simplify your move from a vial to a prefilled syringe
30 July 2024 | By West Pharmaceutical Services
This webinar explores the key considerations in component selection when moving from a vial to a prefilled syringe during biologic drug development.
news
CHMP meeting highlights – July 2024
In its July meeting, the EMA’s human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
article
A holistic approach to safeguard data integrity in Biopharma manufacturing
Data integrity is critical in Biopharma manufacturing yet is often difficult to achieve due to complex regulatory requirements and legacy data management systems, among the many factors. Furthermore, issues such as data accuracy, completeness and security impact product quality, regulatory compliance and ultimately patient safety. Addressing all these challenges demands…
news
Pfizer receives EU haemophilia B gene therapy approval
The single-dose gene therapy was approved for certain patients with haemophilia B in the US and Canada earlier this year, marketed as BEQVEZ.
article
The route to enhanced gene therapies
In this article, Roger Palframan, Head of US Research at UCB, delves into the potential of gene therapy and which modalities have the most promise, what the industry should prioritise to advance the field, as well as what is needed to develop the workforce.
news
Ipsen agrees new oncology licensing deal
The agreement relates to an innovative therapeutic for the most common paediatric brain cancer, where outside the US, there is no approved targeted treatment for certain patients.
news
Utilising naturally occurring endotoxins in recovery studies
The research aimed to address concerns from regulatory agencies about accepting low endotoxin recovery studies that use a naturally occurring endotoxin analyte.
news
Securing Europe’s competitiveness in life sciences
Digitalisation, R&D and AMR were highlighted as key areas of focus to support European competitiveness up to the end of the decade, as set out in new Political Guidelines for Europe.
