whitepaper
Application Note: Automated Set-Up of the PyroGene® rFC Assay
Automating the pipetting steps of the PyroGene® rFC Assay on the ASSIST PLUS helps to reduce the opportunity for pipetting errors and ensures robust reproducibility.
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Biopharma
news
Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
news
New BeiGene Head of Europe, Global Clinical Operations appointed
Bringing over two decades of experience in oncology clinical development, the biotech’s new hire will work to advocate for innovation and patient-centric clinical development for the company’s European initiatives.
article
Analytica 2024 in overview
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum…
news
New data revealed for Novartis SMA gene therapy
Novartis has revealed new data for its one-time gene therapy for spinal muscular atrophy (SMA) in older children.
article
Delivery systems for biologics
Designing systems for delivery of biologics is often a significant challenge during clinical development. Here, Dave Li, Edyta Działo and Anna Baran of KCR Consulting highlight the need for balancing safety, effectiveness, cost and reducing patient discomfort.
news
New antibody drug formulation wins novel MHRA approval
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
news
Joint investment to accelerate UK sustainable biomanufacturing
One project supported through £11.5 million investment will focus on biocatalytic nitro-reductions in scalable continuous flow reactors, using paracetamol as a case study.
article
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.
news
NICE recommends first licenced treatment for AL amyloidosis
Having been available in Scotland and Northern Ireland since 2022, NICE’s positive opinion of the combination treatment means it is now accessible on the NHS.
article
Rare disease spotlight: first EU-approved treatment for Friedreich’s ataxia
In this exclusive article, Biogen’s Vice President and Head of the Neuromuscular Development Unit, Dr Toby Ferguson, discusses the current rare disease landscape and recent developments in treating Friedreich’s ataxia (FA).
article
Making ATMPs a reality for rare disease patients
Advanced therapy medicinal products (ATMPs) will be among the first to undergo joint clinical assessments at EU level in 2025 and these will form the basis for national value assessments and pricing negotiations. Here, Paolo Morgese from the Alliance for Regenerative Medicine discusses how methodologies for joint clinical assessments (JCAs)…
news
MHRA Chief Executive to step down
During Dame June Raine’s five-year tenure as Chief Executive, MHRA delivered regulation facilitating key innovations in gene therapy and the world’s first COVID vaccine.
news
Amgen opens its most advanced manufacturing facility to date
The biomanufacturing facility has been designed to help Amgen meet its target of carbon neutrality in all its operations by 2027, according to the company.
podcasts
EPR Podcast 23 – Inspiring inclusion in pharma – Kylie Bromley, Biogen
In this podcast, recorded ahead of International Women’s Day, Biogen’s Dr Kylie Bromley reflects on her career in the pharmaceutical sector and shares valuable insight into how the industry can work together to build greater gender equality and diversity.
