whitepaper
Whitepaper: Optimising the efficiency of QC laboratory: The power of automation
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.
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Biologics
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Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
whitepaper
Whitepaper: Single-use technologies in biosimilar development
ImaLINK™ manifold, which is designed to minimise the need for fittings, connections or assembly of all leak points, entrapment areas are eliminated.
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Pfizer’s €1.2 billion manufacturing site expansion
Pfizer’s €1.2 billion investment in its Grange Castle site in Dublin is expected to double the plant’s capacity for manufacturing biologics.
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mRNA non-vaccine therapeutics to generate $2 billion by 2028
Driven by the approval of pipeline agents, mRNA non-vaccine therapeutics are set to reach $2 billion in sales by 2028, says GlobalData.
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First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
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CPI opens £88 million manufacturing innovation centre
CPI has opened its Medicines Manufacturing Innovation Centre in Scotland to focus on efficient, sustainable manufacturing and advance medicine research.
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Radiation with immunotherapy increases lung cancer survival
Phase I study analysis determined immunotherapy with radiation is more effective than radiotherapy alone for metastatic non-small cell lung cancer.
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AstraZeneca to acquire Neogene for $320 million
AstraZeneca is set to acquire Neogene Therapeutics to advance T-cell receptor therapies for hard-to-treat cancers like solid tumours.
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First COVID-19 impact report on global vaccine markets
A 2022 WHO report is the first to portray COVID-19’s impact on the global vaccine market, identifying that lower-income countries struggle to access critical vaccines.
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MHRA approves first gene therapy for infusion into the brain
Upstaza™, approved for UK patients 18 months and over, is the first gene replacement therapy infused directly into the brain for the treatment of AADC deficiency.
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2022 WHO Biosimilar Guideline improves access, IGBA says
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
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Early efficacy of arthritis therapy predicts long-term benefits
Tremfya® trial analysis showing early skin and enthesitis response for active psoriatic arthritis could indicate long-term clinical response including disease remission.
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EMA human medicines committee (CHMP) highlights, November 2022
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
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Heart failure: clinical trials update 2022
EPR rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022.
