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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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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.
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Oligonucleotide therapy helps to prevent chronic hepatitis B
Bepirovirsen, an antisense oligonucleotide therapy aided in long-term prevention of chronic hepatitis B in patients on and not on nucleoside/nucleotide analogues in a Phase II trial.
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Swedish innovation agency invests in new ATMP QC method
A new project funded by Swedish innovation agency Vinnova, will help develop an AI-based quality control method for ATMP manufacturing.
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First patients given lab-grown blood cell transfusion
The second-ever patient has been transfused with lab-grown red blood cells in a clinical trial, promising an effective treatment for patients.
