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European Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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Biopharmaceuticals
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Novel biologic could offer ulcerative colitis symptomatic remission
Johnson & Johnson’s selective IL-23 inhibitor demonstrated clinically meaningful improvements compared to placebo in ulcerative colitis, new study data shows.
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AstraZeneca announces $1.5b ADC manufacturing facility
The new manufacturing facility for antibody drug conjugates (ADCs) will be designed to have zero carbon emissions when operational, AstraZeneca stated.
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FDA approves Amgen T-cell engager for small cell lung cancer
Amgen’s Imdelltra™, previously known as tarlatamab, is approved for the treatment of adult patients with advanced small cell lung cancer.
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New EVP, Teva Global Operations appointed
The new Executive Vice President of Teva Global Operations will bring “significant experience at every stage of the manufacturing and supply process” to his new role, the company asserted.
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Ensuring sterility of a novel anti-VEGF bispecific antibody
Safety of the compounded biologic was confirmed following 28-day storage in two different polypropylene syringe types, research shows.
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Cell therapy could help curb progression of heart failure
New clinical trial data demonstrates the potential for a stem cell treatment as a cardiac regenerative therapy.
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Sanofi adds to biomanufacturing investment in France
The pharmaceutical company shared that its new investment adds to the current €2.5 billion planned for major building projects in France.
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Advancing pharmaceutical technology: trends and innovations at ACHEMA 2024
Taking place in Frankfurt, Germany on 10-14 June, ACHEMA 2024 is expected to bring together chemists, engineers and process technicians from across the pharmaceutical and other industries.
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Addressing drug delivery challenges of emerging drug modalities
The new company will work to develop solutions to overcome issues within new therapeutic modalities, in areas such as formulation, manufacturing and supply chain.
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Pharmaceutical continuous manufacturing: what’s next for industry?
13 May 2024 | By European Pharmaceutical Review, sponsored by MasterControl
During this virtual panel, industry experts will discuss adoption of continuous manufacturing in the pharmaceutical industry.
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Improving accuracy of spectroscopy for protein analysis
A study on spectroscopy challenges during biosimilar analysis has highlighted a novel observation with potential implications for quality control when detecting protein structures.
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Challenges and opportunities in the CGT supply chain
This article explores the unique logistics and supply chain challenges of cell and gene therapy development and the future potential of this innovative sector.
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Novel preservation method could improve storage of biologics
Light-assisted drying (LAD) is a new optical processing technique for forming trehalose amorphous solids to preserve biologics, while avoiding the freezing step necessary for lyophilisation.
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US agencies collaborate to address regulation for biotechnology products
In formulating the current Coordinated Framework for the Regulation of Biotechnology, the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA) utilised horizon scanning for novel biotechnology products.
