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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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Biologics
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ICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
news
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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Insights into AstraZeneca’s MANDARA Phase III data
In this Q&A, Dr Michael Wechsler, Professor of Medicine, Director of the National Jewish Health (NJH)/Cohen Family Asthma Institute, reveals details of the data from the MANDARA Phase III trial, showing remission is achievable in EGPA with Fasenra.
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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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Advancements and knowledge gaps in ICH Q2(R2)
In this article, Amanda Guiraldelli Mahr, Joachim Ermer, Jaime Marach, Phil Borman and other members of USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. The authors also identify areas that would benefit from additional guidance and compare…
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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.
webinar
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.
news
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.
news
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.
news
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.
news
Potential best-in-class antibody shows “remarkable efficacy” in atopic dermatitis
Interim trial results show that the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb) provided rapid skin sign improvement in atopic dermatitis (AD).
