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Dr Maria Escolar, Chief Medical Officer, Forge Biologics, explores the advantages of the company’s novel AAV gene therapy for Krabbe disease, which could help to overcome some of the immune and safety challenges the gene therapy sector is facing.
New data for a microbiome-based therapeutic together with an immune checkpoint inhibitor has shown “encouraging clinical benefits” in advanced cancers.
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
The IL-17A and IL–17F inhibitor demonstrated positive efficacy and safety in adults with moderate-to-severe hidradenitis suppurativa, new data shows.
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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.
Johnson & Johnson’s selective IL-23 inhibitor demonstrated clinically meaningful improvements compared to placebo in ulcerative colitis, new study data shows.
The new manufacturing facility for antibody drug conjugates (ADCs) will be designed to have zero carbon emissions when operational, AstraZeneca stated.
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.
Safety of the compounded biologic was confirmed following 28-day storage in two different polypropylene syringe types, research shows.
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…
The pharmaceutical company shared that its new investment adds to the current €2.5 billion planned for major building projects in France.
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.
The new company will work to develop solutions to overcome issues within new therapeutic modalities, in areas such as formulation, manufacturing and supply chain.
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.
