3 天之前 · News on the biopharmaceutical manufacturing industry, focusing on biologics, technology, upstream/downstream processing, cell culture and regulations

5 天之前 · Viralgen and Axovia collaborate to manufacture gene therapy for rare disease vision loss 23-Jan-2025 By Larissa Warneck-Silvestrin

3 天之前 · Inhibikase Therapeutics announced disappointing results from a Phase 2 trial for its Parkinson’s disease drug, risvodetinib, and will now pause its development.

2024年10月8日 · But what does the Act mean for the biotech and pharma industry and how can companies best prepare for any impacts on future business? The Biosecure Act was first proposed by the US government late last year due to concerns about national security and how genetic and other biological data could be misused by foreign adversarial governments with a focus on China. It intends to prevent US federal ...

2025年1月21日 · The Massachusetts based biotech will now press ahead with human trials for its antisense oligonucleotide (ASO) therapy, designed to treat amyotrophic lateral sclerosis (ALS), after the FDA lifted its clinical hold on the trial.

2024年11月14日 · Helen Harrington’s journey: Patience, passion, and problem-solving 20-Nov-2024 By Liza Laws

2024年11月26日 · We’re thrilled to announce that we have migrated BioPharmaReporter to a new platform. Our expert coverage of the sector won’t change, but we’ve tweaked the look and feel of the site to bring you improved navigation, more content-rich articles, enhanced search capabilities and a better browsing experience. We’ve been working hard behind the scenes to ensure it’s a seamless transfer ...

2024年7月24日 · Demand for biosimilars is booming, with no hints of slowing down as the number of biosimilars getting approved keeps growing. Here are all the biosimilars that have received approval in 2024 to date.

2022年6月28日 · The industry had over 50 new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in both 2020 and 2021, up from an annual total of 29 a decade ago.

2024年11月5日 · The European Medicines Agency (EMA) has accepted Alvotech and Advanz Pharma’s marketing authorization application for AVT05, a biosimilar to Johnson & Johnson’s biologic Simponi (golimumab), which is used for the treatment of chronic inflammatory diseases, such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Simponi consists of a monoclonal antibody that targets ...