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The rising impact of biomarkers in early clinical development

Drug Target Review

As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinical development, especially in early phases. Bagyinszky E, et al. 21(10):3517.

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New cell therapy model accelerates cancer treatment development

Drug Target Review

Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies. My focus has always been on advancing novel medicines from research to clinical development. Over the years, Ive had the privilege of working on more than 25 different products, Bock shared.

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EC Approves CAR-T Therapy Using AGC Biologics’ Lentiviral Vectors

The Pharma Data

The collaboration between Autolus and AGC Biologics began in 2020, with AGC’s Milan facility entrusted with the development, manufacturing, and commercial supply of lentiviral vectors, a critical component in the production of Autolus’ obe-cel CAR-T product.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues. Regulatory bodies require strict adherence to Good Manufacturing Practices (GMPs) to ensure that drugs are consistently produced at high quality.

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Why smarter financial planning could be key to clinical trial success

Drug Target Review

This led her to found Condor Software in 2020, a company focused on providing cloud-based solutions that integrate financial operations with clinical trials. Effective financial management is integral to the success of clinical trials, which depend equally on scientific excellence and robust financial oversight.

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FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

Like many other biotechnology firms, it’s seen its stock price fall significantly during a sector-wide pullback, with shares losing more than three quarters of their value since 2020. Still, a deal Nuvation cut last year to acquire AnHeart Therapeutics has given it a chance to rebound.

FDA
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PRITELIVIR MESYLATE

New Drug Approvals

It is currently in Phase III clinical development by the German biopharmaceutical company AiCuris Anti-infective Cures AG. US FDA granted fast track designation for pritelivir in 2017 and breakthrough therapy designation 2020. NCT03073967 ^ 2020-004940-27 ^ Biswas, S.; 316 (23): 2495–2503. doi : 10.1001/jama.2016.18189.