North Carolina Governor Josh Stein announced that pharmaceutical giant Johnson & Johnson (J&J) will expand its presence in ...

Last week, biotechnology company Ascidian Therapeutics announced a manufacturing partnership with gene-therapy–focused ...

The Priority Review Voucher (PRV) program is designed to incentivize rare disease drug development.

Meanwhile, Novotech has appointed Anand Tharmaratnam as its own new CEO. Tharmaratnam has over 30 years of industry ...

Stéphane Bancel, CEO of vaccine maker Moderna, addressed shareholders in a letter that dissected the events of 2025 while ...

But cell and gene therapies (CGTs) are catching up. During Cell and Gene Therapy International Europe 2025, held in Berlin, ...

Contract development and manufacturing organization (CDMO) Rentschler Biopharma has announced a partnership with ...

Contract development and manufacturing organization (CDMO) Samsung Biologics made a splash at the end of 2025, acquiring ...

The 2011 process validation (PV) guidance document from the US Food and Drug Administration (FDA) states that the number of samples used for PV “should be adequate to provide sufficient statistical ...

The biopharmaceutical industry is at the forefront of technological advancements, with “biopharma 4.0” revolutionizing the way biomanufacturing is conducted (1). The concept combines automation, ...