BioPharm Weekly News Roundup—Week of Sept. 8, 2025

Welcome to the BioPharm International® weekly news roundup. In this new video feature, the editors will highlight each week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.

The sixth Stem Cell Community Day, slated to take place on November 4–5, 2025 in Copenhagen, Denmark, will aim to bring together researchers and industry specialists focused on the complexities of stem cell bioprocessing.

Integra closed a €10.7 million (US$12.6 million) pre-Series A investment round aimed at accelerating technical development of its find and cut-and-transfer (FiCAT) gene writing platform.

With approximately 400 exabytes of data produced globally each day, the bio/pharmaceutical industry is on the cusp of a profound transformation, driven by an exponential surge in data generation and the sophisticated capabilities of artificial intelligence, said Toni Manzano, PhD, co-founder and chief scientific officer, Aizon, at the Parenteral Drug Association (PDA) Regulatory Conference 2025.

Telix has reached an agreement with FDA on the conditions under which the company will resubmit a new drug application (NDA) for its investigational agent TLX101-CDx (floretyrosine F18 or 18F-FET, with the provisional brand name Pixclara) intended for the imaging of glioma, a rare and life-threatening brain cancer.

A strategic and well-governed approach to artificial intelligence adoption is not merely an advantage but a necessity for enhancing efficiency while maintaining rigorous good practices (GxP) compliance as the bio/pharma industry undergoes a significant digital shift, said Vinny Browning, executive director of Quality Assurance, Amgen, who spoke at the PDA Regulatory Conference 2025.

A persistent misconception within the biopharma industry suggests that advancing quality and compliance invariably necessitates increased costs or reduced output, but Ossama Eissa, chief operating officer at Cellares, said that this is a myth during his presentation at the PDA Regulatory Conference 2025.

And finally, how a company addresses a Form 483 observation is critical as it establishes the "first impression" of how findings are handled and offers "an opportunity to visually demonstrate [a] site’s quality culture, [a] company's quality culture, and how seriously [the company] takes the findings,” said Captain Tara Gooen Bizjak, associate director, GMP and Quality Standards, Office of Manufacturing Quality and Center for Drug Evaluation and Research Office of Compliance, FDA, and an engineering officer in the US Public Health Service, at this week’s PDA Regulatory Conference 2025.