Advanced Therapies

Cellafa Bioscience, an Astellas-Yaskawa joint venture, uses Maholo robotic automation and AI to standardize cell therapy manufacturing, targeting GMP compliance within two years and global expansion.

Executives leading the commercialization of cell and gene therapies are informing how the industry approaches everything from manufacturing strategy to physician education.

The success of AimedBio’s IPO may indicate investors are returning to the South Korean biopharma sector amid a series of large global out-licensing deals by domestic ventures and the strong performance of some recent biotech debutants on Kosdaq.

Argentina’s medicines regulator, ANMAT, is updating the national pharmacopeia with new guidelines on advanced therapies.

After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, adding a black box warning about liver injury along with suggested liver and cardiac monitoring.

After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, limiting treatment to ambulatory Duchenne muscular dystrophy patients.

French biotech CellProthera is advancing to Phase III with its autologous CD34+ stem cell therapy that regenerates tissue after severe heart attacks.

Patient advocacy organizations are transforming gene therapy development by funding research, de-risking programs and driving ultra-rare disease treatments from concept to clinic at unprecedented speed.

South Korea’s two biosimilars giants have laid out differing strategies to pursue innovative drug R&D, although both are positioning ADCs as a core focus.

In this episode of the In Vivo podcast, Lupus Therapeutics' Stacie Bell discusses transforming lupus drug development through patient-centered clinical trials, promising new oral therapies and revolutionary cell therapy approaches.

Suzhou-based Accuredit Therapeutics led the pack of recent China financings with a $75m series A. Other major funding rounds in the country backed by venture capital and private equity firms included Beijing GRIT Biotechnology's $53.5m series C.

Scrip takes a look at the "burgeoning" South Korea radiopharmaceuticals sector, where a handful of pioneering domestic companies are racing to advance their pipelines, with prostate cancer a strong early focus.