Advanced Therapies

Investors and analysts say cell and gene therapy is entering a disciplined “phoenix” phase, with selective risk taking, AI enabled platforms and new pricing models redefining how one time cures attract capital.

A review of South Korea's GIFT fast track initiative for high-need drugs reveals that foreign firms have been the main beneficiaries over the first three years.

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.