Cellular & Genetic

The biotech announced positive Phase III data for Orca-T, its allogeneic cell therapy, and a company cofounder talked with Scrip about Orca’s commercialization plans.

Aurion Biotech is developing a cell therapy for corneal diseases that is cheap enough to produce and can be scaled that it should reach the masses in a way that other cell therapies cannot.

Rentschler Biopharma CEO Benedikt von Braunmühl tells In Vivo about the CDMO's strategic decision to exit the cell and gene therapy manufacturing space.

The EU, US and other countries with similar health care systems must “take responsibility” for the financial and health risks involved in getting innovative drugs, such as gene therapies, to market, says an academic expert who has worked in the advanced therapy field.

Nonprofits are finding new ways to address market gaps and develop treatments for rare diseases with little commercial attraction.

Beyond the cost savings of biosimilars, the true evolution in wet AMD treatment is happening by companies developing next-generation therapies that aim to reduce injection burden, introduce novel mechanisms, and potentially alter disease progression.

The Centre for Commercialization of Regenerative Medicine has spent over a decade crafting a cell and gene therapy ecosystem in Canada. Now it is replicating the model abroad.

Productive talks with the US FDA after securing Regenerative Medicine Advanced Therapy designation haves speeded up development of bemdaneprocel, which is about to go into a registrational trial to see if it can slow down or even stop progression of the neurodegenerative disease.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Decentralized manufacturing methods for cell and gene therapies will be critical for improving patient access to treatments, but sponsors must prepare to demonstrate “comparability” with centralized manufacturing.