Abeona Therapeutics is developing investigational gene and cell therapies for people living with serious and rare diseases. Last year, Abeona held a ribbon-cutting ceremony to celebrate the groundbreaking of a manufacturing facility that is one year later producing gene therapy material for their clinical and preclinical programs. As is the norm with gene therapy, Abeona uses a virus as vehicles to deliver functional copies of defective genes.
By Jamie Cartland and Philip Winkworth, PA Consulting
The data landscape is evolving rapidly, and some pharmaceutical companies are taking strong positions to gain privileged and preferential access to data. Oncology is at the forefront of this movement and is heralding a wave of activity across other therapy areas.
Mike Novotny, founder and CEO of Medrio, shares an experience from early in his career of building databases that showed him that, by having the right data at the right time, doctors can make decisions allowing patients to live their best lives possible.
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By Samantha Hoopes, Ph.D., RAC, and Sheila Bello-Irizarry, Ph.D., RAC,Rho
Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.