Akron Biotech and U.S.-based industry leaders meet with the Argentine regulatory authority (ANMAT) to discuss regulatory developments in regenerative medicine

Last week, the Akron team joined more than 1,600 participants from 50+ countries at the annual meeting of the International Society for Cell and Gene Therapy (ISCT) in Montreal. Chaired by David DiGiusto, PhD (Stanford School of Medicine), Sarah Nikiforow, MD, PhD (Dana Farber Cancer Institute), and Denis-Claude Roy, MD, FRCPC (Hôpital Maisonneuve-Rosemont), the meeting

First allogeneic stem cell therapy approved in Europe

TiGenix and Takeda announced that the European Commission (EC) has approved Alofisel (darvadstrocel) for the treatment of complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn’s disease, marking the first allogeneic stem cell therapy to receive central marketing authorization approval in Europe. Crohn’s disease is a chronic condition that causes intestinal inflammation. A

FDA approves first gene therapy for hereditary disease — Spark Therapeutics’ Luxturna

On December 19, 2017, the US FDA approved a new gene therapy to treat children and adults with a genetic condition that often results in blindness. Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl) is a one-time gene therapy product that treats biallelic RPE65 mutation-associated retinal dystrophy, an inherited retinal disease that frequently progresses to complete blindness. Approval

FDA and the future of medicine: Advancing regenerative medicine options for patients with safety and science at the forefront

On November 16, 2017, the US FDA announced a policy framework for regenerative medicine, releasing two final and two draft guidance documents. These documents reflect the agency’s commitment to modernize the system to incorporate promising cell and gene therapies and provide a structure for these options to be introduced in a fast, effective, and safe

With CAR-T approval, FDA steps up efforts at regulating stem cell clinics

About two months and two weeks after the FDA’s advisory committe recommended for approval Novartis’ CAR-T therapy for the treatment of  relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL), the FDA followed up with an official approval. Tisagenlecleucel – or, as the therapy is commonly known, Kymriah – will head

Holoclar, Europe’s first stem cell therapy, receives UK approval recommendation

We first heard of Holoclar’s breakthrough success in 2015, when it received recommendation for approval by the European Medicines Agency. Holoclar, developed by Italian pharmaceutical company Chiesi Farmaceutici, is based on ex vivo expanded autologous human corneal epithelial cells, which contain limbal stem cells, and which repair the cornea after injury. Now, Holoclar has received another

Big CAR-T Win: The FDA recommends Novartis’ CAR-T therapy for approval

A commercial and scientific first, and a breakthrough for the emerging field of CAR-T therapy, occurred this week with a pivotal regulatory win for cell therapy. On June 12, 2017, the FDA unanimously recommended for approval Novartis’ CAR-T therapy for the treatment of  relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL),