Read highlights from the latest installment of Dusko Ilic’s industry updates, which discuss the latest developments and news in regenerative medicine and stem cell research, and are published every month in Regenerative Medicine.
Every month, Dusko comments on news of note. Read the full update for June 2019 on Regenerative Medicine here>>
What happened this month that you were expecting?
Gene therapies are very costly, and the first two gene therapies approved in Europe were not profitable. In May, Novartis (Basel, Switzerland) won FDA approval for its gene therapy for spinal muscular atrophy and priced it at US$2.125 million, making it the world’s most expensive drug. Spark Therapeutics (PA, USA) charged US$850,000 for LUXTURNA® (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. Since bluebird bio (MA, USA) has received European approval for Zynteglo®, its gene therapy of beta thalassemia patients, everyone was waiting for the Company to announce a price tag per patient.
What happened that surprised you this month?
A collaboration between Emulate Bio (MA, USA) and INTENZE Products (NV, USA) came as a total surprise. Whereas most of us were aware of Emulate Bio and their cutting-edge organ-chips technology, INTENZE was a new name. INTENZE is actually a tattoo ink manufacturer and they were the first to publicly disclose the ingredients in each one of the tattoo inks it produces. This information allowed customers and artists to know exactly what inks are made with. INTENZE ink is also 100% vegan, containing zero animal products, and absolutely never tests on animals. This is the first time a tattoo company and a biotechnology and health company have collaborated for the advancement of safety testing and risk assessment of tattoo ink.
If we only read about one story this month, what should it be?
FDA introduced a new Rapid Inquiry Program (TRIP) from their Tissue Reference Group, which promises to answer sponsors’ questions about what regulations govern their products within three days of receiving them.
Dusko Ilic is a Senior Lecturer in stem cell science, coordinator of the cross-divisional postgraduate program in stem cells and regenerative medicine, and Head of the Induced Pluripotent Stem Cell Core Facility at King’s College London (London, UK). He is also Head of the Assisted Conception Unit’s Human Embryonic Laboratories at Guy’s Hospital (London, UK). He is also a member of the editorial board of the journal Regenerative Medicine, where he writes the Industry Report, a regular feature compiling information from non-academic institutions in the field of stem cells and regenerative medicine