This is an article from Ingenious number 1, 2020.
The market for gene therapy
Continued strong support for gene therapy from FDA
The US Food and Drug Administration (FDA) continues to show strong support
for the development of new gene therapies.
The FDA has thus far approved four gene therapy products and the administration anticipates many more approvals over the coming year, owing not least to the fact that there are some 900 ongoing clinical studies in this area. The FDA believes this will provide patients and providers with increased therapeutic choices.
In January the FDA issued six guidelines covering, for example, manufacturing and clinical development of gene therapy products.
“The growth of innovative research and product development in the field of gene therapy is exciting to us as physicians, scientists and regulators,” said FDA Commissioner Stephen M. Hahn, M.D. “We understand and appreciate the tremendous impact that gene therapies can have on patients by potentially reversing the debilitating trajectory of diseases. These therapies, once only conceptual, are rapidly becoming a therapeutic reality for an increasing number of patients with a wide range of diseases, including rare genetic disorders and autoimmune diseases.”
CombiGene’s vision is to provide patients affected by severe life-altering diseases with the prospect of a better life through novel gene therapies. CombiGene’s business concept is to develop effective gene therapies for severe life-altering diseases where adequate treatment is currently lacking. Development assets are sourced from an external research network and developed to achieve clinical proof of concept. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while the company may manage this process on its own for drugs targeting niched patient populations. The company is public and listed on the Swedish marketplace Nasdaq First North Growth Market and the company’s Certified Advisor is FNCA Sweden AB, +46 (0)852 80 03 99 firstname.lastname@example.org.