###BASE_URL###
2007-01-05 | permalink
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today provided an update on the expected regulatory strategy for the Company’s plant-produced insulin after a recent meeting with the U.S. Food and Drug Administration (FDA). The preparatory meeting for the Company’s Investigational New Drug Application (IND) for plant-produced insulin was scheduled as part of the normal development process. SemBioSys approached the FDA to confirm the viability of submitting plant-produced insulin under Section 505(b)(2) of the Food, Drug, and Cosmetic Act in order to achieve approval for a New Drug Application.
2007-01-05 | permalink
SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today provided an update on the expected regulatory strategy for the Company’s plant-produced insulin after a recent meeting with the U.S. Food and Drug Administration (FDA). The preparatory meeting for the Company’s Investigational New Drug Application (IND) for plant-produced insulin was scheduled as part of the normal development process. SemBioSys approached the FDA to confirm the viability of submitting plant-produced insulin under Section 505(b)(2) of the Food, Drug, and Cosmetic Act in order to achieve approval for a New Drug Application.
GENET-news is providing a daily news service on a range of topics regarding genetic engineering. We are screening the worldwide English news, press releases and other publications to provide you with a strategic selection of information. GENET-news enables you to stay informed about all aspects of the global controversy around GE technologies and GE organisms. You can subscribe by email.
The GENET-forum list provides you with additional background information and more voluminous reports. It is only open for GENET members. Please contact the coordinator for membership and subscription.