FDA Stem Cell Therapy Regulation: the Framework

Dina Gould Halme and David A. Kessler wrote an article, called FDA Regulation of Stem-Cell–Based Therapies in The New England Journal of Medicine. The key concerns are: i., Stem-cell–based products as therapeutic agents are or could be: biologic products, drugs, devices, xenotransplantation products, human cells, tissues, and cellular and tissue-based products. Human cells, tissues, and… Continue reading FDA Stem Cell Therapy Regulation: the Framework

Non-profit trial to speed up embryonic stem cell research through patent narrowing

From The Scientist by Cathy Tran: At the request of a coalition of non-profit groups, which was initiated by groups in California, a state that has a lot at stake as a result Proposition 71, the U.S. Patent and Trademark Office (PTO) is reexamining patents covering all primate embryonic stem cells, as well as stem-cell… Continue reading Non-profit trial to speed up embryonic stem cell research through patent narrowing

U.S. stem cell companies: a new roundup

From Investor’s Business Daily: Big pharmaceutical firms and major biotechs are holding back as well, William Caldwell CEO of Advanced Cell Technology says. “While all of them have stem cell development labs someplace in the bowels of their organizations, they are not putting capital into the sector.” These companies are nervous about the political and… Continue reading U.S. stem cell companies: a new roundup

Patent trends in recent tissue engineering

In Nature Biotechnology 24, 1095 (2006) there is an interesting table made by Thomson Scientific Search Service about recent patent applications in tissue engineering. From that we can gain a picture of what is hot in current tissue engineering: popular organs, tissues, regeneration targets are skin, bone, cartilage, main problem is how to make 3D… Continue reading Patent trends in recent tissue engineering