This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec The expectations for extractables and leachables of medical devices (delivery systems) are different than those of typical pharmaceutical applications such as container closure systems or single use systems. Learn about how the FDA reviews combination products and learn about testing expectations. Put these expectations to practice with a case study review complete including common pitfalls in testing. Key lessons learned: How does the FDA interact internally…
Wednesday, September 4, 2019 Daily Archives
Vertex looks to stem cell islets for diabetes in $950m ‘toolbox’ deal
Vertex has acquired Semma Therapeutics adding a program using pluripotent stem cell-derived islets as a potentially treatment for type 1 diabetes. While Semma is yet to have brought a therapy into the clinic, the Massachusetts-based firm has created a process it claims can produce stem cell-derived islets (SC-islets) starting from human pluripotent stem cells capable of developing into any cell type in the body. Its lead candidate has completed preclinical proof-of-concept studies demonstrating evidence of the potential of such technology…
FDA rejects Mylan and Biocon’s insulin glargine again
The US FDA has issued a second complete response letter for a follow-on insulin glargine product referencing Lantus made by Biocon at its facility in Malaysia. In June 2018, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Mylan and its manufacturing partner Biocon rejecting their insulin glargine product submitted through the 505(b)(2) regulatory pathway as a follow-on biologic referencing Sanofi’s Lantus. Just over a year later and the firms have reported a second CRL…
Batavia selects CHO platform for Zika Ab on the Horizon
A collaboration led by Batavia Biosciences will use Horizon Discovery’s CHO cell technology in the development of an antibody against Zika. Batavia Biosciences, working with Vanderbilt University Medical Center (VUMC) and IDBiologics, is looking to develop a therapy based on a Zika virus neutralizing antibody that was discovered three years ago. Accessing Horizon Discovery’s GS knockout Chinese hamster ovary (CHO) K1 cell line expression system will allow the development of high yield antibody-expressing cell lines, Batavia CEO Menzo Havenga told…