Browsing items tagged “gene therapy | EVERSANA”

Daiichi Sankyo Submits Yescarta NDA to Japan MHLW

Country: JAPAN | Region: ASIA & SOUTH PACIFIC | Type: Drug Approval | Keywords: #cartcelltherapy #cellandgenetherapy #daiichisankyo #genetherapy #gilead #kite #lymphoma #mhlw #newdrugapplication PRICENTRIC BRIEF: Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor, and Welfare (MHLW) for its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed/refractory (R/R) diffused large B-cell lymphoma (DLBCL) and related lymphomas The NDA for […]

FDA Releases Guidance on Gene Therapy Manufacturing, Clinical Development

Country: UNITED STATES | Region: NORTH AMERICA | Type: Policy | Keywords: #clinicaldevelopment #fda #genetherapy #guidance PRICENTRIC BRIEF: The Food and Drug Administration has approved 4 gene therapy products thus far, and anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area To support the continued development of gene therapies, […]

Cryoport and EVERSANA Form Strategic Alliance to Accelerate Regenerative Medicine Supply Chain

IRVINE, California, July 11, 2019 – Cryoport, Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) and EVERSANA™ have announced a strategic alliance to further create a fully integrated regenerative medicine supply chain solution. The alliance will be designed to leverage EVERSANA’s position as the leading provider of commercial services addressing access, affordability and adherence challenges for cell and […]