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tag wet-amd

FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

pharmaphorum

NOVEMBER 19, 2020

Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration (wet AMD) and has picked up approvals in related eye conditions ever since, although its patent expired in June.

FDA Approval

FDA Approval Marketing Drugs Clinical Development

Roche’s quantitative COVID-19 antibody test; Janssen buys a gene therapy asset; Zimmer Acquires A&E Medical; Glaucoma research study: Merck chooses TriNKET cancer immunotherapy program; Ovid fails Angelman phase 3 study

Delveinsight

DECEMBER 3, 2020

The agreement is for the investigational phase 1 gene therapy HMR59 that is given as a one-and-done shot into the eye to preserve vision in patients with geographic atrophy , which is a late-stage and severe form of age-related macular degeneration (AMD). It has already succeeded in a phase 1 test, with a second in patients with wet AMD.

Gene Therapy

Gene Therapy Gene Antibody Research

FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

Roche’s quantitative COVID-19 antibody test; Janssen buys a gene therapy asset; Zimmer Acquires A&E Medical; Glaucoma research study: Merck chooses TriNKET cancer immunotherapy program; Ovid fails Angelman phase 3 study

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