Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
Hansoh Pharmaceutical Group Co. Ltd. has won a green light for inebilizumab, approved by China’s NMPA for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. The decision marked Hansoh’s first biologic approval.
By using engineered retinal pigment epithelial cells to deliver IL-2 into the tumor microenvironment, investigators at Rice University eradicated ovarian and colorectal tumors in mouse models, and elicited T-cell responses after implantation in primates.
U.K. biotech Complement Therapeutics Ltd has come out of stealth mode with €5 million ($5.7 million) in seed funding to tackle complement-related diseases, initially targeting the currently untreatable condition geographic atrophy due to dry age-related macular degeneration.
LONDON – The team that opened up the market for anti-vascular endothelial growth factor (VEGF) drugs in the treatment of eye diseases has formed a new company, Eyebio Ltd., with the aim of developing a new generation of ocular therapies. David Guyer and Anthony Adamis, founders of Eyetech Pharmaceuticals Inc., which brought Macugen (pegaptanib sodium) through to FDA approval in December 2004, set up Eyebio in August last year, with seed funding from SV Health Investors.
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