Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
After announcing in April that it would discontinue development of its lead candidate, sozinibercept (OPT-302), in wet age-related macular degeneration (AMD), Opthea Ltd. has come to a settlement agreement that will allow it to avoid bankruptcy and continue operations.
Remegen Co. Ltd. is out-licensing its VEGF/FGF dual-target fusion protein drug, RC28-E, to Santen Pharmaceutical (China) Co. Ltd. in a carve-out deal worth more than ¥1.3 billion (US$180 million).
Ribomic’s umedaptanib pegol (RBM-007) looks to have some advantages compared to competitors in the achondroplasia space, and the company plans to progress the oligonucleotide-based aptamer that targets anti fibroblast growth factor 2 to phase III trials, Ribomic’s business development head, Kihei Yamashita, told BioWorld.
Beone Medicines Ltd. (formerly Beigene Ltd.) is selling its worldwide royalty rights on Imdelltra (tarlatamab) sales, excluding China, to Royalty Pharma for up to $950 million.
Akeso Pharmaceuticals Inc.’s gumokimab (AK-111) and manfidokimab met all primary efficacy endpoints in its phase III trials in active ankylosing spondylitis and in moderate to severe atopic dermatitis, respectively.
Ribomic’s umedaptanib pegol (RBM-007) looks to have some advantages compared to competitors in the achondroplasia space, and the company plans to progress the oligonucleotide-based aptamer that targets anti fibroblast growth factor 2 to phase III trials, Ribomic’s business development head, Kihei Yamashita, told BioWorld.
The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.
After announcing in April that it would discontinue development of its lead candidate, sozinibercept (OPT-302), in wet age-related macular degeneration (AMD), Opthea Ltd. has come to a settlement agreement that will allow it to avoid bankruptcy and continue operations.
Remegen Co. Ltd. is out-licensing its VEGF/FGF dual-target fusion protein drug, RC28-E, to Santen Pharmaceutical (China) Co. Ltd. in a carve-out deal worth more than ¥1.3 billion (US$180 million).
