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Kairos Pharma, Ltd. | March 15, 2022
Kairos Pharma, Ltd. a privately-held clinical-stage biotechnology company focused on cancer drug resistance and immunotherapy, announced today that its activated T cell therapy, KROS 201, has received FDA approval to move forward with a Phase 1 clinical trial in patients with recurrent glioblastoma. Kairos Pharma is funding the phase I trial, which will occur at Cedars Sinai Medical Center in Los Angeles. John Yu, M.D., Kairos CEO, commented, "This IND acceptance is the secon...
Eirion Therapeutics, Inc. | September 09, 2021
Eirion Therapeutics, Inc., an aesthetic dermatology company headquartered in Woburn, Massachusetts, announced that HTL Biotechnology, the worldwide leader in biotechnology solutions using hyaluronic acid and other biopolymers, will become Eirion's exclusive botulinum active pharmaceutical ingredient (API) manufacturer. Botulinum is the active ingredient in Eirion's lead product candidate ET-01, a topical neuromodulator being developed for Crow's Feet wrinkles and prima...
Sanofi | November 17, 2020
When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant. The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at...
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Algernon Pharmaceuticals, Charles River Laboratories | February 11, 2021
Algernon Pharmaceuticals Inc. a clinical stage pharmaceutical development company is pleased to announce that is has signed an agreement with Charles River Laboratories for preclinical studies of AP-188 ("N,N-Dimethyltryptamine or DMT") for the Company's stroke clinical research program. Algernon's preclinical study of DMT will be conducted at the Charles River research facility in Finland. Charles River Laboratories, Inc. is an American corporation specializing ...
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