To increase transparency at its advisory committee (adcom) meetings, the U.S. FDA is proposing asking guest speakers to voluntarily disclose their financial interests and professional relationships to determine their eligibility to give a presentation at an adcom meeting.
Strong data for pegylated interferon lambda, Eiger Biopharmaceuticals Inc.’s experimental COVID-19 treatment, boosted the company stock (NASDAQ:EIGR) 23% on Feb. 9 as the company continues to seek regulatory approval. That approval path is blocked as interferon lambda is not currently approved by the U.S. FDA for any use. In October, the company said it would not submit emergency authorization use request after feedback from the FDA.
Harbour Biomed Ltd. has received IND clearance by the FDA to initiate clinical trials in the U.S. with HBM-1022, a monoclonal antibody generated from Harbour's integrated G protein-coupled receptor (GPCR) platform. The antibody can enhance antitumor immunity by depleting CCR8 positive regulatory T cells, activating effector T cells.
Accutar Biotechnology Inc. has received FDA clearance of its IND application for AC-0676 for the treatment of patients with relapsed/refractory B-cell malignancies.
Egret Therapeutics, a portfolio company of Turret Capital Management LP, has announced FDA clearance of its IND application for EGT-101 for the treatment of delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage.
Inmagene Biopharmaceuticals Co. Ltd. has obtained IND approval from the FDA for IMG-008, the company's novel long-acting antagonistic humanized monoclonal antibody that specifically targets human IL-36 receptor (IL-36R) to treat auto-inflammatory diseases.
Pliant Therapeutics Inc. has received FDA clearance of its IND application for PLN-101095, an oral, small-molecule, dual selective inhibitor of integrins αvβ8 and αvβ1.
Adhering to the recommendation of a mixed advisory committee vote, the U.S. FDA cleared use of GSK plc’s daprodustat as the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor for treating anemia in patients with chronic kidney disease (CKD) who are on dialysis. For CKD patients not on dialysis, the agency determined the drug’s safety has not been established.
RSS
