Soligenix Inc. is scratching its chin as it decides how to react to the U.S. FDA’s refusal to file letter regarding Hybryte (synthetic hypericin) for treating early stage cutaneous T-cell lymphoma. The letter means the FDA won’t review the application, which was submitted in December, because there are deficiencies that cannot promptly be resolved, rendering the application essentially incomplete.
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.
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.
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