Clinical & Regulatory
Formosa Pharmaceuticals and AimMax Therapeutics Announce the NDA Submission to the US FDA for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery
Formosa Pharmaceuticals, Inc. (6838.TWO) and AimMax Therapeutics, Inc. (United States) announce the submission of a New Drug Application to the United States Food & Drug Administration (US FDA) for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain following ocular surgery.
ABM Announces First Patient Dosed in Phase I Clinical Trial of MEK Inhibitor for Solid Tumor
ABM Therapeutics, an innovative clinical-stage biopharmaceutical company, with an emphasis on developing drugs with high blood–brain barrier (BBB) penetration for CNS diseases including brain metastases, today announced that the first patient was successfully dosed with ABM-168 in the United States.
Ascletis Announces ASC40, a First-in-Class, Once-Daily Oral FASN Inhibitor, Achieved Endpoints in Phase II Clinical Trial for Acne
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that ASC40 (Denifanstat), a first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, achieved primary and key secondary endpoints in Phase II clinical trial for acne vulgaris.
EirGenix’s Second Breast Cancer Biosimilar EG1206A Successfully Reaches Phase 1 Clinical Trial Objectives
EirGenix, Inc. (6589.TT) announced on 28th of April that it has completed the phase 1 clinical trial (EGC101) of its second breast cancer biosimilar EG1206A in Europe.
Completion of Enrollment in Cohorts C and G of China Phase II Clinical Study of Osemitamab (TST001) in Combination with CAPOX with or without Nivolumab as First-line Treatment of Gastric/Gastro-esophageal Junction Cancer Patients
Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that the enrollment of first-line (1L) CLDN18.2 expressing Gastric / Gastro-esophageal Junction (G/GEJ) adenocarcinoma patients in cohorts C and G for the China Phase II study (Transtar-102, NCT04495296) of its high affinity humanized ADCC-enhanced anti-CLDN18.2 monoclonal antibody Osemitamab (TST001) has been completed.
Oramed Announces Top-line Results from Phase 3 Trial of ORMD-0801 for the Treatment of Type 2 Diabetes
NEW YORK, Jan. 11, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced today top-line results from its Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to placebo in patients with Type 2 Diabetes (T2D) at 26 weeks.
