This is my archive
–Company Receives Five-year Exclusivity Extension Through GAIN Act — SAINT-LOUIS, France & WEILL AM RHEIN, Germany, February 27,2024 – Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for… Read More
Boston/Shanghai/November 3rd, 2022 — Eccogene announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to commence a Phase I trial of its glucagon-like peptide 1 receptor agonist (GLP-1 RA) ECC5004 for type 2 diabetes mellitus (T2DM). This study will evaluate the safety,… Read More
— 12 to 61-fold increase in neutralizing antibodies against BA.5 among participants receiving SCB-2019 (CpG 1018/Alum) as a homologous third dose or with a history of prior SARS-CoV-2 infection — — BA.5 neutralizing antibody levels were approximately two to four-fold higher than BA.1 neutralizing antibody levels, demonstrating a potentially differentiated… Read More
— SCB-2019 (CpG 1018/Alum) elicited approximately 2-fold higher neutralizing antibody titers in adolescents (aged 12 to 17 years) compared to young adults (aged 18 to 25 years) — — Favorable tolerability and safety profile in adolescents, consistent with results previously observed in adults — — Clover plans to submit adolescent data to… Read More
SAN DIEGO, Aug. 23, 2022 /PRNewswire/ — Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, announced today that the first patient has been dosed in the phase 1 clinical study (NCT05431270) of PT199, an anti-CD73 monoclonal antibody (mAb) for the treatment of multiple advanced… Read More
Shanghai/August.1st, 2022 — Eccogene announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to commence Phase I trial of its thyroid hormone receptor agonist ECC4703 in U.S. This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC4703 in healthy participants… Read More
First regulatory milestone as part of a strategy to advance patient care April 11, 2022 08:00 AM Eastern Daylight Time CAMPBELL, Calif.–(BUSINESS WIRE)–Truvic Medical, Inc., a wholly owned subsidiary of Imperative Care, Inc., today announced that it has received 510(k) clearance from the U.S. Food and Drug… Read More
MENDHAM, N.J. and WARMINSTER, Pa., December 14, 2021 – Antios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation (Nasdaq: ABUS) today announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a… Read More
SHANGHAI, July 28, 2021 /PRNewswire/ — Eccogene, Inc., a clinical stage biopharmaceutical company focused on discovery and development of metabolic and immunologic therapeutics, announced the initiation of a Phase 1a clinical trial evaluating ECC0509, an oral inhibitor of semicarbazide-sensitive amine oxidase (SSAO)/vascular adhesion protein-1 (VAP-1), as a potentially novel therapy for… Read More
By Antios Therapeutics, Inc. on Wednesday, Apr 21, 2021 SAVE 1 to evaluate ATI-2173 in combination with tenofovir (TDF) vs. TDF plus placebo SAVE 1 to include cohort of Hepatitis Delta Virus (HDV) co-infected subjects to assess ATI-2173 activity against HDV MENDHAM, N.J., April 21, 2021 (GLOBE NEWSWIRE) – Antios… Read More