FDA
–FDA States Pivotal Clinical Trial May Proceed, Trial Expected to Commence By March 2022– Excerpt from the Press Release: PHILADELPHIA, Jan. 21, 2022 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that they have completed the safety review of the Investigational New…
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– FDA lifts partial clinical hold following agreement on mitigation strategy for differentiation syndrome – – KOMET-001 study to resume screening and enrollment of new patients – – Encouraging safety, tolerability and clinical activity observed among patients on study – Excerpt from the Press Release: SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Kura Oncology,…
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The new company is focused on developing GP-2250, a novel cancer therapeutic with a unique mechanism of action Excerpt from the Press Release: Panavance Therapeutics Inc. (“Panavance”) is a new clinical-stage pharmaceutical company created to advance and develop GP-2250, a patented, novel therapeutic for the treatment of cancer and other therapeutic indications. GP-2250 is a…
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Clinical study found that cudetaxestat, a non-competitive inhibitor of autotaxin, was well tolerated and showed no reports of drug-related serious adverse events or discontinuations when co-administered with either pirfenidone or nintedanib Submission of study data to U.S. Food and Drug Administration (FDA) anticipated in first quarter of 2022 Blade expects to advance cudetaxestat into phase…
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Portfolio includes five investigational gene therapy programs for glycogen storage disorders that have no existing FDA-approved treatments available Warden Bio Co-Founder Kunal Kishnani joins as President of Kriya’s Rare Disease Division and will lead its overall strategic, development, and partnership activities Excerpt from the Press Release: REDWOOD CITY, Calif. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Kriya…
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Excerpt from the Press Release: CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, Jan. 4, 2022 /PRNewswire/ — Harbour BioMed (“HBM”, HKEX: 02142) announced that, its next generation anti-CTLA-4 fully human heavy-chain only antibody (HCAb), HBM4003, has completed the first dosing of first patient in two phase I trials for the treatment of advanced hepatocellular…
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Excerpt from the Press Release: SAN CARLOS, Calif.–(BUSINESS WIRE)–Glycomine, Inc., a biotechnology company focused on developing new therapies for orphan diseases, today announced that the company has received U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for GLM101 for the treatment of PMM2-CDG and has initiated dosing healthy volunteers…
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Only antibody authorized in the US for pre-exposure prophylaxis of COVID-19 Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s EVUSHELD (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retained neutralizing activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data. In this study,EVUSHELD’s Inhibitory Concentration 50 (IC50), a measure…
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– Microbiome data demonstrate the successful engraftment of SER-287 – – Microbiome assessments suggest potential for biomarker-based patient selection – – Company continues to evaluate SER-287 study data, and available preliminary SER-301 Phase 1b study clinical and microbiome data, to inform plans for continued development in ulcerative colitis – Excerpt from the Press Release: CAMBRIDGE,…
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Data demonstrated ONA-XR decreased proliferation in tumors with high PR+ at baseline in early breast cancer Two additional metastatic breast cancer clinical trials in progress also presented Excerpt from the Press Release: PHILADELPHIA, Dec. 09, 2021 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for…
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