Adaptive Phage Therapeutics (APT) said that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections.
Artugen Therapeutics Limited, a Company developing novel live biotherapeutics (LBPs) for patients living with infectious, inflammatory and oncologic diseases announced today the first patient dosed with ART24, the Company’s first clinical product candidate for prevention of recurrence of Clostridium difficile infection (CDI).
Takeda Pharmaceutical said that the phase 3 TOURMALINE-MM2 study evaluating the addition of NINLARO (ixazomib) to lenalidomide and dexamethasone in certain multiple myeloma population could not deliver the desired results.
InMed Pharmaceuticals has completed enrollment in its first Phase 1 clinical trial with INM-755 in healthy subjects (Study 755-101-HV).
Kala Pharmaceuticals said that its dry eye disease candidate KPI-121 0.25% has delivered positive results in a phase 3 trial called STRIDE 3.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the first patients have been dosed with BCX9930 in a proof of concept trial in paroxysmal nocturnal hemoglobinuria (PNH). These patients were naïve to eculizumab and ravulizumab.
Harbour BioMed has secured approval from the US Food and Drug Administration (FDA) to move ahead with clinical studies in the US for its anti-CTLA-4 antibody HBM4003 for the treatment of cancer.
Pandion Therapeutics, Inc., a biotechnology company developing modular protein therapeutics for autoimmune disease, announced the dosing of the first subject in a Phase 1 clinical trial of PT101, a novel and proprietary interleukin 2 (IL-2) mutein Fc fusion protein therapy. PT101 has shown potential to treat autoimmune diseases by expanding populations of regulatory T cells.
Harbour BioMed (HBM) announced completion of a Phase 1 study of HBM9161, a fully human anti-FcRn monoclonal antibody, to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Chinese subjects.
Transgene, a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announces that the first patient has successfully received TG6002, via an intrahepatic artery (IHA) infusion, as a locoregional treatment for unresectable liver metastases from colorectal cancer (CRLM).
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