News Headlines

  1. Spero Therapeutics Announces Positive Results From SPR720 IND-Enabling Studies And Plans To Initiate A Phase 1 Trial

    Spero Therapeutics, Inc., (Nasdaq:SPRO) a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant (MDR) bacterial infections, today announced results from preclinical IND-enabling studies of SPR720, an oral antimicrobial agent being developed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections.

  2. Sanofi And Denali Therapeutics To Develop Treatments For Neurological And Inflammatory Diseases

    Sanofi plans to collaborate with Denali Therapeutics Inc. on the development of multiple molecules with the potential to treat a range of neurological and systemic inflammatory diseases.

  3. Celerion Expands NASH Biomarkers Services With The Implementation Of FibroScan

    Celerion, a leader in early clinical research, is pleased to announce the implementation of FibroScan to complement a suite of soluble biomarkers Celerion has validated to support nonalcoholic steatohepatitis (NASH) clinical studies.

  4. Independent Institute Puts The FDA On Trial—Launches

    The U.S. Food and Drug Administration (FDA) fails in its mission to advance public health by hindering product innovations in its web of bureaucracy and cronyism. In response, the Independent Institute has launched to answer the question: “Is the FDA itself safe and effective?”

  5. ImmusanT Initiates Phase 2 Enrollment For Its Lead Therapeutic Vaccine Candidate In Patients With Celiac Disease In Australia And New Zealand

    ImmusanT, Inc., a clinical stage company leveraging its Epitope-Specific Immuno-Therapy™ (ESIT™) platform to deliver first-in-class peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, initiated enrollment in Australia and New Zealand for its Phase 2 RESET CeD study assessing the safety, tolerability and efficacy of its lead therapeutic candidate, Nexvax2®, in patients with celiac disease who carry the immune recognition genes for HLA-DQ2.5.

  6. InflaRx Initiates Phase II Clinical Trial With IFX-1 In ANCA-Associated Vasculitis With First Patient Dosing

    InflaRx N.V.(Nasdaq: IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced that the first patient has been dosed in a phase II study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis (AAV).

  7. ContraVir Pharmaceuticals Completes Final Cohort Dosing In CRV431 Drug-Drug Interaction Study

    ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of therapeutic drugs for the treatment of hepatitis B virus (“HBV”), today announced that it has completed dosing of the last cohort of healthy subjects for its CRV431 drug-drug interaction (“DDI”) study.

  8. Mustang Bio Announces Updates On CAR T Cell Therapy Clinical Trials With City Of Hope

    Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, today announced that a Phase 1 clinical trial evaluating the safety and effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer with brain metastases has been initiated.

  9. Cymabay Announces The Initiation Of The Seladelpar Global Phase 3 Registration Study (ENHANCE) For The Treatment Of Primary Biliary Cholangitis And Additional Corporate Updates

    CymaBay Therapeutics, Inc. (NASDAQ: CBAY), today announced that the company has initiated the seladelpar Phase 3 registration study for the treatment of Primary Biliary Cholangitis (PBC).

  10. Advarra Completes Integration, Renews Focus On Efficient Research Compliance Services

    Advarra, the premier provider of IRB, IBC and research quality and compliance consulting services in North America, has completed all integration activities.