Current Headlines

  1. BioCompute And WHISE-Embleema Launch Framework For FDA Drug Submissions

    BioCompute, a collaboration between The George Washington University and the FDA to improve communication of bioinformatics pipelines, recently announced a new guidance for life sciences companies using next generation sequencing (NGS) analysis as part of the regulatory approval process

  2. IMMUNE 3D® Expands Platform Into New Disease Areas And Enters Into Drug Discovery

    IMMUNE 3D®, a privately held biotechnology company, announced today an expansion of their business strategy beyond immuno-oncology into areas of autoimmunity, fibrosis and skin immunology. In addition, the company will leverage its proprietary, matched autologous human T cell and tumor cell lines for IO discovery efforts

  3. FDA Grants Orphan Drug Designation To Ayala’s AL101 For Potential Treatment Of Adenoid Cystic Carcinoma (ACC)

    Ayala Pharmaceuticals, a clinical-stage company developing medicines for cancers that are genetically defined, announced recently that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) for AL101, a potent and selective inhibitor of gamma secretase-mediated Notch signalling, for the treatment of ACC

  4. NanoViricides Announces Completion Of Production Of Its Lead Candidate For Upcoming GLP Tox Package Studies

    NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to meet unmet medical needs in treating difficult and life-threatening viral diseases, reports that it has successfully completed manufacture of the drug for the upcoming GLP Safety/Toxicology study of its lead candidate in several kilogram quantities

  5. resTORbio Announces Initiation Of Phase 3 Clinical Program Of RTB101 In Clinically Symptomatic Respiratory Illness

    resTORbio, Inc. (Nasdaq: TORC), today announced the initiation of PROTECTOR 1, the first Phase 3 trial of RTB101, an orally administered, small molecule, potent inhibitor of target of rapamycin complex 1 (TORC1).

  6. Adimab Announces Multi-Target Expansion For The Discovery Of Antibodies With Another Global Pharma Partner

    Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, announced the expansion of an earlier partnership with Novartis

  7. Amerigen Announces U.S. FDA Approval For Generic Penicillamine 250 mg Capsules

    Amerigen Pharmaceuticals Limited ("Amerigen") today announced that Amerigen's Abbreviated New Drug Application ("ANDA") for Penicillamine Capsules USP 250 mg has received final approval from the U.S. Food and Drug Administration

  8. New Approach To Drug Discovery Could Lead To Personalised Treatment Of Neuropsychiatric Disorders

    Mental health disorders are the leading cause of disability worldwide, accounting for 31% of total years lived with disability

  9. Neuronascent Announces FDA Clearance Of IND Application For NNI-362 An Aging Therapy To Treat Alzheimer's Disease

    Neuronascent Inc., a privately-held neuron regeneration therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its proprietary oral therapeutic, NNI-362, to proceed into Phase 1 clinical testing in a healthy aged population

  10. RedHill Biopharma Submits New Drug Application For Talicia® For H. pylori Infection

    RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, today announced that, following a positive pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA), it has submitted a New Drug Application (NDA) to the FDA for Talicia® (RHB-105)1 for the treatment of H. pylori infection