Current Headlines

  1. Tricida Announces FDA Acceptance Of New Drug Application For Veverimer

    Tricida, Inc., a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for veverimer under the Accelerated Approval Program. In its correspondence, FDA also stated that no filing review issues were identified

  2. CURE Pharmaceutical Takes First Step To Acquire Coeptis Pharmaceuticals And Its Combination Drug For Osteoarthritis Pain And Hypertension

    CURE Pharmaceutical (“CURE”), an innovative drug delivery and development company, today announced that it purchased a $200,000 convertible promissory note issued by Coeptis Pharmaceuticals, Inc., a biopharmaceutical company engaged in the acquisition, development and commercialization of branded 505(b)(2) pharmaceutical products

  3. I-Mab Biopharma Receives IND Approval From NMPA To Initiate Clinical Trials For Its Anti-GM-CSF Monoclonal Antibody TJM2 In China

    I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical-stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases today announced that National Medical Products Administration (NMPA) approved its IND application for TJM2 to conduct clinical trials in patients with rheumatoid arthritis (RA)

  4. LifeMax Receives Orphan Drug Designation From The European Commission For LM-030 For The Treatment Of Netherton Syndrome

    LifeMax Laboratories, Inc. (“LifeMax”), a private company focused on treating rare diseases with few or no therapeutic options, today announced that the European Commission granted orphan drug designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into a pivotal clinical trial for the treatment of Netherton Syndrome

  5. Takara Bio Announces Launch Of Human iPSC-Derived Intestinal Epithelial Cells For Drug Discovery Research

    Takara Bio USA, Inc. (TBUSA) announced that its parent company, Takara Bio Inc., has launched the world’s first commercially available small intestinal epithelial cells derived from human induced pluripotent stem cells

  6. ILIKOS Drug Development Solutions (ILIKOS) Launches To Offer Highly Tailored Drug Development Solutions And Progress Clinical Research In Cyprus

    ILIKOS, an innovative drug development solutions provider based in Cyprus, is formally launching its operations

  7. LEO Pharma Exercises Option With HitGen To License Compounds For Development Of Novel Class Of Drugs In Dermatology

    LEO Pharma A/S and HitGen Inc. are pleased to announce that HitGen and LEO Pharma expands their collaboration with a license to develop a novel class of drugs for a dermatology indication

  8. ATAI Life Sciences And Cyclica Launch Joint Venture To Revolutionize Drug Development For Mental Health Disorders

    ATAI Life Sciences AG, a global biotech platform that envisions an end to mental illnesses, and Cyclica Inc., a leading biotechnology company that leverages artificial intelligence and computational biophysics to streamline the drug discovery process, have launched a joint venture aimed at changing the paradigm in which mental health disorders are treated

  9. RMJ Holdings, LLC Develops ‘First In Class’ Hypertension Drug Utilizing Proprietary Inverted Micellar Technology

    RMJ Holdings, LLC's (RMJH) a private company developing drug candidates based on its globally patented inverted micellar technology, today announced that its first drug candidate, RMJH-111B for essential hypertension, is being prepared for Phase 3 development

  10. Frost & Sullivan: Major Drug Companies Are Securing An Edge By Leveraging The 505(b)(2) Pathway

    The discovery and development of new drugs is a long, difficult, and expensive process. A potential new medicine may be rejected at any point in the development process due to safety, efficacy, or quality