Current Headlines

  1. OBI Pharma Announces U.S. FDA Clearance Of IND Application For A Phase 1/2 Study Of Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

    OBI Pharma, a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-999 to conduct a Phase 1/2 study of its antibody drug conjugate (ADC) cancer therapy targeting Globo H, a glycolipid antigen

  2. WuXi AppTec Launches DNA Encoded Library (DEL) Service Package ‘DELight’ To Expedite Early Drug Discovery

    WuXi AppTec today announced its launch of DELight, a novel DNA Encoded Library (DEL) service package, providing cost-effective and efficient hit finding services to expedite early drug discovery and bring new medicines to patients faster

  3. Insilico Medicine Develops And Validates Powerful AI System To Transform Drug Discovery

    Insilico Medicine has developed GENTRL, a new artificial intelligence system for drug discovery that dramatically accelerates the process from years to days. In the industry’s first successful experimental validation of such AI technology for drug discovery in cells and animals, Insilico successfully tested the technology by creating a series of entirely new molecules capable of combating disorders like fibrosis

  4. Beroni Group Incorporates New PENAO Company With University Of New South Wales To Develop The Next Generation Anti-Cancer Drug

    Beroni Group Limited (NSX: BTG) (OTCQX: BNIGF) (“Beroni” or the “Company”) is pleased to advise that it and NewSouth Innovations Pty Ltd (“NSi”), a subsidiary of the University of New South Wales in Australia, have established a new company named PENAO Pty Ltd (“PENAO Company”) to take over the drug development process and licensing rights of the potentially groundbreaking anti-cancer drug PENAO from Cystemix Pty Ltd (“Cystemix”)

  5. FDA Accepts SHINKEI Therapeutics Investigational New Drug Application For MR-301 For Traumatic Brain Injury

    SHINKEI Therapeutics., a clinical stage pharmaceutical company focused on the development of therapeutic drugs for the treatment of Central Nervous System (CNS) disorders, today announced that they received notification from Food and Drug Administration (FDA), stating that FDA has accepted the filing of an Investigational New Drug (“IND”) application for MR-301 for the treatment of Severe Traumatic Brain Injury (sTBI) resulting in minimally conscious and/or vegetative comatose state

  6. Sigilon Therapeutics Receives Orphan Drug Designation For SIG-001 For The Treatment Of Hemophilia A

    Sigilon Therapeutics today announced it has received Orphan Drug Designation for SIG-001, an investigational therapy for hemophilia A that leverages Sigilon’s Shielded Living Therapeutics platform to implant cells engineered to produce stable blood plasma levels of factor VIII, a crucial clotting protein

  7. FDA Grants Fast Track Designation For FARXIGA In Chronic Kidney Disease

    AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD)

  8. Delivering Promising New Medicines Without Sacrificing Safety And Efficacy

    The FDA walks a fine line. We must balance timely patient access to important new medicines with assuring they meet key standards. These standards exist to make sure that approved drugs have a high chance of helping those who use them. Medicines ultimately must lead to overall improvements in how patients feel, function or survive

  9. Presage Announces Collaboration With Bristol-Myers Squibb For Phase O Studies Of Novel Cancer Agents Utilizing CIVO™ Technology

    Presage Biosciences, a cancer biotechnology company pioneering a new cancer drug development approach using its CIVO™ multiplexed intratumoral microdosing platform, today announced it has entered into a research collaboration with Bristol-Myers Squibb Company (NYSE: BMY) to evaluate early stage oncology targets in Phase 0 trials

  10. Ascletis Received IND Approval For Its NASH Drug

    Ascletis Pharma Inc. (1672.HK), an innovative R&D driven, commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and fatty liver diseases, announces today that together with Sagimet Biosciences (formerly 3-V Biosciences, Inc), it received, through its subsidiary, IND approval from National Medical Products Administration (NMPA) for its non-alcoholic steatohepatitis (NASH) drug candidate ASC40 (Sagimet Biosciences code: TVB-2640)