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Clinical Research Newsletter

  • Reports of fragmentary Clinical hold on MGD009 Phase 1 study by Macrogenics (MGNX)
    Macrogenics, Inc. is a biopharmaceutical company at the clinical stage, it is targeting for discovering and developing a monoclonal antibody-based therapeutic system for cancer treatment. This organization made an announcement on December 6th stipulating that they have received a letter from USFDA in which they have put some kind of restriction on Mono-therapy study of MGD009 Phase 1, which is a B7-H3 x CD3 bispecific DART ® molecule along with MGD009 and MGA012 (anti-PD-1) combination study.
    Draft Guidance Released by USFDA to conduct FIH clinical trials for Cancer Drug Developers
    A draft guidance to conduct first in human (FIH) clinical trials for cancer drugs has been released by USFDA which will help sponsors in designing clinical trials to speed up the development of cancer drugs through multiple expansion cohort study designs.
    Domagrozumab (PF-06252616) clinical studies evaluating the treatment of Duchenne Muscular Dystrophy terminated by Pfizer
    A Phase 2 safety and efficacy study (B5161002) and an open label extension study (B5161004) evaluating Domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy has been terminated by Pfizer. Duchenne muscular dystrophy (DMD) is a rare, serious, debilitating childhood genetic disease characterized by progressive muscle degeneration and weakness and significantly shortened life expectancy.
    Pilot Program for encouraging the complex trial designs for Drugs and Biologics launched by USFDA
    USFDA has launched a pilot program to support the use of complex innovative trial designs in the development of drugs and biologics. The launch of pilot program was decided after discussion held during a public meeting held in March although certain concerns were raised by stakeholders such as Genetech and Biogen regarding flexibility and scope of such trials.
    FDA granted Orphan Drug Designation to ASLAN003 for acute myeloid leukemia (AML) treatment
    Orphan Drug Designation has been granted to ASLAN003 which is a product of ASLAN Pharmaceuticals by USFDA for the treatment of acute myeloid leukemia (AML). ASLAN003 is an orally active potent inhibitor of human dihydroorotate dehydrogenase (DHODH) which depletes the intracellular pool of pyrimidines thereby lowering the levels of adenosine triphosphate and induction of the tumor suppressor p53 which at high levels can trigger apoptosis (programmed cell death).
    TrialAssure has joined hands with Otsuka Pharmaceuticals to provide its Clinical Trial Disclosure Reporting System
    TrialAssure is a global clinical trial disclosure and transparency reporting company which helps clients to meet regulatory compliance goals through a flexible, scalable and streamlined platform that gets regularly updated with respect to ever-changing clinical trial disclosure requirements. Otsuka Pharmaceutical Development and commercialization, Inc. is a global healthcare company based in Tokyo, Japan.