FarmaKology-Mendus receives U.S. FDA Fast Track Designation for vididencel in Acute Myeloid Leukemia
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Otsuka Pharmaceutical Co., Ltd. and ShapeTX, the programmable medicine company using AI and RNA to end genetic diseases, announced a multi-target collaboration to develop intravitreally-delivered adeno-associated viruses (AAVs) for ocular diseases, with options to add additional targets and tissue types. The companies will collaborate to apply ShapeTX’s AAVid™ capsid discovery platform and transgene engineering technology along with Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for people living with serious eye diseases.
Mendus AB, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced that it has received Fast Track Designation from the U.S. Food and Drug Administration for the Company’s lead program, vididencel, for the treatment of Acute Myeloid Leukemia (AML) in complete remission with residual disease. Advantages of the Fast Track Designation include close and early interactions with the FDA to support accelerated approval, as well as the possibility of a “rolling review” for a subsequent market application.
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma , harbouring susceptible fibroblast growth factor receptor 3 genetic alterations, with disease progression during or following at least one line of therapy containing a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
Myricx Bio, a UK biotech company focusing on the discovery and development of a completely novel class of selective cytotoxic payloads for antibody drug conjugates, announced an antibody license agreement with Biocytogen Pharmaceuticals Co., Ltd , a global biotech company focusing on the discovery of novel antibody therapeutics.The agreement will enable Myricx to develop and commercialize ADCs based on an antibody developed using Biocytogen’s proprietary RenMice® platform and will expand Myricx’s ADC pipeline of proprietary monoclonal antibodies against important cancer targets to which it conjugates its first-in-class selective cytotoxic payloads based on potent inhibitors of N-MyristoylTransferase , a completely novel concept in the ADC space.