Actinium Pharmaceuticals Inc (NYSE American: ATNM), a company that says it is focused on improving patient access and outcomes to cellular therapies, announced yesterday that it has named Mamata Gokhale, PhD, RAC as vice president, global head of Regulatory Affairs.
In this role, Dr Gokhale will be responsible for developing and implementing a comprehensive clinical regulatory strategy across the company's portfolio of Antibody Radiation-Conjugate product candidates for targeted conditioning. These include the pivotal Phase 3 trial for Actinium's lead candidate Iomab-B, therapeutic and combination trials of Actimab-A, as well as potential next-generation ARC's resulting from its AWE or Antibody Warhead Enabling technology platform.
Dr Gokhale has more than 20 years of regulatory affairs experience that started at the US Food and Drug Administration (FDA) as a reviewer, before transitioning to industry where she worked at biotechnology and pharma companies including Amgen, Watson Pharma, Neumedicines Inc and global Contract Research Organisations including Voisin Consulting Life Sciences and Paraxel International. At Amgen Dr Gokhale successfully contributed to approvals and expansion of Prolia, Xgeva, Vectibix and Sensipar.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT