Cellular therapies company Actinium Pharmaceuticals Inc (NYSE American:ATNM) reported on Tuesday the election of Mamata Gokhale, PhD, RAC as vice president, global head of its Regulatory Affairs.
In the senior position, Dr Gokhale will develop and implement a comprehensive clinical regulatory strategy across the company's portfolio of ARC or Antibody Radiation-Conjugate product candidates for targeted conditioning, including] the pivotal Phase 3 trial for its 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.
Previously, Dr Gokhale has worked at biotechnology and pharma companies including Amgen, Watson Pharma, Neumedicines Inc as well as in global Contract Research Organisations including Voisin Consulting Life Sciences and Paraxel International.
Earlier in her career, Dr Gokhale was part of the US Food and Drug Administration for over 20 years in regulatory positions of increasing responsibility.
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amneal's risperidone extended-release injectable suspension approved by US FDA
Brain+ pilot shows Ayla therapy boosts cognitive outcomes in dementia care
Ascelia Pharma files NDA with FDA for liver imaging drug Orviglance
Biophytis secures EMA clearance to advance Phase 2 obesity trial
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15
Eisai begins rolling sBLA to US FDA for initiation dosing of LEQEMBI IQLIK
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
BeOne Medicines reports positive topline data for sonrotoclax in mantle cell lymphoma
Cinclus Pharma to launch Phase III trial of linaprazan glurate in erosive GERD