United States-based Sen-Jam Pharmaceuticals and United States-based development and manufacturing company KVK Tech, announced on Thursday that they are collaborating to develop a Covid-19 oral therapy.
Both firms are to operate in parallel while they complete the Phase II clinical trials in Nepal. KVK Tech is to provide formulation and chemistry, manufacturing and controls (CMC) for the oral therapy. KVK is also investing strategically in Sen-Jam to conclude the whole development activities required to provide the CMC package to the Food and Drug Administration (FDA) for submitting a new drug application (NDA).
Under the partnership, KVK will have exclusive manufacturing and supply rights for the product in the US, while Sen-Jam is to use the finished formulation and CMC report to enter licensing deals with contracting manufacturing companies (CMOs) globally.
Glenmark Pharmaceuticals USA acquires approved ANDAs from Wockhardt
Soligenix's SGX302 IND clinical trial application receives US FDA approval
US FDA Places Partial Clinical Hold On Nuvation Bio Phase 1 Study of NUV-422 in Solid Tumors