Isotechnika names Daniel Park as CBO

Isotechnika Pharma (TSX:ISA) has appointed Daniel Park to the role of chief business officer, reporting directly to CEO Dr. Robert Foster. Mr. Park will oversee all business development operations at Isotechnika, and will specifically help to lead licensing and partnership discussions and negotiations for voclosporin. He will also maintain his position as executive VP of [...]

Isotechnika partner starts uveitis Phase 3 trial

Isotechnika Pharma’s (TSX: ISA) partner Lux Biosciences has begun an additional Phase 3 trial using voclosporin for the treatment of non-infectious uveitis, a leading cause of vision loss and long-term disability. The six-month study will involve 150 patients in North America and Europe with active non-infectious intermediate, posterior, or pan-uveitis. Lux is conducting this additional [...]

Isotechnika receives financing for Phase 3 trial

Isotechnika Pharma (TSX:ISA) has finalized the development, distribution and license agreement with ILJIN Life Science, a member of the ILJIN Group of South Korea, in order to finance a pivotal Phase 3 trial of voclosporin for the prevention of kidney transplant rejection. Isotechnika will now receive a license fee of $4.5-million plus proceeds of $2.375-million from [...]

Isotechnika licenses voclosporin to ILJIN Life

Isotechnika Pharma (TSX:ISA) has entered into a development, distribution and licence agreement with ILJIN Life Science, a member of the ILJIN Group of South Korea, for the further clinical and commercial development of its voclosporin drug. Isotechnika has granted ILJIN an exclusive license to voclosporin for transplant and autoimmune indications for the U.S. and other [...]

Isotechnika and 3SBio ink licence deal

Isotechnika Pharma (TSX:ISA) and 3SBio, Inc., a Chinese biotechnology company, have signed a development and commercialization agreement for Isotechnika’s voclosporin drug to prevent organ rejection following transplantation and to treat autoimmune diseases. Under the accord, Isotechnika will receive $6 million (U.S.), consisting of an upfront licensing payment of $1.5 million and an additional $4.5 million [...]

Lux-Isotechnika get complete response letter from FDA

Isotechnika Pharma’s (TSX:ISA) partner, Lux Biosciences, has received a complete response letter from the FDA about its new drug application for voclosporin in the treatment of non-infectious uveitis, involving the intermediate or posterior segments of the eye. The FDA has requested additional information and recommended that an additional clinical trial be conducted in order to [...]

FDA to review Isotechnika drug on June 28

An advisory committee of the FDA is scheduled to review on June 28 the new drug application of Isotechnika Pharma’s (TSX:ISA) partner, Lux Biosciences, for voclosporin, a treatment for non-infectious uveitis involving the intermediate or posterior segments of the eye. The FDA is scheduled to make a decision on the NDA on Aug. 3. “We [...]

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