Takeda deal in lupus highlights Isotechnika-Aurinia merger potential

Tweet A $255-million development partnership between Takeda Pharmaceutical and Resolve Therapeutics to develop compounds for the treatment of lupus and other autoimmune diseases highlights the potential of a merger between Isotechnika Pharma (TSX:ISA) and Aurinia Pharmaceuticals to develop Isotechnika’s voclosporin drug for lupus nephritis. Resolve’s lead compound, RSLV-132, will begin clinical development later this year. [...]

Glickman swinging for the fence again in Isotechnika merger

Tweet Richard Glickman is poised to hit another home run with the proposed merger of his closely-held Aurinia Pharmaceuticals and Isotechnika Pharma (TSX:ISA) to create a global nephrology leader. Dr. Glickman has a decades-long track record of successfully developing and selling pharmaceutical and biopharmaceutical companies. For example, in 2001, he co-founded Aspreva Pharmaceuticals which went [...]

Isotechnika merger with Aurinia to create nephrology leader

Tweet Isotechnika Pharma (TSX:ISA) and closely-held Aurinia Pharmaceuticals have signed a binding term sheet to merge and create a premier clinical-stage pharmaceutical company focused on the global nephrology market. Aurinia is a spin-out from Vifor Pharma, the pharmaceutical arm of Swiss-based Galenica Group. Aurinia’s current leadership team is comprised primarily of former senior managers, directors [...]

ILJIN withdraws damage claims against Isotechnika

Tweet Isotechnika Pharma (TSX:ISA) announced that ILJIN Life Sciences of South Korea has formally notified Isotechnika and the arbitral tribunal that it has withdrawn all claims for damages in the parties’ pending arbitration arising from a development, distribution and license agreement. As previously reported, the agreement was declared to be in “full force and effect” [...]

Isotechnika receives partial award in ICC arbitration

Tweet Isotechnika Pharma (TSX:ISA) has received a partial award from the International Chamber of Commerce Court of Arbitration regarding its right to terminate a development, distribution and license (DDL) agreement with ILJIN Life Sciences of South Korea. The partial award provides that the DDL has not been terminated and the company’s contractual relationship with ILJIN [...]

FDA clears Isotechnika for Phase 3 voclosporin trial

Tweet Isotechnika Pharma (TSX:ISA) has received permission from the FDA to commence the first of two planned Phase 3 kidney transplant trials for its lead product candidate, voclosporin, under a special protocol assessment (SPA) from the FDA. The SPA was received after the FDA reviewed Isotechnika’s Phase 2b data and evaluated the proposed Phase 3 [...]

Isotechnika highlights upcoming milestones in Q3 report

Tweet Isotechnika Pharma (TSX:ISA) expects a decision shortly from the International Chamber of Commerce (ICC) Court of Arbitration on its right to terminate a development, distribution and license agreement with ILJIN Life Science Co. Isotechnika made the disclosure in its third quarter report. It terminated the accord with ILJIN last January. In addition, Isotechnika partner [...]

Isotechnika partner completes enrolment in Phase 3 uveitis study

Tweet Isotechnika Pharma (TSX:ISA) partner, Lux Biosciences, has completed patient enrolment in its Phase 3 clinical study using voclosporin (branded as Luveniq) for the treatment of non-infectious uveitis, a leading cause of vision loss and long-term disability. Lux anticipates that data from the Phase 3 study will be available early in the first quarter of [...]

Isotechnika partner cleared for Phase 3 trial in China

Tweet Isotechnika Pharma (TSX:ISA) partner 3SBio (NASDAQ:SSRX) has received approval from the China’s State Food and Drug Administration to conduct a multi-center, Phase 3 clinical trial of voclosporin. According to the approved protocol, the randomized, multi-center, concentration-controlled and comparison study in kidney transplant patients is expected to begin enrolment in the third quarter of 2012. [...]

Isotechnika receives SPA from FDA for volcosporin trial

Tweet Isotechnika Pharma (TSX:ISA) has reached an agreement with the FDA on a Special Protocol Assessment (SPA) for its planned Phase 3 clinical trial of its lead product candidate, voclosporin. The SPA is a written agreement with the FDA that the Phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned [...]

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