Isotechnika in license pact with Vifor Pharma

Isotechnika Pharma (TSX:ISA) has signed a global development and commercialization license agreement with Vifor Pharma, a member of the Swiss Galenica Group, for its lead drug, voclosporin, for the treatment of lupus and all proteinuric nephrology indications, covering the U.S. and other regions outside of Canada, South Africa, Israel, China, Taiwan and Hong Kong. While [...]

Isotechnika releases shareholder letter

In a letter to shareholders issued today, Isotechnika Pharma (TSX:ISA) CEO Dr. Robert Foster explains the company’s decision to move its voclosporin drug into Phase 3 clinical trials for the prevention of kidney transplant rejection.  He outlines the market opportunity, the scientific rationale and the clinical support for the transplantation indication as well as laying [...]

Isotechnika has path forward for pivotal trial

Isotechnika Pharma (TSX:ISA) has taken an important step toward launching final testing of a potential breakthrough drug to prevent rejection of a transplanted kidney. “We now have a clear path forward for a proposed Phase 3 clinical trial protocol of our voclosporin drug,” CEO Dr. Robert Foster says in an exclusive interview with BioTuesdays.com. He [...]

Isotechnika partner nears end of patient recruitment

Isotechnika Pharma (TSX:ISA) said its partner, Lux Biosciences, expects to complete patient recruitment of its continuing Phase 3 trial of Luveniq (voclosporin) in North America for the treatment of non-infectious uveitis in early 2012. Lux also has decided to modify its European regulatory strategy by withdrawing its application for marketing authorization of Luveniq for the [...]

Isotechnika receives positive scientific advice in Europe for voclosporin

Isotechnika Pharma (TSX:ISA) said it has received positive Scientific Advice from the European Medicines Agency for a proposed Phase 3 clinical trial protocol of its drug, voclosporin, after the agency reviewed the study design and endpoints for the proposed clinical study.   This ensures that no major objections regarding the design of the study or the [...]

FDA cancels meeting but review of Isotechnika’s voclosporin continues

The FDA has cancelled a June 28 dermatology and ophthalmology drugs advisory committee review of a new drug application by Isotechnika Pharma’s (TSX:ISA) partner Lux Biosciences for their voclosporin drug as a treatment of non-infectious uveitis. On its website, the FDA said the meeting was cancelled to allow time for the “resolution of several outstanding [...]

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 [...]

Isotechnika has a powerhouse franchise in voclosporin

Dr. Robert Foster still longs to make Isotechnika’s (TSX: ISA) lead drug, voclosporin, the standard of care in the field of preventing organ rejection in transplantation surgery. This may seem somewhat unusual, since voclosporin is currently being considered by regulators in North America and Europe to treat uveitis, a chronic inflammation of the eye that [...]

Isotechnika amends deal with Paladin Labs

Isotechnika Pharma’s (TSX: ISA) wholly owned subsidiary, Isotechnika Labs, has amended its agreement with Paladin Labs (TSX:PLB) on the remaining stake in the revenue stream from the Isodiagnostika business, which was sold to Paladin in mid-2009. Under the original deal, Isotechnika Labs was entitled to receive a revenue stream equivalent to 88% of the net [...]

Cash-rich Paladin on the acquisition trail

Paladin Labs (TSX:PLB) is sitting on a war chest of some $97 million that’s growing by the quarter and itching to be deployed. “We’re going to invest in opportunities with a high return on investment,” CEO Jonathan Goodman, says in an exclusive interview with biotuesdays.com.  “But I’m not going to bet the company on a [...]