Oramed cleared for oral insulin trials in U.S.

Tweet The FDA has cleared Oramed Pharmaceuticals’ (NASDAQ:ORMP) Investigational New Drug application for ORMD-0801, its oral insulin capsule. “We are very pleased to have the FDA clearance to proceed,” CEO Nadav Kidron said in a statement. “The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801′s clinical [...]

Orgenesis and ATMI in process development accord

Tweet Orgenesis (OTCBB:ORGS) has entered into a process development agreement with ATMI (NASDAQ:ATMI), a global technology company and leader in single-use bioprocess solutions. Under the accord, ATMI will supply Orgenesis with a complete disposable manufacturing process for the expansion of a patient’s liver cells outside of the body, an important step in Orgenesis’ therapeutic technology [...]

Oramed readies oral insulin study in U.S.

Tweet Oramed Pharmaceuticals (NASDAQ:ORMP) is awaiting a decision from the FDA, possibly later this week, to conduct a sub-study of the safety of its oral insulin candidate, ORMD-0801, before proceeding to a large, multi-center Phase 2 clinical trial later this year. “Approving a clinical trial in the U.S. for oral insulin is a big deal,” [...]

Oramed to present diabetes data today

Tweet Oramed Pharmaceuticals’ (NASDAQ: ORMP) abstract, entitled, “Oral insulin capsules toward management of Type 1 diabetes mellitus,” will be presented at the Global Technology Community Diabetes Summit 2013 this evening by CSO Dr. Miriam Kidron. The work summarizes the results of Oramed’s key clinical studies assessing the safety and efficacy of its oral insulin formulation [...]

Diabetes expert Dr. Jay Skyler joins Orgenesis’ SAB

Tweet Orgenesis (OTCBB:ORGS) has appointed Dr. Jay Skyler, whose career in diabetes spans over four decades, to its scientific advisory board. Dr. Skyler is a Prof. of Medicine, Pediatrics and Psychology at the University of Miami Miller School of Medicine and deputy director for clinical research and academic programs at the Diabetes Research Institute. He [...]

Oramed submits IND for U.S. oral insulin trial

Tweet Oramed Pharmaceuticals (NASDAQCM:ORMP) has submitted a new Investigational New Drug (IND) application with the FDA for a sub-study on its oral insulin candidate, ORMD-0801. The filing is in response to FDA feedback from Oramed’s initial IND filing on Dec. 31, 2012. The FDA had requested Oramed perform a sub-study in a controlled in-patient setting [...]

Islet Sciences adds Dr. Eitan Akirav to SAB

Tweet Islet Sciences (OTCBB:ISLT) has appointed Dr. Eitan Akirav to its scientific advisory board. “The expertise and deep industry relationships Dr. Akirav brings along with his significant knowledge in the field of diabetes will be quite helpful to the company moving forward,” chairman and CEO John Steel said in a statement. Dr. Akirav’s recent co-authorship [...]

Islet Sciences points to study in Diabetes journal

Tweet Islet Sciences (OTCBB:ISLT) announced that an important study has been published in Diabetes by the American Diabetes Association titled, “Immune Therapy and ß-Cell Death in Type 1 Diabetes”. “This study is another validator of our approach to tackling this worldwide disease,” John Steel, Islet chairman and CEO, said in a statement. “We continue to [...]

Orgenesis to present at ATTD 2013

Tweet Orgenesis (OTCBB:ORGS) CSO Prof. Sarah Ferber is scheduled to present at the 6th International Conference on Advanced Technologies & Treatments for Diabetes, to be held Feb. 27 to March 3 in Paris. Prof. Ferber’s presentation will be based on a peer-reviewed and accepted abstract, entitled “Implementation of Advanced Autologous Cell-Based Therapy for Diabetic Patients.” [...]

Byron Capital ups Transition Therapeutics to buy

Tweet Byron Capital has upgraded Transition Therapeutics (TSX:TTH; NASDAQ:TTHI) to “buy” from “hold” and raised its price target to $3.25 from $2.25 after the company reported fiscal third quarter results and updated its pipeline activities. The stock was quoted at $2.20 on Tuesday morning. Current activities include two sizable Phase 2 CNS trials testing Transition’s [...]

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