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 [...]

Galena to target Abstral as market leader for cancer pain

Tweet Galena Biopharma (NASDAQ:GALE) plans to make its recently acquired Abstral sublingual tablets the market leader for the treatment of breakthrough cancer pain (BTcP) in the U.S., matching the product’s performance in Europe. “Abstral is the latest and best-in-class drug for this indication,” president and CEO Mark Ahn says in an interview with BioTuesdays.com, noting [...]

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,” [...]

Brainsway to launch Deep TMS in the U.S.

Tweet After completing production of approximately 100 Deep TMS systems, Brainsway (TASE:BRIN) intends to initiate U.S. commercial sales of the device within the next few days, with the official marketing launch set for the American Psychiatric Association (APA) 2013 annual meeting in San Francisco on May 18-22. In January 2013, the FDA approved Brainsway’s proprietary [...]

BioLineRx pipeline returns to the winner’s circle

Tweet After disappointing investors in March by terminating a Phase 2/3 clinical trial of an anti-psychotic drug candidate for the treatment of schizophrenia, BioLineRx (NASDAQ:BLRX; TASE:BLRX) bounced back in April, posting positive Phase 2a results with an oral treatment for inflammatory bowel disease (IBD). “BioLineRx is not a binary company, but has a broad and [...]

Tecnofarma to distribute Cipher’s tramadol

Tweet Cipher Pharmaceuticals (OTCBB:CPHMF; TSX:DND) has entered into a definitive distribution and supply agreement with Tecnofarma International, giving Tecnofarma the exclusive right to market, sell and distribute CIP-Tramadol ER in Latin America. Uruguay-based Tecnofarma operates in 18 Latin American countries and will launch the product in certain territories, including Brazil and Mexico. CIP-Tramadol ER is [...]

Vaxil trial validates vaccine technology

Tweet Results of a recent clinical trial of Vaxil Bio’s (TASE:VAXL) ImMucin cancer vaccine in patients with multiple myeloma has validated the company’s VaxHit technology by demonstrating safety and a strong immune response in all patients. “This is not trivial for a first-in-man study,” CEO Lior Carmon says in an interview with BioTuesdays.com, referring to [...]

DURECT files NDA for POSIDUR

Tweet DURECT (NASDAQ:DRRX) announced the submission of a New Drug Application to the FDA for the investigational product POSIDUR, a post-operative pain relief depot that utilizes DURECT’s patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. “If approved by the FDA, POSIDUR will provide [...]

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 [...]

BioLineRx cleared for U.S. Phase 2a trial of BL-8040

Tweet BioLineRx (NASDAQ, TASE:BLRX) has received all necessary regulatory approvals in the U.S. to begin a Phase 2a trial for BL-8040, for the treatment of acute myeloid leukemia (AML). The study is a multicenter, open-label study under an IND, designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adult [...]

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