Friday, August 28, 2015

Dipexium surpasses 50% treatment in Phase 3 trial

Dipexium surpasses 50% treatment in Phase 3 trial

August 20, 2015 by · Leave a Comment 

Tweet Dipexium Pharmaceuticals’ (NASDAQ:DPRX) OneStep-1 Phase 3 clinical trial has passed the 50% enrolment milestone. OneStep-1 and OneStep-2 are identical, pivotal Phase 3 clinical trials, with 180 patients per trial, being conducted under a Special Protocol Assessment agreement with the FDA for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot […]

BriaCell readies trial of breast cancer vaccine

BriaCell readies trial of breast cancer vaccine

August 11, 2015 by · Leave a Comment 

Tweet BriaCell Therapeutics (OTCQX:ANCCF; TSX-V:BCT) anticipates enrolling the first patient later this year in a Phase 1/2 open label study of its BriaVax vaccine in up to 24 breast cancer patients with advanced stages of solid tumors. “While the current focus of the company remains late-staged breast cancers, we recognized that the technology may have […]

Rodman starts Second Sight at buy

Rodman starts Second Sight at buy

July 6, 2015 by · Leave a Comment 

Tweet Rodman & Renshaw has launched coverage of Second Sight Medical Products (NASDAQ:EYES) with a “buy” rating and a 12-month price target of $21. The stock closed at $14.05 on Friday. Second Sight is a pioneer in commercializing implantable prosthetic devices that restore functional vision to blind patients. “We view Second Sight as an attractive […]

Regenicin readying clinical trials of NovaDerm skin substitute

Regenicin readying clinical trials of NovaDerm skin substitute

June 30, 2015 by · Leave a Comment 

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Tweet Regenicin (OTC:RGIN) is completing validation of its NovaDerm skin substitute at a leading institute of technology in the U.S and plans to seek FDA approval to move into clinical trials in the second half of 2015 as well as file for worldwide designation of NovaDerm as an orphan product. “We expect to be in […]

biOasis to file IND for HER2+ brain cancer treatment in 2016

biOasis to file IND for HER2+ brain cancer treatment in 2016

June 23, 2015 by · Leave a Comment 

Tweet biOasis (OTCQX:BIOAF; TSX-V:BTI) hopes to file an Investigational New Drug application with the FDA next year to begin human testing of its Transcend platform against HER2 positive brain tumors, which result from HER2+ breast cancer metastasizing to the brain. “Given the significant unmet medical need of this condition, we are in discussions for a […]

Titan presents nonclinical ProNeura data in Parkinson’s

Titan presents nonclinical ProNeura data in Parkinson’s

June 17, 2015 by · Leave a Comment 

Tweet Titan Pharmaceuticals (OTCQB:TTNP) has presented nonclinical data at the 19th International Congress of Parkinson’s Disease and Movement Disorders in San Diego, demonstrating the potential of Titan’s ProNeura long-term, continuous drug delivery platform in the treatment of Parkinson’s disease. ProNeura’s subdermal implants containing the dopamine agonist ropinirole were first characterized for pharmacokinetics of drug release […]

FDA accepts BiondVax IND for universal flu vaccine

FDA accepts BiondVax IND for universal flu vaccine

June 17, 2015 by · Leave a Comment 

Tweet The FDA has accepted BiondVax Pharmaceuticals’ (NASDAQ, TASE:BVXV) Investigational New Drug (IND) application for its M-001 vaccine. The IND continues BiondVax’s clinical program and will allow the company to conduct an FDA-approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax’s product candidate. In a statement Dr. Ron Babecoff, BiondVax’s CEO, said FDA […]

Titan Pharma Phase 3 data validate ProNeura technology

Titan Pharma Phase 3 data validate ProNeura technology

June 9, 2015 by · Leave a Comment 

Tweet Titan Pharmaceuticals’ (OTCQB:TTNP) positive topline results from a Phase 3 clinical study of Probuphine, its subdermal implant of buprenorphine for the long-term maintenance treatment of opioid addiction, validate the company’s ProNeura continuous drug delivery technology. Yesterday, the company reported that the PRO-814 Phase 3 study, comparing maintenance treatment with Probuphine to treatment with a […]

Titan Pharma posts positive Phase 3 Probuphine results

Titan Pharma posts positive Phase 3 Probuphine results

June 8, 2015 by · Leave a Comment 

Tweet Titan Pharmaceuticals (OTCQB:TTNP) has reported positive topline results from a Phase 3 double blind, double dummy clinical study of Probuphine, its subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction. This study met the pre-specified primary endpoint of non-inferiority, as well as all secondary efficacy endpoints. It was conducted by […]

Dipexium gets positive EMA advice about Locilex filing

Dipexium gets positive EMA advice about Locilex filing

June 2, 2015 by · Leave a Comment 

Tweet Dipexium Pharmaceuticals (NASDAQ:DPRX) has received advice from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) about the clinical and regulatory aspects of its planned submission of a Marketing Authorization Application (MAA) for Locilex for topical treatment of patients with diabetic foot infection (DFI) in European Union. Based upon the […]

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