Sunday, July 5, 2015

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 […]

Provectus taking novel path to treat cancer

Provectus taking novel path to treat cancer

May 19, 2015 by · Leave a Comment 

Tweet Rather than taking a biochemistry approach to develop drugs that kill cancer cells, Provectus Biopharmaceuticals (NYSE MKT:PVCT) is using physical chemistry by harnessing the unique properties of Rose Bengal, a first-in-class halogenated xanthene. “We are taking a different type of molecule and a different basis for the mechanism of action than has been used […]

Relmada gets U.S. patent allowance for SECUREL

Relmada gets U.S. patent allowance for SECUREL

May 12, 2015 by · Leave a Comment 

Tweet Relmada Therapeutics (OTCQB:RLMD) has received a notice of allowance from the U.S. patent office for its proprietary SECUREL abuse deterrent technology platform. The new SECUREL patent application is entitled, “Multimodal Abuse Resistant and Extended Release Opioid Formulations.” Once granted, the patent is expected to be valid until at least 2028. Relmada’s lead development program, […]

TransEnterix readying FDA filing of SurgiBot in mid-year

TransEnterix readying FDA filing of SurgiBot in mid-year

April 28, 2015 by · Leave a Comment 

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Tweet TransEnterix (NYSE MKT:TRXC) plans to file for FDA approval in mid-year of its SurgiBot robotic platform to enhance minimally invasive laparoscopic surgery through a single surgical incision. “We anticipate a six-to-nine month review cycle for our 510(k) submission and hope to launch in the first half of 2016,” CEO, Todd Pope, says in an […]

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