After gaining widespread attention with its FDA-approved Probuphine implant for the maintenance treatment of opioid addiction, Titan Pharmaceuticals (NASDAQ:TTNP) is setting out to develop an implant to treat Parkinson’s disease (PD).Read More
As CEO and one of three co-founders of upstart NeuroGate, Hrishikesh Suresh currently is completing his final year as a medical student at McMaster University in Hamilton, Ontario and plans to pursue a six-year residency in neurosurgery. But since the age of 12, he has had a passion for computer coding and, as a result, contributed to the company’s software development, which aims to capture motion data as a method to diagnose neurodegenerative diseases...Read More
After receiving FDA approval last year for its Probuphine implant as a maintenance treatment for opioid addiction, Titan Pharmaceuticals (NASDAQ:TTNP) is employing its ProNeura drug delivery technology to develop an implant to treat Parkinson’s disease.Read More
Revive Therapeutics (TSX-V:RVV; OTCQB:RVVTF) hopes to begin a pivotal Phase 2b clinical trial in mid-year with its Bucillamine drug candidate for the treatment of acute gout flares.
“We believe that the Phase 2b data in gout will be a partner-enabling study with a large pharmaceutical company,” CEO, Fabio Chianelli, says in an interview with BioTuesdays.com, noting that the clinical trial should be completed by the end of this year.
Mr. Chianelli explains that Bucillamine is an oral, small molecule drug with a 30-year history as a first-line treatment for rheumatoid arthritis in Japan and Korea. It is sold under the brand name, Rimatil. The drug’s safety has been established in 7,000 subjects from clinical studies and post-marketing evaluations.Read More
Titan Pharmaceuticals (NASDAQ:TTNP), which is awaiting an FDA approval decision for its six-month Probuphine implant to treat opioid dependence, is advancing its ProNeura implant technology against Parkinson’s disease (PD) and other disorders.
“We plan to submit our PD briefing material and request a pre-IND meeting with the FDA before the end of 2015,” Kate Beebe, EVP and chief development officer, says in an interview with BioTuesdays.com.
“If all goes according to plan, we will complete our non-clinical PD studies to enable an IND submission in early 2016 and begin pharmacokinetic and proof-of-concept studies in the second half of the year,” she adds.Read More
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 daily dosed sublingual buprenorphine/naloxone tablet, met the FDA’s pre-specified primary endpoint of non-inferiority, as well as all secondary efficacy endpoints.
Buprenorphine, the active ingredient in the Probuphine implant, is the standard of care for the treatment of opioid dependence, replacing methadone. It is currently available as daily dosed sublingual tablets and film formulations, with estimated 2013 sales of $1.5-billion for the oral formulation in the U.S.Read More
As president, CEO and a co-founder of closely-held 4P Therapeutics, a leading developer of transdermal patches, Steve Damon cut his teeth in the sector at Altea Therapeutics and Durect. He was responsible for executing several key partnerships with various pharmaceutical companies for Altea’s novel transdermal patch technology, bringing over $45-million of non-dilutive financing to Altea. Prior to Altea, Mr. Damon had a stint at Durect where, in addition to completing product partnership agreements, he was responsible for certain commercial activities, including the Alzet brand drug delivery pumps and was president of a wholly-owned subsidiary, Absorbable Polymers International. In this interview with BioTuesdays.com, Mr. Damon discusses 4P’s unique business model, transdermal technologies and pipeline products.Read More