Delcath (NSDQ:DCTH) said yesterday the company reached a special protocol assessment agreement with the FDA for the design of a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride. The system is designed to treat patients with hepatic dominant ocular melanoma, the New York City-based company said. The company said the agreement acted as a […]
Medtronic wins CE Mark for In.Pact Admiral DCB for end-stage renal disease
Medtronic (NYSE:MDT) said today its In.Pact admiral drug eluting balloon won CE Mark approval in the European Union for arteriovenous access to help maintain hemodialysis access in patients with end-stage renal disease. The device is now cleared for preventing restenosis in hemodialysis access sites by opening up the artery and delivering paclitaxel to the vessel wall. […]
Artificial pancreas from UVA heads to trials
A device developed at the University of Virginia School of Medicine which automatically monitors and regulates blood-sugar level in type 1 diabetes patients is slated to undergo 2 final clinical trials beginning early this year. UVA said it was hopeful that the long-term clinical trials would pave the way for FDA clearance of the ‘artificial pancreas’ […]
Anika assigned to FDA's drug eval arm for Cingal approval
Anika Therapeutics today said the FDA’s Office of Combination Products assigned the company’s Cingal drug-combo to its Center for Drug Evaluation and Research arm to pursue premarket regulatory approval. Cingal is a combined viscosupplement formulated with the company’s cross-linked sodium hyaluronate and triamcinolone hexacetonide, a steroid used to treat inflammation, the company said. “While we […]
Clearside Biomedical raises $14.4m, enrolls 1st patient in Phase III trial
Clearside Biomedical raised $14.4 million in a new round of equity financing, and said yesterday it enrolled the 1st patient in the Phase 3 Peachtree clinical trial of its CLS-TA for treating patients with macular edema associated with non-infectious uveitis. Clearside is developing CLS-TA triamcinolone acetonide to be delivered using its proprietary SCS microinjector for patients with […]
Transdermal Delivery Solutions launches Testagen pivotal trial
Transdermal Delivery Solutions said today the clinical trial of its Testagen Hypospray has entered its pivotal phase. The Testagen TDS is designed for testosterone replacement through transdermal absorption through a spray-on delivery system. “We are pleased to reach this milestone and expect our progress with the technology to accelerate rapidly from here. As with any […]
Intersect ENT touts economic data from from Propel study
Intersect ENT (NSDQ:XENT) said today that budget impact data on its Propel steroid releasing implant for treating chronic sinusitis showed upfront costs offset by savings post-operatively. The data was presented at the International Society for Pharmaeconomics and Outcomes Research annual meeting in Milan, Italy. “A previous study demonstrated the use of Propel in sinus surgery […]
Intersect ENT files for expanded Propel PMA
Intersect ENT (NSDQ:XENT) said Tuesday it submitted a supplemental premarket approval application to the FDA to expand the indication on its Propel mini steroid releasing implant to cover frontal sinus surgeries. The new indication would allow the drug-device combo to be used in the frontal sinuses, located behind the eyebrows, the Menlo Park, Calif.-based company […]
Intersect ENT touts sinus-implant study results
Intersect ENT (NSDQ:XENT) said today results from 3 clinical studies of its Propel, Resolve and Nova products showed positive results. The data was presented at the American Rhinologic Society’s annual meeting in Dallas. Each of the studies evaluated steroid releasing sinus implants placed in minimally invasive in-office procedures to reduce inflammation for patients with chronic […]
Unilife amends Novartis supply deal
Unilife (NSDQ:UNIS) said today it amended a clinical supply agreement with Novartis (NYSE:NVS) to supply it with additional batches of Unilife’s drug delivery device for use with a novel investigational drug. The agreement, originally signed in 2013 to supply them with the deliver devices for a targeted early-stage pipeline drug, was also amended to include an […]