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 […]
Clinical Trials
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’ […]
pSivida surges on Medidur data
Psivida (NSDQ:PSDV) shares surged today after the company said its Medidur drug-device combination met the primary endpoints in a Phase III clinical trial for treating posterior uveitis. Medidur uses the same injectable implant and drug as the Iluvien drug-device combo pSivida licensed to Alimera Sciences (NSDQ:ALIM) for treating diabetic macular degeneration. Iluvien won FDA approval in September […]
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 […]
Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix (NSDQ:OCUL) said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication. Bedford, Mass.-based Ocular Therapeutix has had mixed results with Dextenza, formerly known as OTX-DP, which is designed to deliver sustained dosage of dexamethasone over 4 weeks, using a hydrogel plug […]
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 […]
Intersect ENT's Propel study meets endpoint
Intersect ENT (NSDQ:XENT) said a new study of its Propel mini steroid-releasing sinus implant used after frontal sinus surgery met the primary endpoint in a clinical trial. The Propel device is already approved for use in the ethmoid sinuses, behind the bridge of the nose, in conjunction with sinus surgery to treat symptoms of chronic sinusitis, […]
Bellerophon plunges on failed cardiac implant trial
Bellerophon Therapeutics (NSDQ:BLPH) said today that its bioabsorbable cardiac matrix failed to meet both the primary and secondary endpoints in a 303-patient clinical trial, sending its share price down nearly -63% today. BCM is a liquid medical device injected into the coronary artery leading to the damaged area of a heart, and is designed for use after […]
