Anika Therapeutics said today it won CE Mark approval in the European Union for its Cingal drug-combo designed to treat osteoarthritis-related knee pain. Cingal is a combined viscosupplement formulated with the company’s cross-linked sodium hyaluronate and triamcinolone hexacetonide, a steroid used to treat inflammation, the Bedford, Mass.-based company said. “The European approval of Cingal marks an […]
Clinical Trials
Bard touts data from Lutonix head-to-head study against MDT's In.Pact
C.R. Bard (NYSE:BCR) subsidiary Bard Peripheral Vascular touted results showing no significant difference in a study pitting its Lutonix DCB against Medtronic‘s (NYSE:MDT) In.Pact DCB in treating patients with complex femoropopliteal lesions. Clinical data from the investigator-sponsored retrospective, single-center study was presented during the Leibzig International Course in Leipzig, Germany last month. The study reported […]
Mercator MedSystems launches dual-therapy BTK Bullfrog device trial
Mercator MedSystems said yesterday it enrolled the 1st patient in its Limbo-PTA clinical trial aiming to examine the use of the company’s Bullfrog micro-infusion device delivering anti-inflammatory steroids along with angioplasty to treat patients with below the knee critical limb ischemia. The Emeryville, Calif.-based company said that the purpose of adding an anti-inflammatory drug, delivered by […]
Glaukos touts 3-year iStent study data
Glaukos (NYSE:GKOS) said today data from a 3-year study of its iStent Trabecular micro-bypass stent indicated that it, along with cataract surgery, lowered mean intraocular pressure 36% and reduced mean glaucoma medications by 86% 3 years post-surgery. The study reported a mean IP of 14.99 mmHg in 39 patients monitored after treatment for 3 years, compared […]
Delcath launches Phase III trial for ocular melanoma treatment
Delcath (NSDQ:DCTH) said today it launched a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride designed for the treatment of hepatic dominant ocular melanoma. The newly initiated Focus trial will examine the safety, efficacy and pharmocokinetic profile of its Melphalan and HDS system when compared with the standard of care, the New […]
Delcath inks FDA deal for design of Phase III trial
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 […]
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 […]
