Cerus (NSDQ:CERS) landed a $15 million amendment to its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority, bringing the total potential value of its deal to $201 million. The expanded agreement is designed to support additional clinical trials of the company’s Intercept blood transfusion technology. Cerus’ Phase III […]
Clinical Trials
Medtronic launches study of drug-eluting stent as treatment for bifurcation lesions
Medtronic (NYSE:MDT) today launched a study to evaluate the safety and efficacy of its Resolute Onyx drug-eluting stent for the treatment of bifurcation lesions in patients with coronary artery disease. The medtech giant said that bifurcation lesions make up nearly 20% of all percutaneous coronary interventions. The assessment of DES tech in this patient group is part […]
PolarityTE aims to ‘wage war on skin grafts’ with regenerative tech
PolarityTE wants to eliminate skin grafts with its platform of regenerative technology. The Utah-based biotech is still new to the industry, but co-founders Denver Lough and Ned Swanson are betting that their company can take on the clinical standard of care for wound management. “No other product, whether it be a drug, a biologic device, […]
Boston Scientific’s drug-coated balloon succeeds in femoropopliteal segment at one year
Data from Boston Scientific‘s (NYSE:BSX) Ranger SFA trial showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty. The results, which were published this month in JACC: Cardiovascular Interventions, demonstrated that both groups of patients – […]
HRS 2018: Study questions benefit of ablation over drug therapy for atrial fibrillation
Long-awaited data released today from a large clinical trial comparing catheter ablation with drug therapy in treating atrial fibrillation showed no significant benefit for ablation, according to Dr. Douglas Packer, who presented the findings today at the annual meeting of the Heart Rhythm Society in Boston. The 2,204-patient trial, sponsored by the National Institutes of […]
OncoSec to combine ImmunoPulse device with Merck’s immunotherapy in breast cancer trial
OncoSec Medical (NSDQ:ONCS) expanded its relationship with Merck (NYSE:MRK) today, announcing a deal to combine its ImmunoPulse IL-12 device with Merck’s anti-PD-1 therapy, Keytruda, in a Phase II trial of patients with triple negative breast cancer. The trial is slated to study the drug-device combination in patients with inoperable locally advanced or metastatic cancer who have failed […]
J&J’s Janssen touts Ph3 data for antidepressant nasal spray
Johnson & Johnson‘s (NYSE:JNJ) Janssen revealed data today from two Phase III trials of its investigational esketamine nasal spray in patients with treatment-resistant depression. The Titusville, N.J.-based company said that if approved by the FDA, esketamine would represent one of the first new approaches designed to treat refractory major depressive disorder in the last 50 […]
Gilead inks $90m deal with Verily to create “molecular map” of inflammatory disease
Gilead Sciences (NSDQ:GILD) is reportedly slated to pay Alphabet’s Verily Life Sciences $90 million over three years to analyze cells from patients with rheumatoid arthritis, inflammatory bowel disease and lupus-related diseases. By probing immune cells from patients involved in Gilead’s clinical trials, the companies hope to glean a better understanding of the immunological signatures of RA, […]
Flexion touts interim data from Ph3 trial of osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) this week touted updated, interim results from an ongoing Phase IIIb study evaluating the safety and tolerability of repeat administration of its osteoarthritis injection, Zilretta. The company’s injectable suspension is an extended-release formulation of triamcinolone acetonide designed for patients with osteoarthritis of the knee. Top-line results from Flexion’s trial showed that 95% of […]
Following first profitable quarter, Vericel’s CEO looks to grow portfolio of autologous cell therapy products
In its latest financial results, Cambridge, Mass.-based Vericel (NSDQ:VCEL) saw sales climb 60% for its permanent skin-replacement product, Epicel, designed for patients with severe burns. Sales for its autologous cellular scaffold, Maci, were up 20% following its launch to the commercial market. Vericel’s growing product adoption helped to fuel the company’s first profitable quarter, according to […]