NanoViricides, Inc. (NYSE:NNVC) said today that it inked a deal with SUNY Upstate Medical University for the evaluation of its nanovirivides drug candidates against varicella zoster virus, also called the shingles virus. The goal of these in vitro, ex vivo, and in vivo studies will be to help select a clinical drug development candidate for toxicology and safety evaluation […]
Clinical Trials
FDA OKs stem cell-gene therapy trial for ALS
The FDA approved a combination stem cell-gene therapy clinical trial to test the treatment’s ability to slow the progression of amyotrophic lateral sclerosis. It’s the 1st clinical trial to use neural stem cells to deliver a particular protein in the hopes of slowing ALS progression, according to researchers at the ALS clinic at Cedars-Sinai Medical […]
Litmus Health looks to bring wearables to drug development
Litmus Health said yesterday that it launched its clinical data science platform into public beta. The company hopes to use big data from wearables and connected devices to help inform endpoints for Phase I & II clinical trials. The goal of its platform, according to Litmus, is to get pharmaceuticals to market faster by putting […]
Monaghan Medical touts Aerobika study
Monaghan Medical yesterday touted data from a 6-month retrospective study showing that its Aerobika device reduced drug use for treatment of chronic obstructive pulmonary device. The Syracuse, N.Y.-based company says its oscillating positive expiratory pressure therapy device is designed to expand the airways, help expel mucus to the upper airways and aid in drug deposition. The […]
Targazyme wins FDA clearance for Phase II bone marrow stem cell study
Targazyme said today that it will begin enrolling patients in a Phase II clinical study to evaluate TZ101-fucosylated bone marrow stem cells in cancer patients, after the FDA granted the San Diego-based company investigational new drug clearance. The treatment is designed to use blood-forming stem cells from bone marrow to restore the body’s ability to make blood […]
Dipexium crashes after Locilex Phase III trials fail
Shares in Dipexium Pharmaceutical (NSDQ:DPRX) dived 84% today after it reported that its OneStep-1 and OneStep-2 Phase III clinical trials of Locilex in patients with mild infections of diabetic foot ulcers did not meet its primary or secondary clinical endpoints. Both trials failed to show any meaningful difference in wound closure rate between the Locilex arm and the […]
Imprimis touts ‘dropless therapy’ study for cataract surgery
Imprimis Pharmaceuticals (NSDQ:IMMY) touted data today from a peer-reviewed study of patients who received its “dropless therapy” following cataract surgery. The San Diego-based company uses a compounded antibiotic and steroid formulation in single, injectable doses administered by physicians following ocular surgery. The treatment is designed to eliminate the need for patient-administered eye drops, potentially eliminating patient […]
aTyr Pharma wins FDA fast track for muscular dystrophy therapy
aTyr Pharma (NSDQ:LIFE) said today that its candidate Resolaris was granted fast track designation by the FDA for the treatment of facioscapulohumeral muscular dystrophy, making it the 1st therapeutic candidate to receive the designation for the rare form of muscular dystrophy. Resolaris is derived from a naturally occurring protein released by human skeletal muscle cells. aTyr is […]
FDA delays Inovio phase III trial of DNA immunotherapy candidate
Inovio Pharmaceuticals (NSDQ:INO) said today that the FDA placed a hold on its proposed Phase III clinical program for its investigational DNA immunotherapy candidate designed to treat pre-cancers and cancers caused by human papillomavirus. The California-based company completed a randomized, double-blind Phase II trial of the candidate in July 2014, evaluating the DNA immunotherapy treatment in women […]
Mylan, Theravance touts Phase III data for COPD drug
Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) said today that revefenacin, the 1st nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease, demonstrated positive results in 2 replicate phase III efficacy studies. Data from more than 1,250 moderate to severe COPD patients showed that both studies met their efficacy and safety endpoints. Revefenacin […]
