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 […]
Clinical Trials
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 […]
Akesys, Elixir Medical tout 1st implant for Prava bioresorbable peripheral stent
Akesys Medical and Elixir Medical Corporation said today that it implanted its 1st Prava sirolimus eluting bioresorbable peripheral scaffold for the treatment of blockages in the superficial femoral artery. The scaffold was developed to keep the large artery in the thigh open and restore blood flow to the leg and resorb into the body, making […]
FDA awards product development grants for rare diseases
The FDA said yesterday that it awarded 21 clinical trial research grants totaling more than $23 million over the next 4 years to stimulate product development for patients with rare diseases. The Orphan Products Clinical Trials Grants Program has awarded more than $370 million to fund more than 590 clinical studies since its creation in […]
