Shares in Ohr Pharmaceutical (NSDQ:OHRP) dropped -83% to trade at 35¢ apiece this morning after the company revealed that its topical therapy did not meet the primary endpoint of a trial evaluating its efficacy as a treatment for wet age-related macular degeneration. The company’s Mako study randomized patients 1:1 to receive either Ohr’s topical, twice-daily […]
Clinical Trials
Bellerophon brings inhaled nitric oxide into Ph2 pulmonary hypertension trial
Bellerophon Therapeutics (NSDQ:BLPH) has enrolled the first patient in a Phase IIb study assessing its INOpulse device in patients with pulmonary hypertension due to interstitial lung disease. The company’s placebo-controlled study is slated to evaluate the safety and efficacy of pulsed, inhaled nitric oxide in patients with PH-ILD, including those with idiopathic pulmonary fibrosis, Bellerophon reported. […]
Mylan, Momenta take aim at Regeneron’s Eylea with biosimilar
Momenta Pharmaceuticals (NSDQ:MNTA) and Mylan (NSDQ:MYL) announced yesterday that they plan to launch a pivotal trial in the first half of 2018 for a proposed biosimilar to Regeneron‘s (NSDQ:REGN) blockbuster drug, Eylea. Eylea, a VEGF-inhibitor designed to treat wet age-related macular degeneration and diabetic macular edema, has little competition on today’s market. The drug brought in […]
Enteris touts Ph2 trial data for oral endometriosis therapy
Privately-held biotech Enteris BioPharma touted data today from a Phase IIa trial of its oral leuprolide formulation, Ovarest. The Boonton, N.J.-based company reported that its product triggered significant suppression of estradiol, which is correlated with efficacy in treating endometriosis. “The positive results from the Phase IIa clinical trial of Ovarest are a significant advancement towards Enteris’ […]
Frequency touts first-in-human safety study for hearing loss therapy
Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss. The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear. The patients enrolled in […]
Nemaura readies CE Mark submission for non-invasive glucose monitor
Nemaura Medical (OTC:NMRD) finished the European clinical trial program for its non-invasive glucose monitoring system earlier this month and reported that it’s preparing to submit the product for CE Mark clearance in the E.U. The company’s clinical trial program in Europe included 75 patients who wore sugarBeat continuously for up to 14 hours over 7 consecutive […]
Nanobiotix’s nanoparticle-immunotherapy trial wins FDA approval
Nanobiotix (EMA:NANO) said today that the FDA has approved its IND application for a cancer trial combining its radiotherapy-activated nanoparticle tech with an anti-PD1 antibody. The Phase I/II trial is slated to evaluate the safety and efficacy of Nanobiotix’s NBTXR3 product administered with checkpoint inhibitors in three groups of patients with recurrent or metastatic head and […]
Bristol-Myers Squibb taps Taris’ drug-release tech for bladder cancer trial
Bristol-Myers Squibb (NYSE:BMY) and Taris Biomedical have inked a deal to combine Taris’ investigational GemRIS drug-releasing tech with the pharma company’s PD-1 immune checkpoint inhibitor, Opdivo, in a Phase Ib muscle invasive bladder cancer trial. As part of the collaboration, Bristol-Myers has also made an equity investment in Lexington, Mass.-based Taris. Taris’ GemRIS system is designed […]
Sensorion, Cochlear collab to study combo therapies for patients with cochlear implants
Sensorion, a biotech working on therapies for inner ear diseases, said today that it inked a deal with Cochlear Ltd (ASX:COH) to study combination therapies for patients with cochlear implants. According to the deal, the companies will combine Sensorion’s SENS-401 compound with cochlear implants in preclinical studies starting next year. The drug-device therapies could be […]
Novocure wins FDA nod for pivotal pancreatic cancer trial
The FDA has given Novocure (NSDQ:NVCR) the green light to bring the company’s Tumor Treating Fields tech into a pivotal Phase III pancreatic cancer trial. The 556-patient study is designed to assess the safety and efficacy of Novocure’s TTFields combined with nab-paclitaxel and gemcitabine as a front-line treatment for unresectable locally-advanced pancreatic cancer. Panova III’s primary […]