Sanofi (NYSE:SNY) and Regeneron (NSDQ:REGN) touted data today from the pivotal Phase III trial of dupilumab in a group of patients with uncontrolled, persistent asthma. The drug is already approved for adults with certain forms of eczema. The two companies said they plan to seek FDA approval of dupilumab in asthma by the end of the year. […]
Clinical Trials
Medtech stories we missed this week: September 8, 2017
From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating […]
Aequus touts proof-of-concept trial for anti-nausea patch
Aequus Pharmaceuticals (CVE:AQS) touted data today from an initial proof-of-concept study of its long-acting, transdermal anti-nausea patch, AQS1303. The patch, which combines pyridoxine hydrochloride and doxylamine succinate, is intended to treat nausea and vomiting associated with pregnancy. The oral form of pyridoxine hydrochloride, Diclegis, is dosed up to four times a day. The single-dose comparative bioavailability […]
MiMedx wins FDA nod for AmnioFix pivotal trial
MiMedx (NSDQ:MDXG) said today that the FDA has approved its Phase III Achilles tendonitis trial. The 158-patient study is designed to compare the company’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. The trial, which is the company’s second late-stage study of AmnioFix, will start […]
Merck leads $11m round for Antidote’s trial-matching tech
Antidote Technologies said today that it inked an $11 million funding round to advance its clinical trial matching technologies. The round was led by Merck’s Global Health Innovation Fund. Existing investors Smedvig Capital and Octopus Ventures participated in the round, which is contingent upon obtaining certain regulatory clearances and is expected to close later this […]
Aerie launches Ph3 trial for Roclatan eye drug in Europe
Aerie Pharmaceuticals (NSDQ:AERI) said today that it launched its European Mercury 3 late-stage trial of Roclatan in patients with open-angle glaucoma or ocular hypertension. The eye drug is a fixed dose combination of Aerie’s Rhopressa netarsudil ophthalmic solution and a widely-used prostaglandin analogue, latanoprost. The company’s Phase III trial was designed to support regulatory approval and […]
Lumicell launches breast cancer, prostate cancer trials with Lum image-guided system
Lumicell said today that it is launching clinical studies in breast cancer and prostate cancer with its Lum image-guided cancer surgery system. The breast cancer trial is a pivotal study following an initial training period with surgeons, the Wellesley, Mass.-based company reported, and the prostate cancer study is a first for Lumicell and its technology. […]
Bellerophon Therapeutics touts Ph2 COPD trial of inhaled nitric oxide
Bellerophon Therapeutics (NSDQ:BLPH) touted data today from a Phase II trial of pulsed, inhaled nitric oxide in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease. The 10-patient trial was designed to evaluate the effects of pulsed, inhaled nitric oxide on targeted vasodilation and the chronic effect on hemodynamics and exercise capacity. The data showed […]
Enteris BioPharma launches endometriosis trial with oral peptide delivery tech
Enteris BioPharma, a 24-person biotech based in Boonton, N.J., last month launched a trial of its oral leuprolide endometriosis therapy, Ovarest. Ovarest is the company’s most advanced internal candidate and represents Enteris’ attempt to overcome the challenges presented by the oral delivery of peptides, according to CEO Joel Tune. The Phase IIa trial, which is […]
LabCorp completes $1.2B Chiltern buy
Diagnostics company LabCorp (NYSE:LH) said today that it has closed its $1.2 billion acquisition of contract research organization Chiltern International. Chiltern is slated to fold into the company’s Covance drug development business, which conducts clinical trials for drugmakers. “The addition of Chiltern advances a key element of LabCorp’s strategy – to bring innovative medicines to patients […]