Before he co-founded Provention Bio, Ashleigh Palmer worked on inhaled nitric oxide for infants with respiratory failure. After the company was sold for $1.2 billion to a Baxter-led consortium, Palmer noticed there was apprehension about conducting clinical trials with neonates. He was concerned that the inhaled NO assets were slated to fall to the wayside. […]
Clinical Trials
Pops Diabetes, Children’s Minnesota to test glucometer
Pops Diabetes Care reportedly enrolled the first patient in a clinical trial evaluating its Pops! one glucometer, according to the StarTribune. The Twin Cities-based company is said to be partnering with the Children’s Minnesota healthcare system to study its device in 50 Type I diabetes patients. Get the full story at our sister site, MassDevice.
Samumed wins orphan drug status for inhaled IPF therapy
Samumed said today that the FDA awarded orphan drug status to its inhaled idiopathic pulmonary fibrosis therapy, SMo4646. The IPF therapy is administered using a nebulizer and can be used as a montherapy or in combination with pirfenidone or nintedanib, according to the San Diego-based company. “The FDA’s decision to grant an ODD to SM04646 […]
BioLight’s glaucoma insert succeeds in Phase I/IIa trial
BioLight Life Sciences (TLV:BOLT) touted data today from a Phase I/IIa clinical trial evaluating its Eye-D latanoprost insert. The device successfully lowered intraocular pressure during the study’s 12-week period and had a favorable safety profile, according to the Israel-based company. The latanoprost insert was designed for glaucoma patients who have trouble taking prescribed eye drops […]
J&J touts first-in-human data for HIV vaccine
Johnson & Johnson (NYSE:JNJ) touted first-in-human clinical data today for its investigational HIV vaccine in development by its subsidiary, Janssen Pharmaceutical. The Phase I/IIa trial enrolled 393 healthy volunteers. According to the data, the vaccine was well-tolerated and triggered an HIV antibody response in 100% of participants. “Finding a preventive vaccine has proven to be one […]
Study: Antiretroviral drug-eluting ring safe in breastfeeding mothers
An antiretroviral drug released from an experimental vaginal ring to protect women against HIV is absorbed in low concentrations into breastmilk, according to researchers from the NIH-funded Microbicide Trials Network. The team touted data today from a Phase I trial of the device at the 9th IAS Conference on HIV Sciences in Paris. The dapivirine […]
Novocure brings Optune tech to drug trial for glioblastoma
Novocure (NSDQ:NVCR) said today that it joined a Phase Ib study to evaluate the safety of Celgene‘s (NSDQ:CELG) marizomib and temozolomide in combination with Optune for patients with newly-diagnosed glioblastoma. The trial is the first to assess Optune, the company’s “Tumor Treating Fields” delivery device, in combination with an investigational drug. Celgene and Triphase changed their ongoing […]
Aerie touts late-stage safety data for Roclatan eye drops
Aerie Pharmaceuticals (NSDQ:AERI) touted 12-month safety data yesterday from the Phase III registration trial of its Roclatan eye drops for intraocular pressure resulting from glaucoma or ocular hypertension. The study was designed to support Aerie’s new drug application submission to the FDA for Roclatan, which it expects to file in the first half of next year. Safety […]
Brainstorm Cell Therapeutics wins $16m grant for pivotal NurOwn ALS study
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today it won a $16 million grant from the California Institute of Regenerative Medicine to engage in a phase 3 study of its NurOwn mesenchymal stem cell-based platform for treating amyotrophic lateral sclerosis. Brainstorm said it is in the advanced stages of planning a Phase 3 clinical trial investigating NurOwn for […]
Medtech stories we missed this week: July 21, 2017
From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation of two […]