BioCardia (NSDQ:BCDA) said today that it finished treating a 10-patient cohort in its pivotal Phase III CardiAmp heart failure trial. The company reported that it expects a review of the 30-day outcomes for this cohort in the third quarter of this year. Get the full story at our sister site, Drug Delivery Business News.
Clinical Trials
Surmodics to launch pivotal trial for drug-coated balloon
Surmodics (NSDQ:SRDX) said today that it won investigational device exemption from the FDA to launch a pivotal trial of its SurVeil drug-coated balloon. The trial is slated to compare the Eden Prairie, Minn.-based company’s device with Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon for patients with peripheral artery disease in the upper leg. Get the full story at our […]
Brainstorm adds UCal Irvine Medical Center to late-stage NurOwn trial
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that it inked an agreement with the University of California Irvine Medical Center to enroll patients in the Phase III trial of its NurOwn mesenchymal stem cell-based platform for amyotrophic lateral sclerosis. This marks the third medical center to work with Brainstorm to enroll patients in the late-stage pivotal trial. […]
Study: Vaginal ring for HIV prevention safe in adolescent girls
A monthly vaginal ring that releases anti-HIV drugs was found to be safe and acceptable in an NIH-funded study of adolescent girls, according this article to data presented today at the 9th IAS Conference on HIV Science in Paris. The experimental ring boasted better adherence throughout the study compared to a daily oral tablet, the […]
AntriaBio launches trial of once-weekly insulin
AntriaBio (OTC:ANTB) said today that the first patient was dosed in a Phase I first-in-human trial of its once-weekly basal insulin. The single ascending dose study is designed to test the safety, pharmacokinetics and dynamics of AB101 in patients with Type I diabetes. Get the full story at our sister site, Drug Delivery Business News.
Abbott to study blood thinners after treatment with Xience drug-eluting stent
Abbott (NYSE:ABT) said today that it enrolled the first patient in a trial evaluating the short-term use of blood thinning drugs, called dual antiplatelet therapy, after implantation of the company’s Xience everolimus-eluting coronary stent. The 2,000-patient study is slated to assess if three months of DAPT is non-inferior to the current standard of 12 months for […]
Provention Bio wants to stop Type I diabetes – with a vaccine
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. […]
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. Pops’ device was designed for users who are dosing themselves […]
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. Get the full story at our sister site, Drug Delivery […]
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. Get the full story at our sister site, Drug Delivery Business News.
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. Get the full story at our sister site, Drug […]