Otsuka Pharmaceutical (TYO:4578) and Lundbeck said last week that its extended-release injectable aripiprazole suspension, Abilify Maintena, won FDA approval as a maintenance monotherapy for adults with bipolar I disorder. The once-monthly intramuscular formulation was created by Otsuka and co-developed and commercialized with Lundbeck, the companies reported. A late-stage trial showed that Abilify Maintena delayed the time […]
Clinical Trials
QT Vascular launches pivotal trial for drug-coated peripheral balloon
QT Vascular said today that it launched the U.S. pivotal trial for its Chocolate Touch drug-coated peripheral balloon in the hopes of winning FDA approval. The device won CE Mark clearance in September 2015. The trial is slated to compare the safety and effectiveness of the Chocolate Touch balloon with Bard‘s(NYSE:BCR) Lutonix drug-coated balloon catheter. […]
Icon beats Street on Q2 earnings, acquires Mapi Group
Drug development provider Icon PLC (Nasdaq: ICLR) saw its stock jump about 6% in value today after announcing second-quarter earnings that beat analysts’ expectations. The Dublin, Ireland–based company, which serves the pharmaceutical, biotechnology and medical device industries, also said it has acquired the Mapi Group, which provides patient-centered health outcomes research and commercialisation. Financial terms of […]
Spectranetics wins FDA nod for Stellarex DCB
Spectranetics (NSDQ:SPNC) said today that its Stellarex drug-coated balloon won FDA pre-market approval. The device is designed to treat patients with peripheral arterial disease, bringing blood flow back to the superficial femoral and popliteal arteries. “The Stellarex DCB has shown safety and efficacy in a cohort of patients which included a higher preponderance of diabetics […]
BioCardia treats 10-patient cohort in late-stage heart failure trial
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. The CardiAmp pivotal trial, which launched in December, is slated to enroll up to […]
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. “By providing a head-to-head comparison […]
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 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 researchers reported. […]
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. The second part of the study is slated to compare AB101 to Sanofi‘s […]
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 […]