Anika Therapeutics (NSDQ:ANIK) touted data today from a study evaluating the use of its Hyalofast biodegradable, hyaluronic acid-based scaffold in combination with autologous adult mesenchymal stem cells as a treatment for cartilage lesions in the knee. The study, which was published in Knee Surgery Sports Traumatology Arthroscopy, showed that the treatment was equally effective among patients, regardless […]
Clinical Trials
Rebiotix launches late-stage superbug trial for microbiome-based drug
Rebiotix isn’t a traditional drugmaker. Its products are alive. The 32-person company, based in Roseville, Minn., is developing a microbiome-based therapy to prevent recurrent Clostridium difficile infection. Its Microbiota Restoration Therapy, which is delivered via enema or a lyophilized, non-frozen oral capsule, is designed to supply a patient’s intestinal tract with an array of healthy, human-derived microbes. […]
MiMedx files IND for Achilles tendonitis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND application with the FDA for the company’s late-stage Achilles tendonitis trial. The 158-patient study is designed to compare MiMedx’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. If approved, the trial will be the second […]
VC shops back CeloNova BioSciences
CeloNova BioSciences said today that it inked a 4-year financing deal with Congruent Investment Partners and SWK Holdings Corp. The funds are slated to support CeloNova’s ongoing clinical trials and product initiatives, including the launch of its Cobra PzF NanoCoated coronary stent. The device, which won FDA approval this year, is designed to treat patients […]
MannKind combines inhaled insulin with One Drop’s digital diabetes tech
MannKind Corp. (NSDQ:MNKD) and One Drop said today that the group launched its A-One trial evaluating MannKind’s inhaled insulin, Afrezza, for use with One Drop’s digital diabetes management platform. The companies reported that they are enrolling people with Type II diabetes and randomizing them in two treatment arms. One group of patients will use Afrezza with […]
Study: Injectable antiretroviral therapy proves as effective as oral treatment
Injectable antiretroviral therapy may be as effective as standard oral treatment in patients with HIV, according to the results of a Phase II clinical trial. The 286-patient study, published in The Lancet, compared a nanoparticle therapy that was injected intramuscularly every four or eight weeks with standard maintenance therapy. “This is the first time that all-injectable […]
ViaCyte launches cell replacement trial for Type I diabetes
Regenerative medicine company ViaCyte said today that the first patients have been implanted in a trial of its islet cell replacement therapy, PEC-Direct. San Diego-based ViaCyte is developing the cell therapy as a functional cure for patients with Type I diabetes who are at risk of suffering acute life-threatening complications. The company’s open-label clinical trial […]
Mallinckrodt enrolls first infant in registry for inhaled nitric oxide gas
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that it included the first patient in its Phase IV registry evaluating the use of inhaled Inomax nitric oxide gas for premature neonates compared to term and near-term newborns. Inomax, which has FDA approval, is designed to boost oxygenation and lessen the need for extracorporeal membrane oxygenation in term and near-term […]
AcelRx’s pain relief drug-device combo succeeds in late-stage trial
AcelRx Pharmaceuticals (NSDQ:ACRX) touted device functionality outcomes today from the Phase III trial of its Zalviso drug-device combination product. Zalviso is designed to deliver a sublingual formulation of an opioid, sufentanil, to adult patients with moderate-to-severe pain in a hospital setting using a hand-held, pre-programmed system. The device allows patients to self-administer sufentanil as often as […]
Injectable, extended-release bipolar drug wins FDA nod
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 […]