Avita Medical (ASX:AVH) said today that it submitted its pre-market approval application to the FDA for its ReCell autologous cell harvesting device. The company’s system is designed to reduce the amount of skin harvesting needed to treat burn injuries compared to conventional treatments. The PMA application is supported by clinical data from two trials. The […]
Clinical Trials
Bellerophon nabs $23m in private placement
Bellerophon Therapeutics (NSDQ:BLPH) said today that it inked a deal with new and existing investors to raise $23.4 million in a private placement of common stocks and warrants. The financing was led by Puissance Capital Management and Venrock Healthcare Capital Partners, supported by existing investors like New Mountain Capital and Linde North America, the Warren, N.J.-based […]
Engage Therapeutics raises $23m Series A for drug-device seizure therapy
Summit, N.J.-based Engage Therapeutics said today that it closed a $23 million Series A round to fund a Phase IIb trial of its lead product, Staccato alprazolam. The round was led by TPG Biotech, Adage Capital Management and Lumira Capital. The drug-device product combines a hand-held inhaler technology, which is FDA-approved, with alprazolam, an FDA-approved […]
ASTRO ’17 Round-up: Novocure touts five-year results for Optune, chemo combo in newly-diagnosed glioblastoma patients
Novocure (NSDQ:NVCR) touted data today from the Phase III pivotal trial of its Optune device in combination with temozolomide for the treatment of newly-diagnosed glioblastoma. The analyses were presented at the American Society for Radiation Oncology’s 2017 annual meeting in San Diego. The company’s EF-14 trial showed unprecedented five-year survival results in patients with newly-diagnosed GBM, […]
Gelesis touts study of hydrogel obesity drug
PureTech subsidiary Gelesis today touted results from a pivotal weight-loss study of its obesity drug, Gelesis100. The study met one of its two primary endpoints, with 58% of adults in the treatment arm experiencing clinically-meaningful weight loss of 5% or more. Nearly twice as many adults lost 10% or more of the body weight in the […]
Clinical trials system is ‘broken’, FDA’s Woodcock says
The clinical trials system is “broken,” according to the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock. The system needs new clinical trial networks and the adoption of master protocols – protocols for trials that focus on multiple therapies for a single disease or a single treatment that could apply to […]
Nemaura Medical touts interim data from next-gen SugarBeat trials
Nemaura Medical touted interim data today from the European clinical trial program evaluating its wireless, adhesive skin-patch for use as a non-invasive and needle-free glucose monitoring system. The clinical trial program enrolled 75 patients, who continuously wore the 2nd-gen SugarBeat device for up to 14 hours per day over the course of seven days in […]
Graybug Vision launches trial for injectable, depot formulation of wet AMD drug
Graybug Vision said yesterday that it launched the first clinical trial of its lead product, GB-102, in patients with wet age-related macular degeneration. The two-part study is slated to evaluate patients being treated with available intravitreal anti-VEGF agents who are later switched over to just GB-102. The first part of the study will evaluate up […]
MiMedx files IND for Ph2 AmnioFix osteoarthritis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee. The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection. […]
CIRSE 2017 Round-up: Delcath touts second-gen hemofiltration system in percutaneous hepatic perfusion
Delcath Systems (NSDQ:DCTH) touted data today from a study of its second-generation hemofiltration system in patients undergoing percutaneous hepatic perfusion with melphalan hydrochloride. The New York-based company presented the results from its study at the Cardiology and Interventional Radiology of Europe annual meeting in Copenhagen, Denmark. The investigational product, an injectable melphalan hydrochloride for use with […]