Intarcia Therapeutics said today that it submitted a New Drug Application to the FDA for its injection-free ITCA 650 candidate, the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The ITCA 650 enables subcutaneous delivery of exenatide using a match-sized osmotic pump placed under the skin in an in-office procedure. With […]
Injectable opioid dependence treatment succeeds in clinical trial
Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals said this week that a late-stage trial of its injectable opioid dependence treatment was successful. CMAX shares surged 16% at the beginning of the week following the announcement. The injectable buprenorphine therapy could be another treatment used to combat the growing opioid epidemic in the United States, which claimed the lives […]
Akesys, Elixir Medical tout 1st implant for Prava bioresorbable peripheral stent
Akesys Medical and Elixir Medical Corporation said today that it implanted its 1st Prava sirolimus eluting bioresorbable peripheral scaffold for the treatment of blockages in the superficial femoral artery. The scaffold was developed to keep the large artery in the thigh open and restore blood flow to the leg and resorb into the body, making […]
FDA awards product development grants for rare diseases
The FDA said yesterday that it awarded 21 clinical trial research grants totaling more than $23 million over the next 4 years to stimulate product development for patients with rare diseases. The Orphan Products Clinical Trials Grants Program has awarded more than $370 million to fund more than 590 clinical studies since its creation in […]
Intersect ENT’s Resolve sinus implant meets endpoints in pivotal trial
Intersect ENT (NSDQ:XENT) said today that its Resolve sinus implant met both primary endpoints in the Resolve II pivotal trial. The Menlo Park, Calif.-based company’s Resolve steroid-releasing sinus implant is a minimally invasive treatment for patients with recurrent ethmoid sinus obstruction. The 300-patient Resolve II trial compared the bilateral Resolve implant with a sham procedure. The study evaluated the change […]
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