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Implants

OCUL registers for $40m stock sale

November 30, 2016 By Sarah Faulkner

Ocular Therapeutix

Ocular Therapeutix (NSDQ:OCUL) is looking to raise $40 million through a public stock offering, according to a prospectus filed with the federal Securities & Exchange Commission this week. The Bedford, Mass.-based company said it inked a controlled equity offering sales agreement with Cantor Fitzgerald & Co., and agreed to pay Cantor Fitzgerald commissions of up to 3% […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Optical/Ophthalmic, Surgical Tagged With: Ocular Therapeutix

Tests to begin for HIV therapy injections, long-acting implants

November 29, 2016 By Sarah Faulkner

Drugs from companies, such as GlaxoSmithKline (NYSE:GSK), Gilead Sciences (NSDQ:GILD) and Merck (NYSE:MRK), are reportedly being considered for large-scale trials evaluating injectable HIV prevention therapies. Eventually, researchers hope to produce matchstick-sized implants that could provide year-long protection to vulnerable populations. Foster City, Calif.-based Gilead has a once-daily pill, Truvada, which prevents HIV infection during sex. Pre-exposure prophylaxis, also known […]

Filed Under: Drug-Device Combinations, Featured, Implants, Preclinical Trials, Research & Development Tagged With: Gilead Sciences, GlaxoSmithKline plc, Merck

Intarcia seeks FDA nod for 1st drug to use Medici drug delivery system

November 21, 2016 By Sarah Faulkner

Intarcia Therapeutics

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants, Pharmaceuticals, Regulatory/Compliance Tagged With: Intarcia Therapeutics

Injectable opioid dependence treatment succeeds in clinical trial

November 15, 2016 By Sarah Faulkner

Camurus, Braeburn Pharmaceuticals

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Pharmaceuticals Tagged With: Braeburn Pharmaceuticals, Camarus AB

Akesys, Elixir Medical tout 1st implant for Prava bioresorbable peripheral stent

October 20, 2016 By Sarah Faulkner

Elixir Medical, Akesys Medical

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Stents Tagged With: Akesys Medical, Elixir Medical Corporation

FDA awards product development grants for rare diseases

October 18, 2016 By Sarah Faulkner

FDA

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Funding Roundup, Implants, Neurological, Oncology, Pediatrics

Intersect ENT’s Resolve sinus implant meets endpoints in pivotal trial

October 17, 2016 By Sarah Faulkner

Intersect ENT

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 […]

Filed Under: Clinical Trials, Featured, Implants, Otolaryngology Ear, Nose & Throat Tagged With: Intersect ENT Inc.

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