The ongoing opioid crisis in the U.S. is harrowing – 91 Americans die every day from an opioid overdose, according to the Centers for Disease Control & Prevention. Companies are searching for innovative ways to deliver opioid maintenance treatment to patients that are hoping to get clean. Buprenorphine is a compound used for medication-assisted treatment, traditionally administered […]
Food & Drug Administration (FDA)
Chinese FDA updates recall process for medical devices
By Stewart Eisenhart, Emergo Group Medical device regulators at the China Food and Drug Administration (CFDA) have issued a new provision on its recall process for defective devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
Medtech stories we missed: Feb. 10, 2017
From Glytec partnering to beat diabetes to Biolase, Gramercy Extremity Orthopedics and more getting FDA clearances, here are 7 recent medtech stories we missed this week, but were still worth mentioning. 1. BioTime proposes public offering of common stock Clinical-stage biotechnology company BioTech is intending to offer common stock shares in an underwritten public offering. BioTime focuses […]
Eli Lilly wins label expansion for Trulicity injection with basal insulin
Eli Lilly (NYSE:LLY) said today that the FDA approved label changes for its once-weekly Trulicity injection. The new label was updated to include use in combination with basal insulin for adults with Type 2 diabetes. The label update was based on results from a phase IIIb randomized clinical trial, Lilly said, which evaluated Trulicity as an […]
Sens. Sanders, Cruz talk drug pricing, Obamacare in town hall debate
Sens. Bernie Sanders (I-Vermont) and Ted Cruz (R-Texas) met last night to debate the future of Obamacare in a town-hall debate. The 2 senators are opposed on how to provide health care coverage to Americans, but found common ground on drug pricing and pharmaceutical importation. Sanders and Cruz agreed that people should be able to […]
FDA accepts Flexion’s NDA for osteoarthritis steroid injection
Flexion Therapeutics (NSDQ:FLXN) said today that the FDA accepted its New Drug Application for Zilretta – its extended-release steroid injection. The Burlington, Mass.-based company won Fast Track status from the watchdog for its osteoarthritis injection in 2015. Flexion touts Zilretta as the 1st intra-articular, extended-release therapy for patients with knee osteoarthritis pain. The injection uses microsophere technology […]
Aura Biosciences wins FDA nod for light-activated ocular melanoma treatment
Aura Biosciences said today that the FDA approved its Investigational New Drug Application for the company’s light-activated viral nanoparticle conjugates for the treatment of ocular melanoma. The federal watchdog’s approval allows Cambridge, Mass.-based Aura to move forward with initial clinical tests of AU-011. The Phase Ib open-label clinical trial, which is currently enrolling, is designed to […]
FDA accepts Intarcia’s NDA for diabetes drug-device combo
Intarcia Therapeutics said today that the FDA accepted its New Drug Application for the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The Medici drug-device combo delivers exenatide subcutaneously using a match-sized osmotic pump placed under the skin in an in-office procedure. The subcutaneous delivery system uses technology to stabilize proteins, peptides, antibody fragments […]
Medtech stories we missed: Feb. 3, 2017
From disappointing Getinge earnings to a $2.25 billion U.S. Defense Department contract for Cardinal Health to a host of 510(k) clearances, here are seven recent medtech stories that are still worth a mention. 1. Getinge disappoints on earnings—again Getinge stock took a nearly 10% tumble last week after releasing earnings that Reuters says lagged analyst […]
FDA offers Pre-RFD program for combination products
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has issued new draft guidance clarifying the agency’s Pre-Request for Designation (Pre-RFD) process whereby combination product manufacturers may request initial feedback regarding classification and regulatory oversight questions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
