Drug Delivery Business

Regulatory/Compliance

FDA changes medical device clinical trial IRB requirements

By

By Stewart Eisenhart, Emergo Group Medical device companies conducting certain types of clinical trials may now rely on central rather than local Institutional Review Boards (IRB) for reviews required by the US Food and Drug Administration. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]

Diabetes double play: Medtronic launches MiniMed 670G, Dexcom wins FDA nod for Android G5 app

By

Medtronic (NYSE:MDT) and Dexcom (NSDQ:DXCM) today announced respective wins for their diabetes care tech, with Medtronic launching its hybrid closed loop MiniMed 670G in the US and Dexcom winning an FDA nod for a Google (NSDQ:GOOG) Android G5 Mobile application. Fridley, Minn.-based Medtronic’s MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients […]

FDA extends UDI deadline for Class I devices

By

By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have extended Unique Device Identification (UDI) labeling and related compliance deadlines for lower-risk devices to late 2022 in order to fully standardize and optimize UDI data already collected on high-risk devices. Get the full story here at the Emergo Group’s blog. The […]

AntriaBio seeks FDA nod for trial of once-weekly insulin

By

AntriaBio (OTC:ANTB) said today that it filed an investigational new drug application with the FDA for its once-weekly basal insulin. If the Louisville, Colo.-based company wins approval from the FDA, it plans to launch a Phase I clinical trial of AB101 in patients with Type I diabetes. The first-in-human study is slated to evaluate the […]

Australian regulators seek faster market access for device approvals overseas

By

By Stewart Eisenhart, Emergo Group Australia’s Therapeutic Goods Administration (TGA) has proposed allowing commercialization of medical devices that have already obtained approval from regulators in other markets without undergoing full premarket review. 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 […]

Medtech stories we missed this week: June 2, 2017

By

From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Dextera seeks expanded indications for MicroCutter 5/80 stapler Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The […]

Chiltern acquires Integrated Development Associates

By

Contract research organization Chiltern announced today that it is expanding its Japanese and Asian presence through its purchase of Integrated Development Associates. Financial terms of the deal were not disclosed. IDA has staff in Japan, Korea and Southeast Asia – and offers opportunities to integrate the region into global drug development, according to Chiltern. IDA’s expertise includes […]

Bayer wins FDA nod for connected MS auto-injector

By

Bayer (ETR:BAYN) said yesterday that the FDA approved a supplemental biologics license application for the BetaConnect Navigator and myBetaApp – software for its electronic BetaConnect auto-injector. The company’s BetaConnect auto-injector administers Betaseron for patients with relapsing-remitting multiple sclerosis. The newly-approved software allows patients to connect their device with the myBetaApp on their mobile device or computer […]

Medtech stories we missed this week: May 26, 2017

By

From Merck’s new licensing agreement to surgical study data being touted, here are medtech stories we missed this week but thought were still worth mentioning. 1. Merck inks exclusive licensing agreement for Alzheimer’s antibody Merck announced in a May 25 press release that it has entered an exclusive worldwide license agreement with Teijin Pharma. The […]