By Stewart Eisenhart, Emergo Group The South African government has formed a new agency to oversee new medical device and pharmaceutical regulatory systems being developed in the country. 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 […]
Regulatory/Compliance
Lilly wins FDA nod for Humalog pre-filled Junior KwikPen device
Eli Lilly (NYSE:LLY) said today that the FDA approved its Humalog Junior KwikPen for the treatment of diabetes. The device is a pre-filled pen with half-unit dosing capabilities, which Eli Lilly said gives patients access to finer dose adjustment. “We are pleased to be able to meet the needs of people who prefer a prefilled […]
Cleveland Clinic spinout Infuseon wins FDA nod for CNS drug delivery device
Cleveland Clinic spinout Infuseon Therapeutics said today that its novel central nervous system delivery device won 510(k) clearance from the FDA as a therapeutic delivery device. The company’s Cleveland Multiport Catheter, which won FDA clearance in March, was designed to effectively deliver therapeutics to the brain. Usually, the blood brain barrier prevents drugs delivered in […]
Braeburn, Knight seek Health Canada nod for opioid dependence implant
Braeburn Pharmaceuticals and Knight Therapeutics (TSE:GUD) said today that Health Canada has agreed to review Knight’s new drug submission for Probuphine, a buprenorphine subdermal implant designed to treat opioid drug dependence. In February last year, Braeburn and Knight inked an exclusive distribution and sublicense deal, giving Knight the exclusive right to distribute Probuphine in Canada. Braeburn’s […]
Milestone Scientific wins 510(k) clearance for epidural anesthesia system
Milestone Scientific (NYSE:MLSS) said today that its CompuFlo epidural computer-controlled anesthesia system won 510(k) clearance from the FDA. The Livingston, N.J.-based company’s CompuFlo Epidural instrument uses dynamic pressure sensing to help anesthesiologists correctly identify the epidural space and significantly reduce complications in real-time, according to Milestone. Shares in the company jumped up 18% today, trading […]
Germany to apply to host European drug agency after Brexit
Germany plans to apply to host the London-based European Medicines Agency and the European Banking Authority after Britain leaves the European Union, Reuters reported. “Germany is throwing its hat into the ring for both agencies – with Bonn for the European Medicines Agency EMA and with Frankfurt for the European Banking Authority EBA,” government spokesman Steffen Seibert […]
Medtech stories we missed this week: June 9, 2017
From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal with […]
Johnson & Johnson wins last regulatory nod needed for Actelion acquisition
Johnson & Johnson (NYSE:JNJ) said today that the European Commission approved its acquisition of Swiss biotech Actelion. The regulatory nod was the last approval needed to complete the company’s transaction. The U.S. healthcare giant added that it expects the settlement of the $30 billion all-cash tender offer on June 16. The EU commission set conditions […]
OncoSec wins orphan drug status for melanoma therapy
OncoSec Medical (NSDQ:ONCS) said today that its DNA-based intratumoral cancer immunotherapy, pIL-12, won orphan drug designation from the FDA for the treatment of unresectable metastatic melanoma. The drug, tavokinogene telsaplasmid, is the biologic agent delivered using OncoSec’s ImmunoPulse IL-12 electroporation device. The company’s device delivers a sequence of short-duration electrical pulses to increase the cancer […]
FDA asks Endo to pull Opana from the market over concerns of abuse
The FDA asked Endo Pharmaceuticals (NSDQ:ENDP) to pull its opioid pain med, Opana ER, from the market, saying that the benefits of the abuse-deterrent drug no longer outweigh the risks. The move marks the 1st time the federal regulatory watchdog has urged a company to remove an opioid painkiller due to concerns of abuse. “We are facing […]
