Amgen (NSDQ:AMGN) said today that the European Commission granted a change to the marketing authorization of its Repatha device, approving a single-dose delivery option. The pre-filled cartridge mini-doser is a hands-free device that is designed to provide 420 mg of Repatha (evolocumab) in a single injection for patients with cardiovascular disease. The company touted its […]
Regulatory/Compliance
BrainStorm seeks early Health Canada nod for NurOwn treatment
Brainstorm Cell Therapeutics (NSDQ:BCLI) is reportedly seeking early regulatory approval in Canada for its NurOwn stem cell treatment for patients with ALS. The company told Reuters this week that it has inked an agreement with a Canadian non-profit organization, CCRM, that helps to support the development of regenerative medicine. The organization plans to help BrainStorm meet Canadian regulatory requirements […]
Alimera, Knight seek Canadian regulatory nod for Iluvien intravitreal implant
Alimera Sciences (NSDQ:ALIM) and Knight Therapeutics (TSE:GUD) said today that Health Canada accepted the companies’ New Drug Application for its intravitreal implant, Iluvien. The FDA approved Atlanta-based Alimera’s sustained release intravitreal implant in 2014 to treat diabetic macular edema in patients who have been previously treated with corticosteroids and did not have a clinically significant rise in […]
FDA accepts Ocular’s NDA resubmission for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval […]
Adapt Pharma seeks regulatory nod for naloxone nasal spray in Europe
Adapt Pharma said today that it filed a European Marketing Application for its naloxone hydrochloride nasal spray for the treatment of opioid overdose. The Dublin-based company’s product is a ready-to-use, needle-free device that delivers a single dose of naloxone in an 0.1 mL nasal spray and does not require assembly prior to use, according to […]
CareFusion expands Alaris warning
The U.K.’s Medicines & Healthcare Products Regulatory Agency issued an 2nd warning for CareFusion‘s Alaris drug pump after the company discovered that the Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication. The UK watchdog 1st warned customers in December last year that the pump could release a dose […]
Chinese regulators modify IVD classification requirements
By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have issued a new order affecting how in vitro diagnostic (IVD) devices are classified according to risk levels. 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 […]
Mexico proposes changes to medical device regulations in 2018
By Stewart Eisenhart, Emergo Group Mexican regulators are in the early stages of revising various elements of the country’s sanitary registration process for medical devices, including classification, biocompatibility and technovigilance. 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 […]
Marathon hikes MD drug price 70x to $89k a year
After winning FDA approval for its muscular dystrophy drug last week, Marathon Pharmaceuticals set the drug’s list price at $89,000 a year – 50 to 70 times greater than what most U.S. patients have paid for decades by importing the drug from Europe. Marathon’s drug is a corticosteroid, deflazacort, that has been shown to improve muscular […]
New Indian medical device regulations for 2017
By Stewart Eisenhart, Emergo Group The Indian government is planning a significant overhaul of its system for regulating medical devices and IVDs. Emergo is still analyzing the new Medical Device Rules 2017 to determine how the new regulations will affect registration requirements in India, but we can now report on some general points found in […]
