By Stewart Eisenhart, Emergo Group India’s Ministry of Health and Family Welfare has released long-awaited new medical device and in vitro diagnostic (IVD) regulations that take effect in January 2018. 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 […]
Regulatory/Compliance
Teva wins FDA nod for inhaled asthma medications
Teva Pharmaceuticals (NYSE:TEVA) said today that the FDA approved 2 inhaled asthma medications to be delivered using the company’s RespiClick breath-activated, multi-dose dry powder inhaler. The products, AirDuo RespiClick and ArmonAir RespiClick, are indicated for use in asthma patients as young as 12 years old. The Jerusalem-based company’s AirDuo RespiClick is a fixed dose combination of […]
FDA OKs Medtronic trial for In.Pact Admiral DCB in renal disease
Medtronic (NYSE:MDT) said today that the FDA approved its investigational device exemption application for a study to evaluate its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The Fridley, Minn.-based company said that its study will compare its DCB to plain balloon angioplasty as a treatment for failing arteriovenous fistulas. The primary efficacy endpoint […]
FDA approves 2mg Narcan nasal spray for opioid overdose treatment
Adapt Pharma said today that the FDA approved the 2mg formulation of its Narcan nasal spray for the emergency treatment of opioid overdose. The 2mg dose is intended for opioid-dependent patients that are at risk for severe withdrawal, but are not at a high risk for continued opioid exposure. The approval comes 1 year after […]
Vectura wins IND for drug-device combo for pediatric asthma
Vectura said yesterday that the FDA approved an Investigational New Device application for its drug-device combination to treat asthma in children 12 months to 8 years old. The UK-based company’s device, VR647, uses the Akita Jet nebulizer for the delivery of nebulized budesonide. Vectura’s drug-device combination product provides faster delivery time and better lung deposition of budesonide, […]
Medical device industry laws in the wake of “Hard Brexit”
By Ronald Boumans, Emergo Group In 2016, we discussed the possible options for what a Brexit could look like and what the British prime minister meant with “Brexit means Brexit.” The official date of announcing formally that the United Kingdom wants to leave the European Union is fast approaching. Get the full story here at […]
Ocular Therapeutix resubmits NDA for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. 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 for the […]
Sanofi’s Suliqua combination therapy approved in European Union
Sanofi (NYSE:SNY) said today that the European Commission granted marketing authorization in Europe for its Suliqua combination product for adults with type II diabetes. The therapy is a fixed-ratio combination of basal insulin glargine and lixisenatide, intended to be used with metformin to improve patients’ glycemic control. Suliqua will be available in 2 pre-filled SoloSTAR pens at […]
Pulmatrix shares soar after winning FDA designation
Pulmatrix (NSDQ:PULM) shares were up 159% to $1.79 apiece in mid-afternoon trading today after the company announced that its drug candidate for treating fungal infections in the lungs of cystic fibrosis patients was designated as a ‘qualified infectious disease product’ by the FDA. With the designation, the Lexington, Mass.-based company will receive 5 years of […]
South Korean medical device regulatory changes updates
By Stewart Eisenhart, Emergo Group Enforcement dates for various new and updated medical device regulations in South Korea have now gone into effect, according to Emergo consultants in Seoul. 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 […]
