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 […]
Regulatory/Compliance
Brazilian regulators drop medical device fees
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulators plan to officially reduce registration and quality inspection fees for medical device companies after the country’s Ministry of Finance attempted to push through a hefty increase of those fees in 2015. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
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 […]
Brazilian regulators add two firms to MDSAP medical device quality inspection program
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has added two more firms to its list of accredited inspectorsfor the Medical Device Single Audit Program (MDSAP). 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 […]
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 […]
New medical device rules from Indian regulators
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 […]
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, […]
