Theratechnologies (TSE:TH) said today that the FDA granted priority review to the biologics license application for ibalizumab as a treatment for multi-drug resistant HIV-1. If the monoclonal antibody is approved, it will be the first antiretroviral treatment with a new mechanism of action to be introduced in a decade. It would also be the only […]
Food & Drug Administration (FDA)
SteadyMed seeks FDA nod for Trevyent drug-device combo
SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy. The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. “The submission of our NDA for Trevyent is the latest in a series of significant […]
Sunovion seeks FDA nod for COPD treatment – again
Sunovion Pharmaceuticals said today that the FDA accepted the revised new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The submission follows a complete response letter that the FDA issued Sunovion in May. The Marlborough, Mass.-based company didn’t provide details as to why the FDA denied its initial application. The U.S. regulatory watchdog is […]
FDA user fee reauthorization advances without $1B fee increase
By Stewart Eisenhart, Emergo Group The US Senate’s version of a bill reauthorizing Food and Drug Administration user fees over the next several years diverges markedly from President Trump’s budget proposal to increase user fees by $1 billion in 2018 alone. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Insulin assay from Ortho Clinical Diagnostics nabs FDA nod
Ortho Clinical Diagnostics said yesterday that its Vitros insulin assay and calibrators won 510(k) clearance from the FDA. The Raritan, N.J.-based company reported that the diabetes and pre-diabetes diagnostic test is slated to be commercially available in the 3rd quarter of this year. The Vitros insulin assay is part of Ortho’s diagnostic platform for diabetes, […]
Icon Bioscience touts FDA NDA submission for Dexycu
Icon Bioscience said today that the FDA accepted the company’s submitted new drug application for its Dexycu drug designed to be used as an anti-inflammatory following cataract surgery. The Newark, Calif.-based company’s Dexycu utilizes the company’s Verisome novel drug delivery system designed to treat ophthalmic diseases and slowly release the drug while the Verisome system […]
Medtech stories we missed this week: June 23, 2017
From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for […]
FDA approves diagnostic that simultaneously screens for multiple cancer biomarkers
The FDA said today that it awarded premarket approval to Thermo Fisher Scientific‘s (NYSE:TMO) next-gen sequencing-based test that can simultaneously screen tumor samples for biomarkers associated with 3 approved therapies for non-small cell lung cancer. The company’s Oncomine Dx Target Test evaluates 23 genes associated with non-small cell lung cancer. The tests results could help […]
Insulin management software wins FDA nod
Insulin Algorithms said today that its decision-support software, designed to help clinicians manage insulin for patients with diabetes, won FDA clearance. The company’s software allows clinicians to analyze a patient’s blood sugar measurements regularly and develop an optimized plan for the patient’s insulin regimen. The software was developed with algorithms that are clinically proven to lower […]
FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label. The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk […]