Medherant said today that it successfully finished two Phase I studies with its ibuprofen transdermal drug-delivery patch. According to the UK-based company, the Tepi patch was well tolerated by the participants of a skin irritation study. The company also touted results from a second study, which compared blood concentrations of ibuprofen following repeated application of […]
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Clearside Biomedical’s combo therapy fails in Ph3 retinal vein occlusion trial
Clearside Biomedical (NSDQ:CLSD) said today that its lead drug, in combination with Regeneron‘s (NSDQ:REGN) Eylea, failed in a phase III retinal vein occlusion trial. The trial’s primary endpoint was the proportion of patients in the combination treatment arm, compared to the group receiving just intravitreal Eylea, that experienced improvements in best corrected visual acuity after eight weeks. […]
FDA to develop new framework for opioid analgesics following AcelRx approval
The FDA last week approved AcelRx‘s (NSDQ:ACRX) Dsuvia sufentanil product, noting that use of the opioid will be tightly restricted to adults experiencing acute pain in medically-supervised healthcare settings. Dsuvia is a tablet that is administered sublingually in a single-dose, pre-filled applicator. The company expects to launch its pain product in the first quarter of […]
Aquestive wins FDA nod for seizure oral film
Shares in Aquestive Therapeutics (NSDQ:AQST) rose today after the company announced FDA approval for its Sympazan oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. The clobazam oral film is the first product of its kind to be approved by the FDA as a treatment for seizures associated with LGS, according to […]
FDA issues Class I recall for Roche Diagnostics’ warfarin test strips
The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices. Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The […]
Janssen touts topline data for long-acting, injectable HIV therapy
Johnson & Johnson‘s (NYSE:JNJ) Janssen touted topline results this week from a Phase III trial of its long-acting, injectable two-drug regimen for the treatment of HIV. The study found that long-acting, once-monthly rilpivirine and cabotegravir had comparable efficacy to GlaxoSmithKline‘s (NYSE:GSK) oral Triumeq product. Janssen and ViiV Healthcare also reported that virologic response and drug resistance […]
New diabetes software from Klue features mealtime insulin reminders
Digital health company Klue announced this week that its latest AI-driven software is a module designed for people with Type I diabetes. The technology features autonomous meal detection capabilities and provides mealtime medication reminders to users, according to the San Francisco, Calif.-based company. The module, which works with hardware like the Apple Watch, also provides […]
Tandem Diabetes Q3 sales top The Street
Tandem Diabetes Care (NSDQ:TNDM) today posted third quarter earnings and lifted its sales guidance for the year, beating Wall Street expectations for the quarter in sales but falling behind on losses per share. The San Diego-based company posted losses of $34.2 million, or 62¢ per share, on sales of $46.3 million for the three months ended […]
Insulet Q3 beats The Street
Insulet (NSDQ:PODD) today posted third quarter earnings that beat expectations on Wall Street and lifted its guidance for the remaining year. The Billerica, Mass.-based company posted profits of $1.7 million, or 3¢ per share, on sales of $151.1 million for the three months ended September 30, seeing a 174.5% swing into the black while sales grew 24.1% […]
Abbott wins FDA nod for FreeStyle Libre’s mobile app
Abbott (NYSE:ABT) said today that it won FDA approval for a mobile app that is designed for the company’s FreeStyle Libre continuous glucose monitoring system. The FreeStyle LibreLink app allows users to capture and view their glucose data in real-time using their mobile phones. Prior to the mobile app, people using Abbott’s FreeStyle Libre CGM had […]