Reva Medical (ASX:RVA) has won CE Mark clearance for its thin strut Fantom Encore bioresorbable, drug-eluting scaffold. The sirolimus-eluting vascular scaffold, which is made from Reva’s Tyrocore polymer, features a 95-micron strut profile and x-ray visibility. “Fantom Encore has the thinnest strut profile of any available bioresorbable scaffold in the 2.5 millimeter diameter size. A thinner […]
Pharmaceuticals
Medtronic wins sensor nod from FDA for MiniMed 670G auto insulin tech
The FDA has cleared Medtronic‘s (NYSE:MDT) Guardian sensor, part of the medtech titan’s MiniMed 670G automated insulin delivery system, to be worn on the upper arm. The device is Medtronic’s newest and most accurate continuous glucose monitor, the company touted, and is the only sensor approved by the FDA for use with a hybrid-closed loop […]
KemPharm wins FDA nod for short-term pain prodrug
Shares in KemPharm (NSDQ:KMPH) soared today after the company said that the FDA approved a re-submitted application for its pain-relief prodrug, Apadaz. The product, which combines benzhydrocodone and acetaminophen, is indicated for the short-term management of acute pain. The FDA rejected KemPharm’s first attempt at regulatory approval for Apadaz in 2016. Today’s win for KemPharm is […]
Novo Nordisk touts promising results from late-stage trial of oral diabetes med
Setting the stage for a battle with rival Eli Lilly (NYSE:LLY), Novo Nordisk (NYSE:NVO) reported data this week from a late-stage trial of its oral formulation of semaglutide, a medication for people with Type II diabetes. The GLP-1 agonist is traditionally administered via injection. Both insulin-makers have approved versions of the injectable semaglutide, but Novo Nordisk is […]
Needle-free flu vaccine will be back in clinics next flu season
MedImmune‘s FluMist, the only needle-free flu vaccine available in the U.S., has regained the support of an expert panel at the Centers for Disease Control & Prevention. The Advisory Committee on Immunization Practices has voted to recommend the nasal spray’s use, reversing a two-year-old decision to keep the product out of clinics due to efficacy […]
Valeritas inks distribution deal in Italy for V-Go insulin delivery device
Valeritas (NSDQ:VLRX) has inked an exclusive distribution deal with Movi SpA for the commercialization of its V-Go wearable insulin delivery device in Italy. According to the terms of the deal, Movi will market and sell the V-Go device to diabetes clinics and patients in Italy, while Valeritas will remain responsible for the product’s development, regulatory approval […]
Anika posts mixed Q4, FY17 results
Shares in Anika Therapeutics (NSDQ:ANIK) rose today after the company topped earnings expectations on Wall Street with its fourth quarter and full-year financial results, but missed sales estimates. The Bedford, Mass.-based company posted profits of $8.1 million, or 55¢ per share, on sales of $29.3 million for the 3 months ended Dec. 31, for bottom-line loss […]
Insulet beats the Street with Q4, FY17 sales
Insulet (NSDQ:PODD) reported yesterday that the insulin delivery device-maker topped sales expectations on Wall Street for its fourth quarter and full-year financial results, but missed earnings estimates. The Billerica, Mass.-based company reeled in losses, posting -$6.9 million on sales of $130.5 million for the 3 months ended Dec. 31, for sales growth of 26% compared with […]
Novocure misses Q4 EPS by a penny, tops sales estimates
Shares in Novocure (NSDQ:NVCR) rose slightly today in premarket activity after the medical device maker met sales expectations, but missed earnings estimates on Wall Street with its fourth quarter and full-year financial results. The St. Helier, N.J.-based company reeled in losses this quarter, posting -$10.9 million on sales of $53.7 million for the 3 months ended […]
Express Scripts to include Novo Nordisk’s once-weekly diabetes drug on 2018 formulary
Express Scripts, one of the nation’s largest pharmacy benefit managers, reportedly plans to include Novo Nordisk‘s (NYSE:NVO) once-weekly Type II diabetes, Ozempic, on its 2018 formulary. The move puts Ozempic directly in competition with Eli Lilly‘s (NYSE:LLY) once-weekly Trulicity drug. Both products will also go up against AstraZeneca‘s (NYSE:AZN) once-weekly Bydureon medication. All three drugs […]