Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two years and older. The U.S. agency approved the intravenous formulation of Actemra for the same indication in 2011. Systemic juvenile idiopathic arthritis affects roughly 30,000 children in the U.S., according […]
Medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound systems. […]
Anika tops sales, EPS estimates with Q2 results
Anika Therapeutics (NSDQ:ANIK) reported its second-quarter financial results today, topping sales and earnings estimates on Wall Street. The Bedford, Mass.-based company posted profits of $10 million, or 69¢ per share, on sales of $30.5 million for the 3 months ended June 30, for bottom-line loss of -11% on sales loss of -9% compared with the same […]
Medtech stories we missed this week: July 13, 2018
From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump […]
Anika swings to a loss in Q1
Shares in Anika Therapeutics (NSDQ:ANIK) fell in premarket activity today after the company missed expectations on Wall Street with its first-quarter results. The Bedford, Mass.-based company swung to a net loss of -$6.7 million, or -46¢ per share, on sales of $21.3 million for the 3 months ended March 31, down -9.1% compared with the same […]
Medtech stories we missed this week: April 27, 2018
From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed to […]
Flexion touts interim data from Ph3 trial of osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) this week touted updated, interim results from an ongoing Phase IIIb study evaluating the safety and tolerability of repeat administration of its osteoarthritis injection, Zilretta. The company’s injectable suspension is an extended-release formulation of triamcinolone acetonide designed for patients with osteoarthritis of the knee. Top-line results from Flexion’s trial showed that 95% of […]
Medtech stories we missed this week: March 16, 2018
From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]
MiMedx wins FDA regenerative med status for AmnioFix
MiMedx (NSDQ:MDXG) won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week. The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee. “The FDA’s RMAT designation for AmnioFix Injectable is […]
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 […]
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