The FDA has approved Kaleo‘s Auvi-Q epinephrine auto-injector designed to treat life-threatening allergic reactions in infants and small children, according to the privately-held biopharma company. The device, which Kaleo touts as the first of its kind, was given priority review by the FDA. The 0.1 mg Auvi-Q auto-injector has a shorter needle and a lower […]
Pharmaceuticals
After FDA nod, Flexion launches osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) today launched its Zilretta therapy designed to help patients manage pain associated with osteoarthritis of the knee. The Burlington, Mass.-based company’s extended-release intra-articular injection combines a commonly administered, short-acting corticosteroid with a polylactic-co-glycolic acid matrix using Flexion’s microsphere technology. The FDA approved Zilretta last month after granting it fast track status in 2015. […]
Amgen launches Enbrel Mini single-dose cartridges with reusable auto-injector
Amgen (NSDQ:AMGN) announced today the U.S. launch of its Enbrel Mini single-dose prefilled cartridges, which are delivered using a reusable AutoTouch auto-injector. The drug-device combination was designed with a needle that stays hidden during injection and a sensor to detect placement on the skin. Amgen’s latest product uses a new drug formulation of Enbrel, an injectable […]
Here’s what the FDA is doing about IV fluid shortages following hurricanes Maria, Irma
Nine weeks after hurricanes Maria and Irma brought devastation to Puerto Rico, FDA commissioner Dr. Scott Gottlieb says hospitals across the U.S. are reporting shortages of IV fluids – medical products that are often sourced from Puerto Rico. Hospitals are specifically noting that 0.9% injection bags of saline, used to inject drugs intravenously, are of […]
JDRF touts win after Anthem decides to cover artificial pancreas systems
JDRF said today it successfully persuaded Anthem to cover artificial pancreas systems, after meeting the health insurer as part of its Coverage2Control campaign. America’s 25 largest health insurers now cover Medtronic‘s (NYSE:MDT) MiniMed system, according to the organization. “This is a great victory for the T1D community. By taking this tremendous step, Anthem is giving […]
iVeena finishes pilot trial of sustained-release implant
iVeena Delivery Systems said earlier this month that it finished a pilot trial for its IVMED-10 bioerodible implant designed to treat pain and inflammation after cataract surgery. Placed during cataract surgery, the sustained-release implant delivers dexamethasone for two weeks from the lens capsule. The company’s Phase I/IIa trial enrolled eight patients and found that IVMED-10 […]
Researchers reverse diabetes in mice by infusing them with blood stem cells
Researchers at Boston Children’s Hospital successfully reversed Type I diabetes in a mouse model using blood stem cells, according to a study published this week in Science Translational Medicine. The researchers used cells that were pre-treated to make more of a protein, PD-L1, which is deficient in mice and people with Type I diabetes. “There’s really […]
Shares in Delcath fall after losses grow in Q3
Shares in Delcath Systems (NSDQ:DCTHD) crashed today after the company posted its third quarter results, revealing that the company’s net losses have grown dramatically quarter-over-quarter. The N.Y.-based company posted a net loss of -$12.6 million on sales of $684,000 for the 3 months ended Sept. 30, for sales growth of 57% compared with the same period last […]
Insulia wins FDA nod, CE Mark clearance to titrate Tresiba, Basaglar insulin
Voluntis said today that its digital management system for people with Type II diabetes, Insulia, won FDA clearance and CE Mark approval to integrate basal insulin brands Tresiba and Basaglar. The company’s software already works with Lantus, Toujeo and Levemir. The Insulia digital companion is composed of a patient mobile app and healthcare worker web portal. […]
Propeller Health, Express Scripts ink smart inhaler sensor deal
Propeller Health said today it inked a strategic partnership deal with Express Scripts (NSDQ:ESRX) to provide Propeller’s digital solutions to Express Script members. Through the deal, St. Louis-based Express Script members will be able to use inhaler sensors and connected mobile applications to manage their asthma or chronic obstructive pulmonary disease. The companies touted it as the largest […]