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. Get the full story at our sister site, Drug Delivery Business News.
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 said today it successfully persuaded Anthem to cover artificial pancreas systems, after meeting the health insurer as part of is Coverage2Control campaign. America’s 25 largest health insurers now cover Medtronic‘s (NYSE:MDT) MiniMed system, according to the organization. Get the full story at our sister site, Drug Delivery Business News.
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 year. […]
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. […]
Merit Medical (NSDQ:MMSI) said today that it agreed to pay $100 million for soft tissue biopsy assets Becton Dickinson (NYSE:BDX) and C.R. Bard (NYSE:BCR) need to sell to consummate their $24 billion merger. The deal covers BD’s Achieve and Temno biopsy systems and Tru-Cut biopsy needles, plus Bard’s Aspira pleural effusion drainage and peritoneal drainage systems, South Jordan, Utah-based Merit said. “We […]
Shares in Pavmed Inc. (NSDQ:PAVM) rose today after the medical device maker beat expectations on Wall Street with its third quarter results. The N.Y.-based company posted a net loss of -$5.37 million, or -40¢ per share, for the 3 months ended Sept. 30, for bottom-line loss of -178.5% compared with the same period last year. Get the […]
Bigfoot Biomedical CEO Jeffrey Brewer has spoken out about a recent data-sharing decision made by CMS, saying that he plans to lobby Medicare to reverse its latest move. Earlier this year, CMS said it would begin covering the use of particular continuous glucose monitors for people with diabetes. But since that decision, the agency has said that […]
BioCorRx (OTC:BICX) said today that it inked a confidentiality agreement with the National Institute on Drug Abuse, which will allow the group to share information and potentially work together on R&D and commercialization of BioCorRx’s therapies for opioid use disorder. The National Institutes of Health division has also agreed to participate as an observer at the […]
Xeltis said today that it closed a Series C round worth more than $53 million (€45 million) for the bioresorbable heart valve technology it’s developing. The Eindhoven, Holland- and Zurich-based company said the round was led by “a global strategic investor,” joined by Ysios Capital, “a number of large private investors,” prior backers LSP, Kurma Partners […]
EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the […]