Eyenovia (NSDQ:EYEN) said today that it enrolled the first patient in the first of two Phase III trials of the company’s MicroStat program. The Mist-1 and Mist-2 trials are slated to study the safety and efficacy of the company’s 2.5% phenylephrine, 1% tropicamide eye solution, delivered as a micro-dose using the Optejet device. The company […]
Valeritas touts use of insulin delivery device with physician-driven titration algorithm
Valeritas (NSDQ:VLRX) touted today the publication of a retrospective analysis showing that adults with Type 2 diabetes experienced improved glycemic control using the V-Go wearable insulin delivery device and a physician-driven titration algorithm. The proof-of-concept study was designed to assess the safety and efficacy of a doctor-driven insulin titration algorithm in adults who were prescribed V-Go. […]
Medtronic’s insulin pumps highlighted in medtech injury report
A new report published this week by the International Consortium of Investigative Journalists and media organizations around the world took aim at medical device companies and the regulations that govern the $400 billion industry. And in a related report about Medtronic (NYSE:MDT), the authors zero in on the company’s diabetes unit and its insulin pumps. Over the […]
Fresenius Kabi recalls sodium chloride injections over latex concern
Fresenius Kabi USA voluntarily recalled 163 lots of sodium chloride injections last week, noting that the product contains latex despite an insert that states otherwise. The company’s recall includes 0.9% injections in 10 mL vials and 20 mL vials. The product insert and the tray label for both kinds of vials say that the products’ stoppers […]
Dr. Reddy’s notches win for generic Suboxone sublingual film
Shares in Dr. Reddy’s Laboratories (NYSE:RDY) shot up yesterday after the U.S. Court of Appeals for the Federal Circuit vacated a previous decision that blocked the company from selling a generic verson of Indivior‘s (LON:INDV) Suboxone buprenorphine and naloxone sublingual film. Dr. Reddy’s said it plans to resume launch activities for the product, which won FDA […]
Insulet’s Omnipod Dash system lands ISO cert for data security
Insulet (NSDQ:PODD) said this week that it won ISO 27001 certification for its Omnipod Dash product, meeting the international standard for best practice in an information security management system. The Billerica, Mass.-based company’s Omnipod Dash system wirelessly connects Insulet’s Personal Diabetes Manager with a tubeless, waterproof insulin pump. The PDM calculates how much insulin should be administered using […]
Dexcom inks $250m amended deal with Verily for next-gen diabetes tech
Dexcom (NSDQ:DXCM) said yesterday that it plans to pay $250 million upfront in stock to Verily in an amended collaboration and licensing deal. The two companies are working to develop a second-generation continuous glucose monitoring system. The updated deal also notes that the companies could collaborate on additional products and software. The new agreement structure makes […]
Boston Scientific puts $4B on the table for BTG’s interventional portfolio
Boston Scientific (NYSE:BSX) said today that it agreed to offer $4.24 billion to acquire British medical device maker BTG (LON:BTG) and its portfolio of interventional drug-device therapies. The Marlborough, Mass.-based company said that its acquisition of BTG will augment Boston Scientific’s capabilities in the treatment of cancer and pulmonary embolism. “We are confident that the addition of these therapies […]
FDA extends decision date for Sage’s postpartum depression injection
Sage Therapeutics (NSDQ:SAGE) said today that the FDA extended its decision date for Sage’s Zulresso brexanolone injection to March 19, 2019. The U.S. regulatory agency was previously slated to decide whether or not to approve the drug as a treatment for postpartum depression by Dec. 19. The Cambridge, Mass.-based company noted that the FDA elected to […]
Intersect ENT touts pooled analysis of steroid-releasing sinus implants
Intersect ENT (NSDQ:XENT) last week touted the publication of a pooled analysis of the company’s Propel Contour and Propel Mini steroid-eluting sinus implants. The company’s devices are designed to prop open the sinus ostia following endoscopic sinus surgery. As the implant dissolves, medicine is delivered directly to the sinus lining. The analysis, published in the International Forum […]
