Eyenovia (NSDQ:EYEN) said this week that the results of its Phase II PG21 study were published in the Nov. issue of the journal Clinical Ophthalmology. The New York-based company’s Phase II study evaluated the effect of self-administered micro-dose latanoprost on intraocular pressure. In the trial, participants successfully self-administered using Eyenovia’s device 88% of the time after limited […]
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Teva launches generic EpiPen at the same price as existing device
Teva (NYSE:TEVA) this week launched its generic version of Mylan‘s (NSDQ:MYL) EpiPen auto-injector and announced that it would sell the emergency allergy therapy for $300 – the same price as Mylan’s own generic EpiPen product. The price for Teva’s product inspired some head-scratching among patient advocates and healthcare professionals. After all, when the FDA first approved […]
Dexcom prices $750m debt offering
Dexcom (NSDQ:DXCM) today priced its $750 million offering of convertible senior notes due 2023 which is slated to be offered to qualified institutional buyers. The San Diego, Calif.-based company said that it will also offer a 13-day option to buy up to an additional $100 million aggregate principal amount of notes to purchasers in the offering. […]
Dexcom readies $750m debt offering
Dexcom (NSDQ:DXCM) said yesterday that it plans to offer $750 million in convertible senior notes due 2023 in a private placement to institutional buyers. The San Diego, Calif.-based company also expects to give buyers a 13-day option to buy up to an additional $100 million aggregate principal amount of notes. The notes will mature on Dec. […]
FDA approves Genentech’s prefilled autoinjector for Actemra
Roche‘s (OTC:RHHBY) Genentech said today that the FDA approved its ACTPen single-dose prefilled autoinjector for Actemra as a new formulation for adults with moderate to severe active rheumatoid arthritis and for adults with giant cell arteritis. The U.S. regulatory agency also approved the device for administration by caregivers to patients as young as two years old […]
Eyenovia launches Ph3 trial for pupil dilation tech
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 […]
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 […]
