Dexcom (NSDQ:DXCM) said that it completed the sale of $850 million of 0.75% convertible senior notes due 2023. The San Diego, Calif.-based company expects to reel in roughly $836 million in net proceeds from the offering. Dexcom used $35.1 million of the offering’s proceeds to pay the cost of the convertible note hedge transactions as described […]
ResMed puts $225m on the table for Propeller Health
ResMed (NYSE:RMD) said today that it inked a deal to acquire Propeller Health and its digital medicine platform for $225 million in cash. Propeller Health, which sells small sensors that attach to inhalers and track medication use, will operate as a standalone business under ResMed’s respiratory care portfolio. ResMed reported that Propeller’s products for people […]
Ocular Therapeutix wins FDA nod for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The regulatory win for the Bedford, Mass.-based company comes after much back-and-forth with the FDA; the agency has twice rejected Ocular Therapeutix’s application for Dextenza. The company’s device is designed […]
Diabeloop wins CE Mark for hybrid closed-loop diabetes management system
Diabeloop won CE Mark clearance in the European Union this month for its hybrid closed-loop diabetes management system, DBLG1. The Paris-based company hopes to launch its “artificial pancreas” system for adults with Type I diabetes in Europe by the second quarter in 2019. Diabeloop’s system connects Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitor, Kaleido’s patch insulin […]
Pulmatrix raises $3m in offering
Pulmatrix (NSDQ:PULM) said this week that it inked a deal with an institutional investor to sell 9,375,000 shares of common stock at 32¢ apiece. The Lexington, Mass.-based company expects to reel in $3 million in total gross proceeds from the offering. Pulmatrix also agreed to issue unregistered warrants to the same investor in a private placement […]
FDA issues revised draft guidances for blood glucose monitors
The FDA issued two revised draft guidances today relating to over-the-counter and prescription blood glucose monitors. The new documents, which are intended to update guidances issued in 2016, were based on feedback from stakeholders, who requested more clarification on design considerations and recommended standards, according to the U.S. regulatory agency. The guidances include recommendations for […]
Eyenovia touts publication of intraocular pressure data for micro-dose tech
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 […]
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 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 […]
