Pixarbio founder & CEO Frank Reynolds reportedly faces two decades behind bars after a jury yesterday convicted him of defrauding investors of nearly $13 million. Federal authorities arrested Reynolds, longtime friend and Pixarbio employee Jay Herod and PixarBio CIO Kenneth Stromsland in April 2018 on securities fraud charges, claiming they misled investors about the opioid substitute […]
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FDA approves expanded indication for Liletta 6-year IUD
Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]
Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin
Insulet (NSDQ:PODD) said last week that it won FDA clearance for the use of Novo Nordisk‘s (NYSE:NVO) Fiasp insulin with the Omnipod insulin management platform. Acton, Mass.-based Insulet said it completed extensive testing to ensure that Fiasp is safe and usable with the Omnipod and Omnipod Dash systems. It’s the first insulin pump in the U.S. […]
DarioHealth beats forecast with Q3 results
DarioHealth (NSDQ:DRIO) posted lower-than-expected net losses during the third quarter and met the consensus revenues forecast. The Israeli company, which makes mobile phone-compatible blood glucose and blood pressure monitors, reported losses of -$2.8 million, or -6¢ per share, on sales of $1.9 million for the three months ended Sept. 30. DarioHealth pared its losses by -31.0% […]
FDA approves Flowonix’s Prometra II programmable pump
Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and its associated software for intrathecal infusion. The pump has expanded reservoir size options that include 20 ml and 40ml pumps, along with the claim of 10-year battery life at average flow rates. Flowonix said in a news release yesterday that […]
Senseonics touts Humana reimbursement nod for Eversense CGM
Senseonics (NYSE:SENS) said yesterday that Humana is now providing coverage for its Eversense continuous glucose monitoring system and insertion procedure. Humana is the fifth-largest health insurer in the U.S. with 17 million patients in 50 states, Washington, D.C. and Puerto Rico, according to a news release. Its coverage policy with Senseonics makes patients with Type 1 […]
Bryn Pharma raises $18m for nasal epinephrine device
Bryn Pharma said today that it raised nearly $18 million in financing to fund U.S. approval and commercialization for its Bryn-NDS1C bidose epinephrine nasal spray device for treating anaphylaxis. The $17.5 million funding round was the company’s fourth completed financing series and it included $15 million from existing and new investors, while the remaining $2.5 […]
Clearside Biomedical inks $76m licensing deal with Bausch for Xipere
Clearside Biomedical (NSDQ:CLSD) said yesterday that it entered into a license agreement with Bausch Health Ireland (NYSE:BHC) worth up to $76 million for the Xipere device for the treatment of macular edema associated with uveitis. The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device. Bausch agreed to […]
Phillips-Medisize wins contract for wearable combination product
Phillips-Medisize said today that it entered into an agreement with an unnamed biotechnology company to manufacture a wearable, electronic-enabled combination product for subcutaneous drug delivery. The hockey puck-sized product is designed as a disposable, single-use combination device that can be worn near the infusion site for two days or adhere to the patient’s body with […]
West Pharmaceutical Services launches NovaPure drug-delivery system
West Pharmaceutical Services (NYSE:WST) said today that it’s launching the NovaPure 3mL cartridge components with its NovaPure product line for delivery of higher-volume injectable drug-delivery systems. The Exton, Pa.-based company also announced that its SmartDose Gen. II 10mL injector for subcutaneous drug delivery is available for commercialization as well. West’s NovaPure portfolio currently includes stoppers and […]