The FDA announced this week that it established Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump as the first in a new category of devices called ‘Alternate Controller Enabled Infusion Pumps’ or ACE pumps. The newly-approved indication for Tandem’s t:slim X2 pump clears the device to communicate with compatible products, including insulin dosing software and continuous glucose […]
Inovio prices $65m senior notes offering
Inovio Pharmaceuticals (NSDQ:INO) said today that it priced an offering of $65 million of 6.5% convertible senior notes due 2024. The Plymouth Meeting, Penn.-based company also gave initial purchasers a 13-day option to buy up to an additional $20 million in notes. Inovio expects to reel in roughly $62.7 million in net proceeds from the offering […]
FDA committee backs J&J’s nasal spray for depression
An FDA advisory committee has voted to support Johnson & Johnson‘s (NYSE:JNJ) Spravato esketamine nasal spray product as a therapy for adults living with treatment-resistant depression. J&J’s Janssen touted that if the U.S. regulatory agency decides to approve Spravato, it would be the first medicine in 30 years to sport a new mechanism of action […]
West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug
scPharmaceuticals’ (NSDQ:SCPH) has signed a development agreement to incorporate West Pharmaceutical Services’ (NYSE:WST) SmartDose drug delivery system with Furoscix, a drug that scPharmaceuticals developed to treat edema in heart failure patients. Burlington, Mass.-based scPharmaceuticals recently completed preliminary feasibility studies of the drug-device combination. The testing included drug stability in the pre-filled cartridge, drug compatibility, and […]
Touting pricetag, Mylan launches Advair generic
Mylan (NSDQ:MYL) today announced the launch of its Wixela Inhub product, a generic for GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus device, for people with asthma or chronic obstructive pulmonary disease. The company touted that its device’s list price is 70% less than Advair Diskus and 67% less than GSK’s generic. The wholesale acquisition costs for Mylan’s Wixela Inhub devices […]
Insulet president & CEO Shacey Petrovic to participate in keynote interview at DeviceTalks Boston 2019
[Press Release] – WTWH Media and MassDevice.com announced today that Shacey Petrovic, president and CEO of Insulet (NSDQ:PODD), will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019, at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices […]
Delcath wins approval for Chemosat in Brazil
Delcath Systems (OTC:DCTH) said today that it won medical device approval for its Chemosat hepatic delivery system from the national health authority in Brazil. The New York-based company plans to market and sell Chemosat in Brazil for the percutaneous intra-arterial administration of melphalan hydrochloride to the liver with subsequent extracorporeal filtration of blood. Delcath will work with […]
Propeller, Orion to develop digital asthma, COPD therapy
Propeller Health said today that it inked a deal to connect Orion’s Easyhaler line of inhalers for asthma and COPD with Propeller’s digital medicine platform. The two companies plan to co-develop a sensor that will attach to Orion’s inhalers and pair with a mobile app. Propeller touted that its existing digital medicine portfolio includes more […]
Study: Researchers develop ingestible capsule for insulin delivery
A team of researchers from MIT developed an ingestible, blueberry-sized capsule that can deliver insulin orally. In animal models, the capsule lowered blood sugar levels and performed comparably with the traditional route of insulin delivery – injections. The capsule features a small needle made of freeze-dried, compressed insulin. The needle is attached to a compressed […]
Regeneron touts one-year diabetic retinopathy data for Eylea
Regeneron Pharmaceuticals (NSDQ:REGN) touted one-year results from a Phase III trial of its Eylea aflibercept injection in people with moderately severe to severe non-proliferative diabetic retinopathy. The primary endpoint of the two-year Panorama trial is the proportion of patients who experience a two-step or greater improvement in the ‘diabetic retinopathy severity scale.’ Of the 133 people […]
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