Senseonics (NYSE:SENS) this week announced that it partnered with Geo-Med to provide access to the Eversense continuous glucose monitor to more than 9 million veterans and U.S. government staff. The company’s Eversense device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days. The system includes a […]
Tandem wins interoperable claim for insulin pump from FDA
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 […]
Ocugen wins orphan drug status for ocular gene therapy
The FDA has given Ocugen orphan drug status for a gene therapy designed to treat NR2E3 mutation-associated retinal degenerative disease. The Malvern, Penn.-based company’s OCU400 product includes an adeno-associated virum serotype 5 capsid that contains the gene for human nuclear hormone receptor NR2E3. In a mouse model of NR2E3 mutation, delivery of NR2E3 to retinal […]
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 […]
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 […]
Former PixarBio worker pleads guilty in fraud case
A former PixarBio (OTC:PXRB) employee pleaded guilty last Friday to charges of fraud and obstruction, according to a recent report from the Boston Business Journal. The employee, Jay Herod, was accused of making false statements to the SEC and impeding their investigation, as well as manipulating company stock trades and misleading investors, according to the report. […]
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 […]
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