Clik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
Insulet president & CEO Shacey Petrovic to participate in keynote interview...
[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....
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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’...
View ArticleClik here to view.
Medtronic wins FDA’s breakthrough status for closed-loop insulin system
Medtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system. The company touted its technology as enabling...
View ArticleClik here to view.
Teva aims for 25% of U.S. EpiPen market by 2020
Teva (NYSE:TEVA) expects its generic EpiPen auto-injector to claim 25% of the U.S. market by the end of this year, according to a report from Seeking Alpha. For years, Mylan‘s (NSDQ:MYL) brand-name...
View ArticleClik here to view.
Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake...
View ArticleClik here to view.
Cash-strapped Aradigm declares bankruptcy
Aradigm Corp. (NSDQ:ARDM) announced last week that it’s officially declaring bankruptcy. Strapped for cash, the Calif.-based company resigned to filing for Chapter 11 protection after it couldn’t...
View ArticleClik here to view.
Hygieia wins FDA clearance for insulin management app
Hygieia said today that it won 510(k) clearance from the FDA for its insulin management app designed to optimize insulin dosing among people with Type 2 diabetes. The Michigan-based company touted its...
View ArticleClik here to view.
Ocular Therapeutix doses first wet-AMD patient in implant trial
Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s...
View ArticleClik here to view.
Abbott, Novo Nordisk ink deal for digital diabetes tools
Abbott (NYSE:ABT) said today that it inked a non-exclusive deal to integrate insulin dose data from Novo Nordisk‘s (NYSE:NVO) pre-filled and connected pens with its FreeStyle Libre mobile app and...
View ArticleClik here to view.
Late mortality rates ‘inadvertently reversed’ in 5-year study of...
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were...
View ArticleClik here to view.
ARS Pharmaceuticals wins fast track status for epinephrine nasal spray
ARS Pharmaceuticals said this week that it won fast track status from the FDA for its investigational intranasal epinephrine spray, ARS-1. The San Diego, Calif.-based company’s device is designed to be...
View ArticleClik here to view.
Mylan launches generic sublingual film for opioid dependence
Mylan (NSDQ:MYL) said today that it launched its buprenorphine and naloxone sublingual film as a generic of Indivior‘s (LON:INDV) Suboxone sublingual film. The product is indicated for the treatment of...
View Article