Pieris Pharmaceuticals (NSDQ:PIRS) has closed an underwritten public offering of 6,325,000 shares of its common stock. The Boston, Mass.-based company said it reeled in $50.6 million from the offering, which it plans to use to fund the pre-clinical and clinical development of its pipeline. Get the full story at our sister site, Drug Delivery Business News.
Drug-Device Combinations
Medtronic expands insulin pump portfolio with MiniMed Mio infusion set
Medtronic (NYSE:MDT) has launched its MiniMed Mio Advance infusion sets, which are designed for people managing their diabetes with insulin pump therapy. The medtech titan touted its product, which was developed by ConvaTec, as boasting a user-friendly design that allows patients to access hard-to-reach sites, like the lower back. The infusion system has no visible needle […]
Tandem Diabetes bids for Health Canada nod
Tandem Diabetes Care (NSDQ:TNDM) has submitted a medical device license application to Health Canada in the hopes of launching its t:slim X2 insulin pump in Canada in the second half of this year. The San Diego, Calif.-based company expects that its device will be able to display both English and French and will include a 24-hour […]
Photocure wins FDA expanded sNDA for Blue Light Cytoscopy with Cysview system
Norwegian urology-focused developer Photocure ASA said last week it won a supplemental new drug application from the FDA extending the indication for its Blue Light Cytoscopy (BLC) with Cysview to include flexible cytoscopes designed for the surveillance of patients with bladder cancer. The company touted the approval, saying it is the only combination of drugs and devices […]
FDA issues warning for Roche’s Accu-Chek diabetes management app
The FDA today issued a Class 2 device recall for Roche‘s (OTC:RHHBY) Accu-Chek connected diabetes management app. The company first notified the regulatory agency of the software bug in June last year. Roche reported that certain iOS and Andriod versions of the app had a program error in the Bolus Advisor feature – a calculator that helps the […]
Tandem inks distribution deal in Scandinavia for insulin pumps
Tandem Diabetes Care (NSDQ:TNDM) has inked a distribution agreement with Rubin Medical to commercialize the medical device company’s t:slim X2 insulin pump, insulin cartridges and t:lock infusion sets in Sweden, Norway and Denmark. According to the terms of the deal, Rubin Medical is slated to perform all sales, marketing and customer training for Tandem’s devices. Get the […]
Tandem Diabetes touts pivotal study of insulin pump with low glucose suspend feature
Tandem Diabetes Care (NSDQ:TNDM) touted data today from a pivotal study of its t:slim X2 insulin pump, which features a predictive low glucose suspend feature called Basal-IQ. The study showed that the system reduced time spent in hypoglycemia by 31% compared to just sensor-augmented pump therapy, according to Tandem. Get the full story at our sister site, […]
Medtronic looks to expand MiniMed 670G into pediatric diabetes
Medtronic (NYSE:MDT) touted data today from an at-home pediatric study of its MiniMed 670G hybrid closed-loop diabetes management system. The company’s study included 105 kids, ages 7 to 13, and found that patients spent more time in the target blood glucose range, had less glycemic variability and experienced less hypo- and hyperglycemia compared to baseline data. […]
Acorda posts Q4 revenue beat, but misses EPS estimates
Shares in Acorda Therapeutics (NSDQ:ACOR) fell today after the biotech company met sales expectations on Wall Street with its fourth-quarter results, but missed EPS estimates. The Ardsley, N.Y.-based company posted a net loss of -$171 million on sales of $188.4 million for the 3 months ended Dec.31, for sales growth of 34% compared with the same period last […]
DreaMed Diabetes wins CE Mark for insulin therapy management platform
DreaMed Diabetes has won CE Mark clearance for its Advisor Pro decision-support platform, designed to help healthcare professionals manage insulin therapy for their Type I diabetes patients. The company’s cloud-based platform provides personalized insulin treatment plans by combining data from insulin pumps and continuous glucose monitors. Using machine learning techniques, the system analyzes all of the […]
Pieris Pharmaceuticals prices $44m public offering
Pieris Pharmaceuticals (NSDQ:PIRS) today priced an underwritten public offering of 5.5 million shares of its common stock at $8.00 per share. The company said it expects to generate $44 million from the offering, which it will use to fund the pre-clinical and clinical development of its pipeline. Get the full story at our sister site, Drug Delivery Business […]