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Sarah Faulkner

Insulet beats the Street with Q4, FY17 sales

February 22, 2018 By Sarah Faulkner

Insulet Omnipod

Insulet (NSDQ:PODD) reported yesterday that the insulin delivery device-maker topped sales expectations on Wall Street for its fourth quarter and full-year financial results, but missed earnings estimates. The Billerica, Mass.-based company reeled in losses, posting -$6.9 million on sales of $130.5 million for the 3 months ended Dec. 31, for sales growth of 26% compared with […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Pharmaceuticals, Wall Street Beat Tagged With: Insulet

Novocure misses Q4 EPS by a penny, tops sales estimates

February 22, 2018 By Sarah Faulkner

Novocure

Shares in Novocure (NSDQ:NVCR) rose slightly today in premarket activity after the medical device maker met sales expectations, but missed earnings estimates on Wall Street with its fourth quarter and full-year financial results. The St. Helier, N.J.-based company reeled in losses this quarter, posting -$10.9 million on sales of $53.7 million for the 3 months ended […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Oncology, Pharmaceuticals, Wall Street Beat Tagged With: NovoCure

Express Scripts to include Novo Nordisk’s once-weekly diabetes drug on 2018 formulary

February 21, 2018 By Sarah Faulkner

Novo Nordisk

Express Scripts, one of the nation’s largest pharmacy benefit managers, reportedly plans to include Novo Nordisk‘s (NYSE:NVO) once-weekly Type II diabetes, Ozempic, on its 2018 formulary. The move puts Ozempic directly in competition with Eli Lilly‘s (NYSE:LLY) once-weekly Trulicity drug. Both products will also go up against AstraZeneca‘s (NYSE:AZN) once-weekly Bydureon medication. All three drugs […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: AstraZeneca plc, Eli Lilly & Co., Novo Nordisk

Pieris Pharmaceuticals closes $51m public offering

February 21, 2018 By Sarah Faulkner

Pieris Pharmaceuticals

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. In May last year, Pieris inked a $45 million deal with AstraZeneca (NYSE:AZN) to develop a group […]

Filed Under: Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: pierispharmaceuticals

Medtronic expands insulin pump portfolio with MiniMed Mio infusion set

February 21, 2018 By Sarah Faulkner

MiniMed Mio

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Medtronic

Tandem Diabetes bids for Health Canada nod

February 21, 2018 By Sarah Faulkner

Tandem Diabetes

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Tandem Diabetes Care

Senseonics’ implantable glucose monitor succeeds in 90-day trial

February 21, 2018 By Sarah Faulkner

Senseonics

A 90-day trial involving patients with Type I and Type II diabetes showed that Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor was safe and accurate compared to reference glucose values, according to a study published in Diabetes Technology & Therapeutics. The single-arm study enrolled 90 participants and implanted them with Senseonics’ Eversense device, which sends glucose data […]

Filed Under: Clinical Trials, Diabetes, Featured, Regulatory/Compliance, Wall Street Beat Tagged With: Senseonics

Pacira shares fall after FDA committee rejects expanded use for Exparel pain drug

February 16, 2018 By Sarah Faulkner

Pacira Pharmaceuticals

Shares in Pacira Pharmaceuticals (NSDQ:PCRX) fell nearly -16% today after a panel of experts convened by the FDA voted against an expanded use for Pacira’s injectable pain drug. The pharmaceutical company previously submitted an application seeking to use the local anesthetic as a regional pain-killer. The committee’s feedback doesn’t necessarily mean the immediate end for Pacira’s […]

Filed Under: Featured, Pain Management, Pharmaceuticals, Wall Street Beat Tagged With: Pacira Pharmaceuticals

FDA issues warning for Roche’s Accu-Chek diabetes management app

February 16, 2018 By Sarah Faulkner

Roche's Accu-Chek 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 […]

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA), Patient Monitoring, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Roche

Tandem inks distribution deal in Scandinavia for insulin pumps

February 16, 2018 By Sarah Faulkner

Tandem Diabetes

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. “This represents […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Tandem Diabetes Care

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