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 […]
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Pieris Pharmaceuticals closes $51m public offering
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 […]
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 […]
Senseonics’ implantable glucose monitor succeeds in 90-day trial
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 […]
Acorda Therapeutics wins FDA NDA nod for Inbrija
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA accepted the New Drug Application for its Inbrija investigational inhaled levodopa product designed for treating symptoms of OFF periods in patients with Parkinson’s disease who are taking carbidopa/levodopa regimens. The approval comes with a target date of October 5, 2018, the Ardsley, N.Y.-based company said. The NDA comes supported […]
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 […]
MiMedx shares tumble on internal accounting investigation, delayed 2017 earnings
MiMedx (NSDQ:MDXG) shares have lost nearly a third of their value today after the company announced it is delaying the release of its 2017 financial results due to an internal investigation into alleged issues with sales and distribution practices at the company. The Marietta, Ga.-based company said that its board’s audit committee has tapped a group of […]
Pacira shares fall after FDA committee rejects expanded use for Exparel pain drug
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 […]
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 […]