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Roche

Roche, Diabeloop partner on insulin pump management

December 11, 2020 By Sean Whooley

Roche (SWX: RO,  ROG) announced today that it is partnering with Diabeloop to advance insulin pump therapy management. Basel, Switzerland-based Roche said in a news release that the partnership will create new opportunities to lower the burden of constant insulin dose adjustment for those with diabetes while also improving therapy outcomes. Roche also said the partnership with Paris-based […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: Diabeloop, Roche

Senseonics extends distribution agreement with Roche Diabetes Care

February 4, 2019 By Chris Newmarker

Senseonics, Roche expand distribution deal for glucose monitor

Senseonics Holdings (NYSE-American: SENS) — maker of an implantable continuous glucose monitoring system for people with diabetes — has extended its distribution agreement with Roche Diabetes Care. The agreement extension, announced yesterday, has Roche continuing as Senseonics’ exclusive distributor in Europe, the Middle East and Africa — excluding Scandinavia and Israel. The agreement also adds 17 […]

Filed Under: Business/Financial News, Diabetes, Featured Tagged With: Roche, Senseonics

Genentech touts data for refillable eye implant in wet-AMD trial

October 29, 2018 By Sarah Faulkner

Genentech PDS implant

Roche‘s (OTC:RHHBY) Genentech touted additional positive data last week from a Phase II study of its Port Delivery System, a refillable eye implant designed to deliver ranibizumab to treat wet age-related macular degeneration. The company first reported top-line results from the Phase II Ladder study in July. The implant is intended to allow wet-AMD patients to go […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Genentech, Roche

Genentech kicks off Phase III trial for eye implant

October 5, 2018 By Sarah Faulkner

Genentech logo updated

Roche‘s (OTC:RHHBY) Genentech reported this week that the company launched Phase III trials evaluating its Port drug-delivery implant in patients with wet age-related macular degeneration and the drug faricimab in patients with diabetic macular edema. The company’s Port device is a refillable eye implant designed to continuously release drugs over a period of several months. “Wet […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Genentech, Roche

Genentech touts positive data for tiny, refillable eye implant

July 25, 2018 By Sarah Faulkner

Genentech

Roche‘s (OTC:RHHBY) Genentech touted positive top-line data today from a Phase II study of its Port Delivery System, an eye implant designed to administer a sustained dose of ranibizumab in patients with wet age-related macular degeneration. The refillable device, which is slightly longer than a grain of rice, is intended to enable wet-AMD patients to go for […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Genentech, Roche

Roche wins CE Mark for Accu-Chek Solo insulin micropump

July 23, 2018 By Sarah Faulkner

Roche

Roche (OTC:RHHBY) said today that it won CE Mark clearance for its Accu-Chek Solo insulin micropump system. The company plans to launch a pilot commercialization phase for its device in the coming weeks in Austria, Poland, Switzerland and the U.K. Roche’s Accu-Chek Solo system features a small, tubeless insulin micropump and a remote control that incorporates […]

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

Companies push back against allegations of FCA violations over excess at-home blood testing

April 9, 2018 By Sarah Faulkner

gavel

A 70-year-old former Marine is taking a group of companies to court over their at-home blood testing services, arguing that the industry players broke the law by requiring patients to conduct weekly tests. The companies then submit these bills to Medicare for reimbursement, even asking to be repaid for services that weren’t rendered, according to […]

Filed Under: Cardiovascular, Diagnostics, Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Wall Street Beat Tagged With: advancedcardioservices, alere, cardiolink, mdinr, patienthomemonitoring, Roche, ushealthcaresupply

Genentech’s pre-filled syringe for diabetic retinopathy wins FDA nod

March 21, 2018 By Sarah Faulkner

Lucentis 0.3mg pre-filled syringe from Genentech

Roche‘s (OTC:RHHBY) Genentech announced today that the FDA approved its 0.3-mg pre-filled syringe as a new way to administer Lucentis to diabetic retinopathy patients. The company’s drug is the only FDA-approved medicine indicated for the treatment of diabetic retinopathy. The 0.3-mg pre-filled syringe is the first device of its kind approved to deliver an anti-vascular endothelial […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Genentech, Roche

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

Pieris Pharmaceuticals prices $44m public offering

February 14, 2018 By Sarah Faulkner

Pieris Pharmaceuticals

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. The offering also includes a 30-day option for underwriters […]

Filed Under: Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals, Wall Street Beat Tagged With: Allergan, AstraZeneca plc, pierispharmaceuticals, Roche

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