The FDA this week named Amy Abernethy, the chief medical officer for Roche subsidiary Flatiron Health, as principal deputy commissioner to replace Rachel Sherman, who is retiring in January. “She’s a highly regarded thought leader who has held numerous positions of leadership in her fields of interest and distinguished herself for her intellect, her passion […]
Genentech touts data for refillable eye implant in wet-AMD trial
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 for months […]
Genentech kicks off Phase III trials for eye implant
Roche‘s (OTC:RHHBY) Genentech reported this week that the company launched three Phase III trials evaluating the Port drug-delivery implant in patients with wet age-related macular degeneration and diabetic macular edema. The device is a refillable eye implant designed to continuously release drugs over a period of several months. Get the full story at our sister site, Drug […]
Genentech touts positive data for tiny, refillable eye implant
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 […]
Roche wins CE Mark for Accu-Chek Solo insulin micropump
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. Get the full story at our sister site, Drug Delivery Business News.
Roche launches CoaguCheck Vantus blood coagulation monitor
Roche (OTC:RHHBY) said today it is launching its CoaguCheck Vantus system designed for monitoring blood coagulation, specifically for patients on warfarin therapy. The Switzerland-based company said the CoaguCheck Vantus features built in Bluetooth technology to allow patients to use their smart devices and a compatible application to send results of the coagulation testing to their healthcare […]
Roche closes $2B Flatiron Health acquisition
Roche (OTC:RHHBY) said today it closed its $1.9 billion acquisition of digital healthcare tech company Flatiron Health. New York City-based Flatiron Health designs and develops oncology-specific electronic health record software, and aids in curating and developing real-world evidence for cancer research, Roche said. Under terms of the acquisition, Flatiron Health will continue to operate as […]
Companies push back against allegations of FCA violations over excess at-home blood testing
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 […]
Genentech’s pre-filled syringe for diabetic retinopathy wins FDA nod
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 growth […]
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 […]
How this biotech plans to go up against big pharma with its eye disease products
Shankar Musunuri has spent time in both the pharmaceutical world and the biotech arena – after 15 years at Pfizer (NYSE:PFE), he went on to launch several biotech start-ups. As co-founder, chairman & chief executive of Ocugen, he is looking to bring eye disease products to the patients that big pharma’s drugs have left out. “There’s so much […]
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