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 […]
First test to screen blood donations for Zika virus wins FDA nod
The FDA today approved Roche Molecular System‘s (OTC:RHHBY) cobas Zika test, which detects Zika virus RNA in plasma specimens collected from volunteer blood donors and living organ donors. The test is designed to be used by blood collection establishments to detect Zika virus in blood donations – not for the diagnosis of Zika virus infection in […]
FDA taps Apple, J&J and others for health software pre-cert pilot
The FDA yesterday named the nine companies that will be included in a pilot program to pre-certify healthcare software developers. The program was designed with the hopes of reducing the amount of information the regulatory watchdog requires for review. The companies include Apple (NSDQ:AAPL), Fitbit (NYSE:FIT), Johnson & Johnson (NYSE:JNJ), Pear Therapeutics, Phosphorus, Roche (OTC:RHHBY), Samsung, Tidepool and Verily. […]
UK warns about alarm failure for Roche’s insulin pumps
The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function. If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, the agency said. […]
Novartis CEO departs, leaving corner office to Harvard doc
Novartis‘ (NYSE:NVS) chief executive Joseph Jimenez is slated to leave his post next February, the drugmaker reported over the weekend. The CEO’s surprise departure leaves the corner office to Dr. Vasant Narasimhan, who currently serves as the company’s CMO and global head of drug development. The move comes just days after Novartis won FDA approval for […]
House Dems launch MS drug pricing probe
Democrats from the House Committee on Oversight and Government Reform have sent letters to seven drugmakers as part of an investigation into why prices for multiple sclerosis drugs have nearly quadrupled since 2004. Reps. Elijah Cummings (D-Md.) and Peter Welch (D-Mass.) penned inquiries to Bayer, Biogen, EMD Serono, Novartis, Roche, Sanofi-Aventis and Teva Pharmaceuticals. Get […]
Roche, Mimetas develop “gut-on-a-chip” tech for drug-testing
Mimetas said today that it collaborated with Roche (OTC:RHHBY) to develop an organ-on-a-chip system that is designed to evaluate intestinal permeability in 3D gut tubules following exposure to drug compounds using the 10 panel drug tests. The results of the collaboration were published in Nature Communications. Get the full story at our sister site, Drug Delivery Business News.
