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.
Roche taps Accenture’s analytics tech for digital diabetes management
Accenture (NYSE:ACN) said today that it inked a five-year deal with Roche (OTC:RHHBY) to incorporate its analytics platform into Roche’s digital diabetes management system. According to the deal, Roche’s new digital “diabetes ecosystem” will be built on the Accenture Intelligent Patient Platform. The system reportedly allows Roche to collect and analyze data from diabetes patients in the […]
Roche buys mySugr diabetes app
Swiss drugmaker Roche (PINK:RHHBY) said today that it bought diabetes management platform mySugr for an undisclosed price. The 2 companies have worked together since 2014. mySugr’s digital tech enables users to track things like their blood sugar, diabetes medications and physical activity. Get the full story at our sister site, Drug Delivery Business News.
Novartis trial results could spell trouble for Regeneron
Head-to-head late-stage clinical trials published on Tuesday showed that a Novartis (NYSE:NVS) drug to treat patients with neovascular age-related macular degeneration doesn’t need to be injected as frequently as a rival drug from competitor Regeneron (NSDQ:REGN). Analysts reportedly said the data gives Novartis’ treatment, RTH258, a competitive edge compared to its rival therapies. Get the full […]
Pieris, AstraZeneca ink $45m deal for inhaled respiratory drugs
Pieris Pharmaceuticals (NSDQ:PIRS) inked a $45 million deal with AstraZeneca (NYSE:AZN) to develop a group of inhaled drugs for respiratory diseases. According to the deal, Pieris will get $45 million up front to bring an experimental asthma drug into human clinical trials. The drug is slated to begin Phase I testing this year, which will […]
Roche warns on bolus advisor issues with Accu-Check Connect app
Roche (PINK:RHHBY) this week warned of potential issues with its Accu-Check Connect diabetes management application which could lead the app to provide inaccurate bolus insulin recommendations. The Swiss company said it recently discovered a software bug in its Accu-Check Connect diabetes management app versions 2.0.0, 2.0.1 and 2.1.0 for Apple (NSDQ:AAPL) iOS and Google (NSDQ:GOOG) Android […]
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