Roche announced today that it received FDA emergency use authorization (EUA) for its cobas SARS-CoV-2 Duo diagnostic. Authorization covers the cobas SARS-CoV-2 Duo on the fully automated cobas 6800/8800 systems, expanding Roche’s COVID-19 portfolio and representing the first automated, RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and […]
Roche
Roche says its research-only COVID-19 tests can detect a range of variants, subvariants
Roche announced today that its TIB Molbiol subsidiary has made available testing solutions that can identify a number of COVID-19 variants. Basel, Switzerland-based Roche’s testing offerings can identify the SARS-CoV-2 (the virus causing COVID-19) B.1.1.529 variant and differentiate between the omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and delta, according to a news release. VirSNiP […]
How medtech and pharma are responding to Russia’s invasion of Ukraine
Medtech and pharma companies continue to support Ukraine relief efforts following Russia’s invasion. Previously, the World Health Organization announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than […]
World Health Organization sending 36 metric tons of medical supplies to Ukraine
The World Health Organization today said that it is sending more than 36 metric tons of medical supplies to support the humanitarian emergency in Ukraine following Russia’s invasion last week. WHO Director-General Tedros Adhanom Ghebreyesus said the organization is sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of […]
Roche launches its connected blood glucose meter in Europe
Roche announced today that it launched its Cobas Pulse system in select countries accepting CE mark approval in Europe. Basel, Switzerland-based Roche designed its Cobas Pulse system to combine the form factor of a high-performance blood glucose meter with simple usability and expanded digital capabilities comparable to that of a smartphone. The platform joins Roche’s connected […]
Glytec partners with Roche to enhance insulin dosing decision support software
Glytec announced today that it entered into a strategic partnership with Roche Diagnostics USA for a digital health collaboration. Waltham, Massachusetts-based Glytec’s partnership combines its FDA-cleared Glucommander insulin dosing decision support software with Roche’s expertise in medical devices and IT solutions in an effort to address the challenges associated with inpatient blood sugar management at the hospital bedside. […]
Freenome raises $290M from Roche
Freenome said today that it has raised $290 million from Roche to advance its cancer early detection platform, which uses a routine blood draw. The South San Francisco, California–based company has raised more than $1.1 billion since its founding in 2014. “With Roche’s investment and expertise, we’ll be able to further accelerate and augment the […]
Medtech M&A: The industry’s biggest mergers and acquisitions of 2021
Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more. Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired. Here are the 10 biggest mergers and acquisitions in medtech in […]
FDA approves Genentech’s Susvimo drug-eluting eye implant
Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD). South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to […]
Europe approves Roche’s Enspryng subcutaneous NMOSD treatment
Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment. Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). Get the full story at our sister site, Drug Delivery Business News.
Roche wins EUA for intravenous tocilizumab in treating COVID-19
Roche announced today that it received FDA emergency use authorization (EUA) for intravenous Actemra/RoActemra in treating COVID-19. Basel, Switzerland-based Roche’s Actemra/RoActemra (tocilizumab) drug received authorization to treat COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or […]
