NHS England chief executive Simon Stevens has indicated that chimeric antigen receptor T-cell therapy (CAR-T) could be available on the NHS this year, offering eligible patients a ‘ground-breaking’ approach to treating cancer.
The Food and Drug Administration plans to launch a full-scale version of its digital health precertification program by the end of the year.
Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for its new liquid biopsy assay, which is an expanded version of its FoundationACT® assay. The new assay will include more than 70 genes and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB). If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.
Company is targeting upstream aspects of native protein degradation pathways to develop new therapies for cancer
- A CD19 CAR with novel targeting properties designed to reduce cytokine release syndrome –
Silvia Pfeiffer started Coviu with CSIRO colleague Nathan Oehlman in 2015, and it is now in use by 1100 healthcare professionals, with 160 of them paid subscribers to the software-as-a-service platform at $20 a month. More than 20,000 patients have been remotely consulted to date via the platform, which is browser-based and does not require a download.
Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
Sale of Oncology business unlocks embedded value within Shire`s portfolio and sharpens focus on core areas reinforcing our leadership in rare diseases
The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
High-flying Cambridge startup Magenta has snagged $52 million in a new financing round to push forward the company’s pipeline of therapies for bone marrow transplant.
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