Aimovig, a ground-breaking drug to prevent Migraines was approved by the FDA last week. Aimovig will be the only player in the market to treat migraines. The new drug has to be taken once a month through an injection similar to an insulin shot or an EpiPen.
A particular proposal regarding displaying drug prices in TV ads flummoxed pharma marketers and ad agencies following the unveiling of the drug-pricing agenda by President Trump. Marketers have been hounded with the whys and hows of the proposal even as the administration remains firm on its implementation.
When it comes to manufacturing CAR T drugs (personalized treatments engineering immune cells to destroy cancer cells of patients) speed is of utmost importance. A new manufacturing site has been decided upon by Gilead for Yescarta, its CAR-T therapy at a Netherlands airport.
Based on data from the phase II JULIET study, tisagenlecleucel (Kymriah) has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
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.
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