FDA has approved Roche Diagnostic’s cobas EGFR Mutation Test v2 as a companion diagnostic to Tarceva (erlotinib), a Roche/Astellas Pharma drug to treat non-small cell lung cancer (NSCLC). The test is the first blood-based genetic test approved by FDA to detect epidermal growth factor receptors genetic mutations that are associated with treatment response to Tarceva.
FDA has approved Roche Diagnostic’s cobas EGFR Mutation Test v2 as a companion diagnostic to Tarceva (erlotinib), a Roche/Astellas Pharma drug to treat non-small cell lung cancer (NSCLC). The test is the first blood-based genetic test approved by FDA to detect epidermal growth factor receptors genetic mutations that are associated with treatment response to Tarceva.
Roche first gained approval for a companion diagnostic to Tarceva in 2013, but that was for evaluating tumor biopsy...
A framework to end the Iran war is in place but fractured supply chains can’t recover overnight. Data from India suggests solvent prices have generally cooled from April peaks, but API costs stay elevated or even climbed in June for some products.
REUSE OF DISPOSABLE CARDIAC CATHETERS TARGETED BY FDA in an effort to address safety concerns about reuse of single-use products. The cardiac catheter product area "seems to jump up as one that is an area for us to focus on," Larry Spears, director of the Office of Compliance's Division of Enforcement III in FDA's Center for Devices and Radiological Health, said June 24 at a Food Drug and Law Institute conference held in Washington, D.C.
St Jude Medical and Spire are to develop anti-bacterial heart valve sewing cuffs using Spire's Spi-Argent silver coating process. The agreement covers a variety of valve designs as well as ancillary components. The treatment is aimed at reducing the incidence of endocarditis, a rare but dangerous complication of valve transplant which has a mortality rate as high as 60%.
Nissho saw sales rise only 1% to ¥17 billion ($930 million) in the year to March 1997. The Japanese company's net income was Yen3 billion, compared with Yen1.7 billion for the previous year, reports Reuters. Nissho produces disposable medical equipment.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
