Category: Acad, Gov/Utilities
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer
Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are... Read more
Xylem, Esri Partnership Pairs Global Leaders In Water Technology And GIS To Help Utilities Worldwide Streamline Data And Insight
Xylem Becomes Platinum Esri Partner, Will Create Joint Solutions, Collaborate On Marketing Water Operators To Benefit From Better Network Visibility, Optimized Infrastructure, Lower Costs RYE BROOK, N.Y.–(BUSINESS WIRE)–Apr. 28, 2021– Xylem (NYSE:XYL), a leading water technology company dedicated to solving the world’s greatest water challenges, has forged a partnership with Esri, the global leader in... Read more
Thermo Fisher Scientific Recognizes Significance of FDA Approval of First CAR T Cell Immunotherapy for Multiple Myeloma with Donation to Leukemia and Lymphoma Society
Thermo Fisher Scientific Recognizes Significance of FDA Approval of First CAR T Cell Immunotherapy for Multiple Myeloma with Donation to Leukemia and Lymphoma Society WALTHAM, Mass. (April 28, 2021) — Thermo Fisher Scientific Inc. has made a donation to the Leukemia & Lymphoma Society in recognition of the recent U.S. Food and Drug Administration approval... Read more
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 2 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally... Read more
Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
About 90,000 women globally die from endometrial cancer each year1 VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI (dostarlimab-gxly) Roche/GSK collaboration represents an important step towards a personalised healthcare strategy that can help identify patients who are most likely to benefit from a... Read more
Illumina Remains Committed to GRAIL Acquisition to Accelerate Access to Breakthrough Multi-Cancer Early Detection Blood Test
SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN), today announced that it disagrees with the European Commission’s Directorate-General for Competition’s decision to review Illumina’s acquisition of GRAIL, a company founded to accelerate early screening of cancer. Illumina will continue to work with the Directorate-General to bring the investigation to conclusion. Illumina remains committed to the transaction, the... Read more
FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications
● Xolair for self-injection offers healthcare providers and appropriate patients another administration option for more flexibility in managing their treatment Basel, 13 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection... Read more
FDA Authorizes New High-Throughput, Automated System for Leading COVID-19 Test
The Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit enables laboratories to rapidly scale high-sensitivity PCR testing capacity as schools and employers seek increased testing to support reopening strategies WALTHAM, Mass., April 12, 2021 /PRNewswire/ — Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today announced that the U.S. Food and Drug... Read more
Thermo Fisher Scientific Completes FDA Listing and Launches the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System for In Vitro Diagnostic Use
Thermo Fisher Scientific Completes FDA Listing and Launches the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System for In Vitro Diagnostic Use Innovative qPCR platform simplifies molecular diagnostic workflows for infectious disease, oncology and COVID-19 testing CARLSBAD, Calif., March 25, 2021 /PRNewswire/ — Thermo Fisher Scientific today announced the completion of the U.S. Food and Drug... Read more