Acad, Gov/Utilities Archives - Page 13 of 53

April 27, 2021 Acad, Gov/Utilities Licensing, IP, and Legal

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

April 20, 2021 Acad, Gov/Utilities Environ, Ag./Food & Bev

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

April 13, 2021 Acad, Gov/Utilities

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

April 12, 2021 Acad, Gov/Utilities Lab Top-10 Liq. Handling & Robotics Microscopy Product Launch

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

March 25, 2021 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 Life Science Tools Liq. Handling & Robotics Microscopy Product Launch

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

March 10, 2021 Acad, Gov/Utilities Liq. Handling & Robotics

Luminex Submits Joint SARS-CoV-2 and Flu/RSV Respiratory Panel to FDA for Emergency Use Authorization

Luminex® Corporation (NASDAQ: LMNX) develops, manufactures, and markets proprietary biological testing technologies, with applications throughout the life-sciences industry. Luminex Submits Joint SARS-CoV-2 and Flu/RSV Respiratory Panel to FDA for Emergency Use Authorization Mar 10, 2021 6:30 AM EST AUSTIN, Texas, March 10, 2021 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that it has submitted an... Read more

March 5, 2021 Acad, Gov/Utilities Microscopy

Roche’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition

Systemic sclerosis (SSc) is a rare disease that affects about 2.5 million people worldwide Approximately 80% of SSc patients may be affected by interstitial lung disease (ILD), a progressive disease that can significantly impact lung function and can be life-threatening In a global study, Actemra/RoActemra reduced the rate of progressive loss of lung function in... Read more

March 4, 2021 Acad, Gov/Utilities Liq. Handling & Robotics PR/Corporate

Luminex Receives FDA Emergency Use Authorization and CE Mark for Expanded NxTAG® Respiratory Panel Test Including SARS-CoV-2

Luminex® Corporation (NASDAQ: LMNX) develops, manufactures, and markets proprietary biological testing technologies, with applications throughout the life-sciences industry. Luminex Receives FDA Emergency Use Authorization and CE Mark for Expanded NxTAG® Respiratory Panel Test Including SARS-CoV-2 Mar 04, 2021 6:30 AM EST Provides labs with high throughput, syndromic respiratory testing capabilities AUSTIN, Texas, March 4, 2021... Read more

February 26, 2021 Acad, Gov/Utilities

EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19

CHMP has completed a review of available data for investigational antibody cocktail casirivimab and imdevimab (REGN-COV2) to be considered for the treatment of confirmed COVID-19 CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency Roche and... Read more