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

February 19, 2021 Acad, Gov/Utilities Clinical Research/Diagn. Environ, Ag./Food & Bev Life Science Tools

Illumina and the University Hospital of Tübingen Evaluate Potential of Whole Genome Sequencing to Improve Diagnosis of Full Range of Genetic Diseases

TÜBINGEN, Germany–(BUSINESS WIRE)–February 19, 2021 — Illumina, Inc. (Nasdaq: ILMN) today announced an agreement with the Institute of Medical Genetics and Applied Genomics at the University Hospital of Tübingen to assess the value of whole-genome sequencing (WGS) as a first-line diagnostic test for patients with genetic diseases and familial cancer syndromes. Illumina will support the... Read more

February 16, 2021 Acad, Gov/Utilities Lab Top-10 Liq. Handling & Robotics Product Launch

FDA Grants Emergency Use Authorization for New COVID-19, Flu A, Flu B Combo Kit

One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B CARLSBAD, Calif., Feb. 16, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit from Thermo Fisher Scientific, the company announced... Read more

February 8, 2021 Acad, Gov/Utilities

FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to be treated with Pfizer’s investigational drug PF-06946860 Unintentional weight loss (cachexia) is a highly prevalent complication of cancer, affecting more than half of all cancer patients worldwide, potentially leading to significant functional impairment and increased risk of death... Read more