Roche announced today that the US Food and Drug Administration (FDA) has approved ENSPRYNG™ (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). Read more
Thermo Fisher Scientific Supports COVID-19 Testing at Historically Black Colleges and Universities Seeking to Provide a Safe Return to Campus WALTHAM, Mass., Aug. 12, 2020 /PRNewswire/ — Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, has committed to supporting the efforts of historically black colleges and universities (HBCUs) in the U.S. to... Read more
Basel, 10 August 2020 In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA Evrysdi helped infants survive without permanent ventilation and achieve the ability to sit without support, a key motor milestone not... Read more
Crosslinking Mass Spectrometry (XL-MS) Now Can Leverage the PhoX Crosslinker and TIMS/PASEF Methods with the Large-Scale Use of Accurate Collision Cross Sections (CCS) BILLERICA, Mass.–(BUSINESS WIRE)– Bruker Corporation (Nasdaq: BRKR) today announced a collaboration with Utrecht University to advance the study of the 3-D structures and interactions of proteins by mass spectrometry. The laboratory of... Read more
Basel, 5 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorisation gives healthcare professionals a key tool in monitoring... Read more
Basel, 31 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles... Read more
Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year, and more than 620,000 people will die from the disease.1 About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive.2 VENTANA HER2 Dual ISH DNA Probe Cocktail assay3 aids in identifying HER2-positive breast cancer patients eligible for the... Read more
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat Thermo Fisher Scientific’s ImmunoCAP Specific IgE alpha-Gal Allergen Component test helps clinicians pinpoint a potentially fatal allergy often resulting from tick bites PORTAGE, Mich., July 23, 2020 /PRNewswire/ — ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been cleared by the U.S.... Read more
AUSTIN, Texas, July 20, 2020 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the company’s xMAP® SARS-CoV-2 Multi-Antigen IgG Assay. Clinical laboratories can now use this serology assay to identify the presence of antibodies in people who have been infected with the... Read more
FRANKLIN LAKES, N.J., July 8, 2020 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the formation of a strategic, public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response,... Read more