FDA approves Roche’s Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD)

Susvimo, previously called Port Delivery System with ranibizumab, is the first nAMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month By continuously delivering medicine into the eye through a refillable implant, Susvimo may help people with nAMD maintain their vision with as few as... Read more

Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)

Lung cancer remains the leading cause of cancer-related deaths worldwide, with more than 2.2 million people diagnosed globally last year.1 The VENTANA PD-L1 (SP263) Assay helps determine which non-small cell lung cancer patients may benefit from treatment with Tecentriq immunotherapy based on the results of the Phase III IMpower010 study. This new test expands Roche’s... Read more

Walsh University and Shimadzu Scientific Instruments to Dedicate New Center for Analytical Excellence Laboratory for Advanced Chemical Analysis

Walsh University (North Canton, OH) and Shimadzu Scientific Instruments (SSI) will dedicate the Center for Analytical Excellence Laboratory, a collaborative project that includes the installation of nearly $1.2 million worth of new analytical equipment. This ongoing partnership was developed through the Shimadzu Partnership for Academics, Research and Quality of Life (SPARQ) program, which is designed... Read more

FDA Authorizes New Saliva Sample Collection Method for High-Throughput, Automated COVID-19 Testing System

FDA Authorizes New Saliva Sample Collection Method for High-Throughput, Automated COVID-19 Testing System CARLSBAD, Calif., Oct. 18, 2021 /PRNewswire/ — Thermo Fisher Scientific, the world leader in serving science, today announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to run COVID-19 tests from saliva samples collected with the... Read more

US FDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting Approval is based on the Phase III IMpower010 study showing adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive Stage II-IIIA lung cancer, compared with best supportive care Basel, 15 October 2021 – Roche (SIX: RO, ROG; OTCQX:... Read more

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer’s disease (AD) Gantenerumab is the first and only anti-amyloid antibody being investigated for subcutaneous administration in late-stage trials for the treatment of AD Ongoing Phase III GRADUATE programme with gantenerumab is anticipated to deliver a comprehensive data set with expected readout in the... Read more

Utility Industry Leaders To Examine How Technology Helps Maximize Value And Serve Customers At Xylem Reach Conference

Sessions Planned For In-Person And Virtual Attendees RYE BROOK, N.Y.–(BUSINESS WIRE)–Oct. 7, 2021– Xylem (NYSE:XYL) empowers utilities across the electric, gas and water industries to pave the way for future infrastructure through the adoption of smart technologies. This year’s annual Xylem ReachSM Conference will showcase the shift toward digital adoption and highlight success stories. The... Read more

PerkinElmer Receives FDA Emergency Use Authorization for Respiratory SARS-CoV-2 Panel

RT-PCR test detects and differentiates SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus WALTHAM, Mass.–(BUSINESS WIRE)–Oct. 7, 2021– PerkinElmer, Inc. (NYSE: PKI) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel 1 assay. Qualified laboratories can immediately begin using this... Read more

EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA Receives FDA Emergency Use Authorization

Assay enabling the measurement of IgG antibodies could yield future discoveries and insights on immune responses to SARS-CoV-2 WALTHAM, Mass.–(BUSINESS WIRE)–Oct. 5, 2021– EUROIMMUN, a PerkinElmer, Inc. company (NYSE: PKI), announced today that the U.S. Food and Drug Administration has provided Emergency Use Authorization (EUA) for its Anti-SARS-CoV-2 S1 CurveTM ELISA (IgG). This assay allows... Read more