August 16, 2021 Acad, Gov/Utilities Lab Top-10

FDA Grants Emergency Use Authorization for Two Next-Generation COVID-19 Assays from Thermo Fisher Scientific

FDA Grants Emergency Use Authorization for Two Next-Generation COVID-19 Assays from Thermo Fisher Scientific CARLSBAD, Calif., Aug. 16, 2021 /PRNewswire/ — Thermo Fisher Scientific, the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and... Read more

August 3, 2021 Acad, Gov/Utilities

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

Basel, 3 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours... Read more

July 29, 2021 Acad, Gov/Utilities

FDA accepts application for Roche’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)

Across four phase III studies, approximately half of patients receiving faricimab could extend treatment time to every four months – the first time this level of durability has been achieved in phase III nAMD and DME studies If approved, faricimab would be the first and only medicine designed to target two distinct pathways that drive... Read more

July 22, 2021 Acad, Gov/Utilities Lab Top-10 Life Science Tools Liq. Handling & Robotics PR/Corporate

PerkinElmer’s COVID-19 RT-PCR Test Kit Receives FDA Emergency Use Authorization for Saliva as Specimen Type

Non-invasive sampling method makes it easier to use the highly sensitive molecular test manufactured by PerkinElmer WHAT: PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that the U.S. Food and Drug Administration (FDA) has authorized the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit for an additional indication that permits... Read more

July 21, 2021 Acad, Gov/Utilities Other Lab Products/Services PAI Top-10

FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes

Every year in the US, approximately 10,000 people are diagnosed with myelodysplastic syndromes (MDS), and there remains a high unmet need for new treatment options1 The designation is based on interim results from the phase Ib M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreated higher-risk MDS This is the 11th Breakthrough Therapy... Read more

July 19, 2021 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 Life Science Tools

Thermo Fisher Scientific Expands Hematology Oncology NGS Portfolio

Immune repertoire assays offer high detection rates of malignant clones, empowering researchers to better assess blood cancers CARLSBAD, Calif., July 19, 2021 /PRNewswire/ — Thermo Fisher Scientific today announced a new suite of Ion Torrent Oncomine immune repertoire assays designed to detect potentially malignant clones of T-cells and B-cells, which play a key role in the immune... Read more

July 5, 2021 Acad, Gov/Utilities Liq. Handling & Robotics

How Fruit Flies Become Male or Female

Researchers use structured illumination and confocal microscopy to study proteins involved in Drosophila sex determination The generation of offspring through sexual reproduction between a male and a female evolved approximately 1.2 billion years ago. An important part of this process is that each new generation contains both males and females in order to continue propagation... Read more

June 25, 2021 Acad, Gov/Utilities Clinical Research/Diagn. Microscopy PR/Corporate

Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children

The authorisation enables emergency use of Actemra/RoActemra for the treatment of COVID-19 in hospitalised adult and paediatric patients Basel, 25 June 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19... Read more

June 24, 2021 Acad, Gov/Utilities Microscopy

FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD)

If approved, PDS would be the first and only eye implant with continuous drug delivery that offers people living with nAMD an alternative to frequent eye injections A pivotal study showed PDS extends time between treatments up to six months for more than 98% of patients and provides vision outcomes equivalent to monthly ranibizumab injections... Read more