BioSpace News Archive

ARTMS Inc. (‘ARTMS’) and Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’) are pleased to announce they have successfully produced Telix’s prostate cancer imaging product, TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11)1, using multi-Curie quantities of cyclotron-produced Gallium-68 (68Ga) via ARTMS’ proprietary Quantum Irradiation System (QIS®) solid target system.

Veralox Therapeutics, today announced it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This regulatory submission was based on Phase III FIDELIO-DKD trial data, which were recently presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020,

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 12-month data from its TRANSCEND clinical trial will be presented at the upcoming Leipzig Interventional Course (LINC) 2021 virtual event.

MatMaCorp (Materials and Machines Corporation), a developer of comprehensive molecular diagnostic systems, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of MatMaCorp’s COVID-19 2SF RNA test for the detection of SARS-CoV-2 on the company’s Solas 8® portable detection system.

Tessera Therapeutics, an early-stage life sciences company founded by Flagship Pioneering, announced today that it has raised over $230M in Series B financing.

Turner Imaging Systems , developers of the revolutionary Smart-C X-ray imaging system, has entered into a Sponsored Research Project with Massachusetts General Hospital to investigate the use of the Smart-C for weight-bearing radiographs of the foot and ankle. The Smart-C mini C-arm has a unique 16-pound portable design that is battery operated and hand-transportable, potentially improving where and how fluoroscopy is

Cognito Therapeutics, a clinical-stage company leading the development of a new class of disease-modifying digital therapeutics to treat neurodegenerative disorders, announced today its lead product has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease.

AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, and First Wave Bio, Inc., (“First Wave Bio”) a clinical-stage biotechnology company developing novel gut-targeted small molecules for inflammatory bowel disease and other serious conditions

CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, pre-announces preliminary unaudited fourth quarter 2020 and full-year 2020 results ahead of filing its Form 10-K.