Press Releases
Resolve Biosciences, the pioneer in Molecular Cartography™, and ZEISS today announced a co-development collaboration to advance spatial biology applications. The companies are working together to optimize advanced microscopy and 3D imaging solutions for subcellular spatial analysis. ZEISS microscopy technology is part of Resolve’s current Molecular Cartography service offering and will be incorporated into the commercial spatial transcriptomics system scheduled to launch later thi
Read more...4 August 2021
Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults older than 60 years of age. “We are pursuing an mRNA RSV vaccine to protect the most vulnerable populations – young children and older adults,” said Sté
Read more...3 August 2021
Autobahn Therapeutics, a biotechnology company focused on restoring hope for people affected by CNS disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the company’s investigational product candidate, ABX-002, for the treatment of patients with X-linked adrenoleukodystrophy (X-ALD). ABX-002 is a CNS-penetrating prodrug that provides a balanced delivery of LL-340001, a potent and selective thyroid hormone receptor beta (TR&b
Read more...3 August 2021
Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participant has been dosed in the Phase 1 study of mRNA-6231, the Company’s mRNA-encoded IL-2 modified for the expansion of regulatory T cells. mRNA-6231 is Moderna’s first autoimmune candidate to enter the clinic. It is also Moderna’s first subcutaneously administered therapeutic program. “The initiation of the Phase 1 study of mRNA-623
Read more...Better Therapeutics, Inc., a prescription digital therapeutics company delivering cognitive behavioral therapy to address the root causes of cardiometabolic diseases, in partnership with Colorado Prevention Center (CPC) Clinical Research, affiliated with the University of Colorado Anschutz Medical Campus, today announced the commencement of a real-world evidence study to evaluate the long-term effectiveness and healthcare utilization changes associated with the use of BT-001 for the treatment
Read more...30 July 2021
GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. CRSwNP accounts for 2-4% of the US popula
Read more...29 July 2021
Oncologists and pathologists in the United States can now access a new in vitro diagnostic (IVD) test that screens for Lynch syndrome in patients with colorectal cancer. The OncoMate™ MSI Dx Analysis System (OncoMate™ MSI), developed by Promega, has been cleared by the US Food and Drug Administration (FDA) as an IVD medical device to determine microsatellite instability (MSI) status in colorectal cancer tumors. This is the industry's first and only PCR-based diagnostic kit for
Read more...29 July 2021
THREAD, a technology and service provider enabling decentralized clinical trials (DCTs), and Almac Clinical Technologies, a member of the contract and development organization, Almac Group, today announced a strategic partnership. The market leaders will integrate their technologies to enable more efficient clinical trials that generate better outcomes. By integrating their proprietary technology platforms, THREAD and Almac will provide sponsors and contract research organizations (
Read more...Once again, the German Packaging Institute (Deutsches Verpackungsinstitut e.V.) has honored Syntegon with the German Packaging Award – this time in the category “Sustainability”. The jury was impressed by the sustainability and good functionality of the paper-based packaging solution “Blister meets Paper”, which should also appeal to the health- and environmentally-conscious customer in terms of feel and appearance. Syntegon developed the innovative blister packa
Read more...28 July 2021
NRx Pharmaceuticals, a clinical stage, global biopharmaceutical company, today announced that the Nation of Georgia's Prime Minister and Minister of Health have issued an Emergency Use Authorization for intravenous ZYESAMI™ (aviptadil) for the treatment of Critical COVID-19. "Lead investigators from our ZYESAMI™ clinical trials are on their way to the Nation of Georgia and will be on the ground there within 24 hours to start teaching physicians how to administer
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