BioSpace News Archive

Novavax, Inc. (Nasdaq: NVAX), today announced that Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) as a homologous and heterologous booster for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for adults aged 18 and older.

This week, a federal judge in California issued a landmark decision siding with the California Stem Cell Treatment Center (CSCTC) in a lawsuit brought by the U.S. Food and Drug Administration, ruling that Cell Surgical Network’s innovative surgical procedure that uses patients’ stem cells to treat a range of medical conditions does not fall under the FDA’s regulatory jurisdiction.

Gritstone bio, Inc. announced that management will present at the 2022 Wells Fargo Healthcare Conference, taking place September 7-9, 2022, in Boston, MA, and participate in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference, taking place September 12-14, 2022, in New York, NY.

Intellia Therapeutics, Inc. (NASDAQ:NTLA), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia’s in vivo CRISPR/Cas9 genome editing candidate, NTLA-2002, for the treatment of hereditary angioedema (HAE).

Revelle Aesthetics, Inc. (Revelle) – a VC-backed Silicon Valley MedTech company – achieves an extended FDA clearance for its precision cellulite release device, Avéli™.

Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, announced that it signed a credit facility for up to $200 million with affiliates of existing shareholders Perceptive Advisors and Community Fund.

Lexogen, a transcriptomics and Next-Generation Sequencing company announced the release of the new RiboCop rRNA Depletion Kit for Yeast today.

Avidity Biosciences, Inc., a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates, announced that the Avidity management team will be participating at the following upcoming conferences.

Cerveau Technologies, Inc. announced a research collaboration agreement with Alnylam® Pharmaceuticals, which will enable Alnylam to use Cerveau’s [F-18]MK-6240, an investigational imaging agent, in Positron Emission Tomography scans to assess the status and progression of neurofibrillary tangles in the brain.

ANGLE plc, a world-leading liquid biopsy company, will be releasing its interim results for the six months ended 30 June 2022 on Thursday 29 September 2022.