Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apeiron, Beyondspring, BMS, Genfit, Hansa, Marinus, Menarini, Novavax, Radius Rhizen, Uniqure.
Ionpath Inc., a developer of high-definition spatial proteomics, scored $18 million in a series B funding round led by Samsara Biocapital. The round also included global mass spectrometry leader Bruker Corp. as a new investor. Menlo Park, Calif.-based Ionpath plans to use the investment for continued development and deployment of the company’s Multiplexed Ion Beam Imaging (MIBI) technology, which provides quantitative protein imaging at a subcellular level.
As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era.
Keeping you up to date on recent developments in diagnostics, including: Distinguishing metastatic SLNs in breast cancer; MRS method reveals insights into Alzheimer’s disease; SARS-CoV-2 multiplex assay allows 3x as many patients per run.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alafair Biosciences, Assure Tech, Quadrant Biosciences, Vela Diagnostics.
LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA stands by plasma EUA; Benzodiazepines to get added warnings; EMA posts draft guidance for registry-based studies; SEC finalizes whistleblower changes; Gilead to pay $97M; Plandai, CEO settle with SEC.
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