Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Atea, Eiger, Evoke, Fate, Foundation, Incyte, Karyopharm, Merck, Morphosys, Octapharma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Arch, Astex, Beyond Air, Cidara, Cyclo, Diffusion, Forma, KBP, Roche, Santhera.
Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Archerdx, Bio-Rad, Cochlear, Invivoscribe, Ortho, Quidel, Theradiag, Thermedical.
According to an analysis conducted by BioWorld of the first quarter 2020 financial reports filed by the top 100 public biopharmaceutical companies ranked by market cap, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the period increased by 13% compared to the same period last year.
Responding to COVID-19’s wakeup call as it exposes the risks of relying heavily on foreign biopharma supply chains, the U.S. Department of Health and Human Services (HHS) signed a four-year, $354 million agreement with a team of private industry partners, led by Phlow Corp., to expand U.S. manufacturing of essential medicines at risk of shortage during the pandemic and in future public health emergencies.
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
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