The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand.
The circuit breakers activated almost immediately when the markets opened this morning as the Dow plummeted, with investors moving into cash and away from equities. Clearly, they were not impressed with the Federal Reserve’s decision to slash its benchmark interest rate to nearly 0% to help combat the economic fallout from the coronavirus outbreak.
Mainz, Germany-based Biontech SE has struck two deals in its Project Lightspeed, one for inside China and one for outside China, to develop and commercialize a COVID-19 messenger RNA (mRNA) prevention vaccine. The agreements caused the stock (NASDAQ:BNTX) to soar 29.3%, or $9.07, to close at $40 on Monday in the midst of a bear market.
LONDON – The European Commission offered up to €80 million (US$89.4 million) of funding to Curevac AG, to scale up development and production of a vaccine against the coronavirus in Europe, following reports that the U.S. administration had made an offer for the German biotech, in order to get exclusive control of its COVID-19 vaccine candidate.
Undetected cases were a major driver of the early spread of SARS-CoV-2 in Wuhan, China, despite being less infectious on a case-by-case basis, according to a modeling study published in the March 16, 2020, online issue of Science.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, Cytodyn, Kadmon, Lilly, Tracon, Zai Lab.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelrx, Advanz, Akebia, Amarin, Armas, Brainstorm, Correvio, Homology, Kirin, Medivir, Nanoviricides, Pharmamar, Protalix, Spherix, Tango, Tetraphase, Therapeuticsmd, Twist, Xortx.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AGTC, Aimmune, Aptevo, Arcutis, Biocryst, Can-Fite, Genetx, Moderna, Novo Nordisk, Regeneron, Sanofi.
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax (nitric oxide) inhaled gas to treat COVID-19-associated lung complications. INOmax is marketed in the U.S. by the Staines-upon-Thames, U.K.-based company to treat full- and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
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