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The U.S. Biomedical Advanced Research and Development Authority (BARDA) commitment of up to $483 million to accelerate Moderna Inc.’s mRNA vaccine candidate, mRNA-1273, in efforts to fight coronavirus (SARS-CoV-2) would enable the company to supply millions of doses per month in 2020 and tens of millions per month in 2021 if the vaccine candidate is successful in the clinic.
LONDON – Researchers at the Jenner Institute in Oxford have given an inside view of how they are accelerating clinical development of a COVID-19 vaccine and at the same time putting in place commercial manufacturing for when phase III efficacy data are available, expected in August or September.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chi-Med, Everest, Redhill, Seattle Genetics.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clarus Therapeutics, Cynata Therapeutics, Evolus, Halix, Highlight Therapeutics, Lipocine, Nicox, Ocumension Therapeutics, Redhill Biopharma, Retrotope, Roche, Storm Therapeutics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Boehringer Ingelheim, Genentech, GSK, Lilly, Mesoblast, Mind Medicine, Momenta, Novartis, Oryzon, Regeneron, Sanofi, Sinovac, UCB, Veloxis.
HONG KONG – Foster City, Calif.-based Gilead Sciences Inc., which is ramping up its COVID-19 candidate production and research and is donating 1.5 million doses for compassionate use, published results in New England Journal of Medicine from a cohort analysis of 53 severe patients hospitalized with severe complications from COVID-19, showing a cumulative incidence of clinical improvement of 84% after 28 days of follow-up, according to Kaplan-Meier analysis.
Gaithersburg, Md.-based startup Hememics Biotechnologies Inc. is partnering with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a rapid, Bluetooth-connected, point-of-care (POC) test for COVID-19. Designed for use in both field and traditional settings, the test detects SARS-CoV-2 and related antibodies from nasal swabs and whole blood, delivering results in a minute or less.
A recent Senate hearing raised the question of whether privacy and confidentiality are at risk when software is installed in smart devices for disease surveillance purposes, but there may be no absolute guarantee of confidentiality, jeopardizing the goodwill of citizens who are wary of big government.
Case Western Reserve University spinout Synapse Biomedical Inc. has received emergency use authorization from the U.S. FDA for its Transaeris diaphragm pacing system (DPS) device to prevent and treat ventilator-induced diaphragm dysfunction (VIDD).
Despite challenges associated with the ongoing COVID-19 pandemic, Abbott Laboratories saw its first-quarter revenue beating expectations, coming in at $7.73 billion vs. an expected $7.44 billion. Cowen’s Josh Jennings highlighted this result, adding in a note that while there are challenges for nondiabetes medical devices and core diagnostics, areas including diabetes, nutrition, the established pharmaceuticals division and COVID-19 testing shined.
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