Robotic-assisted surgical procedures have fallen off steeply as the ongoing global pandemic has unfolded, but the real impact on Intuitive Surgical Inc. will come as its hospital customers may have to limit orders for expensive equipment upgrades as they struggle to manage unprecedented financial burdens. The U.S. accounts for about 70% of its robotic surgery procedures, but by the last few weeks in March, that activity had been curtailed by roughly two-thirds.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cirrusdx, Curative, Vent Multiplexor.
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.
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