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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Antabio, Astrazeneca, BMS, Cabaletta, Immunicum, Interna, Kiadis, Laurent, Medivir, Pulmotect, Zia.
Zoll Medical Corp., of Chelmsford, Mass., received CE mark approval to market its second-generation Supersaturated Oxygen (SSO2) Therapy in Europe and other countries that accept CE mark. The therapy, which delivers hyperbaric levels of oxygen to the ischemic heart muscle immediately following percutaneous coronary intervention, has been shown to significantly reduce damage to the heart muscle after an acute myocardial infarction.
Palo Alto, Calif.-based Varian Medical Systems Inc. has joined the ranks of other companies in withdrawing its guidance even as at least one analyst saw positive news for the second quarter. For her part, BTIG’s Marie Thibault noted that the company missed on Americas oncology gross order metric, while falling short on consensus non-GAAP earnings per share (EPS) by five cents.
BOGOTA, Colombia – As it works to more efficiently fight COVID-19, Chile is developing new regulations to support and boost telemedicine with an eye on the current outbreak but also on improving the provision of health care in the country in the long term. Patients with chronic conditions, who are at a greater risk from COVID-19, are being prioritized as the focus for telemedicine progresses.
PARIS – In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product.
BEIJING – In one of the latest Sino-foreign collaborations formed to find a cure for the pandemic that has infected 3.5 million people worldwide, Shanghai-based Junshi Biosciences Co. Ltd. and Eli Lilly and Co. have disclosed an agreement to co-develop therapeutic antibodies for preventing and treating COVID-19. Under the terms, Junshi grants Lilly an exclusive license, outside of greater China, to conduct R&D, manufacture and distribute the SARS-CoV-2 JS-016 neutralizing antibodies developed by Junshi.
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