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.
Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bio-Rad, Euroimmun, Lifesignals, Nuvasive, Vitalconnect.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diffusion, Diverse, Lipocine, Mateon, Organicell.
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