Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amidebio, Caladrius, CNS Pharma, Cstone, Immuneoncia, Immunomedics, Merck and Co., Rafael, Revive, Samsung Biologics, Vitalis.
Shares of Gilead Sciences Inc. were dented April 23 after reports surfaced that its antiviral drug, remdesivir, failed to improve the condition of patients with COVID-19.
LONDON – A veteran of the European vaccines industry has brought together three companies in three countries, in what is described as an ultra-fast-track COVID-19 vaccine development program. From a standing start less than three months ago, the three biotechs, Reithera Srl in Rome, Leukocare AG in Munich, Germany, and Univercells SA in Brussels, Belgium, have advanced to GMP manufacturing, with first-in-human studies due to start in June.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adocia, Aivita, Amryt, Astrazeneca, Baudax, Cel-Sci, Incyte, Leap, Obseva, Sanofi, Surface, Theravance, United Therapeutics, Windmil.
Recent seizures of fake medical products being marketed in the COVID-19 pandemic underscore the need to curb the growing international trade in counterfeit drugs that’s putting hundreds of thousands of lives at risk, the Organisation for Economic Cooperation and Development (OECD) warned this week.
BEIJING – Nanobody startup Sysvax Inc., with its R&D center in Beijing and manufacturing facilities in Zhongshan, is developing a recombinant protein vaccine and a nanobody therapeutic for COVID-19, while trying to extend the half-life of potential COVID-19 treatments with its expertise in this smallest possible antibody format.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Algernon, Biontech, Clarity, Janssen, Mallinckrodt, Novartis, Pfizer, Vitro.
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