Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Avadel, Axsome, CTI Biopharma, Harpoon, Hua, Italfarmaco, Myovant, Regeneron, Sanofi, Valo.
PERTH, Australia – Australian stem cell company Mesoblast Ltd.’s shares were up nearly 39% on the news that its allogeneic cell therapy showed an 83% survival rate in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) treated at New York’s Mount Sinai Hospital.
LONDON – The World Health Organization (WHO) launched a global collaboration to accelerate development and production of COVID-19 vaccines, therapeutics and diagnostics, with leaders of countries around the world appearing live to pledge their support.
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Biosig, Innovent, Janssen, Lilly, Oryzon, Sanofi, Viralclear.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptvac, AGC, Agastiya, Axovant, Emergent, Johnson & Johnson, Epimab, Hoth, Voltron, Nexstim, Sanofi, Scancell, Sumitomo Dainippon, Takeda, Orifarm, Tracon.
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.
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