Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Betta, Kintor, Moderna, Ocular, Roche, Seqirus, Sigilon, Turnsole.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aft, Alx, Fauna, Hyloris, Immune Regulation, Jaguar Health, Keros, Nanobiotix, Pharmaengine, Revolo, Seagen, Sumitomo, Tallac, Twoxar.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apellis, Aerpio, Bergenbio, Bioeclipse, Brii, Can-Fite, Eli Lilly, GT, Immutep, Longeveron, Macrogenics, Ocuphire, Seelos, Tersera.
CAJICA, Colombia – Cuba’s Center for the State Control of Drugs, Equipment and Medical Devices gave the green light March 3 for phase III trials of a domestically developed COVID-19 vaccine candidate, even though very little peer-reviewed information has been published about it.
The latest global regulatory news, changes and updates affecting biopharma, including: Australia eases substitution requirements; Guidance details fast-tracking modified vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kronos, Nervgen, Nicox, Novadip, Ocumension, Pfizer, RDIF, Regeneron, Sanofi.
As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.”