Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genmab, Hyloris, Novartis, Nrx, Provention.
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare.
The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines.
With vaccines now authorized for children as young as six months, omicron boosters in development for the fall, and the nation’s first protein subunit vaccine for COVID-19 pending authorization, the U.S. appears to be well on its way to exiting the turmoil caused by the deadly SARS-CoV-2 virus. Globally, there is reason for optimism as well.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Ascentage, Aura, Bavarian Nordic, Nurix, Pfizer, Phanes, Skye.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amarin, Bavarian Nordic, Biontech, Emergex Vaccines, Essa, Immunome, Oncodesign, Pfizer, Regeneron, Rome, Sanofi.
Pfizer Inc. and Biontech SE have signed a deal with the U.S. government to supply up to 300 million doses of COVID-19 vaccines in a deal worth more than $3.2 billion. Depending on the U.S. FDA, the vaccine doses fulfilling the order may include the companies’ omicron-adapted candidate, which they reported June 25 demonstrated a high immune response against the omicron BA.1 subvariant of SARS-CoV-2, when given as a fourth booster.
South Korea’s Ministry of Food and Drug Safety has granted marketing authorization to SK Bioscience Ltd.’s COVID-19 vaccine, Skycovione (GB-510), marking the country’s first homegrown COVID-19 vaccine to be approved. The company has already signed an advanced purchase agreement with the Korea Centers for Disease Control for 10 million doses of the vaccine.
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