Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Arrowhead, Avenue, Bausch, Cardiol, Clearside, Eyenovia, Merck & Co., PTC, Recce, Ridgeback.
LONDON – A U.K. study following up 32.5 million people for 28 days after their first dose of a COVID-19 vaccine has shown an increased risk of hemorrhagic stroke after receiving the Pfizer Inc./Biontech SE product, and confirmed case reports of an increased risk of developing Guillain-Barré syndrome after the Astrazeneca plc vaccine.
Interim data from a phase II/III study of Moderna Inc.’s COVID-19 vaccine show a robust antibody response in children ages 6 through 11, stronger than the one the company found in adolescents. Two 50-mcg doses given 28 days apart also produced a favorable safety profile that nearly mirrored that of adolescents and adults.
The race for a Japan-made COVID-19 vaccine is heating up as players make progress with their trials. Daiichi Sankyo Co. Ltd. recently shared the results from its phase I/II trial for DS-5670, its mRNA vaccine. The mRNA vaccine candidate initiated studies in March 2021. The findings showed that in terms of immunogenicity, both neutralizing activity and IgG titer increased after the vaccination.
LONDON – The U.K. Health Security Agency (UKHSA) has designated an offspring of the Delta variant of SARS-CoV-2 as a “variant under investigation” after uncovering some early evidence it may have an increased growth rate.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: J&J, Kintor, Merck & Co., Moderna.
Iceni Diagnostics Ltd. is accelerating efforts to commercialize a diagnostic for detecting COVID-19 using sugars rather than antibodies. Lateral flow diagnostics (LFDs) have been widely used during the COVID-19 pandemic to diagnose people with an active infection. The tests use antibodies, which attach to the SARS-COV-2 virus but Iceni’s Host-Pathogen Glycan Recognition technology has been touted as a potential alternative due to its polymer approach.
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