PERTH, Australia – As COVID-19 infections in Australia continue to mount, a dozen or so Australian compounds are winding their way through the pipeline that could offer additional protection to the vaccines and antivirals that are already provisionally approved by Australia’s Therapeutic Goods Administration.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergy, Ascletis, Cortexyme, Gilead, Hope, Ibio, Immunocore, Incyte, Molecular Targeting.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aridis, Atai, Cocrystal, Dalriada, Johnson & Johnson, Meiragtx, Nanobiotix, Nurosene.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Biotheryx, Cyclerion, Evaxion, Lipidor, Panbela, Tyme, Vaccinex, Valneva, Xbiotech.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Maxim Biomedical.
Pfizer Inc. CEO Albert Bourla has been talking for the past few weeks about creating a vaccine to control the omicron variant. Now the company, with partner Biontech SE, has initiated a clinical study of its new candidate by testing it in healthy adults. Bourla has said the company can adapt its vaccine to new variants in under three months and could have one ready to go in March if necessary.
The amount of clinical data reported in January so far is currently 30% below the amount reported during the same month last year, which was the slowest month of 2021.
The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis.
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