Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprea, Biontech, Cytodyn, Immune-Onc, Ipsen, Jazz, Moderna, Novatek, Pfizer, Rigel.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Chemotherapy, Ampio, Bexson, Cytocom, Fusion, Moderna, Mustang, Nyrada, RDIF, Sen-Jam, Theratechnologies.
The FDA has made allowances for a third COVID-19 vaccine dose to protect certain adults with compromised immune systems. The amended emergency use authorization amendments allow for booster doses of mRNA vaccines from Pfizer Inc.-Biontech SE and Moderna Inc.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coopercompanies, Cytosorbents, Diacarta, Speedx, Syntr Health Technologies.
According to the White House, the FDA is poised to allow COVID-19 booster shots from Pfizer Inc. and Moderna Inc., the two mRNA vaccines, but only for those people with compromised immune systems. The FDA announcement was anticipated to be as early as today, Aug. 12, and the boosters could be available as quickly as this coming weekend.
Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antheia, Artiva, Atai, GC Labcell, Ginkgo, Introspect, Johnson & Johnson, Nimbus, Nobelpharma, Novartis, Novozymes, Noxopharm, Probiogen, Revixia, Schrödinger, Sunshine, Vyne, WHO.
A proportion of patients with COVID-19 develop neurological symptoms, including headaches, encephalopathy and seizures, but it is unknown to which extent.
The FDA’s device center has generated a raft of warning letters for products related to the COVID-19 pandemic, and released another six such letters for the week of Aug. 9. However, the ostensible justification for those warnings varies considerably, as does the elapsed time between the date of the warning letter and its issuance on the FDA’s warning letter webpage.
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