Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Daiichi, Esperion, Durect, Hemoshear, Kite, Novartis, Regeneron, Thetis.
A new FDA assessment of the data behind an emergency use authorization filing for Moderna Inc.'s COVID-19 vaccine candidate, issued in advance of a Dec. 17 meeting of the Vaccines and Related Biological Products Advisory Committee, affirmed efficacy claims for the product and identified "no specific safety concerns that would preclude issuance of an EUA."
Christmas arrived early for Athenex Inc. as the FDA approved Klisyri (tirbanibulin) for treating actinic keratosis on the face or scalp nearly two weeks before the treatment’s PDUFA date.
DUBLIN – Bowing to public and political pressure, the EMA has brought forward its review of BNT-162b2, the mRNA-based COVID-19 vaccine jointly developed by Pfizer Inc. and Biontech SE, to Dec. 21, more than a week ahead of its originally scheduled date of Dec. 29.
Several hospital and pharmacy groups, including the American Hospital Association, filed suit last week in the U.S. District Court for the Northern District of California in an effort to force the Department of Health and Human Services to stop drug companies from “undermining” the 340B prescription drug discount program.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Athenex, Astrazeneca, Can-Fite, Cyxone, Fortress, Genentech, IO Biotech, Nascent, Prometheus, Rafael, Takeda, Xentria.
Following a recent string of emergency use authorizations (EUA) for their jointly developed COVID-19 vaccine, BNT-162b2, Pfizer Inc. and Biontech SE said Dec. 14 that results from an ongoing German trial have helped illustrate "the multiple arms of the immune system that are activated" by the product to fight SARS-CoV-2. Separately, Moderna Inc. raised to 200 million the number of doses of its COVID-19 vaccine candidate it will supply to the U.S. government.
HONG KONG – Takeda Pharmaceutical Co. Ltd. has received Chinese approval for Takhzyro (lanadelumab), its fully human monoclonal antibody, delivered via subcutaneous injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 and older.
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada to extend COVID-19 flexibilities; USTR seeking input on nations with poor IP protections.
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