The FDA has issued Sanofi SA a complete response letter (CRL) regarding its complement pathway inhibitor sutimlimab, citing deficiencies found during a pre-license inspection of a third-party manufacturing facility.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers protest latest 340B scheme; Groups make case for extending sequester moratorium; More $$ needed for global vaccine effort; Russia extends COVID-19 drug, device program.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Agios, Amgen, Bayer, Biomarin, Boehringer Ingelheim, Chiesi, Heron, Innate, Menari, Moderna, Roche, Samsung, Shionogi, Sobi, UCB, Viiv.
BOGOTA, Colombia and VANCOUVER, Canada – Anvisa, Brazil’s health care surveillance agency, re-started phase III trials for Coronavac, the COVID-19 vaccine candidate developed by China-based Sinovac Biotech Ltd., after a suspension of just two days. “Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination,” the regulator said on Nov. 11. Anvisa said it plans to continue monitoring “the possible relationship of causality” between an unexpected serious adverse event and the vaccine.
The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Apollomics, Bavarian Nordic, Halozyme, Janssen, Mycovia, Neonmind, Valeo, Vasomune.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiocrine, Bioxcel, Gyroscope, Inventiva, Sebela, Sorrento, Surface.
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
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