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. Read More
Metagenomi Inc. has raised a $65 million series A financing to expand its gene editing abilities, advance its research and validate its pipeline in preclinical studies. The company’s CRISPR-based systems use algorithms for screening thousands of genomes from microorganisms to advance therapies for use in oncology, genetic diseases and possibly much more. Read More
Researchers at Yale University have described what they have called a “data sanitization tool,” enabling them to strip personal identifiers out of functional genomics data while preserving their usefulness for research. Read More
Mymd Pharmaceuticals Inc., the privately held developer of a synthetic derivative of tobacco alkaloids for the potential treatment of autoimmune diseases and age-related disorders, will soon list on Nasdaq via its acquisition of former point-of-care testing company Akers Biosciences Inc., shares of which (NASDAQ:AKER) climbed 29.1% to $2.22 on Nov. 12. The combined company, to be headquartered in Baltimore, will retain Mymd's name and adopt the trading symbol MYMD. Concurrent with the merger, Akers is raising $18 million in a private placement priced at-the-market. Read More
LONDON – Synendos Therapeutics AG is poised for a fresh attempt at drugging the endogenous endocannabinoid system after raising CHF20 million (US$21.8 million) to take its lead program into clinical development. Read More
HONG KONG – Galmed Pharmaceuticals Ltd. has signed a research and development collaboration agreement with fellow Israeli biotech company Mybiotics Pharma Ltd. to identify and optimize the selected microbiome repertoire associated with the response to Aramchol (arachidyl amido cholanoic acid), Galmed’s fatty acid bile acid conjugate treating nonalcoholic steatohepatitis. Read More
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. Read More
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. Read More
