mRNA
Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklund, CEO of Circio and Jacob Becraft, Co-founder and CEO of Strand Therapeutics. They discuss how post-COVID, emerging platforms like circular and logic circuit RNA are expanding the field’s therapeutic horizons.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
Moderna will continue to lead clinical development and manufacturing of the asset, while Recordati will handle commercialization of mRNA-3927, which is under development for the rare metabolic disorder propionic acidemia.
Despite Sanofi CEO Paul Hudson’s confidence in vaccines, the French pharma has cut at least one mRNA flu shot program.
Attendance at the Biotech CEO Sisterhood’s annual photo of women leaders and allies in Union Square doubled this year. There’s still more work to do.
After winning a surprise approval for its hereditary angioedema drug Ekterly, KalVista is confident the oral offering will capture the lion’s share of the market for on-demand use.
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