mRNA vaccine

Moderna Says FDA Refusal to Review mRNA Flu Vaccine Contradicts Federal Rules, Prior Guidance

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with guidance given prior to the start of Phase 3 testing.

By Frank Vinluan

BioPharma, Legal

BioNTech to Pay CureVac, GSK $740M Plus Royalties to Settle mRNA Patent Disputes

The deal helps move BioNTech’s proposed acquisition of CureVac closer to completion. With the settlement, GSK said it will tender the CureVac shares it owns in support of the $1.25 billion acquisition.

By Frank Vinluan