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Latest From Moderna, Inc.

Pfizer’s COVID-19 Vaccine Data In Young Children Could Place US FDA In Awkward Position Again

The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.

Coronavirus COVID-19 Vaccines

EU New Drug Approvals Hit Record High

Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.

Pink Sheet Perspectives Europe

Year Of IP: From The TRIPS Waiver Proposal To The Moderna-NIH Patent Tussle

Intellectual property became front page news in 2021 as the pandemic ignited a debate on the role of patents in accessing COVID-19 vaccines and therapeutics. 2022 will see a decision on the TRIPS waiver, a new USPTO director, and action on a pending march-in petition.

Intellectual Property Pink Sheet Perspectives

2021 Saw India Enable Accelerated Regulatory Pathways – Can It Become The Norm?

India saw a raft of vaccine and drug approvals in 2021, backed by pandemic-related accelerated regulatory processes, and outlined its intent to step up biopharma innovation in the country.  Pharma wants some of the regulatory flexibility to stay, though experts are seeking increased transparency in the overall approach.

Approvals Drug Approval Standards
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  • Other Names / Subsidiaries
    • Caperna LLC
    • Moderna Therapeutics, Inc.
    • Moderna LLC
    • Newco LS18, Inc.
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