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Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

The Pharma Data

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars.

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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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Codon Digest: Injected Gene Editors

Codon

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Large-scale purification of functional AAV particles packaging the full genome using short-term ultracentrifugation with a zonal rotor. from 2021 to 2022, up to $625 million. Nature Biotechnology. Ricciardi M.J. Gene Therapy.

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