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HealthPartners

www.healthpartners.com

Latest From EMD Serono Inc.

Q&A With Sutro's William Newell

Bill Newell discusses the progress of Sutro’s commercialization programs on ADCs as well as lessons on leading a small biotech in a crowded competitive field of big pharma players.

BioPharmaceutical

Keeping Track: Immuno-Oncology Racks Up More Approvals; Bar Still Too High For Advair Generics

The latest drug development news and highlights from our US FDA Performance Tracker.

Approvals Complete Response Letters

Novel Biologics In US Might Not Start Getting Suffixes Until August

FDA has cleared four novel biologics without a suffix despite finalizing nonproprietary naming guidance; the agency requests sponsors submit proposed suffixes at the time a BLA is submitted.

Biologics Approvals

Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval

Genentech’s ocrelizumab, a CD20-directed antibody, becomes first US-approved treatment for primary progressive multiple sclerosis and is also indicated for relapsing disease. Labeling includes warnings about infusion reactions, infections and malignancy but lacks a boxed warning or REMS.

Approvals Biologics
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  • Worldwide
    • North America
      • USA
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  • HealthPartners
    Phone: (952) 853-8888
    8170 33rd Ave.
    Bloomington, MN 55425
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