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Regulatory front for Feb. 16, 2021

Feb. 16, 2021

The latest global regulatory news, changes and updates affecting biopharma in Asia, including: FDA, Fresenius Kabi Oncology, Therapeutic Goods Administration, U.S. Department of Justice.

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Today's news in brief

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‘Ridiculous’ site-based hitches mar Biovie phase III in Alzheimer’s

BioWorld

For the second time this week, a contract research organization has come under fire for trial-conduct issues – criticism leveled most recently by Biovie Inc.,...

Off-target immune response from modified mRNA impacts future development

BioWorld

The Nobel Prize-winning modification that prevents the innate immune system from recognizing injected mRNA as foreign and blocking transcription of the protein it...

Waging the losing battle: Altimmune takes on challengers as Pfizer falls back

BioWorld

Altimmune Inc.’s peptide-based glucagon-like peptide-1/glucagon dual receptor agonist pemvidutide hiccupped in a phase I study earlier this year but has bounced...

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Regulatory front for Feb. 16, 2021