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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them. Dextrum Laboratories Inc. Dextrum Laboratories Inc.

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Athersys to Host a Virtual Investor Day

The Pharma Data

Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

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Athersys Announces Three Appointments to Board of Directors

The Pharma Data

Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial.

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Small molecule API: Shining a spotlight on new innovations in milling

Pharmaceutical Technology

The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment. This prevents contamination of the elements by the sampled powder.