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Related Concept Videos

Treatment Resistent Cancers02:56

Treatment Resistent Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
Treatment Resistant Cancers02:56

Treatment Resistant Cancers

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Pulmonary Tuberculosis V01:28

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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF01:24

Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF

Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab (Humira),...
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Targeted Cancer Therapies

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Related Experiment Video

Updated: Jun 18, 2026

Tracking Bispecific Antibody-Induced T Cell Trafficking Using Luciferase-Transduced Human T Cells
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Tracking Bispecific Antibody-Induced T Cell Trafficking Using Luciferase-Transduced Human T Cells

Published on: May 12, 2023

How Tysabri survived.

Brady Huggett1

  • 1Nature Biotechnology, USA.

Nature Biotechnology
|November 10, 2009
PubMed
Summary
This summary is machine-generated.

Biogen Idec successfully reintroduced Tysabri, a multiple sclerosis (MS) drug, to the market in under 16 months. This achievement is notable as most withdrawn drugs rarely return after market removal due to serious toxicities.

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Last Updated: Jun 18, 2026

Tracking Bispecific Antibody-Induced T Cell Trafficking Using Luciferase-Transduced Human T Cells
10:19

Tracking Bispecific Antibody-Induced T Cell Trafficking Using Luciferase-Transduced Human T Cells

Published on: May 12, 2023

Area of Science:

  • Neuroscience
  • Pharmacology
  • Drug Development

Background:

  • Market withdrawal of drugs due to serious toxicities often results in permanent discontinuation.
  • Biogen Idec's multiple sclerosis (MS) drug, Tysabri, faced market withdrawal.
  • Reintroduction of withdrawn drugs is a rare and challenging process in the pharmaceutical industry.

Purpose of the Study:

  • To analyze the successful market reintroduction of Tysabri, a multiple sclerosis (MS) drug.
  • To understand the factors contributing to the rapid reintroduction of a drug previously withdrawn for safety concerns.

Main Methods:

  • Review of regulatory filings and timelines associated with Tysabri's withdrawal and reintroduction.
  • Analysis of safety data and risk management strategies implemented by Biogen Idec.
  • Examination of the regulatory landscape for drug reintroduction post-market withdrawal.

Main Results:

  • Tysabri was successfully reintroduced to the market in less than 16 months following its withdrawal.
  • Biogen Idec implemented specific risk mitigation strategies and communicated updated safety information.
  • Regulatory agencies approved the reintroduction based on revised risk-benefit assessments.

Conclusions:

  • The successful and rapid reintroduction of Tysabri demonstrates that drugs withdrawn for toxicity can return to the market.
  • Effective risk management and transparent communication with regulatory bodies are crucial for drug reintroduction.
  • This case provides a model for navigating the complex process of drug reintroduction after safety-related market withdrawal.