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  2. US FDA proposes to remove switching study requirement for ...

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    The FDA has generally recommended switching studies to show evidence of interchangeability of a biosimilar. Regulatory reform is needed so patients can more easily access biosimilars and draw ...

  3. Biological therapy for inflammatory bowel disease - Wikipedia

    en.wikipedia.org/wiki/Biological_therapy_for...

    The anti-TNF-α monoclonal antibody infliximab is a major biological therapy for inflammatory bowel diseaseBiological therapy, the use of medications called biopharmaceuticals or biologics that are tailored to specifically target an immune or genetic mediator of disease, plays a major role in the treatment of inflammatory bowel disease. [1]

  4. Biosimilar - Wikipedia

    en.wikipedia.org/wiki/Biosimilar

    The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. [9] On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz .

  5. Infliximab - Wikipedia

    en.wikipedia.org/wiki/Infliximab

    Infliximab is a chimeric monoclonal antibody biologic. It seems to work by binding to and neutralizing TNF-α, preventing it from interacting with its receptors on the cell. [23] TNF-α is a chemical messenger and a key part of the autoimmune reaction. Infliximab was originally developed in mice as a mouse antibody.

  6. Wearable devices like Fitbit can predict IBD flares 7 weeks ...

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    heart rate variability — the amount of variation in time between heartbeats, or their regularity. steps — an indicator or physical activity. oxygenation — or pulse ox, the amount of oxygen ...

  7. Justin Baldoni claims Blake Lively 'never intended' to file ...

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    Justin Baldoni alleges Blake Lively's intentions in filing a civil rights complaint instead of a lawsuit "were deliberate.". Lively, 37, initially filed a complaint against Baldoni with the ...

  8. Biological response modifier - Wikipedia

    en.wikipedia.org/wiki/Biological_response_modifier

    [4] [9] Adverse effects may be class-dependent, and so switching to a biologic of another class may ameliorate those effects. [ 7 ] Potential serious adverse effects include allergic reactions , liver damage, cancer, and serious infections including tuberculosis , pneumonia , staph infection , and fungal infection .

  9. Feds Investigating 877K GM SUVs & Trucks Over Reported V-8 ...

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    The federal investigation covers select Chevrolet, Cadillac, and GMC trucks and SUVs built with the 6.2-liter L87 V-8 between the 2019 and 2024 model years. Feds Investigating 877K GM SUVs ...