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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immune response, can be highly variable and impact the safety and efficacy of the drug. Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product.

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Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Conversations in Drug Development Trends

Biomarkers provide a rapid way to inform many clinical oncology study development decisions, including study endpoints. They can inform intervention outcomes, serve as study endpoints, and are advantageous across the spectrum of cancer care. What are they, how do they work, and how can they benefit your oncology study?

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Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study

The Pharma Data

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. “In Induction of innate immunity was investigated via specific cytokine markers.

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Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

The Pharma Data

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. High immune response after a single dose in patients with prior infection shows strong booster potential. For media and investors only. Issued: London UK. 1.351 (South African) variants.

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The Long Road to End Tuberculosis

Codon

Fortunately, some novel preventatives and therapies are in the works, including a vaccine equipped with adjuvants that efficiently prime the immune system and newer antibiotics against which the bacteria have yet to evolve resistance. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

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AZ resumes trial of COVID-19 vaccine

The Pharma Data

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. Source link.

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COVID19: Serology is harder than it looks

DrugBaron

This gives a clear indication of current (or very recent) infection, but it tells us nothing about the cumulative number of people exposed, nor the degree or nature of their immune response to the virus. The solution is a test for the immune response to the virus (often called a “serology test”).