Pharmaceutical Technology
MARCH 1, 2023
Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Merck also provides a wide range of products including lab water systems, gene editing tools, cell lines, antibodies and end-to-end systems.
Pharmaceutical Technology
MARCH 1, 2023
Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Merck also provides a wide range of products including lab water systems, gene editing tools, cell lines, antibodies and end-to-end systems.
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Camargo
DECEMBER 13, 2021
Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. Product Type-Specific Analysis.
FDA Law Blog
FEBRUARY 29, 2024
If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.
The Pharma Data
NOVEMBER 21, 2020
In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. Hahn , M.D.
XTalks
FEBRUARY 8, 2021
They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. What is a Biosimilar? Biosimilars are the “generic” drugs of the biopharma world. MYTH: Treatment-experienced patients cannot be prescribed biosimilars.
The Pharma Data
FEBRUARY 13, 2022
Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks.
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