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Solving The Protocol Deviation Puzzle With FDA Draft Guidance

Solving The Protocol Deviation Puzzle With FDA Draft Guidance

by palligoelme@gmail.com | Mar 14, 2025 | Clinical Trials

​  Knowing exactly what to do when a protocol deviation (PD) arises can be challenging. Here, consultant Leila Cupersmith summarizes new FDA guidance on managing PDs.  Knowing exactly what to do when a protocol deviation (PD) arises can be challenging. Here,...
INOVIO Announces Promising Interim Results from Ongoing Proof-of-Concept Clinical Trial of DNA-Encoded Monoclonal Antibodies (DMAbs) for COVID-19

INOVIO Announces Promising Interim Results from Ongoing Proof-of-Concept Clinical Trial of DNA-Encoded Monoclonal Antibodies (DMAbs) for COVID-19

by palligoelme@gmail.com | Mar 13, 2025 | Clinical Trials

​  Long-lasting in vivo antibody production: DMAb levels remained stable for 72 weeks in all participants (n=24) who have reached that timepoint No anti-drug…  Long-lasting in vivo antibody production: DMAb levels remained stable for 72 weeks in all participants...
World-first clinical trial shows promise for transformative oral snakebite treatment

World-first clinical trial shows promise for transformative oral snakebite treatment

by palligoelme@gmail.com | Mar 13, 2025 | Clinical Trials

​  Researchers from Liverpool School of Tropical Medicine (LSTM) have completed a Phase I clinical trial for a new oral treatment for snakebite.  Researchers from Liverpool School of Tropical Medicine (LSTM) have completed a Phase I clinical trial for a new oral...
Combination immunotherapy before surgery may increase survival in people with head and neck cancer: Clinical trial

Combination immunotherapy before surgery may increase survival in people with head and neck cancer: Clinical trial

by palligoelme@gmail.com | Mar 13, 2025 | Clinical Trials

​  Researchers conducting a clinical trial of immunotherapy drugs for people with head and neck squamous cell carcinomas (HNSCCs) found that patients responded better to a combination of two immunotherapies …  Researchers conducting a clinical trial of...
Expanded Access Program for recombinant BCG launches at first US site

Expanded Access Program for recombinant BCG launches at first US site

by palligoelme@gmail.com | Mar 13, 2025 | Clinical Trials

​  There are also 60 sites in the process of launching the EAP.  There are also 60 sites in the process of launching the EAP. 
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