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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC). This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government.

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Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. associates, residents, research fellows). Sites outside of the U.S. Make sure they are signed and dated.

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AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development

The Pharma Data

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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Crescita Announces Licensing Agreement for Pliaglis; in China

The Pharma Data

(TSX: CTX) (OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house research & development (“R&D”) and manufacturing capabilities, today announced that it has entered into an exclusive agreement with Juyou-Biotechnology Co.

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Radioligand therapy pipeline with in-license for compounds targeting Fibroblast Activation Protein (FAP)

The Pharma Data

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. These targeted drugs bind to markers or proteins over-expressed by certain tumors, or tumor-associated tissue, such as stroma. Disclaimer. Source link:[link].

Protein 52
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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 7, 2021.

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Dietary Supplements: Regulations in Research Studies and IRB Considerations

WCG Clinical

Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. Next, let’s look at considerations for study design: Study objectives are crucial in defining the specific aim of the research and the intended use of the product.