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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government. 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).

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

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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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Aurinia Announces Collaboration and Licensing Agreement with Otsuka Pharmaceutical Co., Ltd. for the Development and Commercialization of Voclosporin in Europe and Japan

The Pharma Data

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., The Company focuses its development efforts globally. .–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. commercial hub is in Rockville, Maryland.

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

The Pharma Data

Expands Novartis Oncology radioligand pipeline with exclusive worldwide rights to develop and commercialize therapeutic applications for a library of FAP assets including FAPI-46 and FAPI-74. Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. Disclaimer.

Protein 52
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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity.