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Transforming Biomanufacturing: Potential of Cell Free Systems

Roots Analysis

In addition to the healthcare industry, other industries, such as food industry, cosmetics industry and enzyme synthesis industry, are also benefiting from the cell free manufacturing process.

Protein 52
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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. IMPORTANT SAFETY INFORMATION.

Drugs 99
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From Gene to Protein: The Journey of Protein Expression Technology

Roots Analysis

Protein expression is a potent technology in the field of synthetic biology, that is utilized for the high-throughput production of proteins as well as enzymes and oligonucleotides (DNA / RNA). This process initially involves transcription of DNA to messenger RNA (mRNA). The mRNA is then translated into to form functional proteins.

Protein 40
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FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The Pharma Data

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. SOURCE U.S.

Vaccine 52
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Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. IMPORTANT SAFETY INFORMATION .

Drugs 110
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U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. IMPORTANT SAFETY INFORMATION.

Drugs 69