Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. Additionally, these types of cell free systems do not contain proteases and nucleases as crude cell lysates, which further helps in improving the production of many proteins.

Protein 52

Protein In-Vitro Production Reagent 52

Pfizer

AUGUST 15, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1,

Drugs 110

Drugs Licensing Licensing Production 110

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. NEW YORK, December 20, 2022 -- Pfizer Inc.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

NOVEMBER 23, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). This agreement will supply participating countries up to 3.4 million treatment courses upon orders being placed.

Licensing 40

Licensing Licensing Drugs Manufacturing 40