Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. Following QbD to guarantee a drug product's safety.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

XTalks

AUGUST 2, 2023

2) Veklury (remdesivir) Veklury, approved by the FDA in 2020, is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor designed for the treatment of COVID-19. Veklury generated a revenue of $3.91 Moderna, a pharma and biotech company based in Massachusetts, specializes in RNA therapeutics, particularly mRNA vaccines.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

FDA Law Blog

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. animal, viral, bacterial) DNA and RNA sequences. Javitt & Jeffrey N. Supporters of AMP v.

Gene 64

Gene DNA Genetics Gene Sequencing 64

XTalks

SEPTEMBER 14, 2020

The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. Company Drug Purported Mechanism of Action Evidence to Date Developmental Status. Fujifilm Favipiravir (Avigan) Inhibits RNA-dependent RNA polymerase.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92