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. For biosimilars, however, this process is slightly more complex.

Bioequivalency 130

Bioequivalency Production Branding Contamination 130

XTalks

AUGUST 25, 2023

The FDA established the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires that food labels clearly identify the food source names of any ingredients that contain any protein derived from the nine most common food allergens. But how does this differ from government-set standards?

Allergies 98

Allergies Manufacturing Contamination Production 98

The Pharma Data

MAY 4, 2021

In February 2021, Pfizer and BioNTech announced results from an in vitro study published in NEJM that demonstrated sera from individuals immunized with BNT162b2 neutralize SARS-CoV-2 with the South African variant spike protein. The study investigated the full set of South African variant (also known as B.1.351 Amy Rose 212.733.7410.

Vaccination 40

Vaccination Vaccine Production Sales 40

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92