COVID-19 Update

Combatting Future Viral Threats with Vaccine Advances

The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.

What’s Next for COVID-19 Vaccines and Variants?

More technologies and treatments are emerging for COVID-19—along with new variants.

Key Elements for Assay Transfer Success

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

FDA Gives Guidance on Manufacturing During COVID-19

September 14, 2020

The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.

AZD1222 Clinical Trials Resume in the UK

September 13, 2020

Clinical trials for AZD1222 coronavirus vaccine resume in the UK as per guidance by MHRA.

Career FDA Leaders Say Science Is Agency’s Guide

September 11, 2020

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

AMRI Signs Agreement with AstraZeneca for COVID-19 Vaccine Delivery

September 09, 2020

AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.

AstraZeneca Pauses Clinical Trial on COVID-19 Vaccine for Safety Review

September 08, 2020

The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.

Vaccine Developers Pledge to Stand with Science

September 08, 2020

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

FDA’s “Gold Standard” Critical for Biopharma R&D

September 08, 2020

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

BIO Message: Keep Drug Development Independence

September 03, 2020

BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.

Preparing Pandemic Vaccine Capacity

September 03, 2020

Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.

Tracking API Quality During a Pandemic

September 03, 2020

Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.