Quality Systems

Articles

FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.

Lilly's Investigational Alzheimer's Therapeutic Gets Breakthrough Therapy Designation

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

EC Orders 150 Million Additional Doses of Moderna’s COVID-19 Vaccine

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

Ilya Pharma Receives Approval from Swedish Regulators for Phase II Study

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.

FDA Advisory Committees Under Scrutiny

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

EMA Issues Positive Opinion for CrisBio Developed Vaccine, Validating the Platform

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

FDA Publishes Guidance on CMC Changes to an Approved Application 

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

FDA Gives Guidance on Development of Breast Cancer Drugs

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

FDA Authorizes Use of Drug Substance for Janssen COVID-19 Vaccine

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

Regulatory Oversight and Compliance