Quality/GMPs

The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill.

Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.

Amgen’s Aimovig has become the first and only approved treatment in Japan for treating migraine attacks in adults by blocking the CGRP-R.

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

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

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.

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.

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

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

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.

The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.

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

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

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.

Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.