Quality/GMPs

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

EUA marks a milestone in COVID-19 vaccine development and is hailed as a turning point in pandemic fight.

Success in combatting the pandemic depends on the ability of manufacturers to quickly and efficiently produce and distribute the huge quantities of vaccines demanded by the United States government and public health organizations around the world.

Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.

The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.

The European Medicines Agency has launched a full investigation into a cyberattack.

The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

The collaboration addresses the need for risk mitigation plans in cell therapies.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

A holistic approach to validation and quality assurance is essential.

The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control.

Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.

After a difficult year, biopharma science delivers promising results.

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

The guidelines are part of the independent control of pandemic COVID-19 vaccine batches.

The first public announcement from the Biden-Harris transition team was to name members of a COVID-19 advisory board charged with initiating policies and actions to combat the fast-rising infection rate in the United States.

Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.