Quality/GMPs

The draft ICH Q9(R1) document details the importance of quality risk management principles.

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.

The European Commission has granted conditional marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for treating multiple myeloma.

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.

FDA has approved GSK’s vaccine for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

One get obtain a clearer assessment of gene-editing outcomes through more exacting analytical tools.

Having a clear clinical strategy early on can shave time off overall development projects.

Extensive work has greatly expanded the possibilities for fetal bovine serum sourcing.

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.

Manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers.

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

FDA will use virtual site visits even after resuming active inspections.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

AI could provide solutions to critical manufacturing inefficiencies.

FDA once again is taking steps to facilitate the import of less costly prescription drugs.

Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.

The final guidance addresses safety aspects of container and carton labeling design.

The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.

CDMOs offer expertise and customization options for sponsors of orphan drugs.

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.