Regulatory Oversight

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.

Companies can benefit from developing a single programmatic approach to a GxP training matrix.

The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

Janssen has requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab).

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.

The new framework will position the UK as an attractive prospect for new medicine manufacturers.

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

The updated vaccine will be ready to ship following a positive European Commission review.

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.