Articles

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

Confidentially Agreement Signed Between European Union and Republic of Korea Regulatory Bodies

Feliza Mirasol is the science editor for 

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

SK pharmteco to Ensure Supply of Ferring Pharmaceuticals Gene Therapy

The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.

N4 Pharma and SRI to Collaborate on Intracellular Delivery to Specific Target Cells

The majority of PMCs/PMRs are proceeding according to schedule.

FDA Reports on Status of Postmarketing Requirements and Postmarketing Commitments

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.

Novartis’ Radioligand Therapy Gains FDA Nod for Pediatric Patients 

In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by Bristol Myers Squibb. 

Bristol Myers Squibb to Access Cellares' Cell Therapy Manufacturing Platform in New $380 Million CAR-T Cell Therapy Deal

A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.

INTERPHEX 2024: Implementing Contamination Control Strategies in Cell and Gene Therapy Facilities 

Videos

Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, notes that automation is key when it comes to effective sterile powder transfer of parenteral drug products.

Taking a Deeper Look at Sterile Powder Transfer in Aseptic Fill/Finish of Parenterals (INTERPHEX 2024)

Andreas Frerix, product management director for Quattroflow at PSG Biotech, discussed the advantages and new challenges SUTs present for pumping systems.

Evaluating the Single-Use Trend in Pumping Systems for Fluid Handling (INTERPHEX 2024)

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance. 

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