Feliza Mirasol is the science editor for 

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In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

New FDA Draft Guidance Issued for Sponsors of Allogeneic Cell-Based Medical Products.

The CDMO plans to expand and upgrade its Philadelphia, Ohio, and Milan facilities to meet the continued growth in demand for high potency handling capabilities.

Adare Expands High Potency Handling Capabilities in US and Europe

Key areas to invest include manufacturing process improvements, quality management, and AI.

CPHI Experts Report that Small to Mid-sized US CDMOs Must Invest Now to Benefit from 2025 Contract Funding Surge

The non-profit initiative puts collaboration at the forefront as it tackles the challenges surrounding recycling primary pharmaceutical packaging.

UK Launches Circularity in Primary Pharmaceutical Packaging Accelerator Initiative to Implement Pharmaceutical Packaging Strategies

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

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. 

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