Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.

FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.

In the premiere episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.

The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

A new initiative will advance access to quality medicines and vaccines in Africa.

The transaction, announced June 20, follows Bora’s purchase of Minnesota-based Upsher-Smith Laboratories earlier in 2024.

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.

Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.

The research collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.

Nadia Sellami, PhD, global segment lead for gene and cell therapy at PacBio, talks about long-read sequencing for cell and gene editing in a video interview.

Gabi Hanna, MD, CEO and co-founder of Lamassu Pharma talks about a novel oncology platform and the link between science and patient care.

Novel approaches against chronic inflammation could potentially prevent certain inflammatory diseases and neurological conditions.

Ecolab Life Sciences and Repligen have launched a new affinity resin, DurA Cycle, for large-scale biologics manufacturing.

Syngene's new production platform offers rapid protein synthesis with lower risk.

CordenPharma has partnered with Spain-based Certest to develop ionizable lipids for LNP formulations.

The completed expansion at AGC Biologics'Copenhagen, Denmark, site, doubles the company's single-use bioreactor capacity for mammalian-based services.

Syntegon will expand its processing and packaging by acquiring the Spanish equipment supplier.

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

Lonza’s Joe Garrity and Jerry Jiang discuss the latest trends and challenges in commercializing new CGTs.

Lars Petersen, CEO, FUJIFILM Diosynth Biotechnologies discusses the company’s strategic goals and meeting market demand for mammalian cell culture capacity.

Founder and CEO of Atomic AI, Raphael Townshend, explores AI’s usefulness as a tool to characterize molecular structure and advance molecule engineering.

Andrew Carnegie, head of Strategic Commercial Development at Inaphaea BioLabs, discusses the establishment of translational CROs and the role of PDC models in the drug discovery process.

The PharmTech Group sat down with Himanshu Gadgil, CEO of Enzene Biosciences to discuss the benefits and challenges of continuous manufacturing of biopharmaceuticals.