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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.

The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.

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

The $58 million investment has resulted in a 72,000-square-foot facility with a dedicated LC–MS space and molecular suites and will bring as many as 350 new jobs onto the campus.

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

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

The agency is evaluating risks associated with the painkiller metamizole. It is also reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.

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

Syngene has launched a new protein production platform that offers faster production with lower risk.

AGC Biologics has completed an expansion at its Copenhagen, Denmark, site, which doubles its bioreactor capacity for mammalian-based cell culture.

CDER's new program will create discussion around AI and be administered through the Emerging Drug Safety Technology Program.

Reports by USP and FDA detail drug shortage numbers and challenges through 2023.

CGT manufacturing processes need automation as well as standardization, according to Lonza’s Joe Garrity and Jerry Jiang.

Joe Garrity and Jerry Jiang from Lonza share their insights on the latest trends and challenges for the commercialization of new CGTs.

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

Raphael Townshend, founder and CEO of Atomic AI, speaks on AI’s usefulness in characterizing molecular structure and advancing molecular engineering.

Andrew Carnegie of Inaphaea BioLabs explains the role of a translational CRO and of PDC models in drug discovery.

Chemify founder and CEO, Lee Cronin gives insight into the combination of digital chemistry, robotics, and AI in the drug discovery process.

Pharmaceutical Technology® spoke with Parviz Shamlou, senior vice-president of Science and Technology, Abzena, about the impact of the Biosecure Act on the bio/pharmaceutical industry, as well as the progress of continuous manufacturing in biopharma.

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

Pharm Tech Group looks at the challenges surrounding the development and manufacture of ATMPs in more detail with Agne Vaitkeviciene, CEO of Memel Biotech.

Pharm Tech Group sits down with Bernard Sagaert, CEO of etherna, to examine the role of mRNA in the treatment of autoimmune diseases.

BioPharm International chats with Dr. Monika Paulė, CEO and co-founder of Caszyme about the evolution of CRISPR.

BioPharm International® spoke with Jeff Clement, executive director of Technical Sales for Development and Manufacturing Group at PCI Pharma Services, about the challenges and benefits of incorporating robotics into aseptic manufacturing

CGT Catapult and CATTI have developed aligned training standards for the manufacture of advanced therapies.

BioPharm International® spoke with Stacey Treichler, senior director of Marketing and Strategy for Purolite at Ecolab, about the impact of advanced therapies, new innovations, and sustainability on the biopharmaceutical industry.

Cellular Origins will apply its robotic platform to establish automated CGT manufacturing at CGT Catapult’s manufacturing innovation center in Stevenage, UK.

Enzene's new division will provide end-to-end integrated discovery services.