News

Results of a Phase III trial showed that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death associated with EGFR-mutated non-small cell lung cancer by 44%.

With the Proteologix acquisition, Johnson & Johnson gains two bispecific antibody early phase assets for immune-mediated diseases.

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

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

Novo Nordisk plans to invest $4.1 billion in a second fill/finish manufacturing facility in Clayton, N.C., boosting its current 2024 investments into production to $6.8 billion.

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

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

FDA has granted expanded approval to Sarepta Therapeutics for Elevidys to treat DMD in non-ambulatory patients, in addition to ambulatory patients.

Immunology company argenx gets its third FDA-approved indication for VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy.

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.

Swiss CDMO CordenPharma and Spain-based Certest will collaborate on the development of ionizable lipids for LNP formulations.

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.