GRPR, or gastrin-releasing peptide receptor, is part of the bombesin G protein-coupled receptor family and has been found to be overexpressed in multiple cancers.

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

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%.

This $4.1 billion investment to build a second fill/finish manufacturing facility in Clayton, N.C., boosts Novo Nordisk's current 2024 investments in production to $6.8 billion.

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

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

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

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.

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.

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.

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.