Amgen has announced promising results from a late-stage study of its investigational fibroblast growth factor receptor 2b (FGFR2b)-targeted monoclonal antibody bemarituzumab in gastric cancer.

The phase 3 FORTITUDE-101 trial, conducted with the support of Zai Lab, has been evaluating bemarituzumab plus mFOLFOX6 chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric or gastro-oesophageal junction (G/GEJ) cancer in patients with FGFR2b protein overexpression.

Results from a pre-specified interim analysis showed that the study met its primary endpoint, with bemarituzumab plus chemotherapy demonstrating a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy.

Gastric cancer is the fifth leading cause of cancer-related deaths globally, with almost one million new cases diagnosed every year.

Approximately 38% of patients with advanced G/GEJ cancer have FGFR2b overexpression, which can play a significant role in tumour development and progression.

A late-stage study evaluating bemarituzumab plus chemotherapy and Bristol Myers Squibb’s Opdivo (nivolumab) in patients with first-line gastric cancer is also ongoing, with data from the trial expected to be announced later this year.

The US Food and Drug Administration (FDA) has published more than 200 complete response letters (CRLs), representing a significant step in its aim to improve transparency.

The “initial batch” of letters, issued in response to applications submitted to the FDA between 2020 and 2024, is now accessible to the public, and the regulator said it is “in the process” of publishing additional CRLs from its archives.

The FDA issues CRLs to sponsors of drugs or biological products when it determines that it cannot grant an approval of an application in its current form. This is due to a range of reasons, including safety and efficacy concerns, manufacturing deficiencies, as well as bioequivalence issues.

Deficiencies are detailed in the letters; however, because the FDA has not previously published CRLs for pending applications, sponsors can misrepresent the rationale behind the decision to their stakeholders and the public.

It is hoped that making CRLs available will offer the public a greater insight into the FDA’s decision-making and highlight the most common deficiencies that sponsors must address before their application is approved.

Biogen has unveiled plans to invest an additional $2bn in its existing manufacturing footprint in North Carolina, US.

The upcoming investment in the state’s Research Triangle Park (RTP), where Biogen first broke ground in 1995, is aimed at fuelling the “continued advancement” of the company’s late-stage clinical pipeline.

Spanning 7,000 acres, the RTP is home to hundreds of companies, including science and technology firms, government agencies, academic institutions, start-ups, as well as non-profits.

Biogen said it will continue to invest in “multiple modalities and factories” across its two RTP campuses over the next few years.

This will include establishing clinical and commercial multi-platform fill finish capabilities, and further expanding its antisense oligonucleotide capabilities and infrastructure.

The funds will also go towards modernising manufacturing technologies and controls through further advanced automation and artificial intelligence.

Nicole Murphy, head of pharmaceutical operations and technology at Biogen, said: “With this investment, we will modernise and expand our manufacturing capability to enable our pipeline and provide resilient patient supply, while continuing to support the skilled and dedicated community of life sciences talent in North Carolina.”

AstraZeneca (AZ) has become the latest major drugmaker to announce a significant investment in the US, committing $50bn into the country by 2030.

The funds will go towards establishing a multibillion dollar manufacturing facility that will produce drug substances for AZ’s weight management and metabolic portfolio, including oral GLP-1, baxdrostat, oral PCSK9 and combination small molecule products.

Set to be located in Virginia, the facility will represent AZ’s largest single manufacturing investment globally and will seek to optimise production by leveraging artificial intelligence, automation and data analytics.

Alongside the drug substance facility, the investment will cover a research and development (R&D) centre in Kendall Square, Cambridge, Massachusetts, as well as next-generation manufacturing facilities for cell therapy in Rockville, Maryland and Tarzana, California.

The commitment will also go towards expanding AZ’s R&D facility in Gaithersburg, Maryland, as well as bolstering manufacturing capabilities in Mount Vernon, Indiana and Coppell, Texas.

Together, the investments will support AZ’s target of reaching $80bn in Total Revenue by 2030, 50% of which is expected to be generated in the US, the company outlined.