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Today’s BioPharm Brief looks at Akeso’s bispecific ADC and ivonescimab combination in breast cancer, Novo Nordisk’s AI partnership with AWS, and Ascletis’ once-monthly obesity candidates.

Ascletis has initiated two Phase I studies for its obesity pipeline: ASC36, a once-monthly amylin receptor peptide agonist, and ASC36_35FDC, a once-monthly fixed-dose co-formulation of ASC36 with its GLP-1R/GIPR dual agonist ASC35, following recent FDA IND clearances for both candidates.

Bristol Myers Squibb has selected Houston's Generation Park for a new $2.3 billion multi-modal manufacturing campus capable of producing small molecules, biologics, and antibody-drug conjugates, adding to a growing wave of large-scale US pharmaceutical manufacturing investment.

Akeso is pairing a next-gen bispecific ADC with its PD-1/VEGF antibody, ivonescimab, in a first-line push against hard-to-treat breast cancer.

AWS's AI and cloud tools aim to compress Novo Nordisk's path from drug target to first human dose for chronic disease patients.

This week’s BioPharm Brief looks at FDA Fast Track designation for BioInvent’s BI-1808, Neurocrine’s Phase 1 obesity study of a GLP-1/GIP/glucagon triple agonist, and Replimune’s accelerated approval for Tudriqev plus nivolumab in advanced melanoma.

Moderna's mFLUSIVA approval offers a regulatory case study for mRNA vaccine sponsors, covering comparator selection lessons from the FDA's reversed refusal-to-file, competitive implications for Pfizer and Sanofi's mRNA flu programs, and what the accelerated approval pathway means for long-term regulatory risk.

BI-1808 plus pembrolizumab posted a 24% response rate in platinum-resistant ovarian cancer, tripling pembrolizumab's historical rate alone.

Neurocrine Biosciences has dosed the first participants in a Phase 1 study of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist for obesity, marking the company's entry into the increasingly competitive multi-agonist incretin therapeutics space.

The European Commission has approved an expanded indication for Bavarian Nordic's IMVANEX (MVA-BN) mpox and smallpox vaccine, extending eligibility down to children 2 to less than 12 years old, based on phase 2 data showing an immune response and safety profile comparable to adults.

Moderna expands the reach of mRNA technology with the first FDA-approved mRNA influenza vaccine, Merck seeks to extend RSV protection for vulnerable children, and AstraZeneca and CSPC deepen their manufacturing footprint in China.

Biotech companies entering new markets must consider talent availability, reimbursement strategy, and regional expertise early in development, according to Kirsten Detrick, chief representative, USA, at the Basel Area Life Sciences Supercluster.

Laurent Levy, founder and CEO of Nanobiotix, explains how a physics-based approach to drug delivery could complement existing therapeutic platforms by improving particle behavior in the body while avoiding added complexity.