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The FDA has approved Lupin’s Ranluspec, an interchangeable biosimilar to Lucentis, for wet AMD, diabetic eye disease, and other retinal conditions.

Made Scientific and Pluristyx will integrate iPSC starting materials with CDMO services for cell therapy development.

As the ADC market races toward a projected $32 billion valuation, manufacturers face a precision imperative, as integrated CDMO partnerships, advanced analytics, and emerging technologies like AI and continuous manufacturing may hold the key to unlocking the next wave of oncology breakthroughs.

Today's biopharmaceutical news highlights an FDA breakthrough designation in spinal muscular atrophy, an expanded oncology collaboration focused on tumor activated bispecifics, and a new biosimilar launch for retinal diseases in Europe.

Agilent’s Dr. Ganesh Bala explains how MAM-based LC–MS peptide mapping has become a foundational analytical tool for ADC and bioconjugate CQA monitoring in this Q&A piece.

Teva launches Ahzantive, an EMA-approved aflibercept biosimilar, in select European markets for wet AMD and other retinal diseases.

CytomX and Regeneron aim to deepen their joint effort to develop protease-activated bispecific immunotherapies designed to improve tumor selectivity and widen the therapeutic window in solid tumors.

The FDA has granted Breakthrough Therapy Designation to Biogen's investigational antisense oligonucleotide salanersen for spinal muscular atrophy, supported by Phase 1b data showing motor function improvements and reduced neurodegeneration in children previously treated with gene therapy.

Daily biopharma update covering RNA exon editing licensing, gene therapy clinical data, and preclinical rare disease collaboration advances across the biotech sector.

IDefine and UT Southwestern will assess a preclinical EHMT1 gene replacement strategy for Kleefstra syndrome.

Lilly adds Ascidian’s RNA exon-editing platform for rare inherited kidney disease targets in a deal with no disclosed clinical data.

Interim phase 1b/2 data from Tenaya Therapeutics’ MyPEAK-1 study showed TN-201 gene therapy was generally well-tolerated and associated with improvements in cardiac remodeling, symptom burden, and functional measures in patients with MYBPC3-associated hypertrophic cardiomyopathy.¹

Today’s BioPharm Brief covers FDA draft guidance aimed at streamlining rare disease gene therapy development, Phase 3 trial updates involving dual survival endpoints in oncology programs, and Eli Lilly’s $1.2 billion licensing deal for a GLP-2 therapy in short bowel syndrome.