Monday, January 9, 2023 Daily Archives

CytomX and Moderna partner to develop mRNA-based therapeutics

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CytomX Therapeutics will combine its Probody platform with Moderna’s mRNA technology to create and advance therapeutics for oncology and non-oncology conditions. The partnership and licensing agreement, which aims to generate investigational messenger RNA (mRNA) based conditionally activated therapies, will use Moderna’s mRNA technologies alongside CytomX’s Probody therapeutic platform. According to CytomX, its platform enables proteins to activate in diseased tissue while remaining masked in systemic circulation, expanding the availability of new targets for the potential treatment of a large range…

January 9, 2023

Sarepta expands DMD gene therapy CDMO deal with Catalent

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Catalent will supply commercial doses to Sarepta Therapeutics if its Duchenne muscular dystrophy (DMD) gene therapy delandistrogene moxeparvovec (SRP-9001) wins approval. In November, the US Food and Drug Administration (FDA) accepted the submission from Sarepta for its potential DMD gene therapy SRP-9001. The Agency has given an action date of May 29, 2023, and thus the firm has expanded its partnership with contract development and manufacturing organization (CDMO) to prepare for the potential of commercial production. “Sarepta is working as…

January 9, 2023

Eisai and Biogen: FDA approve Alzheimer’s mAb lecanemab

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Leqembi (lecanemab) has received accelerated approval for Alzheimer’s disease and will be priced at $26,500 per year, roughly half the original price of Biogen’s controversial drug Aduhelm (aducanumab). The US Food and Drug Administration (FDA) approved Leqembi on Friday for patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology under an accelerated pathway based on reduction in amyloid beta plaques observed in Phase II trial patients. Marketing authorization holder Eisai has…

January 9, 2023

Patient access is political, say CGT experts

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Payment models for cell and gene therapies must consider how healthcare systems operate to accommodate patient access, say experts. While the cost of gene therapies is often debated throughout the life sciences space, a panel discussion at Cell and Gene Manufacturing and Commercialization (CGMC) in Amsterdam, The Netherlands last month highlighted that the discussion of innovative payment models must also include cross border healthcare patients and payments. Francis Pang, senior vice president of market access and geographical expansion at Orchard…

January 9, 2023