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Coverage with evidence development (CED), rather than quality-adjusted-life-year (QALY) thresholds, offers the best way forward in balancing evidence-based policy for new oncology products with the needs of developers, payers, physicians and patients.
Impatient with the slow pace of clinical research, families of individuals suffering from untreatable diseases are taking matters into their own hands—with some success. Virginia Hughes reports.
Efficiently generating evidence of clinical utility is a major challenge for ensuring clinical adoption of valuable diagnostics. A new approach to reimbursement in the United States offers a balance between evidence and incentives for molecular diagnostic tests.
Last year, the biologics sector managed single-digit growth in the United States, driven mainly by products indicated for oncology, diabetes and autoimmune disorders. Lurking on the horizon, though, are challenges, such as pricing, competition and follow-on molecules.
The simultaneous detection of multiple mRNA species in thick tissues or whole-mount embryos has remained technically challenging. Choi et al. present a method based on the triggered polymerization of RNA stem-loop structures that allows the distribution of up to five mRNAs in intact zebrafish embryos to be imaged at the same time.
Antibodies that modulate the activity of a target are difficult to discover with display-based approaches, which select only high-affinity binders. Mao et al. identify antibodies with a range of affinities using a small-molecule discovery method that involves one-by-one screening of an optimized small library of antibody fragments with known sequences.
The culture of dedifferentiated plant cells to produce commercially important chemicals has met with limited success. Lee et al. demonstrate the potential of innately undifferentiated cells from Taxus cuspidata as an industrial source of the anticancer drug paclitaxel.
Degeneration of articular cartilage in the joints may be amenable to tissue engineering solutions. Oldershaw et al. present an efficient, chemically defined protocol for differentiating human ES cells to chondrocyte-like cells.
The typical therapeutic antibody binds only two target antigen molecules during its lifetime. Igawa et al. describe a method for engineering antibody recycling in vivo, suggesting an approach to reduce the size and/or frequency of dosage with therapeutic antibodies.