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A printed circuit board ~1 cm2 containing a CMOS integrated circuit and a loop antenna. Mercier et al. designed the chip to harvest the energy of the endocochlear potential in a guinea pig (p 1240). Credit: Rahul Rithe
With the first marketing authorization application for a biosimilar monoclonal antibody now under consideration at the European Medicines Agency, what are the critical issues for regulators?
For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and interchangeable with the brand reference product.
Sales in the biologics sector show modest but healthy growth rates for the fourth consecutive year, with cancer drugs garnering the greatest revenues. As the diabetes epidemic grows and innovation of insulins continues, drug companies in that space are moving up in the ranks.
Even after the enactment of a patent law in 2000, pharmaceutical and biotech-related inventions are perceived to lack strong product patent protection in Pakistan.
Accounting for errors arising from different high-throughput sequencing platforms and those arising from the approaches used to call variants are at the center of a controversy in RNA editing.
Petsch et al. apply mRNA vaccination for the first time to infectious disease, demonstrating immunogenicity and/or protective effects against influenza virus in mice, ferrets and pigs.
Lee et al. use neural crest precursor cells derived from patient-specific induced pluripotent stem cells to screen a small-molecule library for compounds that correct the cellular phenotype of familial dysautonomia.
