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Mainstreaming Genetic Testing

Executive Summary

Genetic testing is progressing at a faster pace than anyone envisioned just a few years ago. The question now is not whether genetic testing will ever be a business, but whether it will evolve.

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The Murky Regulatory Arena of Genetic Testing

The FDA has undertaken several measures to make the regulatory process less burdensome for diagnostics companies, but these may not be enough to incentivize companies to take their new genetic tests through the approval process. At the same time, confusion reigns: a special HHS advisory committee on genetic testing has been disbanded, and the FDA is reviewing its jurisdiction to regulate home brews, which are the dominant route to commercialization for genetic tests. Some critics worry that these developments may stifle innovation and companies are waiting for clarity.

December ANDA Rush Is Largest In Two Years

December's ANDA rush has provided the largest monthly haul in two years. However, the month may be losing its influence over the US FDA's annual submission total.

Korean Pharma Highlights R&D Progress, 2020 Strategy At JPM

Among the Korean firms presenting at J.P. Morgan, Hanmi laid out its strategy for obesity and other core pipeline assets, Celltrion focused on its expanding biosimilar pipeline and China plans and LG Chem unveiled new R&D progress.

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