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Rules of the road: On Boots and Brexit

The U.K. OTC market is, as the Brits would say, brilliant. For North American brand owners, it’s always on the list of attractive potential markets. Complex and unique, there are two “B”s that stand out — Boots and Brexit.

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WSJ: FDA inspection scuttles Theranos' Zika-virus emergency clearance request

Theranos is facing its latest crisis following its withdrawal of its request for emergency clearance of a Zika-virus blood test after federal regulators found that the company didn’t include proper patient safeguards in a study of the new test, The Wall Street Journal reported Tuesday, citing people familiar with the matter. "Theranos founder Elizabeth Holmes announced Aug. 1 a new blood-testing device called miniLab that she said was designed for use outside a clinical laboratory and could run accurate tests from a few drops of blood," The Journal wrote. "But during an inspection by the FDA earlier this month, regulators concluded that Theranos had collected some data supporting the accuracy of the Zika test without implementing a patient-safety protocol approved by an institutional review board." (The Wall Street Journal)

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Report: Biosmilar regulatory pathway promising but there are sill barriers

Two recent unanimous approval recommendations from FDA advisory committees regarding biosimilars is a signal of growing scientific acceptance and understanding of the biosimilar regulatory pathway, suggested The National Law Review in a report Tuesday. The National Law Review has created a chart summarizing pending and approved BLAs for biosimilars using publicly available information, the publication noted, but there are still two barriers to entry. As biosimilars gain FDA approval, patent issues remain a barrier and the exorbitant R&D cost prevent significant price disparities. Accordingly, insurers may be slow to add biosimilars to the formulary, The National Law Review suggested. (The National Law Review)