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Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more
How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more
The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more
Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more
Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more