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PhRMA says it is strongly opposed to a closed-formulary approach for Medicaid and noted that CMS previously turned down a Massachusetts plan to use this approach in 2018. Read More
As confirmed cases of 2019-nCoV coronavirus topped 28,000 this week with 500 fatalities, two senators urged FDA Commissioner Stephen Hahn to ensure that drugs, devices and food imported from China remain safe during the coronavirus outbreak. Read More
In comments to the FDA, multiple drugmakers urged the agency to expand the scope of its planned pilot for reviewing novel excipients outside of drug applications. Read More
The Patent Trial and Appeal Board sided with Biogen in Mylan’s patent challenge over Biogen’s multiple sclerosis drug Tecfidera (dimethyl fumarate). Read More
The FDA revoked orphan drug status for Indivior’s overdose-treatment Sublocade in November 2019, admitting that it made a mistake in granting the designation. Read More