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President Barack Obama Monday signed into law H.R. 1314 that would require generics makers to pay inflation-based rebates if prices rise too quickly, based on the inflation-adjusted baseline average manufacturer price. Read More
FDA Grants Priority Review to Acadia’s Psychosis Drug Merck Wins Breakthrough Therapy Designation for Keytruda FTC Settles Charges Against Concordia, Par DOJ Subpoenas Vertex over Good Laboratory Practices Read More
The FDA is now recommending a traditional approval pathway for development of antiretroviral drugs for HIV-1 infection, a major shift from the condensed process allowed since the epidemic was at its peak. Read More
Continuing its string of proposed buyouts in the rare disease arena, Shire Pharmaceuticals is looking to snap up Massachusetts biotech Dyax in a deal worth up to $6.5 billion. Read More
Pharmaceutical industry watchers are saying that the Warner Chilcott kickback scandal may not single-handedly reshape the drug promotional landscape … but it’ll make one helluva dent. Read More
FDA Grants Fast Track to Insys Therapeutics’ Opioid Overdose Spray FDA Guidance Calls for Two Bioequivalence Studies for Progesterone EC Grants Expanded Approval to Myeloid Leukemia Drug Read More
Hospira is voluntarily recalling more than 24,000 syringes of the injectable Amidate because out-of-specification results for degraded product were confirmed during stability testing. Read More
The FDA will not be forced into a shutdown this year after the Senate passed a two-year budget early Friday morning for fiscal years 2016 and 2017. Read More