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The pharmaceutical and biologics industries aren’t hiding their displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
The moment dietary supplement manufacturers start making specific curative claims, supplements are seen as drugs in the eyes of the FDA and require an IND, says a new guidance document. Read More
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