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The FDA warned two firms for compounding drugs that it said are "essentially copies" of commercially available, approved products without any documented reason.
Bristol-Myers Squibb (BMS) will pay $499 million to the government and sign a corporate integrity agreement to resolve "several investigations involving the company's drug pricing and sales and marketing activities," the company said.
Funding to provide cervical cancer vaccines to women in the developing world must be a priority, as the majority of the 250,000 women who died from the disease last year lived in those countries, U.N. health officials announced.
Elite Pharmaceuticals is teaming up with VGS Pharma to create a research and development company geared toward manufacturing specialty generic drugs, the company announced.
PhRMA is tentatively supporting the Centers for Medicare & Medicaid Services' (CMS) proposal to collect and share prescription drug plan data, but is concerned that the agency may overreach by using the information to compare different products.
In observance of the holiday season, FDAnews Drug Daily Bulletin will not be published Friday, Dec. 22, Monday, Dec. 25, or Tuesday, Dec. 26. The next issue will be published Wednesday, Dec. 27.
With the expectation of a significant surge in sales volume over the next few years, combined with a collective industry effort to bring more high-value, specialty drugs to the market, generic drug companies operating in Europe are looking at the possibility of significant growth, an industry analyst observed at the Merrill Lynch Generics Conference held last week in Frankfurt, Germany.
A new congressional report has concluded that the drug industry's increasing investment in R&D is not resulting in sufficient increases in the new drug pipeline and structural changes are necessary to fix a "stagnant" system.
Merck and Idera Pharmaceuticals announced a collaboration to incorporate Idera's toll-like receptor (TLR) agonists into vaccines Merck is developing for oncology, infectious diseases and Alzheimer's disease.