It is no secret that the price tag to develop and successfully bring a new therapy to the marketplace is on the rise. According to a variety of sources research and development (R&D) expenditures to achieve product approval success can, depending on the therapy, run as high as $1.3 billion.
R&D and “efficiency” aren’t terms that seem to naturally blend together when applied to the operations of the biopharmaceutical industry. One only has to point to the many billions of dollars that companies pour into research and development annually.
Malvern, Pa.-based Ceptaris Therapeutics Inc. received FDA marketing approval for its single asset, Valchlor (mechlorethamine) gel, for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin’s lymphoma, in patients who have received prior skin-directed therapy.
R&D and "efficiency" aren't terms that seem to naturally blend together when applied to the operations of the biopharmaceutical industry. One only has to point to the many billions of dollars that companies pour into research and development annually. The Washington D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA), for example, reported in April of this year that its 31 member companies invested an estimated $48.5 billion into R&D in 2012.
Time was that getting a new medicine over the goal line equated to receiving the "green light" for approval from the FDA. In today's environment of government austerity measures and shrinking health care budgets, however, a drug's approval now only represents a "first and goal." To achieve a "touchdown" drug developers are going to have to demonstrate favorable pharmacoeconomics and real-world value for their products.
Now that biotechnology has become a truly global enterprise, a significant number of U.S. biopharmaceutical companies are generating revenues in addition to their U.S. operations . . . and these overseas cash reserves are piling up.
There is no doubt that senior executives of emerging biotechs spend much of their time on the trail of investment capital. The Coalition of Small Business Innovators (CSBI) would like to ease that burden.
There is no doubt that senior executives of emerging biotechs spend much of their time on the trail of investment capital. The Coalition of Small Business Innovators (CSBI) would like to ease that burden. A study by the group shows that several proposed changes designed to help small R&D-intensive start-ups better use existing tax provisions and incentivize investment in small business innovation would have the dramatic effect of increasing total investment in small businesses by $20.6 billion.
Irritable bowel syndrome (IBS) in its various forms, such as IBS with constipation (IBS-C) and IBS with diarrhea (IBS-D), has proved to be difficult to diagnose and treat. Up until recently the number of therapies available to the physician also has been limited.
