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 FDA, Faster Than Ever?
At the recent BIO annual convention in Washington, D.C., Biotechnology Industry Organization president Jim Greenwood offered up a legislative blueprint to revamp the mission of FDA's (we previewed it briefly last month). Among the proposals were to make FDA an independent agency of government--rather than arm of the Department of Health and Human Services -- and to make promotion of innovation part of its mission. BIO is even seeking to change the agency's system of basing approval decision on two well-controlled clinical trials. The proposal would instead have approval hinge on the "weight of evidence."
All bold stuff, if unlikely to find much traction in Congress anytime soon. But BIO's bold reform initiative is at least in part an expression of industry frustration with the current state of FDA, which they say is approving too few drugs, too slowly, with too many strings attached. More...
More By Karl Thiel
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| |  | | ViiV Healthcare, the 85/15 HIV joint venture between GlaxoSmithKline and Pfizer, looks to have a winner with dolutegravir, a novel HIV integrase inhibitor. The only approved drug in this class is Merck's Isentress, but dolutegravir looks better so far. And it also looks potentially more potent than Gilead Sciences' elvitegravir, a part of the "Quad" pill that company is developing. With the vast majority of Gilead's revenue coming from HIV drugs and patent expirations coming in several years, you can bet the folks there are nervously watching the progress of ViiV. -KT | | | |  | FDA is getting a little more hierarchical after a broad reorganization by Commissioner Margaret Hamburg that will channel reporting through a number of new directorates. Perhaps more significantly, Hamburg has created a new Deputy Commissioner for Medical Products and Tobacco and named Dartmouth University Medical School Dean Stephen Spielberg to the post. Spielberg will "provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products," although management will remain with the heads of each of the Centers.
-KT | | | |  | Bristol-Myers Squibb has over the past several years restructured itself as a lean, mean, pure pharma R&D organization, and it is looking to keep the pipeline flowing with the acquisition of Amira. It isn't coming cheap though--the company is paying $325 million upfront...largely for AM152, a potential treatment for idiopathic pulmonary fibrosis and scleroderma that has only just completed phase 1 trials. It's putting far less up front in its oncology deal with Innate Pharma, although there are large potential payments down the road. The In Vivo Blog notes that the price tag on early stage (i.e. phase 1) partnerships has skyrocketed over the past few years in oncology; perhaps the same is becoming true in other therapeutic areas.
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| | |  | Most talk about stem cells relates to the wonderful things we hope to one day do with them. Verastem, on the other hand, wants to kill them. Or, more specifically, they want to kill cancer stem cells--the hard-to-kill, self-renewing cancer cells that are thought to drive metastasis. There are some heavy hitters among the founders, including Robert Weinberg of MIT's Whitehead Institute at Eric Lander of the Broad Institute of MIT and Harvard University.
-KT | | | |  | It wasn't the best month for Teva. The company has been enjoined from selling Neutroval in the U.S. until November 10, 2013, having acknowledged that the product infringes two Amgen patents. And before Teva management could breathe a sigh of relief that the issue is at least resolved, trouble reared its head again. The Feds are looking into Cephalon's alleged off-label promotion of Treanda, a treatment for chronic lymphocytic leukemia. The Department of Justice is looking into allegations that reps and company-sponsored speakers have been promoting the drug as first-line treatment of non-Hodgkin's lymphoma, for which it is not approved. Teva is in the midst of wrapping up its $6.2 billion acquisition of Cephalon and would probably prefer to avoid the distraction. As we've seen with some of the major pharma mergers, legal problems at an acquired company can be a headache of the parent for a long while after the ink is dry.
-KT | | | |  | AstraZeneca won what one analyst called a "Pyrrhic victory" in gaining FDA approval for the blood-thinner Brilinta. While it is an alternative to the mega-blockbuster Plavix that proved superior in extending survival in some studies, its approval came with a series of strict warnings and limitations. Moreover, it got the green light only shortly before Plavix goes generic later this year. Once considered the most important drug in AstraZeneca's pipeline, most analysts now expect muted sales. AstraZeneca first submitted the drug for approval in 2009, but FDA asked for more data on U.S. patients.
-KT | | | |  |
Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.
You may contact Karl Thiel at Karl.thiel@biospace.com.
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