Biogenerics get an unlikely ally — the Bush administration
The push to create a regulatory framework for generic versions of biotech drugs fizzled last year in Congress, as legislators seemed to lose interest after failing to attach the measure to a major FDA reform bill. But now it’s back, and has gained some unlikely friends in the Bush administration.
The FY2009 federal budget, compiled by the administration’s Office of Management and Budget, for the first time explicitly proposes giving the FDA authority to regulate biogenerics…. Continue Reading
Why dangerous defibrillator leads could usher in new medical-device regulations
(UPDATED: See below.)
Medical-device startups are booming these days, as VCs throw money at everything from artificial spinal-disc fillers to implantable weight-control “neuromodulators” to vacuum devices that suck blood clots out of blocked vessels. (That appears to be in sharp contrast to biotech; see the most recent funding data here.) What relatively few people understand, however, is the degree to which the device industry benefits from looser regulations than those covering biotech — and how that might… Continue Reading
The FDA’s big personalized-medicine push
(UPDATED: See below.)
Personalized medicine — the idea that doctors will one day tailor your medical care based on your genetic profile — has been a long time coming, as I’ve previously written. As it turns out, that’s no fault of the Food and Drug Administration, which has emerged as one of the biggest fans of the concept. Yet the FDA is now pushing ahead with efforts to pair drugs with genetic tests in a way that… Continue Reading
Weekend update: That cold, cold artificial heart, Dendreon-related skulduggery, congressional earmarks, and more
(UPDATED: See below.)
Catching up on a few life-science related items you may have missed over the weekend:
If you prick a cyborg, does he not bleed? — The WaPo’s Joel Garreau brings us this fascinating story about Peter Houghton, the first permananent recipient of a “left ventricular assist device” — a mechanical replacement for a failing chamber of his heart. Houghton’s heartbeat no longer goes lub-dub — instead, it whirrs as an impeller pushes blood through it. He… Continue Reading
Roundup: Guilt-free stem cells, the trials of Avandia, sponsor research bias, news from ASCO, and more
Flip switch for stem cells – Three research teams reported a technique for “reprogramming” skin cells into embryonic stem cells, those primordial bits of protoplasm that can propagate themselves indefinitely and, under the right conditions, transform themselves into any type of cell in the body. Deriving embryonic stem cells normally requires destroying an embryo — the main reason research with the cells remains limited, as does federal support for the work.
Teams from Kyoto University, MIT and… Continue Reading
Patients, CEOs and ideologues vs. evidence-based medicine
The first time you hear it, “evidence-based medicine” sounds like one of those goofily redundant phrases like “animated cartoon” or “past experience.” Aren’t doctors always carrying out studies of one sort or another? Isn’t medicine evidence-based already?
Well, no, not really. One of the biggest and least-understood problems in the U.S. healthcare system is that where many new drugs, medical devices and surgical techniques are concerned, there’s relatively little data as to which benefit patients… Continue Reading
Senate approves new drug-safety powers for FDA
The Senate passed a bill that requires the FDA to monitor the safety of drugs more rigorously once they’re on the market, but punted on other proposals that would have allowed the legal import of drugs from other countries and bolstered the agency’s ability to regulate drug advertising aimed at consumers.
The drug-safety measures incorporate many suggestions from an Institute of Medicine report last year that critiqued FDA’s ramshackle efforts to track side effects and other… Continue Reading
Roundup: No-nukes cancer treatment, E. coli vaccines, ovarian-tissue banking, more
No nukes in lymphoma treatment – Two innovative biotech drugs that target tumor cells for destruction by tiny radioactive particles are struggling in the marketplace, in part because cancer doctors are simply too specialized to make proper use of them. The drugs — Zevalin (pictured at left), from Biogen Idec, and Bexxar, now produced by GlaxoSmithKline — consist of bioengineered antibodies that carry fragments of radioactive material directly to lymphoma tumors in the bloodstream, where the… Continue Reading
“Generic” biologics: Another biotech battle begins
(Note: This item has been copied over to the Life Sciences page from its original location on the VentureBeat main page. To view it in its original context, with comments, click here.)
A second legislative fight for the biotech industry is shaping up in Washington over whether to give the Food and Drug Administration authority to approve “generic” versions of biotechnology drugs whose patents have expired.
Measures that would grant FDA that authority, introduced separately in the… Continue Reading
“Generic” biologics: Another biotech battle begins
A second legislative fight for the biotech industry is shaping up in Washington over whether to give the Food and Drug Administration authority to approve “generic” versions of biotechnology drugs whose patents have expired.
Measures that would grant FDA that authority, introduced separately in the House and Senate, are billed as a natural cost-saving measure by supporters. They note the high cost of many biotech drugs and the fact that several best-sellers are expected to go… Continue Reading