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… 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… 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… 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… 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… 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… 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… 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… 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… 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… Continue Reading