New ONC fee proposal scares health IT sector

The Office of the National Coordinator for Health IT just released its budget plan for 2014, which would increase its funding. But it’s a little-reported line item that’s causing a stir among entrepreneurs — a proposal to boost fees for electronic health record vendors.

New smartphone ultrasound device is (finally) available

In February 2011, Mobisante got the green light from the U.S. Food and Drug Administration for its mobile, smartphone-powered ultrasound device. It took the medical device startup another eight months to meet the various FDA guidelines, but now its MobiUS SP1 Ultrasound System is finally available for commercial sales starting this month.

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.

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.

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?

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.

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 localized radiation can kill cancer cells with fewer side effects than traditional radiation or chemotherapy.

“Generic” biologics: Another biotech battle begins

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“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.