Biogenerics: The bad arguments just won’t stop

It’s always fascinating to see just how entitled biotechnology investors feel about the outsized rewards the industry bestows whenever one of their long-shot companies finally strikes it rich — not to mention how thoroughly that sense of entitlement seems to muddle their thinking.

Horizon Therapeutics: Combining generic pain meds for greater drug safety

Palo Alto, Calif.-based Horizon Therapeutics, a biotech that aims to combine existing generic drugs to fight pain, raised $30 million in a third funding round. The company’s lead drug candidate, known only as HZT-501, is a “proprietary” combination of the generic drugs ibuprofen and famotidine, the latter of which is better known by its brand name Pepcid. It’s aimed at providing pain relief without gastrointestinal discomfort or injury, which is the same claim made by Cox-2 inhibitors such as Merck’s withdrawn pain drug Vioxx.

Roundup: Biogenerics bill in limbo, clashing data on health IT benefits, the RNAi boom, and more

House-Senate confrontation set over biogenerics — Late last month, a key group of senators reached agreement on legislative provisions that would authorize copycat versions of biotech drugs, which are typically complex proteins manufactured by genetically engineered cells (see details here and here). These provisions would finally put biotech drugs — which don’t face cut-rate competition once their key patents expire — on a par with traditional pharmaceuticals, and have been a long time in coming. They’re not perfect, but they’re about as good a compromise as we’re likely to see any time soon..

Roundup: Anemia drugs under assault, stem-cell trial moves forward, medical interventions and poor “quality of death,” and more

Is the bell tolling for EPO? — The news keeps going from bad to worse for the wonder drugs of biotech — the anemia treatments known as ESAs or EPO, shorthand for “erythropoiesis stimulating agents” and “erythropoietin,” respectively. Earlier today, an FDA advisory panel recommended new warnings for the drugs, which stimulate the production of oxygen-carrying red blood cells, as well as fresh clinical studies on their safety. Recent studies in kidney-dialysis patients linked higher doses of ESAs to heart problems and strokes, while studies in cancer patients treated for chemotherapy-related anemia have suggested that the treatments don’t improve patient survival, and may even cut lives short — possibly by encouraging tumor growth.

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.

Health and science roundup: Amgen, generic biologics, the origins of white people and more

Amgen’s anemia rollercoaster — Biotechnology titan Amgen may have dodged a bullet when a study released Thursday showed that its anemia drug Aranesp didn’t shorten the lives of patients, after several other studies had suggested the opposite. But its anemia franchise isn’t out of the woods yet. A Wednesday report in the Journal of the American Medical Association revealed that for-profit dialysis clinics prescribe far higher doses of anemia drugs to their patients than do their non-profit counterparts, suggesting a profit motive behind the overuse of drugs that have been linked to cardiovascular problems at high doses.

“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.