Janssen's IV Simponi wins FDA nod for rheumatoid arthritis Janssen Biotech obtained the FDA's approval to market an intravenous formulation of Simponi Aria, or golimumab, in combination with methotrexate as a therapy for moderately to severely active rheumatoid arthritis. The drug, a tumor necrosis factor inhibitor, already was cleared for subcutaneous administration. The approval was based on data from a 592-patient, late-stage trial. Medscape (free registration) (7/18)  | Getting Ready for the Physician Payment 'Sunshine' Rule
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 | FDA to review Chelsea Therapeutics' drug for symptomatic NOH The FDA has accepted Chelsea Therapeutics' application to market Northera, or droxidopa, as a treatment for symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, non-diabetic autonomic neuropathy and dopamine beta hydroxylase deficiency. "We will continue to work closely with the FDA toward an approval decision for Northera by early next year, and advance our commercial strategy in anticipation of a U.S. commercial launch soon after this," Chelsea's interim CEO, Joseph Oliveto, said. Pharmaceutical Business Review Online (7/18) Celgene halts trial of blood cancer drug Celgene said it will discontinue a Phase III study of its blood cancer treatment Revlimid as a first-line treatment in elderly patients with B-cell chronic lymphocytic leukemia after it noticed more deaths in patients treated with Revlimid compared with patients taking chlorambucil. The FDA put the study on clinical hold last week. Celgene said it will examine data from the trial to determine whether the imbalance is due to factors such as age or comorbidities. Reuters (7/18), The Wall Street Journal (tiered subscription model)/Dow Jones Newswires (7/18) Stem cells help form blood vessel networks Scientists at Johns Hopkins University developed vascular precursor cells from human induced pluripotent stem cells and used them to create self-organized microvascular networks on hydrogel scaffolding. "In demonstrating the ability to rebuild a microvascular bed in a clinically relevant manner, we have made an important step toward the construction of blood vessels for therapeutic use," researcher Sharon Gerecht said. The approach could have significance for regenerative medicine. The study was published in the Proceedings of the National Academy of Sciences. Genetic Engineering & Biotechnology News (7/17) | Calif. drugmaker gets $50M funding boost A Series C funding round from new and existing investors has brought in $50 million for NGM Biopharmaceuticals. The South San Francisco, Calif.-based firm will use the money to develop drug candidates for diabetes, obesity and other metabolic conditions. BioWorld (free content) (7/19) NIH hopes to win over skeptics with drug repurposing successes Nine awardees will divide $12.7 million from the NIH to find new targets for eight abandoned drug compounds. Critics say the National Center for Advancing Translational Sciences program has low odds of succeeding because drugmakers that developed the compounds abandoned them for a reason. Proponents say even moderate success will yield substantial return on the investment. Nature (free content)/News blog (7/17) | | Industrial & Environmental | EPA concludes public-comment period on proposed rules for corn fiber, biobutanol The Environmental Protection Agency's proposed rules on new Renewable Fuel Standard pathways garnered a total of 117 comments. In its comments, the Renewable Fuels Association welcomed the agency's plan to categorize fuel made from corn kernel fiber as a cellulosic biofuel. The association also praised the EPA for coming up with a "sensible and straightforward approach" to assigning Renewable Identification Numbers for fuels made from cellulosic biomass. EthanolProducer.com (7/18) |  | The true sign of intelligence is not knowledge but imagination." -- Albert Einstein, German-born theoretical physicist | | | The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com. | Please contact one of our specialists for advertising opportunities, editorial inquiries, job placements, or any other questions.
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