  - Commentary: 5 ways industry can help the FDA improve
The FDA might need support from the biotech and drug sectors as the agency seeks to improve its processes for reviewing medical products, columnist Luke Timmerman writes. Timmerman breaks down five ways that the industry can take part in restoring public confidence in the agency, including showing support for an FDA budget increase and banning advisory-panel members with conflicts of interest. Xconomy (10/10)        | LET’S GO DESIGN: Episode #5
In this episode of SolidWorks’ interactive web series, Jeremy moves closer to the final design of our Hot Rod Baby Buggy and also hot-wires the golf cart motor to show how the aluminum tracks perform flawlessly. Watch at LetsGoDesign.tv. |
 | Health Care & Policy |  |  | | - Stem cell technique helps turn skin cells into functional liver cells
U.K. scientists reported in the journal Nature that they were able to develop human liver cells that proved to be functional when implanted in mice. They developed the liver cells after reprogramming skin cells taken from patients with a mutation in the alpha1-antitrypsin gene, which produces a protein that helps prevent inflammation, into stem cells and introducing a correct version of the gene using the zinc finger nuclease technique. Although the method holds promise in ending the need for liver transplants, scientists said, it could take 10 years before the technique could be fully tested in humans. Reuters (10/12)  | Earn 2X rewards points on shipping costs with The New Business Gold Rewards Card from American Express OPEN. Designed to earn Membership Rewards® points faster:
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  - Intercell advances clinical testing of anti-bacterial vaccine
Intercell plans to undertake a confirmatory study next year on the clinical efficacy of a vaccine against Pseudomonas aeruginosa infection, after the European Medicines Agency approved the trial's design. The vaccine, part of Intercell's alliance with Novartis, recorded a lower rate of death during a controlled midstage trial. Reuters (10/12) - Transgene: 3 in hepatitis-vaccine trial developed blood disorders
Transgene said three patients developed blood disorders after a midstage trial of its experimental hepatitis C vaccine, TG4040. One developed aplastic anemia, while the other two had thrombocytopenia, with one of them developing neutropenia. "The company has decided to submit an amendment to the study design so as to avoid further exposing patients to possible similar adverse events," Transgene said. Bloomberg Businessweek (10/11) - RetroSense hopes to start human trials of eye drug candidate in 2012
RetroSense Therapeutics said in a regulatory filing that it has started to secure funds as it plans to begin clinical studies of RST-001, its drug candidate for retinal degeneration, next year. The company's experimental treatment helps restore vision by directly delivering to retinal cells a gene, derived from blue-green algae, that produces photoreceptors. The Michigan-based firm said it expects to submit to the FDA an investigational new-drug application for the drug. MedCityNews.com (10/12)  - Decode Genetics and Pfizer partner on genetic research
Decode Genetics will partner with Pfizer to identify gene mutations related to lupus during the next 18 months. Decode said the companies hope the gene variants will prove useful in identifying pharmaceutical targets and pave the way for companion diagnostic tests. Reuters (10/12)  | FREE TRIAL – Thomson Reuters Cortellis™ Pipeline Intelligence
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| Industrial & Environmental | | | | - Vilsack: U.S. will meet its cellulosic biofuel targets by 2022
Agriculture Secretary Tom Vilsack said the U.S. will meet its cellulosic biofuel commitments by 2022, even though a study from the National Academies showed that hitting those targets is unlikely unless technological innovations reach the market and policies change. "The study overlooks many of our recent efforts, including new investments in research and technologies to develop nonfood feedstocks," Vilsack said. "The facts show that biofuels have already helped to reduce our use of imported oil from 60% to 52% over the past two years," Vilsack added. Agweek (10/11) | News from BIO | | | | - BIO argues for a 21st century FDA
In this issue of FDLI's Food and Drug Law Policy Forum (Volume 1, Issue 18), James C. Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), answers this provocative question: Can a 21st Century FDA Accelerate Biotech Innovation to Cure Disease and Save Lives? Greenwood argues that Congress needs to elevate the agency to independent status (like EPA); that FDA must advance regulatory science and innovation through a chief innovation officer; and that FDA should enable modernized patient-centric clinical development, all to make FDA a truly effective regulatory agency. Read the article here.
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