Tomorrow is the deadline to apply for an Innovator Presentation spot at Partnering for Cures | Blog: 5 Takeaways from the 21st Century Cures Initiative - Thus Far | Deep sequencing technique might find mutations missed by whole genome sequencing
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August 21, 2014
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Study: Spike in drug withdrawals coincides with FDA safety initiatives
A study by University of California, San Francisco, researchers counters the notion that the 1992 Prescription Drug User Fee Act encouraged the FDA to approve drugs in the absence of appropriate safety data, as researchers asserted in the journal Health Affairs. This new analysis of the same data found that warnings and withdrawals started to spike in 2005, after Merck's Vioxx was withdrawn, and have been more frequent than in the 1996-2004 period. The spike coincides with the "launch of FDA initiatives to strengthen drug safety surveillance, particularly postmarket reporting," the researchers wrote in JAMA Internal Medicine. MedPage Today (free registration) (8/19)
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News from FasterCures
Tomorrow is the deadline to apply for an Innovator Presentation spot at Partnering for Cures
The call for applications to serve as an innovator presenter at Partnering for Cures is open through August 22. Each 25-minute presentation will provide an opportunity to engage potential investors, partners and/or collaborators in moving your existing initiative forward or amplifying the impact of your approach. We are particularly, although not exclusively, interested in hearing from partnerships that focus on one or more of the following categories:
  • Translation/commercialization of basic scientific discoveries
  • Data sharing
  • Clinical trial innovation/infrastructure
  • Creation of broadly used tools and resources
  • Innovative financing models
Apply now to present.
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Blog: 5 Takeaways from the 21st Century Cures Initiative - Thus Far
The U.S. House of Representatives Energy and Commerce Committee has engaged in a flurry of activity since the May launch of the 21st Century Cures initiative that aims to accelerate the pace of cures and medical breakthroughs in the United States. The committee has held three roundtables and six congressional hearings on various topics affecting the full arc of the drug development process -- from discovery to development to delivery -- as well as published four white papers. As the committee enjoys a brief recess before these meetings continue in September, our recent blog post examines five themes that have emerged from testimony and public submissions thus far. Read the post.
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Science and Technology
Deep sequencing technique might find mutations missed by whole genome sequencing
A new genomic analysis technique called targeted high-coverage sequencing might help scientists spot genetic mutations missed by whole genome or exome sequencing. The new approach, described in the New England Journal of Medicine, involves sequencing a panel of suspect genes 200 or more times. Scientists using the technique identified somatic mutations affecting a small percentage of cells in patients with brain disorders. (8/20)
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Nirmidas moves to commercialize fluorescence technology
Nirmidas Biotech has assembled $2 million for the commercialization of its fluorescence system for improved biomarker detection, allowing for faster and more accurate diagnosis of the early stages of cancer and tough-to-detect autoimmune disorders. The company plans to make the technology available to researchers and eventually develop its own tests. (8/18)
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Finance and Economics
Is fun the key to fundraising?
The Ice Bucket Challenge has been an inexpensive, wildly successful, grass-roots way to raise awareness of and research funds for amyotrophic lateral sclerosis, and the Movember mustache-growing campaign has likewise raised funds for men's health issues, but is gimmick-driven fundraising the way forward? "Nobody knows what the formula is," said FasterCures Executive Director Margaret Anderson. "Why are we able to dump ice on our head and potentially write a check now, but not consistently otherwise?" (8/18)
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Novartis licenses tuberculosis drugs to TB Alliance
Novartis has signed a licensing agreement with the Global Alliance for TB Drug Development for compounds against tuberculosis. Novartis will fully transfer its tuberculosis research and development program to the TB Alliance, which will finance and handle ongoing research, development, approval and distribution of the compounds. One of these is NITD304, which blocks a protein associated with the TB bacterium's survival. Genetic Engineering & Biotechnology News (8/20)
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VC firm to pump $110M into medtech, other health care firms
HealthQuest Capital has secured an investment fund worth $110 million. The venture capital firm plans to invest the money in companies that make diagnostic tests and medical devices, as well as firms that specialize in health information technology. (Boston) (8/19)
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Policy and Regulation
NIH to study racial bias in its grant-review process
The NIH next month will launch a study to determine whether grant reviewers are biased against minority applicants. A study in 2011 suggested that white researchers received NIH grants at almost twice the rate of African-Americans, which led the agency to create a program to train and mentor minority researchers. Now the NIH wants to look within its own grant-review process. Nature (free content) (8/19)
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Pilot initiative will test tools for streamlining medtech regulatory processes
The FDA has released guidelines governing its pilot program to develop tools for streamlining the premarket review and registration process. The agency will seek participants in the Medical Device Development Tools Pilot Program starting next month. Tools that might work for the pilot include those that examine how devices affect public health or tools for speeding development and commercialization of devices, the guidance states. (Boston)/Emergo Group blog (8/20)
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Society and Ethics
Investor helps towns find their way to Wellville
Technology investor Esther Dyson has enlisted five U.S. towns with populations of less than 100,000 to participate in the "Way to Wellville" challenge, a five-year plan to introduce healthy school lunches, corporate wellness programs and urban planning strategies in an effort to reduce overall rates of obesity and chronic disease. The Dyson-founded nonprofit Health Initiative Coordinating Council will sponsor the effort and help local officials raise other funds from investors, local businesses and philanthropists. The programs themselves will not be revolutionary, but they will be remarkable in that they will be done together and reinforce one another for maximum impact, Dyson said. Reuters (8/18)
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Advocates from world of sport reach out to families about brain donation
To help further the study of chronic traumatic encephalopathy, former Harvard football player Chris Nowinski talks with the families of athletes about brain donations to the Sports Legacy Institute. Garrett Webster, the son of a former Pittsburgh Steeler, promotes brain donation for the Brain Injury Research Institute. The Plain Dealer (Cleveland) (8/19)
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FasterCures is an action tank that works across sectors and diseases to improve the effectiveness and efficiency of the medical research enterprise. FasterCures, a center of the Milken Institute, is nonpartisan and independent of interest groups.
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