Read summaries of hottest topics in medical research from P4C | Accelerator brings together technology, neuroscience | Researchers attempt to use randomized trial in health care setting
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November 25, 2014
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Rules would require data from NIH-funded trials to be added to public database
Proposed rules would require all NIH-funded clinical trials to make their results available on the clinicaltrials.gov public database within a year of the study's end. In addition, expansion of FDA rules would require compliance from other studies even if the products are ultimately not offered on the market. The agency estimates this could bring around 650 more NIH-funded study results to the database each year. Tulsa World (Okla.)/The Associated Press (11/21)
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News from FasterCures
Read summaries of hottest topics in medical research from P4C
Check out our Tumblr to read summaries of each panel at Partnering for Cures, covering topics including U.S. research leadership, medical innovation, the future of the biopharma industry, patient-centeredness and more. Read more.
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Science and Technology
Accelerator brings together technology, neuroscience
The Atlanta accelerator program NeuroLaunch is the first in the U.S. to focus solely on neuroscience technology startups. "We believe that technological solutions are going to play a large role in treating patients," said co-founder Jordan Amadio, an Emory University neurosurgery resident. FoxNews.com (11/21)
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Researchers attempt to use randomized trial in health care setting
An Oregon study led by Massachusetts Institute of Technology professor Amy Finkelstein is using randomized trials -- the gold standard for drug evaluation -- to study health care delivery. "The only way to know if our intervention is truly effective is to do a randomized trial," said Dr. Jeffrey Brenner of Camden, N.J. The availability of electronic health records and pressure to reduce cost could lead to more health care delivery trials. The New York Times (tiered subscription model)/The Upshot blog (11/23)
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Finance and Economics
China's VCs back more U.S. biotech startups
The flow of venture capital from China to biotech startups in the U.S. is accelerating. The interest from China is good news for American firms that are getting frustrated with the difficulty of raising funds in the U.S. Forbes (11/24)
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Stem cell institute enters international partnership
The California Institute for Regenerative Medicine is collaborating with the Medical University of Warsaw in Poland to share expertise. The agreement is intended to support funding opportunities for researchers. Genetic Engineering & Biotechnology News (11/20)
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BioMarin boosts pipeline with Prosensa buy
BioMarin Pharmaceutical agreed to pay about $680 million upfront plus up to $160 million in milestone fees to purchase Prosensa Holding. The acquisition, expected to be completed early next year, will give BioMarin rights to Prosensa's Duchenne muscular dystrophy drug drisapersen, which is under evaluation by the FDA. Genetic Engineering & Biotechnology News (11/24), BioWorld (free content) (11/24)
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Harvard professor: Biotech dovetails with entrepreneurship
Harvard Medical School professor George Church advocates getting laboratory research results into the marketplace. His lab, which is focused on genetics research, has played a role in the launch of 14 startups and is working on creating six more. The Harvard Crimson (11/19)
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Policy and Regulation
House bill aims to spur orphan drug research
A proposed House bill would extend market exclusivity for an additional six months to existing drugs that can treat or prevent a rare disease or condition. The Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014, would extend market exclusivity for drugs not initially indicated for a rare disease, and the additional indication would not have to be requested by the FDA. Regulatory Focus (11/24)
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Telemedicine group hopes tech gets a boost in new Congress
The American Telemedicine Association is hoping the 21st Century Cures initiative will drive telemedicine legislation when the new Congress convenes in January. Reps. Fred Upton, R-Mich., and Diana DeGette, D-Colo., are leading the initiative. mHealth News (11/21)
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Society and Ethics
Tufts center report sheds light on drug development's cost
The Tufts Center for the Study of Drug Development analysis estimating the cost of bringing a new drug to market at $2.6 billion has made a positive contribution to the public's understanding of pharmaceutical industry economics despite questions and challenges that can be raised, Bernard Munos writes. The drug industry can and must adopt more efficient models of innovation to make drugs more affordable, he writes. Forbes (11/20)
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On the FastTrack
Non-Dilutive Funding Summit -- San Francisco, Jan. 14
Join more than 400 life science industry leaders in a full day of non-dilutive funding activities at the 10th Annual Non-Dilutive Funding Summit produced by the FreeMind Group. This year the summit is proud to host Rajesh Ranganathan, the director of the Office of Translational Research at the NINDS (NIH), who will describe funding opportunities and other resources available to the community that facilitate and enhance biomedical technology development toward commercialization. Attend additional panel discussions with representatives from NIAID, BARDA, NINDS, private foundations and more. On the agenda is also a presentation by Ram May-Ron, managing partner, FreeMind Group, as well as CEOs of companies who have been successful in raising non-dilutive capital speaking about the impact it had on the organization. Participation is free of charge; registration is required. Learn more.
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Editor's Note
FasterCures SmartBrief will not publish Thursday
In observance of Thanksgiving, FasterCures SmartBrief will not publish Thursday. Publication will resume Tuesday.
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