Financial innovation series highlights ANTABIO and WiSeed | Blog: Working together toward cures for rare diseases | Researchers, advocates say Alzheimer's funding is inadequate
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March 19, 2013
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Sequestration threatens faster FDA reviews, Hamburg says
Across-the-board sequestration cuts could hurt the FDA's efforts to accelerate new drug reviews, said FDA Commissioner Dr. Margaret Hamburg during MassBio's annual meeting. Hamburg said she hopes Congress will allow the agency to put user fees paid by drugmakers toward its operating expenses. Boston Herald (3/15)
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News from FasterCures
Financial innovation series highlights ANTABIO and WiSeed
In this month's series on novel R&D funding models, FasterCures profiles ANTABIO, a France-based biopharmaceutical company that partnered with the crowdfunding platform WiSeed to complete the first successful crowdfunding round for a biotechnology startup company. ANTABIO successfully raised €300,000 ($387,640) in three months from more than 200 investors through WiSeed. An accredited investor then made an approximately €500,000 ($646,218) investment and bought back the crowdfunded shares for a return on investment of 44%. Read this month's case study.
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Blog: Working together toward cures for rare diseases
On Feb. 28, FasterCures joined friends and colleagues in the rare disease community to commemorate Rare Disease Day, the culmination of a week's worth of activities to bring widespread recognition of rare diseases as a global health challenge. We were privileged to be a part of a major event here in D.C. kick-starting the week and celebrating the screening of Here.Us.Now, a documentary highlighting the Hempel Family and their struggle to save their twin daughters, Addi and Cassi, who are living with Neimann Pick Type C. Following the screening, Margaret Anderson moderated a panel about collaborating for cures. Read more.
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Science and Technology
Researchers, advocates say Alzheimer's funding is inadequate
Alzheimer's disease has become the sixth-leading cause of death in the U.S., while death rates related to stroke, HIV and breast cancer have declined. The Alzheimer's Association, along with doctors and researchers, are calling for increased funding to find effective treatments and cures. Funding for NIH research into Alzheimer's was expected to increase this year, but levels are uncertain in light of sequestration and many meritorious grant applications have gone unfunded, says Mayo Clinic neurology professor David Knopman. Bloomberg (3/19), Yahoo/The Associated Press (3/19)
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FindZebra helps docs spot rare diseases
A new search engine called FindZebra combs curated databases on rare diseases and uses an open-source information retrieval tool to help physicians and researchers identify rare diseases based on symptoms. The developers say the search engine significantly outperforms Google for the intended purpose. MIT Technology Review online/The Physics arXiv Blog (3/18)
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Early treatment may functionally cure some HIV patients
Fourteen HIV patients who received very early treatment showed no signs of the virus rebounding seven years after ceasing treatment, researchers report in PLoS Pathogens. "Early treatment in these patients may have limited the establishment of viral reservoirs, the extent of viral mutations, and preserved immune responses," said researcher Christine Rouzioux. Reuters (3/15)
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Finance and Economics
Manufacturing, regulatory complexities slow biosimilars
Merck & Co., Teva Pharmaceutical Industries, Lonza and Samsung are among the companies that have scaled back plans to produce biosimilar versions of brand-name biologic drugs amid regulatory uncertainty, market volatility and high development and manufacturing costs. Bringing a biosimilar to market can cost up to $40 million by some estimates and can take six to nine years, compared with $1 million to $2 million and three years for a generic small-molecule drug. Genetic Engineering & Biotechnology News/Insight & Intelligence blog (3/18)
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Drugmakers cut antibiotics R&D as superbugs take hold
Despite concerns about drug-resistant bacteria, few drugmakers are developing new antibiotics and some have trimmed their antibiotics research spending. Regulatory hurdles and relatively low market pricing make antibiotics development unattractive. Public-private partnerships might shift the playing field, and more research sharing could boost innovation, GlaxoSmithKline CEO Andrew Witty said. Reuters (3/18)
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GSK CEO: Efficiencies will drive down drug prices
Advances in research and development efficiencies should lead to lower prices for new drugs, GlaxoSmithKline CEO Andrew Witty said. Drugmakers are seeing greater success, with 39 new drugs approved last year, and some companies are seeing lower average per-drug development costs. Global demand for drugs is also rising, which should drive down per-unit costs, Witty said. Reuters (3/14)
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Policy and Regulation
Senator seeks return for taxpayers on drugs fueled by public funds
Sen. Ron Wyden, D-Ore., has asked NIH Director Dr. Francis Collins for documents related to the development of Pfizer's new arthritis drug Xeljanz, which was initially developed in collaboration with the NIH. The drug's monthly wholesale price is $2,055, much of which will be borne by Medicare, but Pfizer says it invested 20 years and $1 billion into the drug. "In the face of this difficult economic climate and the increasing scarcity of research dollars it is time to revisit the idea of striking a better balance between encouraging profit, innovation, accessibility and affordability," Wyden wrote in an open letter. The New York Times (tiered subscription model) (3/18)
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Proposed budget hike would increase FDA oversight in China
A Senate bill that aims to raise the FDA's fiscal 2013 budget to $2.5 billion has gained support from the Alliance for a Stronger FDA, which calls it "strongly favorable" to the agency. The measure, which includes the new user fees for medical devices, drugs and biologics, provides $10 million to allow the agency to beef up its inspections in China, the group said. In-PharmaTechnologist.com (3/18)
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Society and Ethics
Neuroscientist hopes virtual brain will unify research
Neuroscientist Henry Markram is the brains behind Blue Brain, a web of nearly 10,000 virtual neurons designed to simulate living brain waves. Markram's next step, the Human Brain Project, will simulate an entire brain on a supercomputer. Critics say the project is poorly defined and premature, and will siphon scarce funds from other programs, but Markram sees his project as a unifying principle for other neuroscientists. The New York Times (tiered subscription model) (3/18)
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On the FastTrack
Evidence, Coverage, & Incentives: A PMC/BIO Solutions Summit
The Personalized Medicine Coalition (PMC) and the Biotechnology Industry Organization (BIO) invite you to join them on April 17 in Washington, D.C., for the first in a series of summits that will explore solutions to one of the central challenges facing personalized medicine: What levels of evidence should be required to define health plan coverage and clinical decisions for personalized medicine? The discounted hotel rate expires March 25. Register today.
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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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