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USDA Biobased Economy Report Indicates Potential for Rural Prosperity with Renewable Chemicals
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Press Release  •  March 20, 2018
BIO today welcomed USDA’s release of a new report, Indicators of the U.S. Biobased Economy, which measures substantial economic growth, job creation, and household income from biofuel and bioenergy production and future growth in renewable chemicals and biobased products.
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BIO Comments on Promoting the Use of Complex Innovative Designs in Clinical Trials
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Letters, Testimony & Comments  •  March 20, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) public meeting on Promoting the Use of Complex Innovative Designs in Clinical Trials. BIO supports the development and launch of this initiative. BIO shares the FDA’s goals for the pilot program to promote public learning about Innovative Clinical Trial Design (ICTD) and to demonstrate the use of novel designs to increase the efficiency and/or feasibility of clinical development. The pilot program will present multiple opportunities for public learning and the advancement of ICTD. To advance the successful implementation of the ICTD Pilot Program, BIO developed recommendations on the timelines, communication, and disclosure of information, among other issues. BIO’s comments also include high-level case studies of innovative clinical trial designs which have historically shown low levels of regulatory, in an effort to provide insight into the general types of innovative clinical trial designs BIO would like to see in the pilot program.
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BIO Statement of Support for the STRONGER Patents Act
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Press Release  •  March 20, 2018
Washington, D.C. (March 20, 2018) – The following statement on the House introduction of the STRONGER Patents Act by Representatives Steve Stivers (R-OH-15) and Bill Foster (D-IL- 11) may be attributed to Tom DiLenge, BIO’s President, Advocacy, Law & Public Policy Division:“BIO supports balanced reforms to reduce abusive patent practices – both by patent owners and against patent owners.  But we also must strengthen the incentives needed to sustain our nation’s global leadership in biotechnology innovation and the creation of high-wage, high-value jobs throughout our country. With the introduction of the STRONGER Patents Act, Congress has begun the process of achieving that critical balance.“I commend Representatives Stivers and Foster for their leadership in introducing legislation that will reform the inter partes review and post-grant review processes, bringing fairness and finality to these Patent Office proceedings. The bill also will enhance patent quality by ensuring that all fees paid to the Patent Office are used for their intended purposes, and will crack down on abusive patent demand letters.“Strong patents are the lifeblood of the biotechnology industry. They are critical in ensuring a steady stream of capital to biotechnology companies developing innovative medicines and more sustainable sources of energy and agricultural products. And they are essential to the technology transfer process that leads from inventions in the lab to products on the shelves.“The majority of biotechnology companies are small companies that have no products on the market, and thus their research and development activities are funded through massive amounts of private sector investment over many years, sometimes even decades. Without strong, predictable and enforceable protections for patented inventions, investors will shy away from investing in biotechinnovation, degrading the ability to provide solutions to the most pressing medical,…
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Wyoming Governor Mead Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines
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Press Release  •  March 16, 2018
Washington, D.C. (March 16, 2018) – The Biotechnology Innovation Organization (BIO) commends Governor Matt Mead for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.Governor Mead signed Senate File 75 this week, following broad bipartisan support in both the Wyoming Senate and House. The policies outlined in the bill align with BIO’s principles on biologic substitution and garnered our support. BIO is grateful to Senator Fred Baldwin for his sponsorship of the bill, and to the legislature and Governor Mead for their leadership on this issue.“Senate File 75 enjoys the support of physicians across Wyoming and the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes provisions to ensure appropriate communication on all biologic medicines dispensed, in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO’s President and Chief Executive Officer. "By signing this bill into law, Governor Mead has added Wyoming to the list of states that allow retail pharmacies to substitute interchangeable biologic medicines."While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. Senate File 75 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies. BIO supports full communication in the substitution process, as patients and their physicians should know what biologic medicine the patient receives from the pharmacy.While the FDA has approved biosimilar products for sale in the U.S., the…
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BIO Submits Comments to House Ways and Means on Expired Tax Provisions
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Letters, Testimony & Comments  •  March 14, 2018
BIO supports a seamless multi-year extension for the Second Generation Biofuel Producer Tax Credit; Special Depreciation Allowance for Second Generation Biofuel Plant Property; Biodiesel and Renewable Diesel Fuels Credit; and the Alternative Fuel Vehicle Refueling Property, which expired at the end of 2017. BIO also supports the extension and expansion of the tax code to include the Qualifying Renewable Chemical Production or Investment Tax Credit and Master Limited Partnerships (MLP) to advanced biofuel and renewable chemicals.
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BIO Submits Testimony for Hearing on Recently Expired Tax Credits
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Press Release  •  March 14, 2018
BIO submitted written testimony to the U.S. House Ways and Means Subcommittee on Tax Policy, for the hearing “Post Tax Reform Evaluation of Recently Expired Tax Provisions,” asking the committee to provide a seamless multi-year extension of the Second Generation Biofuel Producer Tax Credit; the Special Depreciation Allowance for Second Generation Biofuel Plant Property; the Biodiesel and Renewable Diesel Fuels Credit; and the Alternative Fuel Vehicle Refueling Property, which Congress recently extended retroactively for 2017 but are currently expired.
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Oregon Governor Signs Misleading Drug Pricing Bill
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Press Release  •  March 13, 2018
BIO regrets signing of misleading drug pricing and reporting bill by Oregon Governor Brown, as it will fail to provide patients the lower drug costs they were promised
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BIO is Now Accepting Nominations for the 2018 Rosalind Franklin Award
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Press Release  •  March 13, 2018
Washington, D.C. (March 13, 2018) - Each year, the Biotechnology Innovation Organization (BIO) presents the Rosalind Franklin Award for Leadership in Industrial Biotechnology to an outstanding woman in the industrial biotechnology sector who has made significant contributions to the advancement of the biobased economy and biotech innovation. BIO is now accepting nominations for the 2018 Rosalind Franklin Award. The award will be presented at the 2018 World Congress on Industrial Biotechnology in Philadelphia at the Pennsylvania Convention Center from July 16-19, 2018. The deadline to submit nominations is March 28, 2018. 
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International Council of Biotech Associations Launches New Website
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Press Release  •  March 12, 2018
Washington, D.C. (March 12, 2018) – The International Council of Biotech Associations (ICBA) today announced the launch of internationalbiotech.org, a new website to support the organization’s mission of growing and connecting the innovative biotechnology industry worldwide.The website unites publicly available resources of ICBA members, providing a virtual library of materials ranging from economic and employment data to issue specific whitepapers. The site’s interactive map demonstrates the distribution of the biotechnology industry around the world, enabling users to easily contrast key economic data markers, including the percent of GDP spent by businesses and governments on research and development.“The increasingly global biotechnology industry provides breakthrough products and technologies that combat debilitating and rare diseases, reduce our environmental footprint, feed the hungry, use less and cleaner energy, and have safer, cleaner and more efficient industrial manufacturing processes,” said Andrew Casey, Chair of the ICBA and President & CEO, BIOTECanada. “The challenges and opportunities faced by the biotechnology industry cross borders. This website demonstrates the steps our industry is taking to better coordinate, organize and face these issues around the world together.”About ICBAThe International Council of Biotechnology Associations (ICBA) is a coalition of non-profit, national biotechnology trade associations formed to promote public understanding of, and to advocate for, public policies that support the growth of the innovative biotechnology industries. The ICBA represents the global voice of the industry in international fora with the goal of promoting continued innovation in the human health, agriculture, and industrial and environmental sectors. ###
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GREENER Fuels Act Would Undermine Investment in Advanced Biofuels, BIO Says
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Press Release  •  March 8, 2018
BIO voiced its opposition to the GREENER Fuels Act, introduced by Sen. Tom Udall (D-NM) and Rep. Peter Welch (D-VT), because it would revise the Renewable Fuel Standard (RFS) in way that will chill investment in advanced biofuel.
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