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BIO Comments on FDA Draft Guidance on Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
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Letters, Testimony & Comments  •  February 16, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) provide new pediatric information in labeling for over 600 products. BIO appreciates the FDA’s efforts to clarify and provide notice of a policy change intended to enable the FDA to apply the Orphan Drug Act (ODA) and PREA to non-rare adult indications corresponding to orphan-designated pediatric subpopulations. However, BIO’s comments detail general concerns with the guidance and specific line edits to clarify and improve the guidance.  
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Biofuel Sends Letter to EPA Administrator Pruitt on 2019 Cellulosic Volumes
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Letters, Testimony & Comments  •  February 15, 2018
As the U.S. EPA begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), a group of trade association advocates encourage the agency to take a renewed look at commercially ready cellulosic biofuels.
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BIO Submits Comments on FDA Draft Guidance on Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
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Letters, Testimony & Comments  •  February 15, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. This draft guidance provides important information on the expedited programs available to sponsors of regenerative medicine therapies for serious conditions. BIO recommends the FDA provide further guidance to sponsors on which designation (RMAT or Breakthrough Therapy) is most appropriate for different types of programs, along with other comments on how to clarify the guidance.  
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BIO Comments on FDA Draft Guidance on Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
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Letters, Testimony & Comments  •  February 15, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease. BIO welcomes the FDA’s efforts to provide clear, concise guidance on the regulatory and scientific framework for product developers of targeted treatments. This will help sponsors with clinical trial development, including the types/levels of evidence to support a grouping strategy for clinical trial eligibility and benefit-risk evaluation approaches within a disease exhibiting differences in molecular subset. BIO encourages the FDA to continue to gather stakeholder input on the development of targeted therapies to ensure the guidance keeps pace with scientific advances. BIO’s comments include additional suggestions to clarify the guidance, the scope, and FDA’s receptivity to innovative approaches for the development of targeted therapies.
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BIO Statement on President’s Proposed 2019 Budget
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Press Release  •  February 13, 2018
Washington, D.C. (February 13, 2018) — Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement in response to President Trump’s FY 2019 budget proposal.
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BIO Expresses Strong Support for TRID Improvement Act
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Press Release  •  February 12, 2018
Legislation provides critical regulatory relief to small, pre-revenue emerging companiesWashington, D.C. (February 12, 2018)— The Biotechnology Innovation Organization (BIO) announced its strong support today for H.R. 3978, the TRID Improvement Act. The bill includes a provision known as the Fostering Innovation Act, which offers much needed regulatory relief to small biotechnology firms. 
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BIO Releases Report on State of Innovation for Pain and Addiction Therapeutics
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Press Release  •  February 12, 2018
Report highlights the need to stimulate innovationto battle the opioid epidemicWashington, DC (February 12, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction Therapeutics. While many promising treatment approaches are in development, lower investment and pipeline breadth in pain and addiction relative to other disease areas with high societal health burdens demonstrates the need for incentivizing more research and clinical development in these areas.
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BIO Applauds Introduction of the Vaccine Access Improvement Act
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Press Release  •  February 9, 2018
Washington, DC (February 9, 2018) – – The Biotechnology Innovation Organization (BIO) applauds Reps. Mike Kelly (R-PA) and Brian Higgins (D-NY) for introducing H.R. 4993, the Vaccine Access Improvement Act, which would promote timely access to new first-in-class childhood and maternal vaccines. The legislation would update the tax code to ensure new first-in-class vaccines are promptly covered under the National Vaccine Injury Compensation Program (VICP). 
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South Dakota Governor Daugaard Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines
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Press Release  •  February 9, 2018
Washington, D.C. (February 09, 2018) – The Biotechnology Innovation Organization (BIO) and the South Dakota Biotech Association commend Governor Dennis Daugaard for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.Governor Daugaard signed Senate Bill 75 this week, following unanimous passage in both the South Dakota Senate and House. The policies outlined in the bill align with BIO’s principles on biologic substitution and garnered our support.  BIO and the South Dakota Biotech Association are grateful to the legislature and Governor Daugaard for their leadership on this issue.“Senate Bill 75 enjoys the support of physicians across South Dakota 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 Daugaard has added South Dakota 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 Bill 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.“We’re pleased to see…
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BIO Statement on Medicare Part D Changes in Budget Deal
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Press Release  •  February 8, 2018
Washington, DC (February 8, 2018) – BIO President and CEO Jim Greenwood issued the following statement today regarding proposed changes to the Medicare Part D program in the announced budget deal.
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