BIO Comments on FDA docket Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and AddictionNov 22 2019
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide input and recommendations to the FDA on the docket titled Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.
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Speaker Pelosi’s Drug Pricing Plan Could Result in 56 Fewer New Medicines Over 10 YearsNov 21 2019
Speaker Nancy Pelosi’s Lower Drug Costs Now Act of 2019, H.R.3, could result in at least 56 fewer new medicines for patients over 10 years, according to a new analysis from economic consulting firm Vital Transformation. The study examined the impact of foreign reference pricing provisions in H.R.3 on treatments and cures from small, emerging U.S. biotech companies that rely on venture capital to finance their research and development. The analysis was commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO) and the Council of State Bioscience Associations (CSBA).
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Green Energy Solutions Unleashed Through New PartnershipNov 21 2019
BIO and LCFC efforts will promote state-based low carbon fuel policies.
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BIO Comments on RFS Standards for 2020 and Biomass-Based Diesel Volumes for 2021, Response to the Remand of the 2016 StandardsNov 20 2019
The Biotechnology Innovation Organization (BIO) is pleased to provide comment on the U.S. Environmental Protection Agency’s (EPA’s) proposed rule on the Renewable Fuel Standard Program: Standards for 2020 and Biomass-Based Diesel Volume for 2021, Response to the Remand of the 2016 Standards, and Other Changes (proposed rule).
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BIO Comments on Proposed Section 382(h) RegulationsNov 13 2019
The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h), as generally requested in the preamble to the proposed regulations.
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BIO Comments on SEC Proposal to Amend the Accelerated Filer and Large Accelerated Filer DefinitionsNov 11 2019
The Biotechnology Innovation Organization provided comments to the Securities and Exchange Commission on File No. S7-06-19, its proposal to amend the Accelerated Filer and Large Accelerated Filer definitions.
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BIO Commends the Introduction of the Helping Startups Continue to Grow ActNov 8 2019
BIO supports the “Helping Startups Continue to Grow Act” which extends the exemption afforded to Emerging Growth Companies under the JOBS Act from certain executive compensation, financial, and other disclosure requirements for an additional five years.
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State Biotech Associations Warn Part D Redesign Puts New Treatments for Patients at RiskNov 4 2019
In a letter to Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the leaders of the Senate Finance Committee, state biotech associations warn that the Committee’s proposed redesign of Medicare Part D puts new, innovative treatments for patients at risk.
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BIO Comments from Stephen Rapundalo (MichBio) on 2020 RFS SRE Public HearingOct 31 2019
I am appearing on behalf of the Biotechnology Innovation Organization (BIO). BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.
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BIO Submits Comments to the House Energy and Commerce Hearing on "Protecting the RFS: The Trump Administration's Abuse of Secret Waivers"Oct 31 2019
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the to the United States House of Representatives Committee on Energy and Commerce Subcommittee on Environment and Climate Change hearing, "Protecting the RFS: The Trump Administration's Abuse of Secret Waivers."
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