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BIO Statement on CMS Proposed Decision Memo for the CAR-T National Coverage Determination

BIO Executive Vice President for Health Policy Dan Durham issued the following statement regarding the CMS proposed decision memo for the CAR-T National Coverage Determination.

Biomarkers: BIO Submits Comments on FDA Draft Guidance Biomarker Qualification: Evidentiary Framework

February 11, 2019

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BIO Applauds Sens. Tillis, Sinema, Peters, and Perdue for Introducing the Fostering Innovation Act

The Biotechnology Innovation Organization (BIO) applauds Sens. Thom Tillis (R-NC), Kyrsten Sinema (D-AZ), Gary Peters (D-MI), and David Perdue (R-GA) for introducing the Fostering Innovation Act (S.452) to build on the success of the Jumpstart Our Business Startups (JOBS) Act. 

BIO Announces Brent Erickson to Step Down as Executive Vice President, Industrial and Environmental Section

The Biotechnology Innovation Organization (BIO) announced today that after 19 years leading the Industrial and Environmental Section, Executive Vice President Brent Erickson will step down from the organization in March 2019 to begin new business ventures. 

New Report Demonstrates High Costs and Low Benefits of Sarbanes-Oxley 404(b) Compliance for Emerging Biotechs

To recognize National Inventors’ Day, the Biotechnology Innovation Organization (BIO) released a new report, “Science or Compliance: Will Section 404(b) Compliance Impede Innovation by Emerging Growth Companies in the Biotech Industry?” The report shows the detrimental impact of Sarbanes-Oxley 404(b) on biopharmaceutical emerging growth companies (Bio-EGCs) and demonstrates how this regulatory requirement harms innovation and capital formation without any corresponding investor benefit. 

RWE: BIO Submits Comments on FDA Framework for a Real-World Evidence Program

February 5, 2019

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BIO Encouraged by Improved U.S. Ranking in Global Index of Patent System Strength

But New Legislative Proposals Endanger Progress

BIO Statement on Hatch-Waxman Integrity Act of 2019

BIO applauds the leadership of Senator Thom Tillis (R- NC) and Congressman Bill Flores (R-17 TX) for introducing the “Hatch-Waxman Integrity Act of 2019” to preserve the time-tested approach of the HWA while strengthening the ability of patent owners to fairly defend against abusive efforts to invalidate patents for innovative life-saving medical therapies.

BIO Statement on State of the Union Address

BIO’s President and CEO Jim Greenwood issues statement on President Trump’s State of the Union Address.

BIO Statement on New Proposal for Lowering Out-of-Pocket Costs for Medicines

BIO’s President and CEO Jim Greenwood issued a statement after the Trump administration released a proposed rule that would alter safe harbor policies under the federal anti-kickback statute.