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EHB: BIO’s Comments on the Essential Health Benefits Proposed Rule

Dec 21 2012

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Pandemic and All-Hazards Preparedness Reauthorization Act

Dec 17 2012
BIO President and CEO Jim Greenwood wrote a letter in support of H.R. 6672, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2012, sponsored and championed by Chairman Mike Rogers (R-MI).

BIO Comments on EMA Guideline on Biosimilar Quality Issues

Nov 30 2012

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India Traditional Knowledge and Biological Material Draft Guidelines: Biotech Industry Provides Input

Nov 27 2012
Given the importance of protections for basic biotechnology inventions to the survival of the biotechnology sector in India, BIO has reviewed the Guidelines and has identified specific questions, and areas for improvement.

BIO Submits PAHPA Reauthorization Support Letter

Nov 16 2012
  Dear Chairmen Harkin, Upton and Pitts, Ranking Members Enzi and Waxman, Senators Burr and Casey, and Rep. Rogers:   On behalf of the undersigned organizations, we urge you to finalize negotiations on the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA, S. 1855/H.R. 2405) and quickly pass this important legislation. The time is running short to reauthorize many important programs, such as the Biomedical Advanced Research and Development Authority (BARDA), the BioShield Special Reserve Fund, Public Health Emergency Preparedness grants, the Hospital Preparedness Program, and others. We stand ready to work with you in moving the legislation to final passage.

India’s Draft National IPR Strategy: BIO Comments

Nov 7 2012
(BIO) is grateful for the opportunity to provide comments on India’s Draft National IPR Strategy, hereafter referred to as "Draft Strategy".

Unique Device Identification System Comments

Nov 6 2012

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Biosimilar Patent Certification: University Associations Ask FDA to Not Undermine Their Patent Rights

Nov 4 2012
We write with the concern that under the statutory patent dispute resolution scheme, biosimilars sponsors can effectively circumvent every patent litigation provision of the statute simply by failing to provide timely notice and access to the reference product sponsor without meaningful consequences, despite the requirement for such notification. As universities are commonly licensors of biological products, numerous university patents may be affected by biosimilar applications. We do not believe it is appropriate that our member institutions’ rights could be forfeited due to an inadvertent or intentional failure by a biosimilar applicant to notify the reference product sponsor, who in turn can notify the university licensor.

BIO and Other Industry Organizations Urge Congressional Leadership to Oppose any Waiver of RFS Requirements

Oct 18 2012

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The Renewable Fuels Standard: A Successful Federal Policy that Must Be Defended

Oct 17 2012
A keynote Address by James C. Greenwood, President & CEO of BIO, to RETECH 2012 in Washington, DC on October 18, 2012.