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BIO Urges Congress to Reauthorize Pendemic and All-Hazards Preparedness Act

May 11 2011
In testimony before the Senate Health, Education, Labor and Pensions Committee, BIO urged lawmakers to reauthorize the Pandemic and All-Hazards Preparedness Act.

Dr. Stephen Sherwin, BIO Chairman and Chairman & Co-founder of Ceregene, Addresses Attendees at BIO International Convention

May 5 2011

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BIO's Comments on the Internal Revenue Service's (IRS) Proposed Guidance Regarding the Branded Prescription Drug Fee

Apr 29 2011
BIO submitted comments in advance of the May preliminary assessment to ensure that the annual branded prescription drug fee is implemented in a manner that ensures fair apportionment of the fee, adherence to the statue, and also recognizes the practical realities of assembling and verifying the data necessary to complete the task.

Biofuels: BIO Opposes New Hampshire's Proposed Ethanol Ban

Apr 28 2011
BIO presented testimony to the New Hampshire State Senate Transportation Committee arguing that a proposed ban on corn ethanol would have a chilling effect on investment in advanced and cellulosic biofuels, including for research and development being done by New Hampshire companies and universities.

BIO's Comments on the Centers for Medicare and Medicaid Services' (CMS) Proposed Decision Memorandum for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer

Apr 28 2011
BIO submitted comments in support of CMS's proposed decision to preserve the ability for physicians and their patients to make the treatment determination that is optimal for their situation. BIO also highlights the potential impact of initiating on patients' access to novel, cutting-edge therapies of initiating a National Coverage Analysis (NCA) on newly-approved therapies.

BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA

Apr 28 2011
Dr. Ron Portman, BMS, Chair of BIO's Pediatrics Committee, presented on behalf of BIO at an Institute of Medicine (IOM) meeting on pediatric studies conducted under the Best Pharmaceuticals for Children Act and Pediatrics Research Equity Act (BPCA/PREA). Dr. Portman delivered a statement on the importance of BPCA/PREA, its value for the research and development of medicines for children, and responded to questions from the committee. This meeting was part of a series held at IOM in response to an FDA request for a study on BPCA/PREA. IOM is expected to issue a report on the findings of the committee.

BIO's Comments on the Report of the National Vaccine Advisory Committee (NVAC) Adult Immunization Working Group entitled Adult Immunization: Complex challenges and recommendations for improvement.

Apr 25 2011
BIO states that the report tackles the complex issues of adult immunization in a positive, collaborative and forward-thinking manner. However, in these comments, BIO addresses several areas where the report could place more importance.

BIO's Comments on the Centers for Medicare & Medicaid Services' (CMS) Medicare Coverage Gap Discount Program Appeals Guidance

Apr 22 2011
BIO addressed the process and bases for appeals and the implementation of the final appeals guidance.

National Institutes of Health (NIH) Uses American Recovery and Reinvestment Act (ARRA) Funding to Advance Scientific Research

Apr 19 2011

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BIO Comments on the FDA's Draft Guidance for the Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies

Apr 19 2011
BIO recognizes the importance of appropriate consideration and use of clinical pharmacogenomic data by the FDA to ensure that this information is used appropriately to improve healthcare outcomes. BIO represents companies that are involved specifically with pharmacogenomics, therefore, welcome the opportunity to work with the FDA as the Agency develops guidance on clinical pharmacogenomic studies through all phases of product research and development.