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BIO Applauds House Passage of the American Innovation Act

Bill reforms tax rules that currently penalize investment in job creation, innovation   Washington, DC (September 27, 2018) – The Biotechnology Innovation Organization (BIO) today applauded the House of Representatives for passing the American Innovation Act of 2018 (H.R. 6756), which includes a provision that would protect investments in start-ups from inadvertently triggering the net operating loss (NOL) limitations under Section 382 of the tax code. R&D-intensive biotech start-ups frequently accumulate substantial NOLs in their early, pre-revenue years, given their typical reliance on investor capital for more than a decade before realizing any product revenue.

RDOD: FDA Draft Guidance Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

September 25, 2018

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Biosimilars: Facilitating Competition and Innovation in the Biological Products Marketplace

September 21, 2018

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BIO/Food Value Chain letter to Senate and House Appropriations Committee leadership in support of legislative language ensuring consistency under the National Bioengineered Food Disclosure Law

September 21, 2018

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BIO Praises Passage of Small Business Innovation Protection Act

Washington, D.C. (September 26, 2018) – The Biotechnology Innovation Organization applauds the House and Senate’s bipartisan passage of the Small Business Innovation Protection Act. The bill...

BIO Applauds House Passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Legislation will strengthen pipeline of medical countermeasures against serious public health threats   Washington, DC (September 25, 2018) – The Biotechnology Innovation Organization (BIO) today applauds the House of Representatives for passing the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (H.R. 6378). The legislation would re-authorize critical federal biodefense programs and agencies, including the BioShield Special Reserve Fund (SRF), the Biomedical Advanced Research and Development Authority (BARDA), and the Strategic National Stockpile (SNS).  

BIO/Coalition for Safe, Affordable Food letter for Senate and House Ag Committee leadership in support of biotech education provision

Dear Chairman Roberts, Chairman Conaway, Ranking Member Stabenow, and Ranking Member Peterson: As representatives of the U.S. food and agricultural value chain and members of the Coalition for Safe, Affordable Food (the Coalition), we write to express our support for Section 7608 in the House-passed H.R. 2, the Agriculture Improvement Act of 2018, regarding public education on agricultural biotechnology. We believe these provisions will support the U.S. Department of Agriculture (USDA) and other relevant federal agencies in providing consumers with education materials on the National Bioengineered Food Disclosure Law (NBFDL) and its implementing regulations – the National Bioengineered Food Disclosure Standard (NBFDS). Such education materials can assist in explaining how the NBFDS provides consumers with information on the ingredients of the foods they eat, one overriding purpose of the NBFDL...

BIO Applauds Release of New National Biodefense Strategy

“I applaud the Administration for recognizing the importance of strengthening our national biodefense and preparedness efforts. Our nation continues to face a wide range of biological threats, and this strategy is an important step in the right direction."

BIO Applauds Senate Passage of Opioid Crisis Response Act of 2018

“BIO’s member companies are committed to unleashing the power of scientific innovation to develop solutions that will lead to an America free of prescription opioid addiction. Today’s vote advances vital legislation that will help get new innovations to patients suffering from pain and addiction, by ensuring that our research and regulatory environments keep pace with our accelerating scientific knowledge and capabilities."

Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format

Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format.