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BIO Comments to the FDA on the Agency’s Updated Guidance on PREA and BPCA
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Letters, Testimony & Comments  •  July 18, 2023
BIO provides general comments and recommendations on FDA’s Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act (Docket No. FDA-2005-D-0460-0008)
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BIO Comments to FDA on Pediatric Drug Development: Regulatory Considerations
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Letters, Testimony & Comments  •  July 18, 2023
BIO provides general comments and recommendations to FDA on “Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act” (Docket No. FDA-2005-D-0460-0007)
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New long COVID insights
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Good Day BIO Newsletter  •  July 17, 2023
New research provides new insights into long COVID—here’s what we know. Plus, meet Kip Tom, the keynote speaker at BIO Impact in September. (484 words, 2 minutes, 25 seconds)
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Hill talks PAHPA and PBMs
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Good Day BIO Newsletter  •  July 14, 2023
A busy Thursday on Capitol Hill brought progress on PAHPA and questions about PBMs—here’s what happened. (646 words, 3 minutes, 13 seconds)
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Gene-editing Technologies: Powerful Tools for Rewriting the Code of Life
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Webinars  •  July 14, 2023
  The Cell and Gene Therapy (CGT) Science Series is a quarterly seminar series focused on scientific topics related to cell and gene therapy products. The CGT Science Series is intended to foster scientific exchange between the Biotechnology Innovation Organization (BIO), the American Society of Cell & Gene Therapy (ASGCT), and Center for Biologics Evaluation and Research (CBER) review staff on a variety of topics that span the CGT product lifecycle. The seminars are planned as 60-minute virtual webinars featuring a speaker from one of the three organizations. The CGT Science Series will enable a deep dive into a specific technical and/or scientific area. Topics in the series may include but are not limited to, nonclinical, CMC, clinical, or post-market phases of development related to CGT product lifecycle. Moderator: – Anne-Virginie Eggimann, Tessera Opening Remarks: – Cartier Esham, Senior Advisor, Biotechnology Innovation Organization (BIO) Speaker: – Jing Liao, Director, Vector Development and Operations, Alexion Pharmaceuticals
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Inquiry Form for Nikon
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BIO Business Solutions
BIO Business Solutions® is the largest cost savings purchasing program for the biotech industry operated by the Biotechnology Innovation Organization (BIO). With more than half a billion in annual sales, BIO Business Solutions® aggregates the purchasing power of over 4,700 life science companies from North America. Companies of all sizes save substantial money each year through this cost-savings program. To request information for the BIO-Nikon Program, please fill the fields below and click the Submit button at the bottom of the form.   MktoForms2.loadForm("//app-ab15.marketo.com", "490-EHZ-999", 3881);
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Congress continues its focus on PBMs
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Good Day BIO Newsletter  •  July 13, 2023
PBMs were on the agenda in the House and Senate yesterday—here’s what happened. Plus, as demand for protein grows, biotech is providing sustainable options. (646 words, 3 minutes, 13 seconds)
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Coalition Letter Re PIPs Rule
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Agriculture & Environment  •  Letters, Testimony & Comments  •  July 12, 2023
BIO and 59 other organizations have written to House and Senate Agriculture Committee leaders to ask that they direct Congress to withdraw the current rule concerning regulation of plant incorporated protectants and replace it one based on a science-based consideration of the risks and benefits of PIPs.
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Inquiry Form for ShareVault
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BIO Business Solutions
BIO Business Solutions® is the largest cost savings purchasing program for the biotech industry operated by the Biotechnology Innovation Organization (BIO). With more than half a billion in annual sales, BIO Business Solutions® aggregates the purchasing power of over 4,700 life science companies from North America. Companies of all sizes save substantial money each year through this cost-savings program. To request information for the BIO-ShareVault Program, please fill the fields below and click the Submit button at the bottom of the form.   MktoForms2.loadForm("//app-ab15.marketo.com", "490-EHZ-999", 3880);
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AMR is a crisis ‘here and now’
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Good Day BIO Newsletter  •  July 12, 2023
A BIO witness explained to Senators why we need urgent Congressional action to fix the broken marketplace for antimicrobials—we have a recap, plus, how biotech can help tackle the growing number of heat-related deaths. (509 words, 2 minutes, 32 seconds)
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