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Drug Prices: A Dysfunctional Market Limits Patient Access
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I am BIO Podcast  •  May 17, 2022
A convoluted, confusing, and opaque system for pricing drugs has evolved that distorts the market and often limits patient access to the drugs they need to survive. In this episode, three experts explain how the system works—or doesn’t’—and the consequences of a dysfunctional pricing system.
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RI Bio
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BIO Business Solutions - Member Association
Through its partnership with BIO, RI Bio offers its members the opportunity to take advantage of the BIO Business Solutions® programs listed below. Click on the company name to learn more. There is no fee for RI Bio members to participate.
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Good Day BIO: This bill would boost plant biostimulants
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Good Day BIO Newsletter  •  May 16, 2022
A bipartisan bill introduced Friday would boost much-needed plant biostimulants, and we’re celebrating the 10th anniversary of The JOBS Act. (623 words, 3 minutes, 6 seconds)
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Good Day BIO: COVID-19: ‘We have to prevent complacency’
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Good Day BIO Newsletter  •  May 13, 2022
Ending the week with a recap of yesterday’s Global COVID-19 Summit and how climate change is affecting our mental health. (685 words, 3 minutes, 25 seconds)
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BIO Response to Second Global COVID-19 Summit
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Vaccines  •  Press Release  •  May 12, 2022
The White House today hosted world leaders and key public and private sector partners at the second Global COVID-19 Summit, a virtual event. Following the conversation, Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO), made the following remarks: "For the last two years, the scientists within the life sciences industry have worked tirelessly to develop therapeutics and vaccines to fight COVID-19 and save lives. In addition to creating these lifesaving treatments, we have worked with key partners – including governments, NGOs, and more – to promote greater vaccine equity and access around the world. “We have made a lot of progress in this effort. In 2021 alone, companies produced more than 11 billion doses of COVID vaccines, enough to give two shots to every adult on the planet. We anticipate that number jumping to 18.6 billion by the end of this year. "However, as has been made clear at today’s Second COVID-19 Summit, there is still work to be done to help overcome global vaccine hesitancy and to ensure countries around the globe have the health care infrastructure they need to get more shots in arms. “BIO is encouraged by the recommitment of global leaders, including the United States, to strengthen COVID-19 response efforts. The scientists within the life sciences industry stand ready, once again, to help achieve this critical goal of increasing access to vaccines and therapeutics.”
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Good Day BIO: FDA user fee agreements advance with bipartisan support
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Good Day BIO Newsletter  •  May 12, 2022
House Energy and Commerce marked up legislation to reauthorize FDA user fee agreements yesterday—here’s a recap. Plus, the UNCCD is talking about food systems today, and we explain why biotech solutions should be on the menu. (619 words, 3 minutes, 5 seconds)
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Emerging Companies Section Governing Board Statement of Interest Form
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Thank you for your interest in serving as a Director on the Emerging Companies Section Governing Board. To ensure we have accurate information please download and complete the form found below, and upload a one-page biography and photo below. If you have any questions about the ECSGB nomination process, please contact Emily Berst at eberst@bio.org and Cameron Arterton at carterton@bio.org. Download Form  
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Good Day BIO: ‘Brand-name drug prices declined – or grew slowly – in 2021’
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Good Day BIO Newsletter  •  May 11, 2022
New data tells the truth about drug prices in 2021, and a deadly bird flu circulating the U.S. is a harbinger of what’s to come if we don’t take action on biotech innovation and climate change. (581 words, 2 minutes, 54 seconds)
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Good Day BIO: India’s heatwave highlights need for GMO wheat
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Good Day BIO Newsletter  •  May 10, 2022
India’s heatwave is “scorching” wheat crops—highlighting the need for genetically modified wheat. And it’s National Women’s Health Week—a good time to look at the dismal state of maternal mortality in the U.S. and what patient advocacy groups are doing about it. (618 words, 3 minutes, 5 seconds)
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BIO Comments on FDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
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Letters, Testimony & Comments  •  May 9, 2022
On Monday, May 9th, BIO submitted comments in response to the FDA’s recent draft guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates. In the comments submitted, BIO acknowledged the challenge FDA faces in creating a regulatory guidance that is comprehensive yet adaptable, given the diversity and complexities of ADCs today. However, BIO noted that FDA’s inclusion of a broader range of ADC products in the final guidance would be valuable to sponsors and urged FDA to provide further detail when defining and referencing various components of ADCs and their byproducts. The comments also highlighted the current challenges sponsors face in considering the inclusion of organ impairment patients and patients with interacting concomitant medications, and requested the Agency provide additional guidance on when and how these patients should be included. Lastly, BIO encouraged FDA to provide additional examples and recommendations regarding the use of physiologically based pharmacokinetic (PBPK) modeling, and to consider opportunities where sponsors could leverage existing data on ADCs with the same linker-payload (if available).
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