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Vaccines & Biodefense

In the U.S., the recommended immunization series prevents approximately 33,000 deaths each year. Advancements in biotechnology have made it possible to produce vaccines that cannot transmit a virus or bacterium. This method has helped create more than 20 new vaccines against infectious agents, improved existing vaccines, and increased the amount of vaccine that can be produced.

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Biotech Response to COVID-19

As the threat of the novel coronavirus continues to grow globally, innovative biopharmaceutical companies are ramping up efforts to study the virus and develop vaccines and cures to protect individuals from contracting the virus.

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Blog Posts
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AMR
Antimicrobial Resistance: The Silent Pandemic
November 23, 2021
We are on the precipice of a looming crisis. Antimicrobial resistance (AMR) is the evolution of deadly pathogens like bacteria and fungi to resist all current antimicrobial medicines. In this episode, we talk about how…
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Antimicrobial resistance could be the world’s next pandemic—here’s how we can help address it
November 18, 2021
The next global pandemic may already be in the works. Antimicrobial resistance (AMR)—when bacteria, viruses, fungi, and parasites no longer respond to medicines, making infections harder to treat—is a global crisis…
I am BIO Podcast
Pressure on STEM from Covid and Inequity
November 9, 2021
Not only do we need STEM students, but we also need them from every corner of the population, because innovation thrives through diverse perspectives; through the people who bring both their talents and backgrounds to…
Press Releases
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"Build Back Better Act" Drug Pricing Provisions Weaken U.S. Innovation Ecosystem, Hurt Patients
November 19, 2021
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement after the House of Representatives passed the Build Back Better Act: “The legislation that passed the House today will upend a successful Medicare system and weaken…
BIO Cheers Biden Announcement to Share 20 Million Doses of Vaccines with Developing Nations
May 18, 2021
"The White House’s decision to send Covid-19 vaccines to countries in need is an important step to ensuring people around the globe have access to lifesaving shots and ending this global pandemic. “As part of BIO’s recently-proposed Global “SHARE” program, we’ve made clear the urgent need to…
Proposed “TRIPS” Waiver Is the WRONG Way To Attack Global Access for Vaccines to Developing Countries
April 20, 2021
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), yesterday sent a letter to U.S. Trade Representative (USTR) Ambassador Katherine Tai sharing BIO perspectives regarding the proposed WTO “TRIPS waiver” for COVID related products. The letter, written…
Letters, Comments & Testimony
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BIO Comments on Draft Guidance: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C
January 3, 2022
On Wednesday, December 29th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act. Existing regulations require each…
BIO Comments on Draft Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
December 13, 2021
On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation …
BIO Comments on Core Patient-Reported Clinical Outcomes in Cancer Clinical Trials
August 9, 2021
On Thursday, June 10th, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance, Core Patient-Reported Clinical Outcomes in Cancer Clinical Trials, providing recommendations to sponsors on the collection of a core set of patient-reported clinical outcomes in cancer clinical…
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