Skip to main content
  • Policy
    Get Involved
    Join BIOAction
    View Advocacy Toolkit
    Patient Advocacy
    Human Health
    Cost and Value of Biopharmaceuticals
    Antimicrobial Resistance
    Vaccines & Biodefense
    Drug Development & Review
    Agriculture & Environment
    Addressing Climate Change
    Strengthening the Bioeconomy
    Growing Trust in Innovation
    International
    Global Markets & Trade
    Multilateral Organizations
    Intellectual Property
    All Policy
    Patient Advocacy

    Join BIO as we champion for bringing new treatments to patients with serious medical conditions and to support policies that promote innovation and improve patient access.

  • Member
    Membership Options
    Become a BIO Member
    Member Directory
    Have a Voice
    Membership Eligibility
    Member Toolkit
    Benefits By Sector
    member health
    Human Health
    member startups
    Startups
    member ag&evnt
    Agriculture & Environment
    member non R&D
    Non-R&D Companies
    Member Savings
    BBS-Programs-vwr
    VWR, Part of Avantor
    75% off Lab Supplies
    Save with BIO
    Save with BIO
  • News & Insights
    Latest biotech news
    Popular blogs
    Events
    Policy
    BIO Statements
    Press Releases
    Letters, Testimony & Comments
    Amicus Briefs
    BIO Reports
    Industry Analysis Reports
    Biotech Jobs
    Economic Development Best Practices
    BIO Briefly
    Issue Briefs
    BIO.News
    I am BIO Podcast
    All News & Insights

    Sign up for the BIO.News Newsletter >

  • Events
    Event Portfolio
    Business Development
    Health
    Agriculture & Environment
    International
    Professional Development
    Members Only
    All Events
    BIO International Convention

    June 16-19, 2025 | Boston, MA

    Learn More
    BIO Asia-Taiwan
    BioSafe General Membership Meeting

    April 7-9, 2025
    Basel, Switzerland

    BIO Investor Forum
    Partnering @JPM Week

    San Francisco, CA

    BIO Patient & Health Advocacy Summit
    BIO CEO & Investor Conference

    Miami, FL | 2026

    BIO Webinars

    Explore the webinar opportunities for interactive, online learning about emerging issues in biotechnology public policy, scientific progress, and raising capital, plus methods to benefit from BIO’s membership services.

  • About
    About Us
    Learn about our priorities
    BIO Leadership
    Meet BIO's Senior Leadership and Board of Directors
    Biotech Basics
    Read about biotechnology
    Industry Recognition
    Get to know the outstanding people and companies BIO supports
    Careers @ BIO
    Explore job openings with BIO today
    Diversity & Inclusion >

    Our tools and initiatives on workforce development, diversity and inclusion are designed to advance a more globally competitive industry.

  • Resource Hub
    Latest Resources
    BIO Early-Stage Resources Hub
    BIO Professional Development
    BIO Content Hub
    Biotech News (BIO.News)
    BIO.News Newsletter
    I am BIO Podcast
    BIO Advocacy Toolkit
    Resources Hub
    BIO Early-Stage Resources Hub
    BIO Professional Development
    BIO Webinars
    BIO Microsites
    Clinical Trials: The Power of Participation
    Covid Vaccine Facts
  • Search Results
    Previously Searched
Logo
Logo
Home
Search
  • Policy
    Human HealthPatient AdvocacyAgriculture & EnvironmentInternationalIntellectual PropertyAll Policies
  • Member
    Become a BIO MemberBenefits By Sector
    Human HealthAgriculture & EnvironmentStartupsNon-R&D Companies
    Member DirectoryHave a VoiceMembership EligibilitySavings
  • News & Insights
    Press ReleasesBio.News BlogLetters, Testimony & CommentsAmicus BriefsIndustry Analysis ReportsBiotech JobsEconomic Development Best PracticesIssue BriefsBIO.NewsVideosAll News & Insights
  • Events
    BIO International ConventionBIO Asia-TaiwanAll Events
  • About
    About UsBIO LeadershipDiversity & InclusionBiotech BasicsIndustry RecognitionCareers @ BIO
  • Resource Hub
    Biotech News (BIO.News)BIO.News NewsletterI am BIO PodcastBIO Advocacy ToolkitBIO Early-Stage Resources HubBIO Professional DevelopmentBIO WebinarsClinical Trials: The Power of ParticipationCovid Vaccine Facts
Search Results
Previously Searched
Search Results
Previously Searched
3091 results found
Expand All
Apply All
3091 results found

BIO Comments on FDA Draft Guidance on Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals
Share
Letters, Testimony & Comments  •  June 25, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals. The draft guidance is a positive step toward articulating a streamlined, science-based approach for nonclinical development of pharmaceuticals. BIO supports the FDA’s goal of getting safe, effective biopharmaceutical products to patients while avoiding the unnecessary use of animals. On the whole, BIO supports the draft guidance. While BIO understands the draft guidance is specific to severely debilitating or life-threatening hematologic disorders (SDLTHDs), BIO believes it could be used as a model for other disease areas. In the comments, BIO provides high-level comments to strengthen and clarify areas including examples of severely debilitating or life-threatening hematologic disorders, incorporation of ICH S9 guideline, and nonclinical studies vs. nonclinical assessments.
Read More

Distinguished Professor and Dean from South Korea to Receive 2018 George Washington Carver Award
Share
Press Release  •  June 21, 2018
The Biotechnology Innovation Organization (BIO) today announced that Distinguished Professor Sang Yup Lee at the Department of Chemical and Biomolecular Engineering at the Korea Advanced Institute of Science and Technology (KAIST) will receive the 11th annual George Washington Carver Award for Innovation in Industrial Biotechnology. The award will be presented on Wednesday, July 18, 2018 during a plenary session at the 2018 BIO World Congress on Industrial Biotechnology. The world’s largest conference on industrial biotechnology and partnering event will be held July 16-19, 2018, at the Pennsylvania Convention Center in Philadelphia. 
Read More

Corteva Agriscience’s Krysta Harden to Receive 2018 Rosalind Franklin Award
Share
Press Release  •  June 21, 2018
The Biotechnology Innovation Organization (BIO) today announced that Corteva AgriscienceTM Vice President of External Affairs and Chief Sustainability Officer Krysta Harden will receive the 5th annual Rosalind Franklin Award for Leadership in Industrial Biotechnology and Agriculture. Corteva Agriscience™ is the Agriculture Division of DowDuPont. The award will be presented on Wednesday, July 18, 2018 during a plenary session at the 2018 BIO World Congress on Industrial Biotechnology. The world’s largest conference on industrial biotechnology and partnering event will be held July 16-19, 2018, at the Pennsylvania Convention Center in Philadelphia. 
Read More

BIO Statement on Growing American Food Exports Act of 2018
Share
Press Release  •  June 21, 2018
The Biotechnology Innovation Organization (BIO) today released the following statement in response to the introduction of the bipartisan “Growing American Food Exports Act of 2018” (S. 3103) by Senator Todd Young (R-IN), Senator Joe Donnelly (D-IN), Senator Roy Blunt (R-MO), and Senator Claire McCaskill (D-MO):
Read More

BIO Comments on FDA Draft Guidance on Scientific and Ethical Considerations for Including Pregnant Women in Clinical Trials
Share
Letters, Testimony & Comments  •  June 8, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry. This guidance is an important step towards providing information to patients and providers about the safety and efficacy of therapies for pregnant women. The guidance provides insight to sponsors on how and when to include pregnant women in drug development clinical trials. BIO provided general and detailed comments to clarify the draft guidance, including what types of studies it applies to, terminology such as the meaning of "nonpregnant women," and how to analyze and interpret data obtained from pregnant women in clinical trials that are not for medical products specifically indicated for pregnant women.
Read More

BIO Comments on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation
Share
Letters, Testimony & Comments  •  June 8, 2018
BIO submitted comments to the Food and Drug Administration’s (FDA) on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation, following the Public Workshop on May 9, 2018. While advances in genomics and precision medicine have significantly improved the ability to develop medicines aimed at specific molecular targets that may be present in multiple diseases and/or cancers, there is much to be learned through continued research and development. BIO appreciates the FDA taking a forward-looking approach and having early discussions about how these advances may affect other aspects of drug development and review, such as orphan drug designations. In comments following the public workshop, BIO provided several items for the FDA’s consideration, including on the importance of the Orphan Drug Act as well as how to encourage innovation for novel therapies to treat rare diseases. BIO encourages the FDA to consider how to apply a tissue agnostic approach outside of oncology. BIO also asks the FDA to partner with stakeholders to discuss the impacts of tissue agnostic therapies on drug development and review.
Read More

BIO 2018 Makes History in Boston
Share
BIO One-on-One Partnering  •  Press Release  •  June 7, 2018
Boston, MA – (June 7, 2018) – The 2018 BIO International Convention (BIO 2018) today wrapped up four days of programming under the theme of “Make History.” Hosted by the Biotechnology Innovation Organization(BIO), BIO 2018 attracted thousands of U.S. and international attendees, celebrated innovations that have shaped the past 25 years and recognized the companies, patient groups, academic centers and investors that continue to advance novel solutions to the world’s toughest challenges... 
Read More

BIO Sets the GUINNESS WORLD RECORDS™ Title for the Largest Business Partnering Event
Share
Business Development, BIO One-on-One Partnering  •  Press Release  •  June 6, 2018
Washington, DC (June 6, 2018) – This morning at the Biotechnology Innovation Organization’s (BIO) International Convention in Boston, BIO proudly attempted – and set– the GUINNESS WORLD RECORDS title for the Largest Business Partnering Event.
Read More

South Dakota Governor Dennis Daugaard Presented BIO Lifetime Champion Award
Share
Press Release  •  June 6, 2018
Boston, MA (June 6, 2018) –  The Biotechnology Innovation Organization (BIO) presented South Dakota Governor Dennis Daugaard with a Lifetime Champion Award in recognition of his stalwart leadership and commitment to strengthening South Dakota’s growing biotechnology industry. He received the award in conjunction with the 2018 BIO International Convention."Biotechnology innovation is not just good for South Dakota’s economy. It unlocks the door to important medical, food production, animal health and renewable energy advances as well," said Governor Daugaard. "I am proud to say companies across the biotechnology spectrum have taken notice of what we are doing in South Dakota and have decided to put down roots with us. I am honored to receive this acknowledgement on behalf of the State of South Dakota for our support of innovations that help feed, fuel and heal the world.""Thanks to the leadership of Governor Daugaard, South Dakota has steadily grown and diversified its biotechnology industry," said Jim Greenwood, President and CEO of BIO. "Governor Daugaard has demonstrated his unyielding commitment to building a strong bioscience economy in South Dakota. As a champion of innovation, Governor Daugaard recently signed forward-looking legislation that will provide patients more opportunities to address their medical needs, through the substitution of interchangeable biologic medicines. This bill particularly benefits severely ill patients who rely on complex biological treatments, but also ensures better communications between patients, pharmacists and physicians. We thank him for his service!""Governor Daugaard has been an exemplary leader in enhancing South Dakota’s excellence in the field of biotechnology through strong support for policies that benefit a pro-jobs and pro-biotechnology environment. Governor Daugaard has always been a pro-business advocate for initiatives that support the unique needs of our state’s early-stage companies," said…
Read More

BIO Presents the Henri A. Termeer Biotechnology Visionary Award to Gates Foundation’s Dr. Sue Desmond-Hellmann
Share
Press Release  •  June 6, 2018
Washington, D.C. (June 6, 2018) – The Biotechnology Innovation Organization (BIO) is pleased to announce the establishment of the Henri A. Termeer Biotechnology Visionary Award – created in honor of the late Genzyme CEO who was instrumental in transforming Boston into a thriving hub of life science research, development and innovation... 
Read More

Pagination

  • First First page
  • Prev Previous page
  • …
  • 263
  • 264
  • 265
  • …
  • Next Next page
  • Last Last page
Biotechnology Innovation Organization
Explore BIO
Policy
Events
About
Industry Insights
Join Now
BIO PAC
For Members
Member Directory
BIO Policy Committees
Cost-Savings Program
BIO Events
BIO International Convention
BIO Partnering at JPM Week
BIO CEO & Investor Conference
BIO Investor Forum
BIO Patient Health & Advocacy Summit
BIO Intellectual Property Counsels Committee Conference
1201 New York Avenue NW, Suite 1300, Washington, DC, 20005 ・ 202-962-9200
© BIO 2024 All Rights Reserved
Privacy Policy
Terms of Use
Contact BIO