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
    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 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
    International
    Professional Development
    Members Only
    All Events
    BIO International Convention

    June 22-25, 2026 | San Diego, CA

    Learn More
    BIO Asia-Taiwan
    BIO Europe

    November 3-5, 2025
    Vienna, Austria

    BIO Investor Forum
    Partnering @JPM Week

    January 12-15, 2026
    San Francisco, CA

    BIO Patient & Health Advocacy Summit
    BIO Investment & Growth Summit

    March 2-3, 2026
    Miami, FL

    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 AdvocacyInternationalIntellectual PropertyAll Policies
  • Member
    Become a BIO MemberBenefits By Sector
    Human HealthStartupsNon-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
3143 results found
Expand All
Apply All
3143 results found

BIO Submits Comments in Response to FDA Guidance on Digital Health Technologies
Share
Human Health  •  Letters, Testimony & Comments  •  March 21, 2022
On Monday, March 21st, BIO submitted comments in response to the recent FDA draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. In the comments submitted, BIO expressed appreciation for the issuance of this draft guidance as it provides greater clarity on FDA’s approach to the regulation of remote data acquisition, which will in turn encourage the use of digital health technologies (DHTs) and methods in product development. To further enhance this Guidance, BIO recommended that the Agency expound on the utility these technologies provide for facilitating better oversight of patients participating in remote studies, while allowing sponsors to collect data that is more relevant to patients’ needs. Additionally, though the Guidance encourages leveraging of prior work in verification and validation of DHTs, which will be critical as the field continues to advance; BIO noted that it does not provide specific evidentiary requirements for verification and validation, nor does it reference an available source as guidance. BIO urged the Agency to address these requirements in its final guidance. Furthermore, while the inclusion of topics such as data collection, storage, and protection in this guidance are helpful to sponsors; BIO encouraged the Agency to provide detail on specific issues like source data management, safeguards to ensure data integrity, expectations for raw data submission, and mitigation strategies for connectivity disruptions. Finally, BIO requested the Agency provide further clarity on how and when sponsors should engage with the various centers at FDA during development of a DHT for remote data acquisition in clinical trials.
Read More

Good Day BIO: Fertilizer is a big story—here’s why
Share
Good Day BIO Newsletter  •  March 21, 2022
We’re starting a new week focused on fertilizer—here's why it’s such a big story and what biotech has to do with it. ICYMI, an agreement on a TRIPS waiver for vaccine IP was leaked last week, and we have the industry’s take. Plus, the Senate is taking up legislation on China competitiveness. (743 words, 3 minutes, 42 seconds)
Read More

Good Day BIO: ‘Patient-centric, effective, and inclusive’
Share
Good Day BIO Newsletter  •  March 18, 2022
It’s a health-heavy Friday, with a recap of what BIO’s Dr. Cartier Esham told a House panel yesterday about PDUFA and patient-centric drug development and a new letter urging HHS to reject a “march in” petition for a prostate cancer drug. (710 words, 3 minutes, 33 seconds)
Read More

Good Day BIO: Price negotiation? Try price ‘extortion.’
Share
Good Day BIO Newsletter  •  March 17, 2022
There’s a lot to unpack from yesterday’s Senate Finance hearing on drug price controls—here are the facts (and a few tired myths). Also, BIO member LanzaTech testified yesterday on how the government can support biotech solutions and BIO’s Dr. Cartier Esham will testify today on PDUFA riders. (832 words, 4 minutes, 9 seconds)
Read More

Bio Nebraska
Share
BIO Business Solutions - Member Association
Through its partnership with BIO, the Bio Nebraska Life Sciences Association 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 Bio Nebraska members to participate.
Read More

BIO Statement to House Agriculture Committee on the 2022 Farm Bill and Climate Change
Share
Agriculture & Environment, Food & Farm Innovation  •  Letters, Testimony & Comments  •  March 16, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture hearing entitled, “A 2022 Review of the Farm Bill: The Role of USDA Programs in Addressing Climate Change.”
Read More

BIO Statement on House Science Committee Hearing on Bioenergy for Tomorrow
Share
Agriculture & Environment, Sustainable Fuels  •  Letters, Testimony & Comments  •  March 16, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Science, Space, and Technology Subcommittee on Energy hearing entitled, Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.
Read More

Good Day BIO Breaking News: Agreement reported on vaccine IP waiver
Share
Good Day BIO Newsletter  •  March 16, 2022
There’s reportedly an agreement on a COVID-19 vaccine IP waiver – here's what we know so far. Also, we recap yesterday’s mark-up of a pandemic preparedness bill and look ahead to two agriculture hearings today. (984 words, 4 minutes, 55 seconds) P.S. Early-bird registration for the BIO International Convention ends tomorrow, March 17—register today to save $200 per person!
Read More

BIO Statement on Reports of a Proposed Deal on COVID-19 Vaccine IP Rights Waiver
Share
Intellectual Property, Human Health  •  Press Release  •  March 16, 2022
John Murphy, Chief Policy Officer at the Biotechnology Innovation Organization (BIO), released the following statement regarding reports of a proposed deal on a Covid-19 vaccine intellectual property rights waiver: “While we have seen the reported outlines of an alleged compromise on the TRIPS waiver, we still need to see and review the full text before rendering a final judgment.  However, the irrational fixation on weakening IP is simply a distraction from the real challenge of overcoming global vaccine hesitancy, removing actual trade barriers, and helping countries to strengthen their healthcare infrastructure so that we can get more shots in arms.  In 2021 alone, companies produced more than 11 billion doses of COVID vaccines, enough to give two shots to every adult on the planet. “Strong, predictable intellectual property protections are what allowed biopharma companies to produce COVID vaccines and therapeutics in record time. It laid the foundation for cross-border partnerships, global scientific collaboration, and an unprecedented manufacturing scale-up that ensured vaccines could reach every corner of the world.  Dismantling the foundation of innovation—a strong and predictable IP system—will only make us less prepared to respond to the next pandemic and weaken our ability to develop new classes of medicines the world needs.”
Read More

Good Day BIO: Indo-Pacific strategy can support biotech – here’s why
Share
Good Day BIO Newsletter  •  March 15, 2022
Today, we’re watching a hearing on Indo-Pacific strategy and a markup of the Senate’s pandemic preparedness bill. We’re also getting ready for tomorrow’s Research!America awards with a look at their recent data on investment in health research and why it matters. (751 words, 3 minutes, 45 seconds)
Read More

Pagination

  • First First page
  • Prev Previous page
  • …
  • 152
  • 153
  • 154
  • …
  • 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 2025 All Rights Reserved
Privacy Policy
Terms of Use
Contact BIO