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
3124 results found
Expand All
Apply All
3124 results found

Good Day BIO: Biden to boost biomanufacturing
Share
Good Day BIO Newsletter  •  September 12, 2022
President Biden’s set to announce an executive order today that will provide more funding for biomanufacturing, and also announce a BIO member company scientist to lead ARPA-H. Plus, the HHS Secretary expressed support for addressing AMR during last week’s World AMR Congress. (768 words, 3 minutes, 50 seconds)
Read More

BIO Comments on WHO White Paper: Regulation of Cell and Gene Therapy Products
Share
Human Health  •  Letters, Testimony & Comments  •  September 9, 2022
Today, BIO submitted comments to the World Health Organization (WHO) regarding its revised, draft white paper on the regulation of Cell and Gene Therapy Products (CGTPs). As stated previously, BIO emphasized that this paper represents a major milestone and will be the first global regulatory guidance on these innovative therapeutics. In response to the new and extensively revised draft, BIO expressed appreciation and support for this very important and thoughtful document. In particular, the paper provides valuable terminology, which is important given the current global inconsistencies in nomenclature and definitions. BIO also stated support the utilization of a risk-based approach for the proper regulatory oversight of ATMPs and HCT, as is described in the paper. However, BIO suggested there could be challenges when determining the level of regulatory oversight commensurate with product risk, given the paper’s recommendations for basing this assessment on the extent to which cells and tissues are manipulated, as this measure could be somewhat subjective. Therefore, BIO recommended that the paper maintain clarity for when the therapeutic will be for heterologous use, so as to avoid ambiguity. Furthermore, BIO requested additional clarity on how the regulatory reliance mechanisms laid out in the paper will address the challenges that are discussed. Lastly, BIO stated that as the ATMP space continues to rapidly change, it will be crucial for regulators to assess when new issues which need regulatory guidance arise and to quickly provide guidance to ensure clear recommendations.
Read More

Good Day BIO: IRA climate investments and long COVID
Share
Good Day BIO Newsletter  •  September 9, 2022
Ending the week with BIO’s letter to President Biden explaining what needs to be done to bolster the Inflation Reduction Act’s historic climate investments, plus what we know—and don’t—about long COVID. (697 words, 3 minutes, 29 seconds)
Read More

BIO Calls for Actions to Bolster IRA's Climate Investments by Advancing Biotech
Share
Press Release  •  September 8, 2022
As the Biden Administration begins implementation of the Inflation Reduction Act, the Biotechnology Innovation Organization today called on the administration to take additional steps to foster the development and deployment of pioneering technologies that are critical to meeting the nation’s greenhouse gas reduction targets.   “By proactively advancing biotechnology, we can take bold and drastic action to tackle the climate crisis, bolster the climate investments made in IRA, and ensure the U.S. meets its emissions reduction goals,” wrote BIO President and CEO Dr. Michelle McMurry-Heath in a letter to President Biden.   From swift implementation of tax credits for sustainable fuels and actions to increase federal procurement of biobased products, to leveraging the regulatory system to quickly deploy climate-positive biotechnologies and incentivize their use, BIO outlined several steps that federal agencies should take to complement the climate investments made by IRA and realize the full climate-positive potential of biotechnologies and bioproducts.   BIO staunchly opposed passage of IRA due to its damaging and counterproductive provision establishing government price controls on prescription drugs, which will erect barriers to developing much-needed new therapeutics and combating future pandemics. However, BIO also has acknowledged that the historic investments to tackle climate change will advance environmental and public health goals and encourage investment in the biotech industry’s agriculture and environment sector.   “Biotechnology is enabling a dramatic paradigm shift in the production of fuels and chemicals,” BIO wrote the president. “More biorefineries are converting domestic sources of renewable biomass, wastes, and residues into sustainable low carbon fuels, chemicals, and products.”   Actions the administration could take, according to BIO, to deploy biobased technologies and create more sustainable supply chains…
Read More

BIO Letter on Inflation Reduction Act Implementation, Climate & Biotechnology
Share
Climate Change, Rare Diseases  •  Letters, Testimony & Comments  •  September 8, 2022
As the federal government begins to implement IRA, BIO urges the administration to take additional steps to foster the development and deployment of pioneering technologies that will further reduce greenhouse gas emissions in manufacturing, transportation, and agricultural supply chains to build a stronger, more resilient, and environmentally sustainable economy. 
Read More

Good Day BIO: Athletes fight rare disease – plus, a new high-protein soybean advances
Share
Good Day BIO Newsletter  •  September 8, 2022
Football season starts today—and college athletes are kicking off a contest to support rare disease R&D. BIO member Benson Hill recently announced a new partnership to advance high-protein soybeans—with AI, data science, genomics, and biology. Plus, news from D.C. on a key USTR nominee and EUA for monkeypox tests. (729 words, 3 minutes, 38 seconds)
Read More

Good Day BIO: Mental health and America's kids
Share
Good Day BIO Newsletter  •  September 7, 2022
Back to work, back to school—and back to mental health challenges. Mental Health America has insights on the mental health of America’s kids, and resources to help. Plus, the White House is planning for a major food security summit—and we hope biotech is on the menu. (595 words, 2 minutes, 58 seconds)
Read More

Good Day BIO: McKalip vote and new boosters
Share
Good Day BIO Newsletter  •  September 6, 2022
And we're back. With Congress returning from recess (and BIO returning from a break), we have news on Doug McKalip’s hearing tomorrow in the Senate and news from the break about COVID boosters. (684 words, 3 minutes, 25 seconds)
Read More

BIO Comments on FDA Guidance for Risk Management Plans to Mitigate the Potential for Drug Shortages
Share
Human Health  •  Letters, Testimony & Comments  •  August 31, 2022
Today, BIO submitted comments in response to the FDA’s recent draft guidance on the development, maintenance, and implementation of Risk Management Plans (RMPs). While the comment letter expressed broad support for the systematic approach for establishing risk management plans (RMPs) laid out in the draft guideline, BIO also conveyed serious concerns related to the scope and timing of the guideline. For example, one critical concern is the guidance’s introduction of the terms and definitions of “primary stakeholder”, “secondary stakeholder” and “other stakeholder” to describe “manufacturer” in FD&C section 506C(a). These stakeholder definitions are very broad and could be interpreted that manufacturers of any step in the active pharmaceutical ingredient (API) or drug product manufacturing process need to prepare RMPs for the designated products. Additionally, BIO pointed out that the language used throughout the guidance to define covered products (i.e., life-supporting, life-sustaining, etc.) are subject to interpretation from individual manufacturers. Likewise, BIO noted the use of the term API (active pharmaceutical ingredient) in the guidance, which usually applies only to small molecule drugs, rather than the more inclusive term “drug substance.” Next, BIO stated concerns that neither the draft guideline nor the Federal Register notice provides a timeline for implementation of the final guideline. In response, BIO requested a period of at least two years from publication of a final guideline before FDA reviews RMPs during inspections or as part of a 704(a)(4) records request. Finally, BIO expressed concerns for the overly prescriptive recommendations contained within Section III-C along with the language on information sharing contained within Section IV-A. 
Read More

Good Day BIO Summer Reading
Share
Good Day BIO Newsletter  •  August 26, 2022
It’s the last Friday of August—and we’re getting ready to join Congress in a Labor Day recess. Good Day BIO is officially out of office next week, but before we go, we’ve got news and summer reading to kick off the break. Enjoy your holiday—we’ll be back on Tuesday, September 6. (437 words, 2 minutes, 11 seconds)
Read More

Pagination

  • First First page
  • Prev Previous page
  • …
  • 130
  • 131
  • 132
  • …
  • 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