Biotechnology Innovation Organization

To remain globally competitive, the U.S. must promote timely access to safe and effective medical products. A new report from the @reaganudall Foundation for the FDA, developed in collaboration with BIO, outlines a roadmap for modernizing the clinical trial process and making America the best place to develop new medicines. Key recommendations include modernizing IND requirements, enhancing Phase 1 trial designs, improving FDA-sponsor coordination, and building a dedicated Phase 1 trial infrastructure. Access the full report: reaganudall.org/publications/e…

Our second annual AI Summit explored where AI is already delivering results in biotech - and what companies need to do to unlock its full potential. What does meaningful AI adoption in biotech actually look like? Read more on Bio.News: bio.news/bio-convention… #BIO2026 #Biotech #AI

#BIO2026 may be behind us, but an innovator’s drive never leaves. While in San Diego, we asked Nolan Townsend, CEO of Lexeo Therapeutics, what drives him. Save the date for #BIO2027 in Philadelphia, June 7-10. convention.bio.org

#News for #Investors and #Media: We’re expanding our U.S. manufacturing footprint. Today, we're announcing a $300 million expansion of our flagship U.S. manufacturing and clinical R&D facility at the Princeton West Innovation Campus in Hopewell, New Jersey. The investment adds small molecule manufacturing capacity, brings our total U.S. manufacturing investment to more than $1 billion, creates 120 new jobs, and supports the advancement of our deep oncology pipeline of 35+ clinical and commercial-stage assets. 🔗ir.beonemedicines.com/news/beone-med… #BeOneInnovator #Oncology

BiotechTV's inaugural U.S. Science Summit brought together some of the best science communicators, storytellers, and biotech leaders for a day of real collaboration and learning. Thank you to @BiotechTV, @MassBIO, @BradLoncar, Chloe Kirk, and every communicator and leader in the room. The future of science depends on how well we tell its story - and this week showed why.

A proposed OMB rule to regulate federal grants could have far-reaching consequences for the biomedical research ecosystem - from academic institutions to private-sector investment and the development of new therapies. BIO has submitted formal comments urging OMB to reconsider. What would disruptions to federal funding mean for the future of U.S. biotech innovation? Read more on Bio.News: bio.news/latest-news/bi…

From candy manufacturing to the world’s most renowned labs, we’re excited to be here in Kendall Square — “the most innovative square mile on the planet” — alongside industry leaders and science communicators for @BiotechTV’s inaugural U.S. Science Summit hosted at @MassBIO This morning, BIO’s own Sarah Alspach will lead a conversation focused on how the lives of patients can be transformed by scientific progress.

BIO member @Merck has reached a significant milestone in cardiovascular care. The FDA has approved LIPFENDRA® (enlicitide) - bringing a new once-daily oral option to adults with hypercholesterolemia. Congratulations to the Merck team. #Biotech #CardiovascularHealth

BIO is pleased to welcome several newly elected members to our Board of Directors. At a critical moment for the industry, their leadership will help advance our mission to protect patient access, defend the innovation ecosystem, and cement biotech's role as a cornerstone of America's health, economic, and national security. #BiotechLeadership #BiotechInnovation #Biotech

Congratulations to BIO member @sanofi on the FDA approval of Sarclisa Escena® - a new subcutaneous treatment option designed to improve the experience for multiple myeloma patients and providers. #Biotech

A new treatment option for the approximately 160,000 Americans living with IgA nephropathy. Congratulations to BIO member @Official_VeraTx on the FDA accelerated approval of TRUTAKNA™ - a novel therapy targeting both BAFF and APRIL in adults with the disease. #Biotech #RareDisease

A first for patients with hematologic malignancies. Congratulations to BIO member @OrcaBio on the FDA approval of TREGZI™ - the first and only precision-engineered cell therapy for allogeneic transplant in adults with hematological malignancies. #Biotech #CellTherapy

#MustRead: Bio.News recently covered a new report from @MagnoliaAccess that highlights how pressures on research funding, regulatory capacity, and investment incentives are slowing innovation and threatening the pipeline of future medicines. As the report shows, these policies don’t exist in isolation, and their combined effect is what puts long-term innovation at stake. Read more: bio.news/health/as-poli…

BIO applauds the bipartisan leadership driving this legislation and urges continued action to advance sustainable solutions that both fuel innovation and protect patient access to critical antibiotics.

Antimicrobial resistance (AMR) continues to outpace innovation, leaving patients with fewer effective treatment options. The PASTEUR Act tackles this crisis head-on.

Last week, the bipartisan PASTEUR Act of 2026 was reintroduced in the Senate, building on the House’s action earlier this year and marking an important step forward in addressing one of the most urgent public health challenges of our time.

What drives Silvia Taylor? As the Executive Vice President, Chief Corporate Affairs Officer and Head of @Novavax Sweden - and Co-Chair of BIO's Trust in Science Task Force - she understands the intersection of science and purpose. #BIO2026

What does the sixth decade of biotech look like? After 25 years as a biotech investor, Jim Healy, MD, PhD, Managing Partner at Sofinnova Investments, explains why this is a terrific time to be in the industry. Hear his perspective from this week's #BIO2026 session on shaping biotech's next chapter.

What does the current investment landscape really look like for emerging biotechs? BIO's Chad Wessel and @danpharma, VP of Thought Leadership at @NorstellaCo, broke down the data on venture capital, M&A, licensing trends, and what early stage companies need to know to navigate today's market. #BIO2026 Read more in Bio.News: bio.news/bio-convention…