Health Care

In an effort to bring innovative new medicines to patients more efficiently, while protecting and enhancing patient safety, BIO is developing an initiative to modernize clinical trials.

William Schaffner, MD, the immediate past president of the National Foundation for Infectious Diseases, explains why it is important for all adults to become fully immunized according to recommended schedules.

Successful multi-sector global health programs engage partners and policymakers early, communicate openly and frequently with relevant stakeholders, and empower and involve communities, according to a website relaunched this week, Case Studies for Global Health.

BIO Ventures for Global Health (BVGH) and the Biotechnology Industry Organization (BIO) have collaborated on a new report that builds upon the findings in BVGH’s previous analysis, Developing New Drugs and Vaccines for Neglected Diseases of the Poor: The Product Developer Landscape.

Janelle Curtis, Vice President of Programs at the Biotech Institute, interviews Tonia Moore-Davis, a certified Nurse-Midwife and Instructor of Clinical Nursing at the Vanderbilt University School of Nursing and Immediate Past Chair for the Board of Directors of HOSA.

Celiac disease is one of the most common autoimmune conditions in the U.S. but frequently goes undiagnosed. The cause is currently unknown and it can develop at any point in life. In this podcast, Dr. Peter H.R. Green, Director of The Celiac Disease Center at Columbia University, explains what celiac disease is, how it is diagnosed and the treatment options.

In recognition of National Infant Immunization Week, Dr. Yabo Beysolow, Medical Officer at the CDC, talks about the benefits of immunization for children under the age of two.

BIO's President and CEO Jim Greenwood talks to BIO Ventures for Global Health (BVGH) CEO Don Joseph about global health and BVGH's new report on global health.

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important regulatory issues facing the industry, specifically PDUFA reauthorization, the FDA and regulation. Also, hear his programming highlights from the Achieving Regulatory Approval and Compliance Track at the upcoming 2012 BIO International Convention.

Capital formation challenges in the industry have forced many biotech companies to halt projects, lay off staff or shutdown all together. Our analysis shows that the industry is approximately one-quarter smaller than it was in 2008.

BIO believes that the level of support provided by the TDP simply cannot meet the needs of the growing biotech field. As evidence of the project's popularity suggests, Congress should consider extending or expanding the project in order to support American innovation and speed the development of life-saving cures.

The biotech industry is a thriving sector employing 1.3 million Americans in high quality, high paying jobs.

A new study shows that Kineret (anakinra), a medication approved for the treatment of rheumatoid arthritis, is effective in stopping the progression of organ damage in people with neonatal-onset multisystem inflammatory disease (NOMID).

Mutations in a gene called XRCC2 cause increased breast cancer risk, according to a study in the American Journal of Human Genetics.

Letters, Testimony & Comments

July 10 2015
We applaud Chairman Fred Upton (R-MI), Ranking Member Frank Pallone (D-NJ) and Congresswoman Diana DeGette’s (D-CO) efforts on H.R. 6., which takes important steps toward placing patients at the center of the drug development process, and we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on rare conditions and other unmet medical needs. We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
June 5 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
June 4 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
February 23 2015
The Biotechnology Industry Organization (BIO) thanks you for the opportunity to provide our initial thoughts on your report Innovation for Healthier Americans. BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.
February 5 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (the "Framework Guidance") and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (the "Notification Guidance) (Collectively the "LDT Guidance").

Press Releases

November 18 2015
BIO released a list of seven proposed topics for the November 20th U.S. Department of Health and Human Services (HHS) Forum on Pharmaceutical Innovation, Access, Affordability and Better Health. The consideration of these topics at the Forum will help to ensure that patients have access to the most innovative new treatments and cures.
October 8 2015
Communication Important for Patients and Physicians