Health Care

Congress created the 340B program in 1992 to help uninsured indigent patients gain better access to prescription medicines. This white paper examines the history and original intent of the program as well as highlights key findings to help policymakers ensure that the 340B program meets its stated purpose and to provide a roadmap for next steps to be considered.

The biosimilars pathway is critical for China's biotechnology industry – and this is evident in the investment the government is making in the manufacture of biotech products

In the next several months, the president and members of Congress will decide whether to continue the funding and authorities associated with Project BioShield, which seeks to expand the U.S. stockpile of medical countermeasures for potential chemical, biological, radiological and nuclear (CBRN) attacks.

Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a substantial period of time.

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.

Letters, Testimony & Comments

March 1 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday,...
March 1 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 21 2013
Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H....
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...

Press Releases

February 28 2013
WASHINGTON, DC – February 28, 2013 –The Biotechnology Industry Organization (BIO) lauds the Senate for...
January 25 2013
The Biotechnology Industry Organization lauds the House of Representatives for passing H.R. 307, the Pandemic and All...
October 1 2012
Washington, D.C. (October 1, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and...
July 23 2012
Groups Issue Booklet to Help Biotechnology and Pharmaceutical Companies Identify Pipeline Medicines with Doping...
June 28 2012
  Pleased to move forward on biosimilars pathway Washington, D.C. (June 28, 2012) –Biotechnology...