Health Care

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.

A repression of gene activity in the brain appears to be an early event affecting people with Alzheimer's disease, researchers funded by NIH have found.

With the launch of a new clinical trial supported by NIH, researchers are working to determine whether treating children diagnosed with the most severe form of fatty liver disease with a drug called cysteamine will help improve the liver.

A single dose of an experimental gene therapy boosted production of a missing blood-clotting factor in people with hemophilia, a new study shows.

Results from studies presented March 6 at the Conference on Retroviruses & Opportunistic Infections in Seattle demonstrated the importance of identifying & treating HIV-infected infants within the first year of life to prevent harm to the immune system & to enable normal neurological development.

Letters, Testimony & Comments

May 8 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format .”
May 7 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the FDA Draft Plan on “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making.”
April 19 2013
BIO appreciates the opportunity to comment on the “WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology.” 
April 12 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products.”
April 8 2013
BIO supports the goals of the Affordable Care Act (ACA) in providing greater transparency regarding financial relationships with healthcare providers and we recognize the significant challenges that were presented in implementation of these ACA provisions. 

Press Releases

May 24 2013
Rx Response elevates to Alert status to address potential impact from Moore tornado on supply chain.
February 28 2013
BIO lauds the Senate for passing H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), yesterday by a unanimous vote.
January 25 2013
Bill will accelerate R&D to help support nation’s preparedness against chemical, biological, radiological and nuclear threats.
October 1 2012
Pharmaceutical Research and Manufacturers of America PhRMA President and CEO John J. Castellani and BIO President and CEO Jim Greenwood released the following joint statement on the implementation of the Prescription Drug User Fee Act (PDUFA V).
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.