Health Care

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.

Tracey Mumford from The Michael J. Fox Foundation discusses Parkinson's disease, the Foundation’s work toward a cure, and partnerships they're currently seeking. The Foundation will be one of the patient advocacy groups attending the 2012 BIO International Convention on June 18-21 in Boston, Mass.  

Gary Godsey, President and CEO of the PKD Foundation, explains what resources the Foundation provides for patients and how they're working with researchers to repurpose compounds through the "Accelerating Treatment to Patients” initiative. He encourages listeners to take the 31 Day PKD Challenge as part of National Kidney Month and to join him on Facebook.

Lisa Tate, CEO of WomenHeart, the National Coalition for Women with Heart Disease, discusses what we can each do to prevent heart disease.

Drugs approved with companion diagnostic tests represent the next wave of personalized medicine and have the potential to significantly improve patient outcomes.

BIO Asia will be held January 31 – February 1, 2012 in Osaka, Japan.

Learn about the role biotechnology plays in the on-going fight against HIV/AIDS.

Diseases of the eye affect more than 10 million Americans, and biotechnology holds great promise for treatments and cures

In three minutes, this video tells the pertinent story of how recombinant DNA technology was used to produce human — or synthetic — insulin in large amounts and how it became the first biotechnology treatment approved by the FDA.

BIOtech-NOW talks to Laurence Marton, Co-Chair of the Personalized Medicine World Conference 2012, about the outlook for personalized medicine.

The world's best hope for turning breast cancer — and other forms of cancer — into a chronic manageable disease lies within biotechnology.

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for making 35 novel new treatments available to patients in FY11.

Underlying the PDUFA V recommendations are the principles that a science-based, transparent, and well-managed review process that appropriately balances benefits and risks can enhance public trust and increase patient access to new medicines.

March 14 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the "Proposed Rule: Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products."
March 10 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the docket regarding “Complex Issues in Developing Drug and Biologics Products for Rare Diseases.” Comments are being provided in two areas; general comments on the challenges of rare disease drug development, and specific comments in response to the public workshop.
March 4 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Request for Nominations: Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.”
February 3 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”
January 31 2014
The Biotechnology Industry Organization (BIO) respectfully submits these comments in response to the Generic Pharmaceutical Association (GPhA) Citizen Petition requesting the Food and Drug Administration (FDA) to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition).
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.
March 25 2014
The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation today designed to create a pathway for the substitution of interchangeable biologic medicines.
March 5 2014
Many of the provisions included in this budget proposal would jeopardize the continued biotech research and development that is necessary to find cures and breakthrough medicines for patients living with debilitating and life-threatening diseases. 
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed