Health Care

BIOtechNOW’s Tracy Cooley talks to Dr. Reed from the   Sanford-Burnham Medical Institute about the NIH’s new National Center for Advancing Translational Sciences.

Some of the most pressing challenges for the advent of personalized medicine relate to the reimbursement of novel diagnostics. Reimbursement policies must reflect the potential benefit that novel diagnostics can bring to patients and the healthcare system. This value proposition can be realized through reimbursement policy reforms that provide a clear and consistent pathway to obtain affirmative coverage, appropriate and timely coding, and market-based payment for diagnostic tests. BIO recommends that the following reforms be made to diagnostic reimbursement policy.

The number of Americans diagnosed with diabetes — the seventh leading cause of death in the U.S. — has risen by epidemic proportions. In addition, the disease is estimated to affect 435 million people worldwide by 2030. BIO and the Juvenile Diabetes Research Foundation will feature a two-day diabetes forum for the first time at the 2011 BIO International Convention in Washington, DC. The sessions will showcase the latest research in novel therapies, vaccines, and biomarkers.

BIOtechNOW speaks with Dr. Trounson is a pioneer of human in vitro fertilisation (IVF) and associated reproductive technologies.

BIO is committed to increased access to biologic medicines for patients throughout the world. 

Emerging biotech companies with promising scientific innovation need a policy environment that will enable them to continue critical research and development of medical advancements and breakthroughs.

The world’s largest biotech hubs are busy planning their delegations’ visits to the  BIO International Convention  next month. The international program at the Convention will be one of the most robust to date, with International Case Studies, breakout sessions focused on globalization and Super Sessions focused on the emerging markets.

BIOtechNOW’s talks to Bernard Siegel about recent developments in stem cell research and the upcoming BIO International Convention.

Soelkner discusses the benefits of working with a contract manufacturing organization and how to identify, select and work with CMOs.

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant.

April is Parkinson's Awareness Month so it seemed like a good opportunity to learn more about the Michael J. Fox Foundation for Parkinson's Research.

April is Parkinson's Awareness Month so it seemed like a good opportunity to learn more about the Michael J. Fox Foundation for Parkinson's Research.

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and interfered with the growth and survival of small private biotechnology companies and the development of promising technologies and products

The Maryland initiative’s 10-year plan helps build biotech access to funding

October 27 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.” BIO shares FDA’s commitment to enhancing communication with, and thereby the protection of, human research subjects.
October 14 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 Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.  BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.  
September 2 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 Current Good Manufacturing Practices—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act.”
August 26 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 Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices (Draft Guidance).
July 31 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.”
October 1 2014
Relationships between life sciences industry and physicians lead to stronger R&D collaboration and educate health care providers
September 22 2014
Washington, D.C. (September 22, 2014) – BIO President and CEO James Greenwood joined AdvaMed President and CEO Stephen Ubl and PhRMA President and CEO John Castellani in a letter to CMS Administrator Marilyn Tavenner highlighting ongoing concerns about a potential lack of necessary context around the Sunshine data release.  
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.