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

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