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New Diabetes Forum at the 2011 BIO International Convention

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.

Prof. Alan Trounson, Ph.D., President of the California Institute for Regenerative Medicine

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

The Role of Intellectual Property in Global Health

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

Policies Necessary for Supporting Small Biotech Businesses

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 Global Biotech Industry Comes to BIO

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.

Bernard Siegel speaks about recent developments in stem cell research

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

Peter Soelkner, Managing Director of Vetter Pharma International

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

New Report Shows Monoclonal Antibody Development Times Are Lengthening

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.

A Conversation with 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.

A Conversation with 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.

The Cost of Losing Innovation

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

On a Roll: Governor Seeks Continued Investment in BioMaryland 2020

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

John Sterling, editor-in-chief of Genetic Engineering and Biotechnology News (GEN)

BIOtechNOW talks to GEN's John Sterling regarding the upcoming BIO International Convention.

Top Ten "Must Attend" Breakout Sessions at the 2011 BIO International Convention

GEN's Editor-in-Chief John Sterling outlines his picks for the top ten "must attend" breakout sessions at the 2011 BIO International Convention.

World Health Day: The Global Impact of Vaccines

As we celebrate World Health Day today, it is an opportunity to remember that vaccines represent one of the most important global health investments.

Letters, Testimony & Comments

PBRER: BIO Comments on Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
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 .”
Benefit-Risk: BIO Comments on FDA's Prescription Drug User Fee Act V Benefit-Risk Plan
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.”
Recombinant DNA: BIO Comments on WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology
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.” 
Immunogenicity: BIO Comments on Draft Guidance on Immunogenicity Assessment for Therapeutic Protein Products
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.”
Sunshine: BIO Files Comments on Estimated Burden of complying with Section 6002 of the Affordable Care Act (“the Sunshine Act”)
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. 
More Letters, Testimony & Comments →

Press Releases

Rx Open Activated to Report on Status of Pharmacies in Oklahoma
May 24 2013
Rx Response elevates to Alert status to address potential impact from Moore tornado on supply chain.
BIO Praises U.S. Senate for Passing the Pandemic and All-Hazards Preparedness Reauthorization Act
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.
BIO Praises The House of Representatives for Approving H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act
January 25 2013
Bill will accelerate R&D to help support nation’s preparedness against chemical, biological, radiological and nuclear threats.
PDUFA V Sets New Course for Regulatory Science – Joint BIO/PhRMA Statement
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).
IFPMA, BIO and WADA Advance Anti-Doping Collaboration with the Launch of 2 Fields 1 Goal Campaign
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.
More Press Releases →