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Countdown to Partnering With John Carroll from Fierce Biotech

John Carroll discusses the upcoming BIO International Convention.

Countdown to Partnering - John Carroll, Editor of Fierce Biotech

 John Carroll, editor of Fierce Biotech, shares what he won't miss at the 2011 BIO International Convention.

Japan’s Crippled Nuclear Plant Demonstrates Need for New Radiation Treatments

As Japan works to stabilize the crippled nuclear power plant in Fukushima, people are stocking up on potassium iodide tablets – one of the only drugs available to block the body's absorption of some radioactive materials.

FDA Funding: Budget Increase Sought for 2012

President’s call for more funding comes as Congress focuses on reducing budget deficits.

Massachusetts Life Sciences Center Awards $3.75 Million to Early Stage Companies

The Massachusetts Life Sciences Center, which is tasked with administering the $1 billion state's life sciences initiative, has awarded five loans to start up companies, totaling $3.75 million.

Continuing the Legacy: BIO to Present George Washington Carver Award

Honoring the father of chemurgy, the award will be presented at the World Congress on Industrial Biotechnology and Bioprocessing in May.

Virginia Makes Gains: Lawmakers Pass Biotech-Friendly Budget

Budget victories will help biotechnology in the Commonwealth

Senate committee marks up SBIR/STTR reauthorization
Innovation Wanted

Bringing biotechs into global health R&D.

Interplay Between IP and Global Health at BIO IP Counsels Committee Spring Conference

The Biotechnology Industry Organization (BIO) will hold its Intellectual Property Counsels Committee Spring Conference and Meeting in Seattle, Washington from April 13-15.

It’s not too late to vaccinate – Get your flu vaccine today!

When you see “Get Your Flu Vaccine Here” signs and banners outside pharmacies and in doctor’s offices, you might think, “isn’t it too late for that?” The answer is no.

The Reimbursement Landscape for Novel Diagnostics: Current Limitations.

Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare system through personalized medicine is to deliver the right treatment to the right patient at the right time.

New Report Analyzes Impact of Limitations of Current Reimbursement System on Development of Novel Diagnostics

A report by Health Advances found that significant limitations in the current reimbursement system for novel diagnostics lead to inconsistent coverage decisions and impede the investment necessary for the development of the next generation of diagnostics.

Early Life
Vaccines

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 →