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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.

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

Letters, Testimony & Comments

BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter
March 1 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday,...
SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need
March 1 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
Medicaid, Children’s Health Insurance Programs, and Exchanges
February 21 2013
Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H....
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
More Letters, Testimony & Comments →

Press Releases

BIO Praises U.S. Senate for Passing the Pandemic and All-Hazards Preparedness Reauthorization Act
February 28 2013
WASHINGTON, DC – February 28, 2013 –The Biotechnology Industry Organization (BIO) lauds the Senate for...
BIO Praises The House of Representatives for Approving H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act
January 25 2013
The Biotechnology Industry Organization lauds the House of Representatives for passing H.R. 307, the Pandemic and All...
PDUFA V Sets New Course for Regulatory Science – Joint BIO/PhRMA Statement
October 1 2012
Washington, D.C. (October 1, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and...
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...
Supreme Court Affordable Care Act Ruling Must Now Lead to Implementation That Will Promote Innovation and Expand Access
June 28 2012
  Pleased to move forward on biosimilars pathway Washington, D.C. (June 28, 2012) –Biotechnology...
More Press Releases →