Rare Diseases: BIO Comments on FDA Draft Guidance Rare Diseases: Natural History Studies for Drug Development

BIO appreciates the Agency’s work to develop a much-needed guidance on natural history studies for rare disease drug development. The Draft Guidance serves as an important communication tool between the FDA and Sponsors on issues pertaining to natural history studies for rare disease drug development. Such guidance ensures that Sponsors have appropriate information for developing new therapies for rare disease patients, especially given that many rare diseases still do not have an FDA approved treatment. In the following pages of this letter, BIO has included general comments as well as line edits that we believe will make the Draft Guidance more useful for various stakeholders.

BIO Applauds Senate Passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act

Legislation will strengthen pipeline of medical countermeasures against serious public health threats

New BIO Report: More Progress Needed in Innovation of Alzheimer’s Disease Therapeutics

Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases Volume IV: Alzheimer’s Disease Therapeutics, the fourth in a series on the innovation landscape of highly prevalent, chronic diseases. This volume takes an in-depth look at the state of innovation for therapeutics in Alzheimer’s disease, which is expected to affect more than 13.8 million people in the United States by 2050 and cost well over $1 trillion annually.

BIO Continues Partnership with NIH for Fifth “Innovation Zone” Exhibit

“The theme for this year’s Convention sets a perfect tone for the Innovation Zone: It Starts with One. One idea, one vision, one sleepless night – that’s how breakthrough medicines and technologies are first imagined, and that’s why our partnership with NIH to sponsor companies focused on early stage R&D is so important,” said BIO’s President and CEO, Jim Greenwood.

Congress to EPA: Stop Undercutting Family Farms and Our Nation’s Renewable Fuel Future

Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood today expressed support for a U.S. House of Representatives letter, authored by Representatives Cindy Axne (D-Iowa) and Adrian Smith (R-Neb.), requesting U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler immediately end the practice of granting small refinery exemptions under the Renewable Fuel Standard (RFS) for large or unqualified refiners. 

Biosimilars: BIO Comments on FDA Draft Guidance Nonproprietary Naming of Biological Products: Update

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Nonproprietary Naming of Biological Products: Update.

BIO Submits Comments Supportive of EPA Plan to Allow Year-Round Use of E15

The Biotechnology Innovation Organization (BIO) today submitted comments supportive of the U.S. Environmental Protection Agency’s (EPA) “Proposed Rulemaking for Modifications to Fuel Regulations to Provide Flexibility for E15 and to Elements of the Renewable Identification Number (RIN) Compliance System,” which would allow for year-round use of gasoline blended with up to 15 percent ethanol.

Influential CEO Jamie Dimon to Deliver Keynote at BIO 2019

The Biotechnology Innovation Organization (BIO) today announced that Chairman and CEO of JPMorgan Chase & Co., Jamie Dimon – a leader in the banking industry and catalyst for innovation across American business, including the healthcare industry– will headline a keynote address at the 2019 BIO International Convention, the world’s premier life sciences event being held in Philadelphia, June 3-6.

Digital Tech: BIO Comments on FDA Prescription Drug-Use-Related Software

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the open docket on Prescription Drug-Use-Related Software.

Athena Diagnostics Inc., et al. vs. Mayo Collaborative Services, LLC. (US Court of Appeals for the Federal Circuit)

BIO files amicus brief joined by CropLife Int’l, WARF, and PhRMA in support of petition for rehearing in case addressing patent-eligibility of diagnostic technology.