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BIO Investor Forum Concludes

The BIO Investor Forum finished today after hosting two days of expert-led panel discussions, fireside chats, over 165 company presentations and more than 2,750 individual meetings arranged through BIO One-on-One Partnering — a 26 percent increase over last year. The event was attended by more than 1,000 representatives of private and early stage biotech companies, leading investment firms, research organizations and others who came together to foster the development of new medical treatments and to grow the industry’s pipeline. 

Hill Leaders Urge Support for Reg System that Supports Ag Innovation

USDA, FDA and EPA must “coordinate with each other and stakeholders”  Washington, D.C. (October 17, 2017) – Under the leadership of Reps. Neal Dunn (R-Fla.) and Jimmy Panetta (D-Calif.), 79 Members of the House of Representatives signed on to a letter urging for a “consistent, science-based, risk-proportionate regulatory system” for agricultural biotechnology.

CMC: BIO Comments on FDA Draft Guidance CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports

 

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BIO's Letter to the Senate Committee on Judiciary Regarding Deficiencies at the USPTO

BIO President and CEO James C. Greenwood details deficiencies at the USPTO that are undermining longstanding and carefully-balanced procedures governing market entry and patent dispute resolution under the highly successful Hatch-Waxman Act.

BIO Statement on California Governor Brown Signing Drug Price Reporting & Transparency Bill

BIO will continue to oppose legislative efforts, such as SB 17, that harm patient access to needed care by undermining competition, disrupting existing drug product availability, or stifling investment in the innovation ecosystem through misguided government intrusion.

BIO Congratulates SAB Biotherapeutics on Pharm Groundbreaking

Sioux Falls, S.D. 80-acre biological pharm is first-of-its kind   Washington, D.C. (October 5, 2017) – Sioux Falls, S.D.-based SAB Biotherapeutics, Inc. (SAB), celebrated construction of their 80-acre biopharmaceutical production pharm operation with a groundbreaking ceremony today in Lincoln County. 

Sixth Annual BIO Patient and Health Advocacy Summit Concludes Today

The 2017 Patient and Health Advocacy Summit wrapped up today, having offered the nearly 240 patient groups, companies and organizations new ways to connect, strategize, learn and partner.  For the past six years, the BIO Patient and Health Advocacy Summit has brought together a diverse group of organizations including patient advocacy, health care providers, academia, government, think tanks, professional societies and the biotechnology industry to focus on bringing the patients’ voice to the drug development process. 

BIO to Offer Complimentary Access to One-on-One Partnering™ During J.P. Morgan Healthcare Conference (“JPM Week”)

BIO will offer complimentary access to its proprietary BIO One-on-One Partnering™ during "JPM" week January 7-11, 2018  

BIO Comments to USDA’s Office of Budget and Program Analysis on Identifying Regulatory Reform Initiatives, September 15, 2017

United States Department of Agriculture Jamie L. Whitten Building, Room 101-A 1400 Independence Ave SW Washington DC 20250 Re: Identifying Regulatory Reform Initiatives Dear Ms. Adcock: The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the USDA’s request for information on “Identifying Regulatory Reform Initiatives,” published in the Federal Register on July 17, 2017.1 Thank you for the opportunity to provide input as the U.S. Department of Agriculture (USDA or the Agency) considers opportunities to improve customer service and remove unintended barriers to participation in its programs in ways that least interfere with its customers and allow USDA to accomplish its mission.

BIO Submits Comments Re: Medicare CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B

BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS) proposed rule regarding the calendar year (CY) 2018 Physician Fee Schedule (PFS), other revisions to Part B, and Medicare Shared Savings Program (MSSP). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biological. In this letter, BIO responds to CMS’s proposals in the order in which the Agency addresses each issue in the Proposed Rule, for ease of reference. However, there are several issues of particular importance to our members given the goal of ensuring patient access to necessary vaccines, treatments, and therapies.