BIO Statement on CMS National Coverage Determination for Drugs Used to Treat Patients Suffering from Alzheimer’s Disease

On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) released a national policy for coverage of aducanumab (brand name Aduhelm™) and any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer’s disease. In its official statement, the Biotechnology Innovation Organization (BIO) shares why the CMS Decision is an enormous setback for Alzheimer’s patients and a dangerous infringement on FDA’s Scientific Autonomy.

 

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Get Engaged In the SBIR STTR Reauthorization Discussion

The SBIR/STTR Programs are currently set to expire on September 30, 2022. It would be damaging to American innovation and competitiveness if these programs were to expire before a full reauthorization can be passed. The SBIR/STTR Programs enable small businesses to develop and commercialize new innovative technologies and have a proven track record of promoting competition through a merit-based application process.  Since their establishment in 1982, these programs have provided over 179,000 awards, totaling more than $54.3 billion, to U.S. small businesses. A study by the National Academy of Sciences found a commercialization rate of 50-60% for SBIR/STTR investments. You can see the impact of SBIR/STTR in Arizona by clicking here.  

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HB2039 Health; Innovation; Trust Fund

On March 29, 2022, Arizona’s  Senate Appropriations Committee voted unanimously to give a Do Pass as Amended recommendation for HB2039.  The next step in the process is review by the Senate Rules Committee.

If HB2039 successfully completes the legislative process and is signed into law by the Governor, it will establish the statutory framework for the Arizona Health Innovation Trust Fund within the Arizona State Treasurer’s Office with the State Treasurer as Trustee. Continue reading

Nearly 100 Organizations and Experts Urge HHS Secretary Xavier Becerra to Reject Xtandi March-In Petition

WASHINGTON, D.C. (March 17) — In a letter transmitted today, the Bayh-Dole Coalition and nearly 100 prominent academic and private sector innovation experts and organizations, public policy associations, and legal scholars urged U.S. Department of Health and Human Services Secretary Xavier Becerra to reject the latest march-in petition on prostate cancer drug Xtandi.Continue reading

What Drives the Creation and Delivery of Cures and What Doesn’t

AZBio President & CEO, Joan Koerber-Walker,  shared insights with Duane Schulthess, Managing Director of Vital Transformation on the the Vital Health Podcast.  The popular podcast series has a global reach and features relaxed, one on one discussion with health care professionals, researchers, and regulators. Topics explore the implications of new medical procedures, technologies and policies as well as  their impact on current clinical practices.

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Life Science Leaders Weigh In On Build Back Better Provisions

On Friday, November 19, 2021, the U.S. House of Representatives passed the Build Back Better bill on a 220-213 vote.  The bill now moves to the Senate for further review and action. Valued at close to $2 trillion, the bill includes  a potpourri of  Democratic social spending priorities that includes free preschool for 3 and 4 year old children, initiatives to fight climate change and affordable housing programs. The bill also includes increases to  Pell grants for college tuition, expands family leave, and provides new hearing benefit for seniors.   It also incudes “pay fors” including   increases corporate taxes, funds additional resources for IRS enforcement, AND implements price controls on certain medicines.  Investors and life science companies of all sizes have expressed serious concerns that if the latter provisions pass the Senate and are implemented the impact on future health innovation could be devastating. Continue reading

Arizona’s Launch of the NAM Pharma Manufacturing Report

Learn about the biopharmaceutical industry’s footprint in the state of Arizona as we discuss the National Association of Manufacturers’ report:

Ensuring a Health Future: The Impact and Importance of Pharmaceutical Manufacturing.

 

 

Speakers:

Shawn DuBravac, PhD, CFA, President, Aviro Institute and New York Times Best Selling Author

Garrick Taylor, EVP, Arizona Chamber of Commerce & Industry

Moderator: Joan Koerber-Walker, president & CEO, Arizona Bioindustry Association (AZBio)

Clouds Over the Capitol

TRIPS Waiver, MCIT, HR3.  If you are not familiar with these policy developments, you probably should be.

The United States medtech and biotech industries make a tremendous impact on people’s lives.   When policy makers and Federal Agencies work together, the impact is made even greater.  However, some policy decisions can have the opposite effect.

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