On Sunday, August 7, 2022, the United States Senate passed the Inflation Reduction Act of 2022 in a party line vote with Vice President Kamala Harris casting the tie breaking vote. The legislation now moves back to the House of Representatives. Speaker Pelosi stated, “The House will return and move swiftly to send this bill to the President’s desk ….”
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.
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.
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
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
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.
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
The Business Market Assessment tool to helps you understand the initial investment and recurring regulatory compliance costs you’ll face. The guide walks you through the revenue vs cost modeling calculations to help you judge the market viability of your product and see if a specific market makes sense.
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)
On May 5, 2021, Governor Ducey signed H.B. 2454, legislation which dramatically expands access to telehealth services in Arizona. The legislation—the most expansive in the country—makes telemedicine a permanent fixture of Arizona’s healthcare system.Continue reading