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
Category Archives: Advocacy and Regulations
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.
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
leanRAQA releases new Business Market Assessment Tool for Life Science Innovators
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.
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)
Arizona Expands Telehealth Law, Making it Broadest in the Nation
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
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.
Governor Ducey’s Budget Focuses On Education, Tax Relief
News Release: January 15, 2021
Budget Also Invests In Public Health, Public Safety, Infrastructure And Wildfire PreventionContinue reading
CMS Releases Final Rule on Medicare Coverage of Innovative Technology (MCIT)
The CMS rule the establishes a new coverage pathway – MCIT – for breakthrough medical technologies.
BIO Leads Group Challenging Administration’s “Most Favored Nation” Rule
On December 4, 2020, the Biotechnology Innovation Organization (BIO), the California Life Sciences Association (CLSA), and BIOCOM California today filed a challenge against the Department of Health and Human Services’ (HHS) attempt, during the final days of the Trump Administration, to implement for the first time ever a “Most Favored Nation” reimbursement policy for certain drugs administered by Medicare Part B providers – drastically altering this system in ways that will harm their ability to serve America’s most vulnerable senior citizens.Continue reading