Posts by jamiek
A Huge Win for Michigan’s Innovation Economy – R&D Tax Credit Reestablished
In a milestone for Michigan’s innovation economy, the legislature passed a long-awaited and long-fought Research & Development (R&D) Tax Credit legislation – fifteen years in the making! It was a protracted, and at times frustrating, journey for MichBio in its advocacy to reestablish an economic development incentive specifically aimed at R&D in Michigan. We watched…
Read MoreEnsuring Patient Access to Critical Breakthrough Products
This bipartisan legislation would enable millions of patients to receive quicker access to life- changing medical innovations. The legislation is designed to expedite the Medicare coverage determination process of breakthrough medical technologies for patients. Although the House of Representatives generated some momentum on related legislation, H.R. 1691, a Senate companion bill, S. 5349, the “Ensuring…
Read MoreCMS Finalizes Accelerated Approval Pathway for Devices
The Transitional Coverage for Emerging Technologies (TCET) pathway was finalized by the Centers for Medicare & Medicaid Services (CMS). It aims to provide Medicare beneficiaries with more timely access to new medical technologies. It also seeks to improve the quality of life for people with Medicare and encourage innovation. Medical devices must meet the following…
Read MoreBiosecure act Fails to be Enacted
The Biosecure Act missed its expected ride through the U.S. Congress when the Senate failed to include it in the National Defense Authorization Act. However, it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed Chinese “biotechnology companies of concern.” The U.S.…
Read MoreNo R&D Tax Amortization Relief
The Tax Relief for American Families and Workers Act of 2024, the $78 billion tax package passed by the House in January that would’ve restored full expensing under Internal Revenue Code Section 174 continued to be blocked by Senate Republicans through the end of session and thus died. The Senate’s failure to move forward the…
Read MoreGenerative AI Medical Writing Tool for the Pharmaceutical and Biotechnology Industries From TrialAssure Gets a Major Upgrade to Make Scientific Document Creation Easier
CANTON, Mich. (December 10, 2024) – TrialAssure®, a global leader in AI-enabled, human-driven solutions for the pharmaceutical industry and beyond, today announced a groundbreaking addition to its TrialAssure LINK® AI content creation and medical writing tool. The new Microsoft Word AI Assistant enables content generators, like medical writers, and other content generators across several industries,…
Read MoreLatest Bill Introduced That Threatens Ethical Animal Research
SB 1019, or “Queenie’s Law”, was recently introduced by Sens. Wojno and Polehanki, as a companion to 2023 legislation in the Michigan House as a response to research studies conducted at Michigan’s public universities. If enacted, public bodies, i.e., research institutions, would be prohibited from using “a dog for experimental purposes in a manner that…
Read MoreMichBio Joins Medtech Partners in Asking Congress to Pass H.R. 1691
MichBio joined AdvaMed, MDMA, as well as fellow state medtech associations and other stakeholders in a letter seeking Congressional passage of H.R. 1691, the Ensuring Access to Critical Breakthrough Products Act. It comes on the heels of the Centers for Medicare & Medicaid Services (CMS) issuing its final rule back in August 2024 on the…
Read MoreHouse Approves BIOSECURE Act
The U.S. House of Representatives recently passed HR 8333, commonly known as the BIOSECURE Act. The bill passed 306-81, far exceeding the two thirds vote required to pass. The text of this bill was unamended from the version approved by the House Committee on Oversight and Accountability in May (the “House bill”). Analysts have said…
Read MoreMichigan Launches Rare Disease Advisory Council
The Michigan Department of Health & Human Services has made appointments to a newly constituted Rare Disease Advisory Council. A rare disease is a condition that affects fewer than 200,000 people in the United States. There are more than 7,000 known rare diseases and almost 1 in 10 Michiganders suffer from a rare disorder. The…
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