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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…
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…
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.…
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…
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,…
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…
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…
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…
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…
M3D Inc. has secured a $275,000 SBIR Phase I award from the National Science Foundation (NSF) to advance its research on gamma camera designs aimed at improving sentinel lymph node biopsies, particularly in tough-to-navigate head and neck cancer cases. Surgeons often face a challenge when a lymph node is too close to the tumor. Radiotracers…
ANN ARBOR, Mich., September 13, 2024 – ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that it has secured $65M in Series D financing. Johnson & Johnson Innovation – JJDC, Inc. led the round that was backed by a consortium of investors that included…
The Centers for Medicare & Medicaid Services (CMS) finalized a new Transitional Coverage for Emerging Technologies (TCET) Pathway to expedite Medicare coverage of some FDA-approved breakthrough products. Under this finalized pathway, eligible US Food and Drug Administration (FDA) designated breakthrough devices that fall within a Medicare benefit category can obtain national coverage for several years…
The Centers for Medicare & Medicaid Services (CMS) announced recently the prices that they have set for the first 10 medications as an outcome of the Inflation Reduction Act’s drug provisions. For the first time, the law provides Medicare the ability to directly “negotiate” (in effect, set, as otherwise significant penalties are imposed) the prices…
The Federal Trade Commission (FTC) held a virtual open meeting on the heels of issuing its Interim Report on Pharmacy Benefit Managers (PBMs). A press release summarized the report’s findings. Members of the public and other stakeholders provided arguments for PBM reform at the virtual meeting, citing the many ramifications that PBM business practices have had on patient…
On January 22nd, 2007, Pfizer Global Research and Development in Ann Arbor closed its doors, resulting in thousands of job losses. Just two days later, Dan Ross established TransPharm Preclinical Solutions. Ross’s motivations for starting the company were numerous, with the loss of his beloved job being a significant factor. Determined to continue working in…