Posts by jamiek
Generative 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…
Read MoreM3D Inc Awarded NSF SBIR Phase I Grant for Advanced Gamma Camera Design
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…
Read MoreONL Therapeutics Closes $65 Million in Oversubscribed Series D Financing
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…
Read MoreCMS Finalizes Expedited TCET Coverage Pathway
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…
Read MoreFirst Drugs Subject to Inflation Reduction Act Price Provisions
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…
Read MoreFTC HOLDS PUBLIC MEETING ON PBMs
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…
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