MichBio Opposes Criminalization of Fetal Tissue Research

HB 5558, sponsored by Rep. Albert and others, was recently introduced and seeks that “Research shall not knowingly be performed on an organ, tissue, or cell taken from a dead embryo, fetus, or neonate obtained from an abortion.” This legislation is the latest attempt to criminalize and restrict fetal tissue research conducted legally and ethically.…

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Creation of Rare Disease Advisory Council Proposed

HB 4654, legislation to establish a Rare Disease Advisory Council (RDAC) within the Department of Health & Human Services has moved to the Senate for their consideration. Substitute language was introduced at the House Health Policy Committee that accommodated changes sought by MichBio. These included expanding the RDAC membership to include greater representation from the…

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Build Back Better Act to Impact Bio-Industry Negatively

The U.S. House on November 19 voted 220 to 212 to pass the “Build Back Better” Act (BBBA) reconciliation bill (H.R. 5376) that includes more than $1.5 trillion in business, international, and individual tax increase provisions. The legislation is now being debated in the Senate, initially by the Finance Committee It includes several drug pricing…

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uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B

~ Largest gene therapy study in hemophilia B achieved primary endpoint of non-inferiority in annualized bleeding rate after stable Factor IX (FIX) expression, assessed at 18 months following a single dose of etranacogene dezaparvovec ~   ~ Etranacogene dezaparvovec also achieved secondary endpoint demonstrating statistical superiority in reduction of annualized bleeding rate compared to baseline…

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