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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…
MichBio joined other state and federal partners in a letter to President Biden ahead of his recent meeting with the leaders of Mexico and Canada. It requested that the U.S. government engage the Government of Mexico at the highest levels to address its recent actions affecting agricultural biotechnology and trade of U.S. agricultural products produced…
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…
~ 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…
UPDATE On Nov. 6, the U.S. Court of Appeals for Fifth Circuit issued an order staying implementation of the OSHA Emergency Temporary Standard (ETS) requiring mandatory vaccination or weekly testing requirements for employers with 100 or more workers. While the decision is stayed, employers do not have to comply with its terms. However, that stay…
The SoftVue™ 3D Whole Breast Ultrasound Tomography System from Delphinus Medical Technologies, Inc. is indicated for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue. Clinical evidence has demonstrated that SoftVue enhances dense breast screening and identifies up to 20% more cancers with greater accuracy and potentially…
SACRAMENTO, Calif. 10/28/2021 – MMS Holdings (MMS) – a data-focused CRO – provided regulatory strategy support to Praxis Bioresearch in the development of a therapeutic for apathy in Alzheimer’s disease. This comes as Praxis was awarded a $2.9 Million Fast-Track SBIR Grant to advance the company’s lead development candidate, PRX-P4-003. Experts at MMS provided regulatory…
Original Source The Food and Drug Administration granted emergency use authorization to the Covid-19 vaccine developed by Pfizer and its partner BioNTech Friday for children ages 5 to 11, a significant step toward making the vaccine available to millions of school-age children. Before the vaccine becomes widely available, it will also need to be recommended…
Original Source Democrats are zeroing in on a deal to lower prescription drug prices that the party hopes it could add to President Joe Biden’s $1.75 trillion social spending bill as soon as Monday, according to sources familiar with the effort. The conversations involve a group of Senate Democrats, including Sen. Kyrsten Sinema of Arizona,…
Original Source From medications to gloves to crutches, the strains of the global supply chain are hitting U.S. health care hard. Why it matters: Shortages of health care supplies can quickly jump from a nuisance to a life-or-death proposition. They indicate serious vulnerabilities in the U.S. health care supply chain. State of play: After seeing major supply…
Menlo Park Software Founder and CEO Rick Bollinger has begun an industry discovery campaign. He is interviewing manufacturing experts to explore their most pressing problems and how they deal with them. He says “medical device manufacture is a high-stakes industry”. It’s still using mainframe era software for product development and regulatory compliance. “what’s needed is 21st…
Original Source Stryker has snatched up Gauss Surgical after being drawn to its artificial intelligence-powered platform for monitoring a patient’s blood loss during surgery as well as following cesarean sections and childbirth. The company’s Triton system uses a computer vision app and an iPhone to visually measure a person’s loss of blood by capturing images of sponges,…
Original Source September 14th, 2021 [DETROIT, MI] – The Gilbert Family Foundation, a private nonprofit established by Jennifer and Dan Gilbert to accelerate a cure for neurofibromatosis type 1 (NF1), today announced funding of a new $5.4 million clinical study. The study, to be led by investigators at Children’s Hospital of Philadelphia and the Stanford University School…
Original Source LANSING — Food and animal safety products maker Neogen Corp. has bolstered its holding in the fast-growing veterinary market with the acquisition of an Atlanta-based companion animal health company. On Monday, Lansing-based Neogen (Nasdaq: NEOG) said it acquired CAPInnoVet Inc., a provider of pet medications that offer protection from fleas, ticks and mosquitoes at what…
Plymouth, MI – September 22, 2021 – Phenomics Health Inc., a platform bioinformatics-based precision medicine company, today announced completion of clinical product development and validation for its PrecīsMed™ pharmacometabolomics (PMx) technology in its new CLIA laboratory located at the Michigan Life Science and Innovation Center. The company’s laboratory operations, validation, as well as ongoing research…