Archive for November 2021
New Federal Vaccine Mandate Details Issued – What Employers Must Know
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…
Read MoreDelphinus Receives FDA Approval for its SoftVue 3D Whole Breast Ultrasound Tomography System
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…
Read MorePraxis Bioresearch Seeks Regulatory Strategy Support from MMS Holdings to Develop Therapeutics for Alzheimer’s Disease
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…
Read MoreFDA authorizes Pfizer Covid-19 vaccine for children aged 5 to 11
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…
Read MoreDems close in on Medicare prescription drug negotiation compromise
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,…
Read MoreHealth care plagued by new supply chain shortages
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…
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