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SHAKOPEE, Minn., April 1, 2021 /PRNewswire/ BIO-CAT Microbials, LLC is pleased to announce receipt of a Letter of No Objection from the United States Food and Drug Administration regarding the GRAS (generally regarded as safe) status of its OPTI-BIOME
®
1. In addition to the FDA letter, BIO-CAT Microbials OPTI-BIOME
® MB40 has a Master File submitted to Health Canada to allow its usage in dietary supplements.
BIO-CAT OPTI-BIOME® MB40 Probiotic Strain receives FDA non objection letter. ingredient safety is paramount for all of our products from microbial strains to digestive enzymes We have sold this safe and remarkably stable ingredient into the dietary supplement and food market for a few years now. This letter of no objection opens the door to more formulation options, including functional foods and beverages, BIO-CAT CEO and co-founder Chris Schuler said in a company release.
Greg Raymond to assume role as Southern Region President for Children s Hospital Colorado on April 1
Margaret Sabin to transition to Southern Region Past President
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COLORADO SPRINGS, Colo., April 1, 2021 /PRNewswire/ Children s Hospital Colorado (Children s Colorado) announced that on April 1, 2021, current Southern Region Chief Operating Officer Greg Raymond will fully transition to the role of Southern Region President and current Southern Region President Margaret Sabin will transition to the role of Past President. Margaret and Greg have both played integral roles in standing up our new hospital in Colorado Springs and have been trusted leaders during these tenuous times, said Jena Hausmann, President and Chief Executive Officer of Children s Colorado. We have been so humbled by the work the two of them have done and are grateful that they are both transitioning into their new, respective roles.
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PLEASANTON, Calif., April 1, 2021 /PRNewswire/ Unchained Labs, the life sciences company that s all about getting researchers the right tool for the job, launched its new gene therapy and vaccine applications on the Big Tuna platform today. Big Tuna is already the ultimate buffer exchange platform for biologics, and now it can take on buffer exchange, concentration and clean-up of adeno-associated viruses (AAVs) and lipid nanoparticles (LNPs).
AAVs are produced at low concentrations and need to be concentrated up for characterization. LNPs are made in the presence of ethanol which needs to be cleared out quickly to keep them stable. Both are tough to handle due to their large size and how fast their buffers flow through filtration membranes. Big Tuna s new high molecular weight cutoff plates, concentration application and tunable pressure settings make it perfectly dialed in for these molecules.
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ResearchAndMarkets.com s offering.
Amid the COVID-19 crisis, the global market for Dental Biomaterials estimated at US$ 7.5 Billion in the year 2020, is projected to reach a revised size of US$ 10.6 Billion by 2027, growing at a CAGR of 5% over the analysis period 2020-2027.
Ceramic, one of the segments analyzed in the report, is projected to record a 4.7% CAGR and reach US$ 3.8 Billion by the end of the analysis period. After an early analysis of the business implications of the pandemic and its induced economic crisis, growth in the Metallic segment is readjusted to a revised 4.8% CAGR for the next 7-year period.
First Patient Enrolled in KIDCARES10, Kedrion Biopharma Pediatric Primary Immunodeficiency Study
- Objectives of KIDCARES10 Study (KIg10 in peDiatric subjects: effiCacy, sAfety and phaRmacokinEticS of a 10% IG) a phase III, open-label, prospective, multi-center study are to assess the efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in pediatric patients aged 2 to 17 years and affected by primary immunodeficiency disease (PI)
- Primary efficacy endpoint of KIDCARES10 is incidence rate of acute serious bacterial infections from day 1 to week 51/52
- Primary safety endpoint of KIDCARES10 is safety in the overall study population from day 1 to week 51/52
- Secondary endpoints of KIDCARES10 include clinical, laboratory, pharmacokinetic, and health-related quality of life (HRQoL) measures