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The US Food and Drug Administration (FDA) has approved certolizumab pegol injection (Cimzia) for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first FDA-approved treatment for the inflammatory arthritis condition. "Today's approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there [have] been no FDA-approved treatments until now," said Nikolay Nikolov, MD, associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research. The FDA’s decision to approved was supported by efficacy results from a clinical trial of adult patients with non-radiographic axial spondyloarthritis with objective signs of inflammation— elevated C-reactive protein (CRP) levels and/or sacroiliitis on MRI. The trial included 317 adult patients who were randomized to certolizumab or placebo.
ATLANTA, March 27, 2019 /PRNewswire/ -- MiRus has received FDA 510(k) approval for the MoRe® based Europa™ Pedicle Screw System making it the first FDA approved medical device with this new class of implant material. The Europa™ System received the 2018 Spine Technology Award at the NASS meeting for excellence and innovation in spine surgery. MiRus has developed MoRe®, a proprietary molybdenum rhenium superalloy for medical implants, to provide an unprecedented combination of strength, ductility, durability, and biological safety that is unmatched by current materials. MoRe® was designed to meet these criteria and is patent protected for use in all medical devices. The clinical needs of many patients remain unmet due to the limitations of current titanium, cobalt and iron based alloys originally developed more than 40 years ago. The MoRe® superalloy allows for the design of a new generation of smaller, stronger, more durable, and bio-friendly implants that will result in less soft tissue disruption, quicker recovery and better outcomes for patients.
Takeda receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia
March 18, 2019 − FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). Albumin is not indicated as an intravenous nutrient − Takeda received its first FDA approval for the Georgia facility, to manufacture GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, in June 2018 − This state-of the art facility supports continued growth of Takeda’s plasma-derived therapies portfolio and further strengthens our ability to deliver these complex therapies for patients
CSI Laboratories Begins Offering VENTANA PD-L1 (SP142) Assay as Companion Diagnostic Test for Triple Negative Breast Cancer as a Result of FDA Approval for TENCENTRIQ® (atezolizumab)
ALPHARETTA, Ga.--(BUSINESS WIRE)--CSI Laboratories, a nationally renowned laboratory specializing in comprehensive cancer diagnostics, today announced that it has added the newly approved VENTANA PD-L1 (SP142) Assay as a companion diagnostic test for use in selecting triple-negative breast cancer (TNBC) patients for TENCENTRIQ® (atezolizumab). TENCENTRIQ® was granted accelerated approval for use in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 on March 8, 2019. The indication is approved under accelerated approval based on progression-free survival and continued approval may be contingent on verification and description of clinical benefit in confirmatory trials, according to the FDA. CSI is one of the first reference laboratories to offer the new companion test. The new Assay is used to determine PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area.
Advantage Capital Invests $6.5 Million in Danimer Scientific, Supporting Company’s Growth in Rural Georgia
NEW ORLEANS--(BUSINESS WIRE)--Advantage Capital today announced a $6.5 million investment in Danimer Scientific, a leading biotechnology company producing biodegradable and compostable polymers used in consumer and industrial products. The investment was made through the GARJA program and supports the company’s anticipated growth as it seeks to boost capacity and significantly increase its workforce at its Bainbridge, GA location over the next few years. “The Georgia Agribusiness and Rural Jobs Act was created to bring investment capital and jobs to the more rural parts of the state,” said State Representative Jay Powell (R-Camilla). “Danimer’s growth is not only helping to solve key environmental issues facing the world today but is also bringing additional high-quality jobs to the local community of Bainbridge.” Bainbridge, with a population just north of 12,000, faces many of the same challenges confronting towns, businesses and residents across Georgia’s rural areas. The loss of both residents and jobs looms large. And as many rural communities are still struggling to recover from the 2008-2009 recession, barriers to investment capital make it difficult for rural businesses to compete, expand, and create good quality jobs.
ATHENS, Ga – March 18, 2019 - ArunA Bio, a leader in the development of exosomes and exosome therapeutics for the treatment of neurodegenerative disorders, today announced the appointment of Al Medwar as Executive Vice President, Corporate and Commercial Development. Mr. Medwar joins the company and its leadership team contributing over 30 years of pharmaceutical industry experience. Mr. Medwar joins recently appointed Chief Executive Officer, Dr. Mark A. Sirgo, and team as they focus on progressing ArunA’s neural exosome platform toward commercialization, including partnerships with companies in the CNS therapeutic area. “I am pleased to have Al join the leadership team at ArunA Bio as we move aggressively to utilize our neural exosome platform to develop novel therapeutics to treat serious neurodegenerative disorders through both our internal pipeline and industry collaborations,” said Dr. Sirgo. “Al played a significant role in building BioDelivery Sciences into a fully integrated pharmaceutical company based on a platform technology. I look forward to successfully collaborating with Al again in this new and exciting venture.”
Novartis (NYSE:NVS) subsidiary Alcon said today that it acquired intraocular lens developer PowerVision for $285 million. PowerVision is developing fluid-based intraocular lens implants that use the eye’s natural accommodating response to transport fluid in the implanted lens, Fort Worth, Texas-based Alcon said. The fluid-based lens creates a continuously variable monofocal lens using the natural contractions of the eye’s muscles, Alcon said, allowing a patient to actively focus on objects in a style similar to a young eye’s crystalline lens.
Washington, DC (March 11, 2019) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding President Trump’s FY 2020 budget proposal: “While we are still reviewing the details of the President’s proposed budget, we applaud the President’s efforts to lower patients’ out of pocket costs for prescription drugs, and to rein in abuses and increase accountability within the 340B drug discount program." “That said, we have serious concerns that elements of this proposal threaten to harm some of the nation’s most vulnerable patients, including seniors and low-income families. The budget would fundamentally upset the successful Medicare drug benefit that has provided American seniors with affordable prescription drug coverage while costing taxpayers less than originally expected."
Emory University’s Office of Technology Transfer will celebrate its faculty entrepreneurs and their innovative discoveries at the 13th Annual Celebration of Technology and Innovation. The celebration will be held Thursday, March 21, 2019 at the Emory Conference Center, Silver Bell Pavilion, 1615 Clifton Rd., Atlanta, GA 30322.
WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on introduction of bipartisan legislation –the Protect Medical Innovation Act – in the U.S. Senate to permanently repeal the medical device excise tax: “Unless Congress acts quickly, America’s medical technology companies face a $20 billion tax hike at the end of 2019 when the device excise tax returns. If not stopped, this tax will put future patient innovations and good-paying U.S. jobs at risk. “Today’s Senate action is the first step in ensuring continued American leadership of this vital industry. We thank the bill’s lead sponsors, Sens. Pat Toomey (R-Pa.) and Amy Klobuchar (D-Minn.), for their long-standing support of improving patient lives and medtech innovation. The broad bipartisan backing of this bill reflects members’ understanding of the negative impact on job creation, investment and patient care should this tax return, and the urgent need for repeal.
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