ArunA Bio Appoints Al Medwar as Executive Vice President, Corporate and Commercial Development
Monday, March 18, 2019 12:00 AM

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.”

Takeda receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia
Monday, March 18, 2019 12:00 AM
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)
Monday, March 18, 2019 12:00 AM

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
Monday, March 18, 2019 12:00 AM

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.

BIO Statement on President’s Proposed 2020 Budget
Thursday, March 14, 2019 11:01 AM

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."

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