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Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for inebilizumab, an investigational anti-CD19 monoclonal antibody, for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis.

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Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced that it received a $3 million Phase IIB Small Business Innovation Research (SBIR) grant from the National Institutes of Health to use its EchoMark & EchoSure devices to support arteriovenous (AV) fistula maturation and long-term viability. The award provides capital for prospective clinical studies and continued research and development efforts.

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A University of Maryland (UMD) team has been awarded a $1 million grant by the National Science Foundation’s Integrative Strategies for Understanding Neural and Cognitive Systems (NCS) program to investigate the complex effects of intestinal serotonin on both gut and brain health. The project, “Developing engineering solutions to investigate microbiome-to-neuron communication,” aims to provide a more realistic picture of the complex gut-microbiome-brain axis system (GMBA).

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Baltimore-based Gemstone Therapeutics has received $250,000 in a new investment from the Maryland Momentum Fund.

The investment from the fund, which was created by the University System of Maryland to support startups created by students, faculty, alums and other affiliates, is part of a new funding round for Gemstone, according to the fund.

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Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced on August 29 that the company has entered into an agreement to invest up to US$30 million in Remiges Biopharma Fund II, LP a biopharma venture capital fund formed by Remiges Ventures, Inc. Taiho Pharmaceutical invested the same amount in the Remiges BioPharma Fund I established in 2014.

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Liftstream, a U.K.-based executive recruiting firm, released an oft referenced report called “A Public Reality for Women in Biotech Boardrooms” in 2016. Lifstream’s research found that only 7 to 9 percent of biotech CEOs were women, less than 11 percent of board seats were held by females and 98 percent of board chair positions were held by men. The report surveyed 177 publicly-listed biotechs that went through the IPO process from 2012 to 2015.

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For the third consecutive year, Children’s National Health System is co-locating its annual Symposium with The MedTech Conference, powered by AdvaMed. If you are interested in advancing innovation in pediatrics and exploring solutions to the challenges associated with device trials, we hope that you will join key industry stakeholders at the  7th Annual Pediatric Device Innovation Symposium on Sept. 22 in Boston, one day before The MedTech Conference. 

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Kenton Lee was traveling through Nairobi when he had, as he says jokingly, “the only idea I’ve ever had.” He saw an orphan girl’s shoes that were way too small; someone had cut off the front so her toes could stick through. “Right there, I thought, Wouldn’t it be nice if there were shoes that could grow?” Then he went home to Boise, Idaho, developed a shoe that expands five sizes, and founded the nonprofit Because International -- which today, 12 years later, has distributed more than 250,000 pairs worldwide.