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Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced today that on March 8, 2019 it received 510(k) clearance from the U.S. Food and Drug Administration for its EchoSure device to deliver definitive blood flow data on demand.

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Cell therapy is emerging, cell by cell, into the repertoire of medical therapies. However, it still has not broken into mainstream use. For instance, there are only two FDA-approved chimeric antigen receptor (CAR) T-cell treatments in the United States: Kymirah, Novartis’s treatment for acute lymphoblastic leukemia, and Yescarta, Kite Pharma’s treatment for non-Hodgkin’s lymphoma.

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Visibility, speaking out, courage and organization. Forty years ago, these were the things that brought the Orphan Drug Act to life. On Sunday, February 24, across the U.S. and India, over 7,000 supporters gathered in the same passion: speaking out and bringing visibility to the more than 7,000 disorders collectively known as rare diseases, organized under the banner of Racefor7USA and its parent organizations, the Organization for Rare Disease India (ORDI) and Organization for Rare Diseases India in the U.S. (ORDIUSA).

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Cutting Edge Lab Space Available

The NIH is the cornerstone to the world scientific community and is the largest life sciences engine in the US.  

Bethesda Bio gives life science companies the ability to be on the doorstep of this invaluable wealth of resources, community, talent, technology, intellectual property, clinical studies. The existing Bethesda central business district provides a vibrant live, work and play environment to recruit and retain the best scientific minds. Over the past two decades, Bethesda has been the center of Montgomery County and the hub of innovation.

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Emmes today announced that Behrman Capital, a leading private equity firm, has made a significant investment in the company.  The capital will allow Emmes, one of the Washington area's top 100 largest private companies, to expand and strengthen its service offerings and international presence.

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan?  Sign up by noon 3/19 to schedule your feedback session with BHI Entrepreneurs-in-Residence (who have industry experience in therapeutics, Dx, medtech and more) next Wednesday, March 20th.  (The next session is scheduled for 3/20 and 5/22.)  Pre-registration is required; sign up here("EIR resource" at BHI).  For questions/more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it..

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More than 120 people registered for last week’s SBIR Workshop organized by BioHealth Innovation in partnership with Launch Workplaces and support from TEDCO and NIH FCU.  

The event featured program overviews, “how to” sessions regarding specific aspects of proposal development and 1:1 partnering meetings with the program managers.  

Speakers included:  Todd Haim,  Ph.D., Chief, Office of Small Business Research NIA;  Mike Pieck, Ph.D., Small Business Coordinator, NHLBI; Maureen (Cusick) Thomas, Outreach Coordinator, NIA;Victor Prikhodko, Business Advisor, NIDA; Amir Rahbar, PhD, MBA, Program Director, NCI;  Vladimir M. Popov, PhD, Business Dev. Manager, NCI-FNL;Amir Rahbar, PhD, MBA, Program Director, NCI; Henry Ahn, Program Director SBIR/STTR, NSF; and Colleen Gibney, SBIR Deputy Project Mgr, USAMRMC.  

44% of the attendees had applied for SBIR funding before with half of these innovators receiving a Phase 1.  Only 16% had received a Phase II award.  The majority of attendees were from Montgomery and Frederick Counties and the City of Baltimore.  However, registrants also traveled from Virginia, DC, Illinois and Pennsylvania.

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MaxCyte, the global cell-based medicines and life sciences company, announced today that it has expanded its relationship with Kite, a Gilead Company, by entering into a multi-drug clinical and commercial agreement. Under the terms of the agreement, Kite will use MaxCyte’s Flow Electroporation® Technology to enable non-viral cell engineering for development of multiple CAR-T drug candidates for up to 10 targets.

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Francis deSouza Photographer: Jeff Spicer/PA Wire via AP For years, the cost to decode a full human genome has been falling much like computer processing costs -- from hundreds of thousands of dollars per person to about $1,000 today. With a $100 genome getting closer, the CEO of the top maker of DNA sequencers thinks the world may not be ready.

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The biomedical research community has made major progress in achieving a balance of men and women in human studies, however compelling questions about the underlying mechanisms that increase women’s risk or resilience for certain heart, lung, blood, and sleep (HLBS) diseases continue to challenge the scientific and medical community.

In support of its Strategic Vision, the National Heart, Lung, and Blood Institute (NHLBI) is advancing a scientific research agenda for women’s health. As part of that agenda, the Institute has issued a Request for Information “Understanding the Health of Women and the Role of Sex/Gender in Mechanisms of Heart, Lung, Blood, and Sleep Diseases and Disorders.” The RFI offers the research community, health care professionals, patient advocates, and others an opportunity to provide input on topics ranging from scientific gap areas in mechanisms of HLBS diseases, to training and resource needs, among other topics.  

The NHLBI greatly values your perspective as it works with the wider scientific community to uncover the mechanisms of disease that will set a stronger foundation for clinical research focused on more effective prevention and treatment strategies for HLBS diseases and disorders in women. Please submit your responses via email to This email address is being protected from spambots. You need JavaScript enabled to view it. by March 15, 2019. Don’t forget to include the Notice number (NOT-HL-18-660) in the subject line.

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When: Wednesday, March 13, 2019 from 5:00 PM to 7:00 PM

Where: Bar Louie 150 Gibbs St Rockville, MD 20850

Join BioBuzz and Founding Sponsor JHU MoCo for our next exciting event of 2019 at Bar Louie in Rockville on March 13th. 

The Johns Hopkins University Krieger School of Arts and Sciences created the Center for Biotechnology Education to engage diverse audiences in the world of biotechnology and to prepare the leaders of today, tomorrow and the next generation for the challenges of the 21st century.

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Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that it has added two new members to its Board of Directors, Dr. Kavita Patel and Garry Allen Nicholson. Dr. Patel and Mr. Nicholson bring significant healthcare expertise that is aligned with and can further empower PGDx’s corporate growth strategy of driving global access to precision medicine in oncology.

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Dr. Darryl Sampey has been through the grind as CEO of Frederick’s BioFactura, a thriving biotech company that’s a key part of the BioHealth Capital Region’s second largest biotech hub. On a rainy, cold February night at FITCI, Sampey shared BioFactura’s compelling story during a “fireside chat” hosted by StartUp Grind’s Frederick chapter.