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Scott Gottlieb, who resigned as head of the FDA in March, has rejoined NEA as a special partner focused on healthcare investments. Gottlieb was a venture partner with the firm for 10 years before leading the FDA. Founded in 1977, the Maryland-based firm's portfolio includes Opendoor and Desktop Metal.

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Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform.

The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021.

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Navitas Life Sciences, a TAKE Solutions Enterprise today announced the acquisition of US based niche full service CRO and health research company, KAI Research Inc.

KAI Research brings on board top of class offerings in 3 key areas – Clinical Trial Management, Clinical Research Consultation, and Data Management & Standardization. Through this acquisition, Navitas Life Sciences expands Phase II and Phase III capabilities in North America adding to its current capabilities in Europe and APAC. KAI strengthens Navitas' therapeutic expertise in mental health, musculoskeletal diseases, neurological disorders, pain, diabetes, infectious diseases and oncology for Pharma and medical devices. The company has differentiated offerings in the areas of patient registries and e-clinical solutions as well as long-standing relationships with clinical sites and trusted network of service providers across the United States and Africa.

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QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that QuantiFERON ® -TB Access, a new solution under development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high disease burden of tuberculosis, will be recognized by the Joint United Nations Programme on HIV/AIDS (UNAIDS) at the organization’s Health Innovation Exchange from May 21-23 in Geneva, Switzerland. The event will be held during the World Health Assembly and brings together ministers of health, nonprofits and industry to spotlight innovations with potential to change the world’s health landscape and benefit sustainable development.

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NAVAN, Inc. (NAVAN), a privately-held biotechnology company enabling the development of next generation cell and gene therapies through its novel, non-viral NanoStraw platform, announced today the appointment Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti, Inc., and Howard Grimes, Ph.D., Associate Vice President and Associate Vice Provost for Institutional Initiatives at The University of Texas at San Antonio, to its Strategic Advisory Board.

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Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue,  when Chairman  Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY)  that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee.

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Alzheimer’s disease (AD) arises from molecular events that scientists are piecing together to discern an overall story, parts of which are well known, others less so. Some of the lesser-known epigenetic events in the Alzheimer’s story have just been filled in by scientists based at the Van Andel Research Institute (VARI). What’s more, these epigenetic events, which occur early in Alzheimer’s, appear to fit well with what we know about the disease’s progression to its most devastating biological features.

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Wed, Jun 12, 2019 at 11:30 AM

The 3rd Annual NCI and FNLCR Technology Showcase will showcase technologies being developed at the National Cancer Institute (NCI) in Bethesda and Frederick, and Frederick National Laboratory for Cancer Research (FNLCR) to encourage startup formation, technology licensing, and collaborations. It will introduce the local scientific community to the regional technology development stakeholders and highlight available resources.

Prospective investors, established companies, interested stakeholders, entrepreneurs and those looking to commercialize technologies are invited and encouraged to attend. The day will feature short technology summaries by NCI and FNLCR innovators, as well as presentations from regional stakeholders involved with technology development and commercialization. An interactive poster session by innovators and technology ambassadors will concurrently occur.

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Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has successfully obtained marketing authorization for its oral typhoid vaccine Vivotif® (Typhoid Vaccine Live Oral Ty21a) in five additional European Union Member States, including France, Portugal, Poland, Czech Republic and Slovakia as well as approval of harmonized prescribing information in the EU also known as the Summary of Product Characteristics or SmPC.

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BioHealth Innovation has announced the schedule for the next year’s Entrepreneur-in Residence (EIR) feedback sessions.  These 1:1 Sessions with EIRs take place at BioHealth Innovation's office in Rockville OR by videoconference.  There is no charge to participate but entrepreneurs must be working on a biohealth Start-Ups/innovation in the BioHealth Capital Region (MD, DC, VA).  The upcoming dates are:  

2019:  5/22, 7/24, 9/4, 10/9, 11/20

2020:  1/22, 2/26, 3/25, 4/22, 5/27         

Schedule your appointment online here.  For questions or more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it..

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NextStep Robotics Inc., an early-stage company that has developed a personalized robotic therapy to help treat foot drop in recovering stroke patients, announces the closing of its second funding round. The $600,000 round will allow NextStep to transition from prototyping and development to manufacturing and sales. Led by the Abell Foundation, a new investor, this round includes investments from previous private investors from Vancouver, Canada and new investors the Abell Foundation, University of Maryland (UM) Ventures, and Jeff and Brad Quinn of Engineered Medical Systems, Inc. (EMS), a partner company of the newly-formed LaunchPort™ Accelerator.