351st Edition – April 30, 2019

The company is seeking to go public just three years after its founding.

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United Therapeutics Corporation (Nasdaq: UTHR) today announced that its collaborator, XVIVO Perfusion, Inc., a subsidiary of XVIVO Perfusion AB (STO: XVIVO), has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the products XPS™ and STEEN Solution™. This approval means that STEEN Solution, XPS and the accompanying single-use articles are the only medical device products that are approved in the United States for ex-vivo lung perfusion (EVLP) of initially unacceptable donated lungs at body temperature.

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GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age.

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Sirnaomics Inc. has taken in yet another $11 million in investments, closing a Series C funding round that totaled $47 million.

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With an FDA approval for its pricey CAR-T therapy Yescarta under its belt and more treatments in the pipeline, Gilead’s Kite Pharma was on the hunt for a new manufacturing site to fuel those hopes. The company found it in Maryland.

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Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a clinical stage biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced the official opening of its new manufacturing facility. Precigen commenced the build-out of the nearly 5,000 square foot manufacturing facility in 2018 to support gene therapy manufacturing. The good manufacturing practices (GMP) facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early stage clinical trial needs. The new facility adds to Precigen’s existing footprint in Germantown, Maryland, which supports more than 95 employees. To mark the official opening, the company held a ribbon cutting ceremony attended by elected officials and local community members with remarks from Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon, Helen Sabzevari, PhD, President of Precigen, United States Congressman David Trone representing Maryland’s 6th Congressional District and Jeffrey Schlom, PhD, Chief of the Laboratory of Tumor Immunology and Biology at the Center for Cancer Research, National Cancer Institute. Dr. Schlom is the principal investigator of a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute and Precigen. Under this CRADA, the National Cancer Institute and Precigen are collaborating to evaluate Precigen’s proprietary adenoviral vaccines in preclinical and clinical studies for the treatment of cancer.

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Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).

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Today, the U.S. Department of Commerce’s National Institute of Standards and Technology announced 15 key findings from a final version of a new “green paper” on maximizing U.S. innovation from government-funded research.

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GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the first patient in a Phase 3 clinical trial being conducted under the auspices of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI), part of the National Institutes of Health. The second in a series of trials designed to evaluate uproleselan across the continuum of care in AML, this NCI-sponsored study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. A third trial, to be conducted by the European HOVON consortium, is expected to initiate later this year.

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CoapTech LLC, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today that the U.S. Food and Drug Administration (FDA) on April 10, 2019 granted the company 510(k) clearance for its PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.

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The Small Business Administration (SBA) has statutory authority to establish federal Government-wide policies to implement the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. SBA recently issued a significantly revised final SBIR/STTR Policy Directive, which is effective May 2, 2019. See 84 FR 12794. Below we highlight the major changes implemented in the revised policy directive.

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The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces 12 finalists that will present at the “Make Your Medical Device Pitch for Kids!” competition on April 30, 2019 at the University of Maryland, College Park. The finalists, all innovators in the orthopedic and spine sector, have a chance to win up to $50,000 in grant funding and access to the newly created NCC-PDI “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.

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Are you excited about the work you do in the biohealth industry? How did you get to where you are? Would you like to be connected to the newest career ready talent pool?

Join us for a Happy Hour with post docs from NCI and other NIH institutes who have expressed interest in transitioning to our exciting industry! Help them learn about your work and opportunities in the field. You may find one of your best future hires in the process!

These events are being cohosted by BioHealth Innovation, American Gene Technologies and SciPhD. The events are free but registration is required.

Postdoc Industry Connections Happy Hour

5/8 – 5-6:30 p.m. – American Gene Technologies

9640 Medical Center Dr Rockville, MD 20850

Register Now »

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Bio‑Rad welcomes you to attend the 3rd Annual Downstream Purification Symposium at Institute for Bioscience and Biotechnology Research. This event will include discussion of new developments in purification of biologics and key industry regulatory topics. Thursday, May 9, 2019

9:00 AM–5:00 PM

Location

Institute for Bioscience & Biotechnology Research

9600 Gudelsky Drive

Rockville, MD 20850

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Researchers at the Institute for Bioscience and Biotechnology Research (IBBR) recently received $3.5M from the National Institutes of Health (NIH) to advance understanding of the complex process by which the immune system produces highly specialized antibodies. The goal of the project is to design and test novel vaccine candidates that improve the protective antibody response against HIV-1. IBBR Fellow Dr. Yuxing Li (Associate Professor, Department of Microbiology and Immunology, University of Maryland School of Medicine) is principal investigator on the award.

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GSK announces that it will spend $100m to expand production capacity for components of Shingrix, amid a US market where demand outstrips supply of its shingles vaccine.

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Redox, a Madison, Wisconsin-based healthcare technology company that is transforming the way healthcare providers and software vendors share data, announced it has raised $33 million in Series C funding led by Battery Ventures. Also participating in this round is .406 Ventures, RRE Ventures, and Intermountain Ventures. In conjunction with this funding round, Battery general partner Chelsea Stoner is joining Redox’s board.

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A pioneering medical breakthrough that will help organ transplant recipients was announced by the University of Maryland Medical School.

Drone technology was developed by the University’s School of Medicine and Engineering to transport donor organs. The LG-1,000 is the first-ever organ delivery drone and weighs 50 lbs.

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Every two years leader of the life science industry gather from across the state to connect, celebrate, learn, inspire, imagine, and drive forward the development of R&D and commercialization in Virginia in focused ways.

On Thursday May 2, 2019 we expect over 400 attendees – leaders of bioscience companies big and small, research universities, policy makers, innovative health care systems, patient groups, CROs and professionals, and others from across Virginia and beyond to gather in Richmond for THRiVE 2019: Creating the future of bioscience in Virginia.

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MCEDC learns how Pat’s love for science drove her to found a company in Montgomery County, MD that delivers the cutting-edge buildings innovators need to make the world healthier.

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Most recently, the biotech executive helmed one of the fastest-growing public companies in Baltimore last year.

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An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings.

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Kite Pharma, a California-based biopharmaceutical company that develops innovative cancer immunotherapies, announced plans today to open a new biologics manufacturing facility in Frederick County that will produce innovative cell therapies for people with cancer. A Gilead company, Kite will open the new facility on a 20-acre site in the Urbana Corporate Center, with plans to create a significant number of job opportunities.

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The startup incubator Y Combinator plans to fund more early-stage drug makers, with a partnership designed to bring academic spinouts developing small-molecule drugs into its famed accelerator program. And in a Silicon Valley twist, the compounds it’s backing will often be recommended by an algorithm.

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Last week ended with another Friday night blitz of biotech S-1s as a fresh wave of new offerings forms to crash into Nasdaq. Entering the Wall Street spotlight now is one transatlantic operation that is out to develop a new class of meds, a Dallas biotech with a Phase III kidney cancer drug and a startup that in-licensed its lead drug from Novartis.

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Illumina has added four genomics startups to its accelerator program, marking its ninth funding round, the company said on Tuesday.

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