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BRAINBox Solutions today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's BRAINBox TBI (Traumatic Brain Injury) test in development, the first to aid in both the diagnosis and prognosis of mild TBI (concussion). The BRAINBox TBI test is a multi-modality, quantitative test that combines injury-related blood protein biomarkers with computerized neurological assessments.

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At the molecular level, we may not age gracefully; that is, we may not follow a continuous, linear downward slope. Instead, we may fall precipitously after we lose control of our exquisitely balanced anti-aging programs, sometime in our 50s. These findings, derived from a study of tissue-coding and noncoding RNA, may help explain why human disease burden increases so sharply from the sixth decade of life onward. They may also lead to therapies that enhance longevity, provided the natural termination of protective gene expression patterns does not indicate that they have outlived their usefulness.

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Whether you’re starting a business, relocating one, or just moving to live and work, there are endless reasons for why Maryland is the top state to relocate to. The BioHealth Capital Region continues to climb the GEN’s annual ranking of the nation’s top biopharma clusters, and was ranked fourth in 2018. There are many factors that make Maryland a great place to headquarter your BioHealth company. Biotech and life science companies are high-risk high expense ventures, and the location of your company is key to its success.

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Biotechnology venture capital firm Third Rock Ventures has raised $770m for its fifth fund, a sign that investor interest in funding early-stage science continues unabated despite volatile public markets.

The investment vehicle, the largest ever raised by Third Rock in its 12-year history, will support investments in 10 to 12 companies. The Boston-based firm's new fund came together quickly.

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For augmenting readability, The Research Insights has added a fresh market study, titled Vaccines Market to its flared database. The report has been put together in a chapter-wise arrangement, by separating required illustrations transversely. This report is an expedient tool to get responses to some of the queries that hold significance for the growth of the Vaccines Market during the forecast period. The evidence in the report was congregated from qualified organizations & dependable sources and was further authenticated by industry specialists for increased integrity

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The Biotechnology Innovation Organization (BIO) released “Transforming Ideas into Advances: Best Practices in State and Regional Bioscience Economic Development Initiatives” today at the 2019 BIO International Convention.

The fifth edition of the Best Practices Guide is the bioscience industry’s leading comprehensive analysis of state legislative and regulatory initiatives in support of economic development.

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Whether you have a medical device, diagnostic, health IT app, or therapeutic, if you have to obtain FDA approval to commercialize your product, you should attend this event! Learn about the obstacles, opportunities, draft guidances and new pathways you must consider when creating a regulatory strategy. In this ever-changing environment, the key to success is both transparency and a keen understanding of the options available for your regulatory pathway. 

June 19, 2019 6:00pm-8:30pm

Hood College, 401 Rosemont Avenue, Frederick, MD 21701

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Emergent BioSolutions Inc. (EBS) today announced approval by the U.S. Food and Drug Administration (FDA) of the Prior Approval Supplement (PAS) submitted by the company for its oral cholera vaccine, Vaxchora® (Cholera Vaccine, Live, Oral). The PAS supports the change in storage conditions of the vaccine from frozen to refrigerated at 2-8°C and the transfer of bulk drug substance manufacturing from Emergent’s product development facility in San Diego to its manufacturing facility in Bern, Switzerland. The PAS also covers changes in labeling regarding these developments. The company’s oral cholera vaccine is the only FDA-licensed vaccine for the prevention of cholera caused by Vibrio cholerae serogroup O1, a potentially serious intestinal disease.

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Catalyze and BioHealth Innovation announce transatlantic partnership.

Amsterdam and Rockville, Maryland — Catalyze and BioHealth Innovation, Inc. have entered an agreement to actively bridge the Life Sciences communities in the US and the EU. This transatlantic partnership will increase opportunities for translating biohealth discoveries to market through grant writing services, expanded technology commercialization and international soft-landing support. The two parties have a wide range of resources and knowledge which combined will better aid in delivering high-impact, customer-specific solutions.

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Dr. Andrew Lees, founder and Chief Scientific Officer of Fina Biosolutions, holds over 25 patents and is the author or co-author of more than 70 peer-reviewed papers. He holds a B.S. in Chemistry from Harvey Mudd College and a Ph.D. in Biophysics from The Johns Hopkins University. GlaxoSmithKline, the Serum Institute of India, the Chengdu Institute of Biological Products, and others all use conjugation chemistry (CDAP) developed by Dr. Lees in their S. pneumonia and meningococcal conjugate vaccines. He received the Johns Hopkins University Distinguished Alumni Award in 2019 for his efforts in making conjugate vaccines affordable for low-income countries.

Dr. Lees is also an associate professor at the University of Maryland School of Medicine’s Center for Vaccine Development, an affiliate at the University of Maryland Bioprocessing Scale-Up Facility, and an adjunct professor in the Department of Medicine at the Uniformed Services University. He teaches protein chromatography through the post-graduate level and is a frequent speaker on conjugation chemistry and biotech entrepreneurship. 

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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The great American political divide shows no sign of ending as the United States lurches toward the 2020 presidential election. However, one of the few areas where the parties have joined together in recent years has been where NIH funding is concerned.

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Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract award by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) valued at approximately $535 million over 10 years for the continued supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile (SNS) in support of smallpox preparedness.

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REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the first U.S. Food and Drug Administration (FDA) approval of a gene therapy that leverages REGENXBIO's proprietary NAV Technology Platform, Novartis AG's ZOLGENSMA® (onasemnogene abeparvovec-xioi; AVXS-101). ZOLGENSMA was approved by the FDA as a one-time infusion for pediatric patients with spinal muscular atrophy (SMA) who are less than two years of age.

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Today, the Biotechnology Innovation Organization (BIO) released the 2019 Emerging Therapeutic Company Trend Report, highlighting ten years (2009-2018) of biotechnology funding and deal making across five areas: venture capital, Initial Public Offerings (IPOs), follow-on public offerings, licensing, and acquisitions. The report also contains a 2019 snapshot of the industry’s clinical pipeline to highlight the significant contribution of emerging companies.

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For aspiring entrepreneurs, the thought of building a company from scratch can be daunting. What if no one wants to buy what you're selling? Where will the money come from to grow the business? And what will happen if you fail?

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June 12, 2019! 

Register now for the 3rd annual Technology Showcase! The 2019 Technology Showcase will again highlight technologies being developed at the NCI and Frederick National Laboratory for Cancer Research (FNLCR) to encourage technology licensing and collaborations, startup company formation and the translation of NCI discoveries into solutions to benefit patients.

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QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the immediate launch of its therascreen® PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis.

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Regenxbio (RGNX) announced that a gene therapy developed based on its technology was approved by the FDA. This gene therapy product is known as Zolgensma, which Novartis (NVS) now owns after acquiring AveXis for $8.7 billion back in 2018. While Novartis does own Zolgensma, it will have to pay royalties to Regenxbio on net sales for it. That means Regenxbio can start earning revenue for one of its very first products. The company is in good shape because it has many other gene therapy programs in its pipeline. The most notable one would be RGX-314, which is being developed to treat patients with wet age-related macular degeneration.