We have released exciting new coverage of the stem cell industry. Check it out and let me know what you think?
2017 Marks the 1st Year That Regenerative Medicine Disrupted Healthcare
With two CAR-T approvals, as well as the first gene therapy and digital pill approvals in the U.S., 2017 saw a lot of FDA "firsts." The regenerative medicine industry first gained momentum when Novartis made history by winning FDA approval for its CAR-T cell therapy in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta). In November, the FDA approved Abilify MyCite as the world’s first “digital pill.” To conclude the year, the FDA approved Spark Therapeutics’ Luxturna, a novel gene therapy to treat patients with an inherited form of vision loss.
The Definitive Guide to Calculating Market Size
There are two primary approaches for calculating market size determinations: Bottom-Up versus Top-Down approaches. A bottom-up approach to market size determination seeks to add up all market participants. In comparison, a top-down analysis is a procedure in which a larger reference market is used and the percentage of that market that a company expects to capture is estimated. If you are investing in market research, then your research provider had better understand these 5 methods of market size determination and the advantages/disadvantages of each.
ArunA Biomedical announces the official launch of a new class of cell-free exosome biologics to treat central nervous system and neurodegenerative disorders. With an initial focus on an exosome therapeutic for stroke, the company published results of a study today in Translational Stroke Research that found extracellular vesicles (EVs) derived from human neural stem cells improved tissue and functional recovery in murine thromboembolic stroke models.
Exosome Manufacturing Escalates: $2.18M Grant Awarded to VivaZome TherapeuticsAustralian biotech company VivaZome Therapeutics has been awarded an Australian Government CRC-P grant of $2.18m in support of the project “Enabling Exosome Therapy: Developing an Advanced Manufacturing Process”, with the funds provided under the Advanced Manufacturing Scheme. The VivaZome CRC-P project work will commence in early 2018 with a series of significant scientific, industrial and education milestones to be achieved by end 2020.
CAR-T was the Star of 2017: Learn More about Its Future in 2018
Following a successful year of FDA approvals in both USA and Europe, along with Gilead’s recent acquisition of Cell Design Labs, as well as Celgene and bluebirdbio’s latest launch into the next phase of their BMCA-targeting study, 2018 will be a pivotal year for CAR-T. Join 25+ industry leaders on March 20-22, 2018 to learn more about the latest innovations in manufacturing, solid tumor targeting, and alternative CARs constructs at the CAR-T Congress USA.
GenCure opened the first phase of a new biomanufacturing center designed to facilitate large-scale stem cell manufacturing and support services required for cGMP-compliant production of biologics for use in human clinical trials and commercial manufacturing. It is one of only a handful of independent manufacturing facilities in the U.S. for human bone marrow-derived mesenchymal stromal cells (hMSCs), the most widely used type of stem cell in both research and clinical settings.
Research indicates that respecting our bodies’ natural circadian rhythms when we are younger may be an important factor in arresting the rate of stem cell aging. Studies show that a good night’s sleep has the ability to keep your stem cells younger for longer. What the findings show is that when our circadian rhythm is disrupted, it affects how well we sleep, as well as impacts our whole body – including the performance of our stem cells.
The Market for Stem Cell Exosomes
This 134-page global strategic report reveals trend rate data for exosome patents, grants, scientific publications, and clinical trials, as well as social analytics from Google Trends and Google Adwords. It explores the growing demand for exosome therapeutics, diagnostics, research tools, consumer care products, and manufacturing processes. It identifies the five market segments forming the industry, reveals the market player competing in each niche, presents market size determinations with 5-year projections, and identifies opportunities for commercializing exosome products.
In late 2014, Japan passed two new laws that revolutionized the commercialization of cell therapies within the country by providing an accelerated pathway for product approvals. These laws were the Act on the Safety of Regenerative Medicine (Law No. 85/2013) and the Pharmaceuticals and Medical Device (PMD) Act (Law No. 84/2013). These regulations allow companies to receive conditional marketing approval and commercialize regenerative medicine products while clinical trials continue through the later stages.
Complete 2017-18 Global Cord Blood Banking Industry Report
This 265-page global strategic report reveals key benchmarks to track and why you should care. Benchmarks are critical to assess, because the cord blood banking industry has matured substantially over the past few years, creating both serious threats and novel opportunities. Therefore, judging individual company performance relative to the broader cord blood marketplace has become substantially more complex. Cellular Dynamics International Sends iPSCs to International Space Station on NASA Resupply Mission
Cellular Dynamics International (CDI), a FUJIFILM company, announced that its iCell® Cardiomyocytes were launched into space via SpaceX’s 13th commercial resupply services mission to the International Space Station on Dec.15, 2017. The purpose of the scientific research project utilizing CDI’s iCell Cardiomyocytes in space is to validate the function of NASA’s new Bioculture System for automated cell culture on the International Space Station and to study human cardiac cell function in microgravity.
Global Regenerative Medicine Industry Database 2018 (Limited-Time for 50% Off)
This database features all 600+ regenerative medicine (RM) companies worldwide, including companies involved with cell and gene therapies, tissue engineering and biomaterials, 3D printing, exosomes, and more. It was originally developed in-house for our own purposes, but we agreed to make available a limited number of downloads per day. If the page is live when you get there, act fast because you can get it for 50% off if there is supply available.
Be Great,
Cade President/CEO of BioInformant.com "1st and Only Market Research Firm to Specialize in the Stem Cell Industry"
p.s. Do you have stem cell news to share? Hit reply to this email.
p.p.s. Will I see you at the co-located Cell and Gene Therapy World and World Stem Cell Summit at the end of this month? Reply "yes" if we should look out for you there. If you are not yet registered, use the code "BIO10" to get 10% off.
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