News Article | December 2, 2016
A Debate on the Future of Parenteral Drug Delivery and Combination Products London, United Kingdom, December 02, 2016 --( SMi Group will invite participants at the 9th annual Pre-Filled Syringes Europe show, which attracts over 100 senior PFS professionals, to join two topical debates led by some of the industries most experienced KOL's. Day 1 Panel Discussion: Combination Products - Challenges & Opportunities Moderated by Aphons Fakler, Group Head Risk Management, Novartis Speakers: Serkan Oray, Senior Director, Device & Technology, UCB David Ottolangui, Device Technology Director, GSK Ed Cahill, Senior Director, Technical & Scientific Affairs - Sterile Products, Teva The in-depth discussion on combination products will delve further into manufacturing, regulations and patient interaction to promote safety and adherence to products. Day 2 Panel Discussion: The Future of Parenteral Drug Delivery. Moving from Drug Delivery Devices to Therapy Management Ecosystems Moderated by Aphons Fakler, Group Head Risk Management, Novartis Speaker: Ignace Wallaert, Principle Scientist Packaging Development, Janssen Attendees will discuss new windows of opportunity in injectable technology as well as best practise in switching to needle-free delivery systems. The debate will allow participants to share their experiences in overcoming industry obstacles and will explore pens versus pumps. The panel debates will follow a day of keynote presentations from an array of senior PFS industry leaders from big pharma, government bodies and top manufacturers including MHRA, Behringher Ingelheim, GSK, Sanofi, Nipro PharmaPackaging, F.Hoffman Roche, Glenmark Pharmaceuticals, Medical Device Usability, Sandoz, Terumo Pharmaceutical Solutions, and Novartis. Further information including a full speaker line-up and conference agenda is available online at www.pre-filled-syringes.com Pre-Filled Syringes Europe 2017 9th Annual Conference: 18th & 19th Jan | Interactive Workshops: 17th Jan Copthorne Tara Hotel, Kensington, London UK www.pre-filled-syringes.com Follow the conversation on LinkedIn and Twitter at #pfssmi Sponsored by: Datwyler, Früh Verpackungstechnik Ag, Medical Device Usability, Mitsubishi Gas Chemical, Owen Mumford, Mikron Automation, Nemera, Nipro Pharmapackaging, Terumo Pharmaceutical Solutions, West Pharmaceutical Services, Worrell, Zeon Contact Information: For all media enquiries contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email: firstname.lastname@example.org To register for the conference, visit www.pre-filled-syringes.com or contact Fateja Begum on Tel: +44 (0)20 7827 6184 / Email: email@example.com To sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: firstname.lastname@example.org About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, December 02, 2016 --( PR.com )-- What path is the industry following on the road to patient centric drug delivery? What technical challenges present obstacles in developing and manufacturing combination products? Are market leaders taking advantage of new opportunities in wearable injector technology? How is safety incorporated in the design of a syringe?SMi Group will invite participants at the 9th annual Pre-Filled Syringes Europe show, which attracts over 100 senior PFS professionals, to join two topical debates led by some of the industries most experienced KOL's.Day 1 Panel Discussion: Combination Products - Challenges & OpportunitiesModerated by Aphons Fakler, Group Head Risk Management, NovartisSpeakers:Serkan Oray, Senior Director, Device & Technology, UCBDavid Ottolangui, Device Technology Director, GSKEd Cahill, Senior Director, Technical & Scientific Affairs - Sterile Products, TevaThe in-depth discussion on combination products will delve further into manufacturing, regulations and patient interaction to promote safety and adherence to products.Day 2 Panel Discussion: The Future of Parenteral Drug Delivery. Moving from Drug Delivery Devices to Therapy Management EcosystemsModerated by Aphons Fakler, Group Head Risk Management, NovartisSpeaker:Ignace Wallaert, Principle Scientist Packaging Development, JanssenAttendees will discuss new windows of opportunity in injectable technology as well as best practise in switching to needle-free delivery systems. The debate will allow participants to share their experiences in overcoming industry obstacles and will explore pens versus pumps.The panel debates will follow a day of keynote presentations from an array of senior PFS industry leaders from big pharma, government bodies and top manufacturers including MHRA, Behringher Ingelheim, GSK, Sanofi, Nipro PharmaPackaging, F.Hoffman Roche, Glenmark Pharmaceuticals, Medical Device Usability, Sandoz, Terumo Pharmaceutical Solutions, and Novartis.Further information including a full speaker line-up and conference agenda is available online at www.pre-filled-syringes.comPre-Filled Syringes Europe 20179th Annual Conference: 18th & 19th Jan | Interactive Workshops: 17th JanCopthorne Tara Hotel, Kensington, London UKwww.pre-filled-syringes.comFollow the conversation on LinkedIn and Twitter at #pfssmiSponsored by: Datwyler, Früh Verpackungstechnik Ag, Medical Device Usability, Mitsubishi Gas Chemical, Owen Mumford, Mikron Automation, Nemera, Nipro Pharmapackaging, Terumo Pharmaceutical Solutions, West Pharmaceutical Services, Worrell, ZeonContact Information:For all media enquiries contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email: email@example.comTo register for the conference, visit www.pre-filled-syringes.com or contact Fateja Begum on Tel: +44 (0)20 7827 6184 / Email: firstname.lastname@example.orgTo sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: email@example.comAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group
News Article | November 8, 2016
Catalent Pharma Solutions (Booth 901), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced it will host and present multiple industry-centric discussions, present scientific papers, and exhibit at the forthcoming 2016 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition, which runs from Nov. 13 -17, at the Colorado Convention Center, Denver, Colo. Catalent will also be showcasing its award-winning OptiForm® Solution Suite platform, designed to match the best, most innovative, drug delivery technologies to each developmental molecule, with the goal of providing optimal candidate formulations for animal PK studies in twelve weeks. This year, the technology been expanded to include macromolecules, and the identification of suitable non-invasive methods of drug delivery for biologically derived drug products. On Monday, Nov. 14 at 9 a.m., Dr. Cornell Stamoran, Catalent’s Vice President of Strategy and Corporate Development, will chair "New Technologies and Techniques to Accelerate Early Development and Reduce Risk," a half day seminar with participants including Dr. Keith Horspool, Vice President of Development, Boehringer Ingelheim, Dr. Shaukat Ali, Technical Support Manager, BASF Corporation and Debra Bingham, Partner, Valeo Partners. Additionally, on Wednesday, Nov. 16, at 10 a.m., Dr. Ronak Savla, Catalent’s Scientific Affairs Manager, will take part in the debate, "Let’s (Not) Take a Stab at This: Non-invasive Macromolecule Delivery." Throughout the show, Catalent will be hosting a number of "TECH Talks" at its in-booth Discovery Zone. These are short-format educational talks on subjects ranging from drug discovery through to development. Catalent will also present 24 scientific posters at the AAPS meeting on a broad spectrum of topics, including use of lipid-based formulations, processing of sustained release formulations using a twin-screw extrusion process, in situ solubility screening via fiber optic assay: comparison with high-performance liquid chromatography, parallel screening approaches for the non-invasive delivery of macromolecules, and applying six sigma to analytical tech transfers. A full list of poster topics and presentation times can be found at http://www.catalent.com/index.php/news-events/events/AAPS-2016. To arrange a meeting with any of the Catalent team at AAPS, please contact Richard Kerns at NEPR- richard(at)nepr.eu. About Catalent Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 9,500 people, including over 1,400 scientists, more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
News Article | February 27, 2017
TUCSON, Ariz., Feb. 27, 2017 /PRNewswire/ -- More than 500 pathologists, oncologists, scientific researchers and healthcare leaders will converge in Tucson for the 13th annual Tucson Symposium, February 28 to March 1. The two-day conference, which is sponsored by Ventana Medical Systems, Inc., a member of the Roche Group, draws top scientific collaborators from around the globe to hear from leading experts about the latest hypotheses, breakthroughs and innovations in cancer research and treatments. Topics will focus on developments in immunotherapy, genomics, technology, tumor heterogeneity and cancer evolution and personalized healthcare. Tucson Symposium was conceived in 2005 by Ventana Medical Systems, Inc. Founder and Senior Vice President of Scientific Affairs Dr. Thomas Grogan to provide a forum for thought leaders to share scientific advancements in cancer research and medical practice. "We are extremely pleased to announce that our distinguished opening keynote speaker this year is Dr. Antoni Ribas, a leading oncologist who will speak to advances in revolutionary new immune blockade therapy," Grogan said. Ribas, who is a Professor of Medicine, Professor of Surgery and Professor of Molecular and Medical Pharmacology at the University of California at Los Angeles (UCLA), will deliver information on the unprecedented response to this new therapy in patients with multiple metastatic cancers as well as combination approaches to improving treatment options. Charles Swanton, PhD, of London's Francis Crick Institute – a leading expert on heterogeneity and cancer's drug resistant and incurable nature – will return to the Symposium for a third year to deliver the Day 2 keynote address on our expanding knowledge of tumor genetic heterogeneity. Other sessions stretch beyond the traditional bounds of pathology to include discussions on genomics and innovative technologies that are transforming the field, including novel, emerging multiplexing technologies. "Having hosted the Tucson Symposium for 13 years, we've reached a pinnacle in terms of the experts delivering content on a broad range of cancer-related topics," said Dr. Eric Walk, a pathologist who is Senior Vice President, Medical and Scientific Affairs, and Chief Medical Officer at Ventana Medical Systems, Inc. "They are imparting the most current, critical knowledge that will enrich and advance the field of medicine and scientific research." For more information on Tucson Symposium, held at the Hilton Tucson El Conquistador, please visit www.ventana.com/tucson-symposium/. About Ventana Medical Systems, Inc. Ventana Medical Systems, Inc. (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA products are used in clinical histology and drug development research laboratories worldwide. The company's intuitive, integrated staining, workflow management platforms and digital pathology solutions optimize laboratory efficiencies to help reduce errors, support diagnosis and enable informed treatment decisions by anatomic pathology professionals. Together with Roche, Ventana is driving Personalized Healthcare through accelerated drug discovery and the development of companion diagnostics to identify the patients most likely to respond favorably to specific therapies. Visit www.ventana.com. All trademarks used or mentioned in this release are protected by law.
News Article | November 14, 2016
BOSTON, Nov. 14, 2016 /PRNewswire/ -- BERG, a biopharmaceutical company uncovering health solutions through a data-driven, biological research approach, today unveiled data from a recent study that clarified the role of a genetic mutation in the LRRK2 gene, which represents a major risk factor for both sporadic and familial Parkinson's disease (PD), at the Society for Neuroscience's Neuroscience 2016 meeting. The study utilized BERG's Interrogative Biology ® platform with the aim to understand the mechanism behind LRRK2-driven PD, and the resulting analysis identified p53-inducible gene 3 (PIG3) as a novel regulator of cell death in Parkinson's disease. The discovery may serve as a novel drug target for development of new therapeutics for PD. Through BERG's Interrogative Biology® platform, the study analyzed data points of skin cells from PD patients obtained from BERG's partner The Parkinson's Institute to understand the neurological disorder. This study also showcased the predictive power of Interrogative Biology® as a discovery tool for mining fundamental biology from peripheral cells to better understand inherent molecular drivers of neurodegenerative disease. "We're excited to continue to push the boundaries of what's possible with the Interrogative Biology® system," said BERG CEO, co-founder and president Niven R. Narain. "The Interrogative Biology® system is able to fill the knowledge gap through seemingly unrelated patient biology – as in this instance, where we used skin cells to discover key insights about a neurological disorder. In addition, unraveling novel biology into the CNS disease space where the basic understanding of diseases like PD is not fully elucidated offers the field insight that may lead to developing disease modifying drugs." The BERG Interrogative Biology® platform maps patient disease states by interrogating both the healthy and diseased states of the patient biology and data to uncover a network of causal relationships between historical, molecular and other data types and patient outcomes. BERG will further explore mechanisms associated with LRRK2 and PIG3, and develop additional uses for the Interrogative Biology ® platform to understand the mysteries associated with Parkinson's disease, and other neurodegenerative diseases, to develop safe and effective treatment pathways. "I am very encouraged by the progress of the BERG Interrogative Biology® system as not only did it identify PIG3 as a novel contributor to cell death in PD patients, it also uncovered that a LRRK2 mutation leads to a core abnormality in GBA-related pathways," stated Eric Nestler, MD, PhD, Dean for Academic and Scientific Affairs, Nash Family Professor of Neuroscience and Director of the Friedman Brain Institute at the Icahn School of Medicine at Mount Sinai. More information on BERG's session 287.09 - Interrogative Biology®identifies p53-inducible gene 3 (PIG3) as a potential contributor to LRRK2-mediated neuronal cell death in Parkinson's Disease: http://www.abstractsonline.com/pp8/index.html#!/4071/presentation/32939 About BERG BERG is a clinical-stage company disrupting and re-defining the approach to drug discovery, research and development through its Interrogative Biology® platform. Its platform identifies therapies and biomarkers by applying algorithm- and probability-based artificial intelligence to analyze large numbers of patients' genotypic, phenotypic and other characteristics. BERG's platform operates at the intersection of biology, technology and artificial intelligence analytics and integrates many data characteristics regarding patients' lifestyles, demographics and biology. BERG believes this allows the company to better understand patients' disease profiles and consequently to identify and reveal molecular signatures to guide and accelerate product candidate selection and development. By identifying biomarkers and patient characteristics that are unique to the disease state, BERG is able to identify novel therapeutic product candidates and develop companion diagnostics to enhance specificity in its drug development process. BERG has leveraged its Interrogative Biology® platform to develop a robust pipeline of therapeutic product candidates and diagnostics in cancer, diabetes and neurology. Its lead drug, BPM-31510 (IV), has the potential to slow or reverse cancer cell growth by changing a hypothesized fundamental driver of many different types of cancer. BERG has initiated a Phase II clinical trial for BPM-31510 (IV) in advanced pancreatic cancer in combination with a common cancer drug, among other ongoing and planned trials for BPM-31510 (IV) in various oncological indications.
News Article | December 15, 2016
Kyowa Hakko U.S.A., Inc, and Pure Encapsulations today announced the launch of the new Pure Encapsulations Nrf2 Detox product, formulated with Setria® Glutathione, to target Nrf2 (nuclear factor erythroid 2-related factor 2), a transcription factor that acts as a genomic “switch” and master inducer of more than 1,000 genes throughout the body, helping to protect against toxins, reactive metabolites, reactive oxygen species and environmental xenobiotics.* Nrf2 Detox includes resveratrol and broccoli sprout concentrate, an ingredient that promotes Nrf2-mediated signaling. Nrf2 controls the expression of numerous genes responsible for detoxification and protection against oxidative stress. Add in Setria® – a form of L-glutathione, called nature’s “master antioxidant” – and Nrf2 Detox becomes a daily supplement that helps protect cells and support the body’s natural detoxification processes.* Setria® is a well-studied form of L-glutathione that can help increase the body’s glutathione blood levels. It provides intracellular antioxidant support, benefits cellular detoxification, and supports a healthy immune response. Glutathione helps protect the body’s cells from the effects of oxidative stress and toxins. Setria® Glutathione is made through a patented fermentation process and is patent-pending for increasing natural killer (NK) cell activity. It is pure, vegetarian, and allergen-free.* “The combination of broccoli sprout concentrate and Setria® allows the body to fight the constant attacks of oxidative stress caused by things we come in contact with every day,” said Kelly Heim, Ph.D., Senior Director of Scientific Affairs at Pure Encapsulations. “The strong scientific support of Setria® as an antioxidant made it the best choice for Nrf2 Detox.” For more information about Nrf2 Detox, visit http://www.pureencapsulations.com/nrf2-detox.html About Setria® Glutathione Setria® Glutathione, manufactured by Kyowa Hakko Bio Co., Ltd., is a clinically studied and patented form of glutathione that, when taken orally, has been shown to replenish the body's reserves, which may be depleted as a result of lifestyle choices, stress or natural aging. Called the "master antioxidant," glutathione helps protect cells in the body from the effects of oxidative stress and toxins. Setria® Glutathione is manufactured through a patented fermentation process to yield high purity and high quality, and is both vegetarian and allergen-free. For more information about Setria® Glutathione, visit http://www.SetriaGlutathione.com. About Kyowa Hakko USA Kyowa Hakko USA is the North & South American office for Kyowa Hakko Bio Co. Ltd., an international health ingredients manufacturer and world leader in the development, manufacturing and marketing of pharmaceuticals, nutraceuticals and food products. Kyowa is the maker of branded ingredients including Cognizin® Citicoline, Lumistor® L-Hydroxyproline, Pantesin® Pantethine, Setria® Glutathione, as well as Sustamine® L-Alanyl-L-Glutamine. For more information, visit http://www.kyowa-usa.com. About Pure Encapsulations A business unit of Atrium Innovations Inc., Pure Encapsulations is committed to producing the most complete line of research-based nutritional supplements. Available through health professionals, finished products are pure and hypoallergenic to optimize the long-term health of all patients, even the most sensitive. Through research, education, strategic partnerships and science-driven formulations, Pure Encapsulations is dedicated to helping practitioners make the best clinical decisions for every patient, every time. Pure Encapsulations is an industry leader in quality assurance, with an extensive raw material and finished product testing program that includes analysis for identity, potency, environmental contaminants, oxidation and more by certified third-party laboratories. Pure Encapsulations is NSF-GMP registered in the U.S., GMP certified in Canada and exceeds the ¬¬¬¬¬standards of the United States Pharmacopeia (USP) for supplement manufacturing. For additional information, please visit PureEncapsulations.com. *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
News Article | December 19, 2016
John Maslowski Succeeds David Pernock as Chief Executive Officer; Douglas Swirsky Appointed Chairman of the Board of Directors EXTON, Pa., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Fibrocell Science, Inc. (NASDAQ:FCSC) today announced that John Maslowski has been appointed Chief Executive Officer (CEO) and Douglas Swirsky has been appointed Chairman of the Company’s Board of Directors, succeeding David Pernock effective immediately. In addition, Mr. Maslowski has been appointed to the Company’s Board. “During 2016, Fibrocell has completely transitioned to a clinical-stage gene therapy company and we are confident that under John’s leadership its significant momentum will continue. We look forward to fulfilling the promise of our proprietary fibroblast platform for patients suffering from rare, devastating genetic diseases of the skin and connective tissue,” said Mr. Swirsky. “We appreciate David’s contributions to Fibrocell and wish him well as he pursues new business opportunities.” Mr. Maslowski joined Fibrocell in 2005 and most recently served as the Company’s Senior Vice President of Scientific Affairs with oversight of research and development, clinical and regulatory affairs. Previously, he was Vice President of Operations with responsibility for manufacturing and quality operations. Prior to joining Fibrocell, he held various positions at Wyeth Pharmaceuticals, Inc., Merck & Co., Inc. and Teva Pharmaceutical Industries Ltd. Mr. Maslowski earned a B.S. in Biology from Ursinus College and an M.S. in Biology from Villanova University. “I am honored to be appointed CEO of Fibrocell and have the opportunity to lead our dedicated team as we move into 2017 and beyond,” said Mr. Maslowski. “Our pipeline consists of therapies with transformative potential that target the underlying cause of disease and I look forward to working with our team, Doug and the Board as we advance FCX-007, our clinical-stage candidate for the treatment of recessive dystrophic epidermolysis bullosa, and our other cell-based gene therapy programs.” FCX-007 is Fibrocell's clinical-stage, gene-therapy product candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a congenital and progressive orphan skin disease caused by the deficiency of the protein type VII collagen (COL7). FCX-007 is a genetically-modified autologous fibroblast that encodes the gene for COL7 and is being developed in collaboration with Intrexon Corporation (Intrexon). By genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection, FCX-007 offers the potential to address the underlying cause of the disease by providing high levels of COL7 directly to the affected areas while avoiding systemic distribution. To learn more about the FCX-007 Phase I/II clinical trial, please visit www.clinicaltrials.gov and search the identifier NCT02810951. FCX-013 is Fibrocell’s gene-therapy product candidate for the treatment of linear scleroderma, a chronic autoimmune disease characterized by thickening of the skin and connective tissue that can be debilitating and painful. FCX-013 is an autologous fibroblast cell genetically modified to express a protein to breakdown excess type I collagen and type III collagen at the site of the localized disease and is also being developed in collaboration with Intrexon. FCX-013 incorporates Intrexon’s proprietary RheoSwitch Therapeutic System®, a biologic switch activated by an orally administered compound which allows control of future protein expression once the initial fibrosis has been resolved. FCX-013 is currently in pre-clinical development for the treatment of linear scleroderma, a form of localized scleroderma. Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin and connective tissue. Fibrocell’s most advanced product candidate, FCX-007, has begun a Phase I/II trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its product candidate for the treatment of linear scleroderma. In addition, Fibrocell has a third program in the research phase for the treatment of arthritis and related conditions. Fibrocell’s gene-therapy portfolio is being developed in collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology. For more information, visit www.fibrocell.com or follow us on Twitter at @Fibrocell. Fibrocell, the Fibrocell logo, Fibrocell Science and LAVIV® are trademarks of Fibrocell Science, Inc. and/or its affiliates. All other names may be trademarks of their respective owners. Forward-Looking Statements This press release contains, and our officers and representatives may from time to time make, statements that are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential advantages of FCX-007 and Fibrocell’s other product candidates; Fibrocell’s expectation to dose the first subject in the Phase I portion of its FCX-007 trial at the end of the year; and other statements regarding Fibrocell’s future operations, financial performance and financial position, prospects, strategies, objectives and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated herein including, among others: whether pre-clinical and clinical trial results will validate and support the safety and efficacy of Fibrocell’s product candidates; and the risks, uncertainties and other factors discussed under the caption “Item 1A. Risk Factors” in Fibrocell’s most recent Form 10-K filing and Form 10-Q filings. As a result, you are cautioned not to place undue reliance on any forward-looking statements. While Fibrocell may update certain forward-looking statements from time to time, Fibrocell specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise.
News Article | December 14, 2016
GUANGZHOU, China--(BUSINESS WIRE)--Mannatech®, Incorporated (NASDAQ: MTEX), a global health and wellness company committed to transforming lives to make a better world, announced its cross-border e-commerce launch in China, bringing 15 new products, including its Ambrotose powders, to the Asia market. Mannatech’s innovative Glyconutritional Ambrotose supplement powders have been clinically shown to provide cognitive support, including improved focus, attention and memory for adults, which are key factors to success at school and at work. According to clinical research funded by Mannatech, randomized, double-blind, placebo-controlled human clinical trials conducted by independent researchers and published in peer reviewed journals have shown that Ambrotose powders can improve memory and positively impact brainwaves associated with attention in young adults and improve memory and reduce cognitive fatigue in middle-aged adults. The positive impact from Ambrotose helps support student achievement as well as adults working long hours who need to stay focused. Clinical studies have also found that Ambrotose powder provides perceived beneficial changes in well-being and supports the immune system. Ambrotose powder is made with aloe vera gel including Manapol® powder, a unique Glyconutrient ingredient exclusive to Mannatech. Manapol is extracted from fresh, washed and filtered aloe gel through a proprietary extraction method that yields the highest potency possible. “This is an exciting new product offering for young adults and families in China,” said Dr. Rolando L. Maddela, MHP, CCRP, Mannatech’s Senior Director of Clinical Research and Scientific Affairs. “Improved focus, attention and memory are important components of healthy cognitive function, and Mannatech’s Ambrotose products can offer a positive addition to their regular health and wellness regimen. Specifically, Ambrotose can support those seeking a way to have an edge at their job or in school.” Dr. Maddela suggests that four grams per day of Advanced Ambrotose® powder or Ambrotose Complex powder can help support some of the factors that contribute to improved cognitive function. Mannatech is the pioneer in developing Glyconutritional technology, which includes Ambrotose powders. Some of Mannatech’s core products are supported by industry-standard clinical studies, including 17 human clinical trials that have been published, 12 of which were double-blind, placebo-controlled studies — the gold standard for product validation. Mannatech’s nutritional technology has 123 patents in global markets, helping ensure Mannatech’s high standards are maintained throughout the world. Additionally, Mannatech products maintain the highest possible standards with many of the Ambrotose products certified for quality by NSF International. Advanced Ambrotose and Ambrotose Complex powders have been clinically shown to improve cognitive function and support the body’s immune system. From Mannatech’s e-commerce site in China, shoppers can now purchase these products directly from the website and refer friends and family to shop. Please visit www.MeiTaiChina.com for details. Mannatech, Incorporated, offers a profound wellness experience that makes a difference in the lives of people across the world. Through its innovative Glyconutrition products, Mannatech changes lives, providing an unprecedented level of natural wellness. With more than 20 years of experience and operations in more than 25 countries, Mannatech is committed to transforming lives. For more information, visit www.MeiTaiChina.com. Please note: This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by use of phrases or terminology such as “intend” or other similar words or the negative of such terminology. Similarly, descriptions of Mannatech’s objectives, strategies, plans, goals or targets contained herein are also considered forward-looking statements. Mannatech believes this release should be read in conjunction with all of its filings with the United States Securities and Exchange Commission and cautions its readers that these forward-looking statements are subject to certain events, risks, uncertainties and other factors. Some of these factors include, among others, Mannatech’s inability to attract and retain associates and members, increases in competition, litigation, regulatory changes and its planned growth into new international markets. Although Mannatech believes that the expectations, statements and assumptions reflected in these forward-looking statements are reasonable, it cautions readers to always consider all of the risk factors and any other cautionary statements carefully in evaluating each forward-looking statement in this release, as well as those set forth in its latest Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other filings filed with the United States Securities and Exchange Commission, including its current reports on Form 8-K. All of the forward-looking statements contained herein speak only as of the date of this release.
News Article | February 28, 2017
GUANGZHOU, China--(BUSINESS WIRE)--Mannatech®, Incorporated (NASDAQ: MTEX), a global health and wellness company committed to transforming lives to make a better world, offers the innovative nutritional supplement Ambrotose® which is clinically proven to provide cognitive support for young adult functions essential to reach their potential in the classroom. This is even more critical now as success in the upcoming Zhongkao and Gao Kao are essential for future academic advancement. According to human clinical trials published in peer reviewed journals, Ambrotose powders can positively impact brainwaves associated with attention in young adults and improve memory and alertness in middle-aged adults. The cognitive factors of focus, attention and memory are crucial for young adult students aiming for high academic achievement. “Clinical studies conducted by independent scientists who are experts in their fields have found that Ambrotose powder gives a helpful boost in memory, focus and attention as well as providing perceived beneficial changes in well-being,” said Dr. Rolando Maddela, MD, MPH, CCRP, Mannatech’s Director of Clinical Research and Scientific Affairs. “For young adults who are students, Ambrotose products can be a positive addition to a comprehensive approach to academic achievement. Ambrotose may also play an important role in the overall health and wellness of students, a factor that also contributes to academic success.” Dr. Maddela suggests that as little as four grams per day of Advanced Ambrotose® powder or capsules may help support some of the factors that contribute to success in the classroom. Mannatech is the pioneer in developing Glyconutritional technology, which includes Ambrotose powders. Ambrotose encourages cellular communication and is shown to support cognitive functions – including memory, focus and attention, as well as supporting the body’s immune and digestive systems to encourage overall health. Some of Mannatech’s Glyconutritional products are supported by industry-standard clinical studies, including 17 human clinical trials that have been published, 12 of which were double-blind, placebo-controlled studies — the gold standard for product validation. For more on Mannatech’s rigorous scientific research, please visit MannatechScience.org. Advanced Ambrotose is clinically tested to improve cognitive function and support the body’s immune system. For more information about Mannatech and its products, please visit www.MeiTaiChina.com.†^ Mannatech, Incorporated, offers a profound wellness experience that makes a difference in the lives of people across the world. Through its innovative Glyconutrition products, Mannatech changes lives, providing an unprecedented level of natural wellness, freedom and purpose. With more than 20 years of experience and operations in 26 markets, Mannatech is committed to transforming lives. For more information, visit MeiTaiChina.com. Please note: This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by use of phrases or terminology such as “intend” or other similar words or the negative of such terminology. Similarly, descriptions of Mannatech’s objectives, strategies, plans, goals or targets contained herein are also considered forward-looking statements. Mannatech believes this release should be read in conjunction with all of its filings with the United States Securities and Exchange Commission and cautions its readers that these forward-looking statements are subject to certain events, risks, uncertainties and other factors. Some of these factors include, among others, Mannatech’s inability to attract and retain associates and members, increases in competition, litigation, regulatory changes and its planned growth into new international markets. Although Mannatech believes that the expectations, statements and assumptions reflected in these forward-looking statements are reasonable, it cautions readers to always consider all of the risk factors and any other cautionary statements carefully in evaluating each forward-looking statement in this release, as well as those set forth in its latest Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other filings filed with the United States Securities and Exchange Commission, including its current reports on Form 8-K. All of the forward-looking statements contained herein speak only as of the date of this release. †Customers who invite other customers to the Mannatech China cross-border e-commerce site gain rewards for future product purchases or cash redemption. The e-commerce business model is not multi-level marketing or direct selling. ^Mannatech’s cross-border e-commerce model in China is a different opportunity from Mannatech’s MLM business in other markets. Our cross-border e-commerce model in China is not an MLM or direct selling business.
News Article | December 23, 2016
The Office of Special Counsel, an independent U.S. agency that protects whistleblowers and investigates prohibited practices that affect government employees, declined this week to further investigate a questionnaire sent from the Trump transition team to the Energy Department. The memo asked for the names of staffers who attended international climate change meetings or interagency meetings related to the economic consequences of climate change. In a letter to Sen. Richard Blumenthal (D-Conn.), Carolyn Lerner, the special counsel, noted that the Trump transition team had said the questionnaire “was not authorized” and that “transition officials are not considered federal employees” legally. “The Energy Department also stated it did not provide employee names to the President-elect’s transition officials, and no Department employee has reported a prohibited personnel action resulting from the questionnaire,” Lerner continued. However, Lerner also elaborated on the kinds of practices that will be prohibited once the Trump government (like any government) takes over, noting that “any effort to chill scientific research or discourse is inconsistent with the intent of the” 2012 Whistleblower Protection Enhancement Act. In early 2017, Lerner said, the office will “contact the incoming heads of all agencies and offer training on the whistleblower law, the Hatch Act, and the other laws enforced by OSC,” as part of a program to train and certify government employees and agencies for compliance with whistleblower laws. Lerner’s letter was provided by Blumenthal’s office. The Office of Special Counsel declined to comment for this story. Blumenthal, who sent the original letter requesting the investigation with eight Democratic Senate colleagues, said in an interview that “the special counsel is saying, we have no clear jurisdiction here because the transition team is not an official governmental entity, and employees for the transition team are not federal officials.” “But,” he continued, “the tone of the letter clearly is to take seriously the concerns we’ve raised, and in effect, sort of raise a warning, or an alarm, about this practice.” There the matter might have ended — for now — but Blumenthal also drew attention to reports in The Washington Post this week that at the State Department, transition team inquiries have focused on the funding of environmental organizations and programs devoted to “gender-related staffing, programming, and funding.” According to The Post’s reporting, the State Department’s Bureau of Oceans and International Environmental and Scientific Affairs was asked last week by the Trump transition team, “How much does the Department of State contribute annually to international environmental organizations in which the department participates?” According to another story in The Post, meanwhile, on Wednesday, the transition team sent a request to a range of State Department offices for information on programs that “promote gender equality, such as ending gender-based violence, promoting women’s participation in economic and political spheres, entrepreneurship, etc.” “They seem to be continuing the practice, of asking very pointed and loaded questions, seemingly as part of an agenda,” Blumenthal said. “And if they continue that, we’ll pursue it.”
News Article | November 15, 2016
First oral bivalent live vaccine for immunization of pigs against F4 and F18 Escherichia coli post-weaning diarrhea MONTREAL, QUEBEC--(Marketwired - Nov. 15, 2016) - Prevtec Microbia Inc. is pleased to announce that its German subsidiary, Prevtec Microbia GmbH, received a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA), recommending the granting of a marketing authorization for Coliprotec® F4/F18 in the European Union. Coliprotec® F4/F18 will be the first single dose oral vaccine intended for active immunization of pigs against enterotoxigenic F4- and F18-positive E. coli, a causative agent of post-weaning diarrhea (PWD), a major cause of economic loss for swine producers. Through preventative immunization, Coliprotec® F4/F18 contributes to the health of piglets by reducing the incidence of moderate to severe post-weaning diarrhea (PWD) and the fecal shedding of enterotoxigenic F4- and F18-positive Escherichia coli from infected pigs. "The adoption of the positive opinion by the CVMP represents an important milestone towards the registration of Coliprotec® F4/F18 in the European Union," says Michel Fortin, President and CEO of Prevtec Microbia Inc. "We believe our product will be very well received by veterinarians and swine producers in the European Union and will contribute to the responsible use of antibiotics for Escherichia coli control, enabling a shift towards more sustainable farming", added Dr. Éric Nadeau, Vice-President Scientific Affairs. Following the adoption of the market authorization by the European Commission, Coliprotec® F4/F18 will be distributed in the European Union giving access for European Veterinarians and Swine Producers to an innovative product to better prevent both F4 and F18 E. coli causing post-weaning diarrhea. A temporary use authorization for Coliprotec® F4/F18 was recently released by the French Agency for Veterinary Medicinal Products (ANMV). Coliprotec® F4/F18 has been developed by Prevtec Microbia. Prevtec Microbia is a Canadian biotechnology company developing biological products for the prevention of diseases in food animals and as an alternative to antibiotics. The Company's mission is to find better ways to feed the planet by developing technologies that improve animal health and increase animal production performance. Prevtec Microbia's first commercial product, Coliprotec®F4, a swine E. coli vaccine, has been sold across Canada since 2007. In March 2015, the European Commission granted a marketing authorization for for Coliprotec® F4 in the European Union. See more information at www.prevtecmicrobia.com.