Today Stories

AMRA, the international leader in body composition analysis, and BioTelemetry Research (“BTR”), a leading global imaging and cardiac core lab, announced today the formation of an exclusive alliance for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) clinical trials. This first-to-market partnership will advance imaging science and benefit clinical trial sponsors in several musculoskeletal and metabolic therapeutic areas. In clinical studies, muscle and fat fractions have traditionally been measured by scanning individual organs such as the liver, or particular body regions such as the abdomen. Commonly, researchers would prefer to scan the entire body in order to learn exactly where study participants are losing or gaining muscle or fat mass. However, un…

Micro Interventional Devices, Inc.™ (MID) announced today the second successful implantation of its MIA (Minimally Invasive Annuloplasty) technology.  The patient was enrolled in the first arm of the STTAR (Study of Transcatheter Tricuspid Annular Repair) clinical trial studying the safety and efficacy of MID's MIA device designed to eliminate or greatly reduce tricuspid regurgitation.  This is the second patient enrolled in the surgical arm of the STTAR study utilizing a bicuspidization approach.  The procedure took less than 14 minutes.  The rapid, reproducible deployment of the MIA implant resulted in a 24% reduction in annular area and a reduction in tricuspid regurgitation from moderate regurgitation pre-procedure to trace regurgitation post-procedure.  As wi…

Cardax, Inc. (OTCQB:CDXI) announced today that it has entered into a mutual exclusivity agreement with General Nutrition Corporation ("GNC") for ZanthoSyn, the Company's premium astaxanthin dietary supplement for inflammatory health and longevity.* The exclusivity agreement builds on the Company's recently announced national rollout of ZanthoSyn across GNC's more than 3,200 US corporate stores and now designates GNC as the exclusive "brick-and-mortar" retailer of ZanthoSyn in the United States. ZanthoSyn will also continue to be available online at gnc.com, amazon.com, and zanthosyn.com. The exclusivity agreement covers the use of ZanthoSyn as a human dietary supplement, with an initial term of two years and provides for automatic renewals. The exclusivity obligation is subject to GNC c…

GIMDx, Inc. (hereinafter referred to as "GIMDx") announced today that it has concluded an exclusive OEM and International Distribution agreement for IncellDx, Inc. (hereinafter referred to as "IncellDx") single cell immune-oncology and oncology diagnostic products in China. GIMDx will supply its parent company, Guangzhou Improve Medical Instruments Co., Ltd. (hereinafter referred to as "Improve Medical"), with IncellDx component products which will be kitted and co-labeled for the Chinese IVD market. Products included in the agreement are IncellDx's proprietary single cell quantification of Programmed Death Ligand 1 (PD-L1) on tumor cells and immune cell subtypes, single cell HPV E6/E7 mRNA detection for cervical cytology, and the IncellPREP® tissue single cell suspension system for solid…

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that it has entered a collaboration with Seventh Sense Biosystems, Inc. (7SBio), a private medical device company developing TAP™, a novel, push-button, blood collection device to make blood testing more convenient and virtually painless. As part of its commitment to the collaboration, Ionis has made a strategic investment of $2 million in 7SBio as part of a Series C financing that will also include other investors. 7SBio aims to create a new standard for blood collection that increases patient compliance with blood testing by improving patients' experience with blood collection, leading to faster diagnoses and better outcomes. The U.S. Food and Drug Administration (FDA) recently approved TAP for the collection of blood by a healt…

Plasticell, the biotechnology company specialising in stem cell screening and cell therapy development, has entered into a collaboration with GSK to use its combinatorial stem cell screening technology, CombiCult®, to optimise the directed differentiation of induced pluripotent stem cells (iPSCs) to specific blood cell lineages for use by GSK in its therapeutic research. In the collaboration, Plasticell will use its CombiCult® technology to screen combinations of molecules provided by GSK to identify and optimise iPSC differentiation protocols. Plasticell’s proprietary technology will allow the simultaneous screening of multiple iPSC lines, facilitating the development of a robust protocol that is applicable across lines. Commenting on the collaboration, Plasticell’s founder and Executiv…

CASI Pharmaceuticals, Inc. (the "Company") (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced that it has entered into definitive agreements with certain institutional and accredited investors, including existing shareholders, to purchase approximately $23.8 million of securities in a registered direct offering.  CASI expects to receive net proceeds of approximately $23.3 million after deducting agent's fees and other offering expenses.  CASI has agreed to sell an aggregate of approximately 7,951,868 shares of its common stock and warrants to purchase shares of its common stock. …

Leadership at Jefferson and the Monell Center announced today the signing of a non-binding Letter of Intent (LOI) to move forward with discussions of merging the two organizations. The proposed merger would combine Monell, the world's leader in taste and smell research, with research operations at the new Jefferson (Philadelphia University + Thomas Jefferson University) and Jefferson Health to open new frontiers that will take transformative discoveries about the senses and translate them into clinical practice. "We will be able to go further than ever before to link the senses to health," said Stephen K. Klasko, MD, MBA, President and CEO of Thomas Jefferson University and Jefferson Health. "When you combine our clinical work with the entrepreneurial, academic environment of our Univers…

UPMC WorkPartners, a leading provider of integrated health and productivity solutions and part of UPMC Insurance Services Division, today announced the acquisition of HCMS Group, LLC (HCMS), a privately-held health information service company headquartered in Cheyenne, Wyo. For more than two decades, WorkPartners has partnered with employers nationwide to assist them in reducing health care costs and improving worker productivity. WorkPartners' expansive product portfolio includes tailored health management and wellness offerings, employee assistance programs, workers' compensation coverage, employee health services, short-term disability management, FMLA programs, and benefit administration services. The acquisition of HCMS will complement and further strengthen this portfolio. "We look…

CryoLife, Inc. ("CryoLife"; NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has entered into a definitive agreement to acquire JOTEC AG ("JOTEC").  JOTEC is a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair.  The combination of CryoLife and JOTEC will create a Company with a broad and highly competitive product portfolio focused on aortic surgery, and will position CryoLife to compete strongly in the important and growing endovascular surgical markets. Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife, said, "We believe this acquisition will enable CryoLife…

The MED Group, a Managed Health Care Associates, Inc. (MHA) company, is pleased to announce a strategic partnership with HealthCall® LLC, a medical communications company and the first provider of patented Automated Patient Response™ solutions. The MED Group is a leading group purchasing and member services organization serving the home medical equipment industry. The new strategic partnership with HealthCall addresses the most challenging post-acute care populations and the need for reduction of hospital readmissions. For MED members, this paves the way to support a broader section of chronic care management and capture hospital-to-home transitional care opportunities above and beyond today's equipment-centric HME space. To enable optimum care and reduce unnecessary hospital readmission…

Therapix Biosciences Ltd. (Nasdaq: TRPX) ("Therapix" or the "Company"), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced it has entered into an exclusive agreement with Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, for the formulation, development and clinical manufacturing of THX-TS01, a first-in-class, proprietary investigational drug candidate for the treatment of the symptoms of Tourette Syndrome. Pursuant to the agreement, Catalent will develop THX-TS01 in softgel form in support of Therapix's clinical development program and in accordance with current good manufacturing practice (cGMP).…

Mylan N.V. (NASDAQ, TASE: MYL) today announced that partner, Synthon, received marketing authorization approval in Europe for Glatiramer Acetate Injection 40 mg/mL, a therapeutically equivalent generic version of Teva's Copaxone® 40 mg/mL, indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. This approval complements last year's approval of Glatiramer Acetate Injection 20 mg/mL, which already is available in several European markets.  Granting of national marketing authorizations is expected to follow in the near future. Mylan CEO Heather Bresch commented, "We're pleased with the approval of Glatiramer Acetate Injection 40 mg/mL, and look forward to leading the marketing and selling of…

The program for the first assembly of the World Congress on Targeting Metabesity is now available at www.metabesity2017.com. Metabesity refers to the major public health challenges—cardiovascular disease, cancer, dementia, diabetes and the aging process itself—all of which share metabolic roots. These root metabolic disorders can be targeted to prevent—not just treat—these major diseases. This unique conference, featuring internationally-acclaimed experts and commentators, will be held 30-31 October 2017 in London. The Congress, co-chaired by endocrinologist and therapeutic development expert G. Alexander Fleming, M.D., Stanford University professor and therapeutic discoverer Lawrence Steinman, M.D. and UK healthcare think tank 2020health CEO Julia Manning, serves as a call to p…

Ergomed plc (AIM: ERGO) ("Ergomed" or the "Company"), is pleased to announce that, further to the Company's announcement on 28 September 2017, the acquisition of PSR Group BV ("PSR") has completed following the admission to trading on AIM of the 2,081,389 new ordinary shares of 1p each at 8.00 a.m. on 2 October 2017.   A total of 1,757,576 new ordinary shares in the Company of 1p each (the "Placing Shares") were placed at a price of 165p per Placing Share (the "Placing Price") with new and existing investors, raising proceeds of £2.9m (before expenses) to part-fund the acquisition of PSR. In addition, a further 323,813 new ordinary shares were issued at a price of 165p per share to PSR as initial share consideration (“Initial Consideration Shares”).   Following the Admission…

Ixaltis, the start-up specialized in developing treatments for urogenital disorders, and Xigen, a privately-owned biopharmaceutical company that specializes in the development of peptides for use against inflammation, have signed an option agreement for exclusive worldwide rights to one compound in urogenital diseases.   Following this agreement, Ixaltis will perform preclinical proof of concept (POC) for two of Xigen’s compounds - XG-102 and XG-104 - in animal models and human tissues. XG-102, an innovative JNK inhibitor, has been successfully tested in clinical trials for ocular diseases and is already licensed out for another promising indication. XG-104, a second JNK inhibitor, is an L/D-amino-acids peptide.   In the case of positive outcome in the POC program, the selected c…

Orexo AB (publ.) today announced that Orexo has signed an asset purchase agreement with Gesynta Pharma AB – a recently formed research company located in Stockholm, Sweden. Among the founders are highly reputed executives from the biotech industry and experienced researchers at the Karolinska Institute within the field of arachidonic acid pathways and inflammatory diseases. The lead candidate drug in the OX-MPI program, BI1029539, has been identified as a highly selective anti-inflammatory compound targeting microsomal prostaglandin E synthase (mPGES-1). Under the asset purchase agreement, Gesynta Pharma AB acquires the assets relating to the OX-MPI program and will progress the candidate drug into proof-of-concept clinical trials. Under the terms of the agreement Orexo will receive a tie…

The partnership will enable the automation of summary documents using Artificial Intelligence based software   Frankfurt, Germany, September 29th 2017: As at 14th September, 2017, the PharmaLex Group, a leading specialist provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance Services as well as Pharmacovigilance, has entered into collaboration with Kiana Systems, a leading provider of data science, machine learning and artificial intelligence based in Saarbrücken, Germany.                 The partnership will utilize the respective expertise of both companies to develop bespoke Artificial Intelligence based software that will ultimately automate the creation of summary…

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for Dupixent® (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.   Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.[i],[ii],[iii],[iv] Moderate-to-severe atopic dermatitis is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.[v],[vi] Itch is one of the most burdensome symptoms for patients and can be debilitating.7 In addition, people with moderate-to-severe atopic dermatitis experience impaire…

Amgen (NASDAQ: AMGN) and Simcere Pharmaceutical Group today announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology. Under the terms of the agreement, Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars. Simcere will be responsible for distribution and commercialization in China, while Amgen will have a limited right to co-promote the products. The biosimilars included in the agreement are a part of Amgen's existing biosimilars portfolio. "We are pleased to enter this strategic collaboration with Simcere as we continue to enhance patient access through broader adoption of mo…