MIAMI, Oct. 3, 2018 /PRNewswire/ —

Leading companies and regulatory agencies adopt LifeSphere Intake and Triage, the principal application of LSMV suite   

ArisGlobal, a leading life sciences technology provider, announced the launch of LifeSphere MultiVigilance – the next-generation platform for individual case safety report (ICSR) intake powered by LifeSphere Nava – ArisGlobal’s cognitive computing engine. LifeSphere MultiVigilance is developed on a completely new, cutting-edge technology architecture designed for the cloud with the latest robotic automation and cognitive computing technologies including natural language processing (NLP) and machine learning to transform all pharmacovigilance (PV) activities.

LifeSphere MultiVigilance is also the first and only unified platform fully integrated with product quality complaints and medical information management, delivering a new dimension on compliance with seamless exchange of safety cases between these critical functions.

ArisGlobal has been partnering with leading pharmaceutical companies and regulatory agencies to develop the new platform. Together, ArisGlobal and its strategic partners focused on identifying business critical problems within safety case processing, and then identified innovative ways to solve these problems. Each of the PV platform’s automation functions were extensively tested during the development process by ArisGlobal’s PV and IT experts, with additional PV expertise provided by its partners.

LifeSphere Intake and Triage will transform into a fully functional safety system by Q3 2019, which Boehringer Ingelheim, one of ArisGlobal’s strategic automation partners, will implement. The new PV platform will replace legacy ARISg, and migration of its multi-tenant customer base to the new platform will occur over the next 12-18 months.

“LifeSphere MultiVigilance is the only production ready, cognitive computing enabled, case intake platform available today that can integrate with any type of safety system. This platform not only simplifies safety case processing but also leads to significant cost savings for all marketing authorization holders. We believe this platform is a game-changer for the industry, as our customers will achieve cost savings greater than 30% with higher data quality and compliance,” said Sankesh Abbhi, President and CEO, ArisGlobal. “No other platform can deliver this type of performance.”

Boehringer Ingelheim has been working closely with ArisGlobal on LifeSphere MultiVigilance. “We are extremely excited and optimistic about the quality and productivity gains that this technology will provide,” said Claudia Lehmann, Head of PV Operations, Boehringer Ingelheim. “We have seen how the platform’s advanced robotic automation and cognitive features will allow us to automate many of our key PV steps in the area of case processing, which are currently resource intensive.”

Additional Information 

For more on LifeSphere Intake and Triage: https://www.arisglobal.com/products/lifesphere-intake-and-triage/.

About ArisGlobal 

ArisGlobal is a visionary technology company that’s transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. The ArisGlobal LifeSphere® cognitive technology platform integrates machine-learning capabilities to automate the core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.

CHRISTCHURCH, New Zealand, Oct. 3, 2018 /PRNewswire/ — ARANZ Medical now provides General Data Protection Regulation (GDPR) compliance with Microsoft’s Azure cloud hosting service, enabling the secure hosting of clinical trial data collected across multiple countries.

Data security and privacy has always been important for clinical trials, and now with the GDPR in place making sure that trial data collected across Europe meets these new rules is paramount.

Microsoft Azure is a GDPR compliant cloud computing service created by Microsoft for building, testing, deploying, and managing applications and services through a global network of Microsoft-managed data centers.

Bruce Davey, ARANZ Medical CEO says, “Being able to offer secure data hosting across countries with Microsoft Azure is a significant milestone for ARANZ Medical and Silhouette. Microsoft Azure also increases the capabilities of our clinical trial customers to monitor their systems and manage data in new and innovative ways.”

One of ARANZ Medical’s first European customers to benefit from the Microsoft Azure service is Promore Pharma AB who is running a Phase IIb clinical trial with the company’s product candidate LL-37 for treatment of venous leg ulcers. The trial will recruit 120 patients in Poland and Sweden.

ARANZ Medical has been a Microsoft Certified Development Partner for a number of years, utilizing a range of Microsoft development tools and support services, and now Microsoft Azure will enable growth for the company. Gabe Rijpma, Microsoft Senior Director Health Industry for Asia says, “I’m delighted to see ARANZ Medical taking this next step to build their presence in the EU after a long association with the company. Microsoft Azure will enable ARANZ Medical’s Silhouette solution to securely operate across multiple countries, which is often required for the kinds of specialized clinical trials that Silhouette is used for.”

ARANZ Medical’s Silhouette skin imaging and measuring solutions are a popular choice both for organizations undertaking clinical trials on skin and wound treatments and for clinical practice providers looking to improve their business and patient outcomes.  

About ARANZ Medical

ARANZ Medical Limited is a global medical device company focused on commercializing innovative, proprietary medical image-capture devices and recording, reporting and analysis software. The company’s systems are primarily used in the chronic wound market, and are well-suited to clinical trials and telemedicine applications. www.aranzmedical.com

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PASADENA, California, Oct. 3, 2018 /PRNewswire/ — iHerb announces the opening of the company’s fifth distribution center in early 2019.  iHerb’s fifth and newest distribution center is located in Easton, Pennsylvania and is the company’s fourth distribution center on the East Coast of the U.S.  In addition to the Pennsylvania distribution centers, additional locations include California, Kentucky, Illinois and a soon to be opened international center in South Korea.

Herb Announces the Opening of a Fifth Distribution Center

As iHerb continues to grow at a rapid pace, the company required a facility that could meet global customer demand. Easton, Pennsylvania is the ideal location to serve the East Coast of the U.S. as well as international customers serviced by the Air Cargo hub of New York.

“The Lehigh Valley – in particular, Easton – made perfect sense for iHerb’s next distribution and fulfillment location as we continue to expand our customer base rapidly,” said Mark Hoffman, Sr. Vice President of Operations. “This location will allow iHerb to reach a broad portion of the U.S. with fast delivery times and excellent customer experience, further demonstrating the continued importance of the Lehigh Valley area as one of the country’s top logistics hubs.”

The 242,200 square foot Easton facility will be equipped with the latest technology and systems optimized for health products to ensure thorough quality control.  The fully automated climate controlled distribution center will immediately hire 130 employees to open, with a potential employee population of over 300 as the business continues to grow.

“The Workforce Board Lehigh Valley and its premier workforce system called PA CareerLink® is pleased to be a strategic partner with iHerb in assisting with their current and ongoing hiring needs for a skilled and qualified talent pipeline. Another company adding flavor to the Lehigh Valley! Welcome, iHerb!”  – Nancy Dischinat, Executive Director of the Workforce Board Lehigh Valley.

iHerb has invested extensively in offering the best overall value in the world for over 30,000 quality brand name natural products, shipped directly from state of the art climate controlled facilities. The investment in Easton further demonstrates iHerb’s commitment to quality and customer experience.

About iHerb:  iHerb is one of the largest US-based e-commerce retailers offering 30,000 products from 1,200 top brands to millions of customers around the world. iHerb ships directly from GMP certified, state-of-the-art climate controlled warehouses to customers in over 150 countries. Since 1996, iHerb has continued to innovate in bringing the highest quality products, at the best possible value, delivered with the most convenient customer experience. https://www.iherb.com/.

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Veloce BioPharma’s VBP-926 (Povidone-Iodine) Demonstrates Statistically Significant and Clinically Significant Results in Phase 2b Study for Chemotherapy-Associated Paronychia

Positive clinical results provide basis for pivotal Phase 3 clinical trials

FORT LAUDERDALE, Fla., Oct. 3, 2018 /PRNewswire/ — Veloce BioPharma, LLC (“Veloce”), a clinical-stage biopharmaceutical company dedicated to developing topical therapeutics for unmet needs in dermatologic and ophthalmic diseases, today announced positive results of its Phase 2b study of dilute povidone-iodine in a novel DMSO solvent system for the topical treatment of chemotherapy-associated paronychia, or painful and inflamed nail units resulting as a side effect of chemotherapy.

The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability and efficacy of two strengths of VBP-926 (1% PVP-I, 2% PVP-I) vs. vehicle in 102 subjects with chemotherapy-associated paronychia.  Results from the study showed that VBP-926 (2%) met the primary efficacy endpoint of grade-improvement on the Paronychia Severity Grading Scale. Consistent with previously reported case series results, VBP-926 was well-tolerated at both doses and provided both morphological resolution and symptomatic relief in affected nails. 

“This trial clearly demonstrated the clinical benefit of VBP-926 2% solution,” said Dr. Kara Capriotti, MD, President and Director of Dermatology programs at Veloce.  “We are well positioned to move VBP-926 into Phase 3 development and continue advancing a product that targets an indication with no approved therapies. Addressing the pain and discomfort suffered by patients with chemotherapy-associated paronychia is an enormous unmet need and we are encouraged to be getting closer to a topical therapy that can solve this problem.”   

Phase 2b results showed that VBP-926 at the higher concentration met the primary efficacy endpoint.  The 2% dose reached statistical significance for nail grade improvement from baseline to the end of therapy for change in the Paronychia Severity Grading Scale (p=.0003). No treatment-related serious adverse events were reported.  Adverse events were mild in severity and reversible when treatment was discontinued.

Mario Lacouture, MD, Director, Oncodermatology Program at Memorial Sloan Kettering Cancer Center and Lead Investigator of the trial, commented, “Chemotherapy-associated paronychia is a frequent side effect of cancer treatments, and may impair quality of life and administration of anti-cancer treatments. This study is of interest, as it showed a significant reduction in paronychia score at the higher concentration of VBP-926 solution.” Dr. Lacouture’s research was funded by Veloce BioPharma.

About VBP-926

VBP-926 is a broad-spectrum, resistance-free biocidal topical solution that has the ability to eradicate all known microorganisms including bacteria, viruses, yeasts, molds, fungi and protozoa. 

About Chemotherapy-Associated Paronychia

Systemic chemotherapy employed for the treatment of a variety of common malignancies can induce painful nail changes associated with mixed polymicrobial infections in a subset of patients. Iatrogenic paronychia has been clearly associated with numerous classes of cancer chemotherapies.  Epidermal Growth Factor Receptor Inhibitors, taxanes, MEK inhibitors, mTOR inhibitors, anthracyclines and DNA/RNA synthesis inhibitors are known inciting drugs.  Nail changes associated with higher morbidity include periungual erythema, edema, exudate, suppurative onycholysis and periungual or subungual pyogenic granuloma. 

About Veloce BioPharma

Veloce BioPharma, LLC is a privately held clinical-stage pharmaceutical company focused on the development of topical therapeutics for unmet needs in dermatology and ophthalmology.

For more information, please contact:

Veloce BioPharma:

Kara Capriotti, MD
President, Veloce BioPharma LLC
kcapriotti@velocebiopharma.com

For Business Development Inquiries:

Triad Securities Corp.

Mark Palmer
Managing Director
mpalmer@triadsecurities.com

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BOSTON, Oct. 2, 2018 /PRNewswire/ — With the successful installation of the 100^th Mediso multi-modality preclinical PET system, the Tulane National Primate Research Center (TNPRC), division of the Tulane University, has become the fourth site in North America to install the MultiScan LFER150 PET/CT preclinical imager.

In keeping with the mission of the center, the MultiScan LFER150 PET/CT will help enable researchers to improve human and animal health by using non-invasive in-vivo imaging techniques to find better treatments for major infectious diseases. The MultiScan LFER 150 PET/CT is the only research-focused, large bore integrated PET/CT scanner supporting whole-body imaging of non-human primates (NHPs) and smaller animal models at sub-millimeter PET resolution. The system features the most versatile integrated PET/CT gantry ever built, enabling dynamic studies both in lying and sitting position, required for awake NHP studies. Due to its unique construction, CT and PET systems share the same field-of-view, eliminating the need for moving the subject during acquisition.

The LFER150 PET/CT will support TNPRC’s research program in infectious diseases, particularly in tuberculosis research focused on vaccine development, pathogenesis, and therapeutics.

“We have invested years to make the LFER150 PET/CT a dedicated and effective tool for imaging nonhuman primates for both PET and CT modalities. We are proud to be working with prestigious institutions like the TNPRC”, says Illes Muller, Managing Partner of Mediso USA. Like all preclinical PET/CT systems from Mediso, the LFER150 has been designed for quantitative assessment of PET and CT studies.

About Mediso USA, LLC 

Mediso USA distributes the preclinical imaging portfolio of Mediso in the U.S. and Canada and provides the application development and technical support for life science research. The company’s headquarters is located in Boston, Massachusetts. For more information, please visit http://www.medisousa.com.

About Mediso Ltd. 

Mediso Ltd. specializes in the field of nuclear and molecular imaging focused on the development, manufacturing, sales and servicing of multi-modality in-vivo imaging systems. It offers complete solutions from hardware design to quantification software, both for clinical patient care and high-level life science research. The nanoScan^® family is the first-line choice for preclinical imaging including the world’s first integrated preclinical PET/MRI, PET/CT, SPECT/CT and SPECT/MRI combinations.

Illes Muller, info@medisousa.com, +1-617-933-8771

SEOUL, South Korea, Oct. 2, 2018 /PRNewswire/ — The Korea Ginseng Association announced schedules of local Korean Ginseng festivals that will be held in many cities in Korea in October.

Seoul (Korean Ginseng Festival)

In Korea, 16 festivals celebrating the harvest season of Korean Ginseng are happening across the country, including Seoul, Gyeonggi, Gangwon, Chungcheong, Jeonbuk, and Gyeongbuk regions. The first event on the list is “The 1st Anseong World Organic Ginseng Summit” that is set to start on October 3.

These annual local Ginseng festivals provide an exciting opportunity to try out Korean Ginseng inspired recipes and foods, along with variety of programs and cultural events.

This year’s programs include harvesting Korean Ginseng, ginseng footbath, ginseng curling and many more that will surely entertain all ages and tastes.

During the festival period, locally produced Korean Ginseng will be available for sale at affordable prices as well.

Ginseng festivals has attracted many foreign tourists as well as Koreans, promoted Korean Ginseng by providing festive opportunities to demonstrate and experience the efficacy and superb quality of Korean Ginseng.

The Korea Ginseng Association’s chairman Ban-Sang-Bae said, “Korean Ginseng is already world-famous,” and added “I hope people from all around the world to become more familiar with Korean Ginseng, formerly known for its medicinal use, through tasting and experiencing Korean Ginseng at these festivals.

List of festivals starting in October in Korea:

• Seoul (Korean Ginseng Festival)
• Gyeonggi (Anseong World Organic Ginseng Summit, Anseong Ginseng Festival, Hwaseong Ginseng Festival, Icheon Ginseng Festival, Ganghwa Korean Ginseng Festival, Kimpo Ginseng Festival, Paju Kaesong Ginseng Festival, Kaesong Ginseng Festival)
• Gangwon-Do (Hongcheon Luxury Ginseng and Korean Beef festival)
• Chungcheong (Geumsan Insam Festival, Seosan Ginseng Farmers Market)
• Chungbuk (Eumseong Ginseng Festival, Jeungpyeong Ginseng Festival)
• Jeonbuk (Korean Red Ginseng Festival)
• Gyeongbuk (Gyengbuk Yeongju Punggi Ginseng Festival).

Detailed information and schedules for Korea’s Korean Ginseng festival can be obtained at the Korea Ginseng Association’s website (http://www.korean-ginseng.org).

Photo – https://photos.prnasia.com/prnh/20181002/2251642-1

New international report also shows almost 120 countries and territories now require graphic picture warnings on cigarette packages

TORONTO, Oct. 1, 2018 /PRNewswire/ — An international report released today by the Canadian Cancer Society (CCS) shows there is tremendous momentum worldwide for tobacco plain packaging. There are now 25 countries and territories moving forward with plain packaging, with 9 having adopted the measure and 16 working on it.

Canadian Cancer Society (National Office)

The number of countries requiring plain packaging is expected to accelerate further because of the World Trade Organization (WTO) decision on June 28, 2018 that Australia’s plain packaging requirements are consistent with WTO’s international trade agreements.

The CCS report, Cigarette Package Health Warnings: International Status Report, documents global progress on plain packaging, ranks 206 countries and territories on the size of their health warnings on cigarette packages and lists countries and territories that require graphic picture warnings.

The report found that 118 countries and territories now require picture health warnings on cigarette packages, an increase from 100 in 2016. This represents 58% of the world’s population. Canada was the first country to require picture health warnings in 2001.

“There is an unstoppable worldwide trend for countries to use graphic pictures on cigarette packages to show the deadly health effects of smoking and to require plain packaging,” says Rob Cunningham, senior policy analyst, Canadian Cancer Society. “Australia was the first country to implement plain packaging in 2012 and now the dominoes are falling.”

Guidelines under the international tobacco treaty, the WHO Framework Convention on Tobacco Control (FCTC), recommend that countries consider implementing plain packaging. Plain packaging includes health warnings on packages and prohibits tobacco company branding such as colours, logos and design elements. It also requires the brand name to be a standard font size, style and location on the package and the brand portion of each package to be the same colour such as an unattractive brown. Finally, the package format is standardized. Plain packaging regulations put an end to packaging being used for product promotion, increases the effectiveness of package warnings, curbs package deception and decreases tobacco use.

Plain packaging has been implemented in Australia (2012), France (2016), the United Kingdom (2016), Norway (2017), Ireland (2017), New Zealand (2018) and Hungary (2018). It will be implemented in Uruguay (2019) and Slovenia (2020) and is in process or under consideration in Canada, Belgium, Thailand, Georgia, Singapore, Nepal, Sri Lanka, South Africa, Romania, Jersey, Guernsey, Taiwan, Chile, Finland, Turkey and Saudi Arabia.

Cigarette package warnings are a highly cost-effective way to increase awareness of the negative health effects of smoking and to reduce tobacco use. Picture-based warnings convey a more powerful message than a text-only warning and the effectiveness of warnings is known to increase with size.

Guidelines under the FCTC recommend that warnings should:

• be as large as is achievable;
• include a rotated series of graphic pictures;
• be at the top of both the front and back of packages.

Picture warnings are especially valuable for low- and middle-income countries where there are higher rates of illiteracy and where governments may have few resources. Health departments determine the content of warnings and the tobacco industry is responsible for printing the warnings on packages. Examples of graphic picture warnings include a diseased lung or mouth, a patient with lung cancer in a hospital bed and a child being exposed to second-hand smoke.

“It is extremely positive for global public health that almost 120 countries and territories have implemented picture health warnings and that so many are moving toward plain packaging,” says Cunningham. “The international momentum poses a threat to tobacco industry sales worldwide and will save lives lost to cancer and other tobacco-related diseases.”

In total 107 countries and territories have required warnings to cover at least 50% of the package front and back (on average), up from 94 in 2016 and 24 in 2008. There are now 55 countries and territories with a size of at least 65% (on average) of the package front and back. The top countries ranked by warning size as an average of the front and back of the package are:

1.  92.5% East Timor (Timor-Leste) (85% of front, 100% of back)
2.  90% Nepal (90%, 90%)
2.  90% Vanuatu (90%, 90%)
4.  87.5% New Zealand (75%, 100%)
5.  85% Hong Kong (S.A.R., China) (85%, 85%)
5.  85% India (85%, 85%)
5.  85% Thailand (85%, 85%)
8.  82.5% Australia (75%, 90%)
9.  80% Sri Lanka (80%, 80%)
9.  80% Uruguay (80%, 80%)

In the 2016 report, Nepal and Vanuatu were top ranked at 90%.

The report was released today in Geneva, Switzerland, at the 8th session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control (FCTC) being held October 1-6. The report supports the implementation of the FCTC. The FCTC has an obligation for parties to require health warnings that “should be 50% or more of the principal display areas but shall be no less than 30% of the display areas” and may be in the form of, or include, picture warnings. There are now 181 countries that are parties to the FCTC.

This is the 6th Canadian Cancer Society international report on cigarette package health warnings. Previous reports were published in 2008, 2010, 2012, 2014 and 2016.

Cigarette Package Health Warnings report in English
Cigarette Package Health Warnings report in French

About the Canadian Cancer Society
The Canadian Cancer Society is a national community-based organization whose mission is the eradication of cancer and the enhancement of the quality of life of people living with cancer. When you want to know more about cancer, visit our website www.cancer.ca or call our toll-free, bilingual Cancer Information Service at 1 888 939-3333.

For further information: Rob Cunningham, Senior Policy Analyst, Canadian Cancer Society, Phone: +1-613-762-4624, Email: rcunning@cancer.ca; Rosie Hales, Communications Specialist, Canadian Cancer Society, Phone: +1-416-934-5338, Email: rosie.hales@cancer.ca

YONGIN, South Korea, Sept. 30, 2018 /PRNewswire/ — GC Pharma (formerly known as Green Cross) announced today it has received approval from the South Korean Ministry of Food and Drug Safety (MFDS) expanding the indication for GCFLU Quadrivalent™ (Seasonal Influenza Vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was approved for use in persons 3 years of age and older.

“The flu is a serious diseases with a significant impact on public health, “said Byung-Wha Kim GC Pharma Executive Vice President. “The expanded indication builds upon GC Pharma’s legacy as the first local manufacturer to bring quadrivalent flu vaccines to the South Korean marketplace.”

With this approval, provides are now able to use the GCFLU Quadrivalent™ to vaccinate all eligible persons from 6 months and older.

This expanded indication for the vaccine was based on Phase III clinical studies conducted in children 6 months through 35 months of age. 

GCFLU Quadrivalent™ was first approved in 2015 in South Korea for the prevention of influenza disease. It has also received prequalification status from the World Health Organization (WHO). 

About Seasonal Influenza

Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year worldwide. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalisations.

About GC Pharma

GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, GC Pharma is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand to GC Pharma in early 2018. Green Cross Corporation remains the company’s registered, legal name.

This release includes forward-looking statements, which express the current beliefs and expectations of GC Pharma’s management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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Source: Innovent Biologics, Inc.

Source: Innovent Biologics, Inc.