KFAR SABA, Israel, 9-Nov-2021 — /EPR HEALTHCARE NEWS/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing a partnership to help Medical Device startups get products to global markets faster.
Medical Device startups face unique pressures due to numerous country-specific regulations. This new partnership will help companies efficiently manage their regulatory approval processes, and enable rapid business growth.
Origami’s medical device customers operate around the world. With recent EU regulatory updates, companies are seeking strategic regulatory and business guidance to help them get and maintain product approval in that geography. The new partnership will provide Origami customers with access to citoQualis expertise in business and complex regulatory landscapes.
The citoQualis team points out that Medical Device startups have global workforces that “expect to access their systems from wherever they’re located, and to use those systems to collaborate internally and with citoQualis” says Mr. Wolfgang Werner, CEO of citoQualis.
According to Mr. Werner, “As advisors, it’s our job to identify opportunities and share our insights. For startups, the faster a product moves from idea to production, the better. With Origami’s flexibility, we are able to give our clients a software option that works for them now and as they scale.”
Germany and other EU countries have strong medical device startup ecosystems, which citoQualis is well connected to. Origami is excited to work with citoQualis and the startups they advise, noting how both companies focus their solutions and teams on helping customers succeed in complex environments.
Yaniv Shimony, CEO of Origami says “startup CEOs recognize Origami’s business value, in that they always have the solution their company needs. When you create a new and innovative medical device, using inflexible software point solutions slows your business down. With Origami, information is instantly available about any part of your business such as sales, quality, design, product approvals, manufacturing, equipment maintenance, purchasing, supplier compliance, invoicing, complaints and more.”
Existing customers will be able to maintain and expand EU market access by working with local regulatory experts, facilitating hundreds of millions of Euros of revenue.
SAARBRÜCKEN / VIENNA, 17-Feb-2021 — /EPR HEALTHCARE NEWS/ — In the fight against the SARS-CoV-2 virus, a large number of pharmaceutical companies are looking for new approaches to combat the pandemic. In addition to vaccines, intensive research and development efforts around the world are focusing on identifying new anti-COVID therapeutics that includes re-evaluation of existing product portfolios with a view to re-purpose drugs that have antiviral properties.
With this goal in mind, URSAPHARM Arzneimittel GmbH, based in Saarbrücken, and the Vienna-based biotech company CEBINA GmbH (Central European Biotech Incubator and Accelerator) are collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic. Azelastine has been successfully used for many years in anti-allergic therapy.
Starting with a novel computational drug repurposing prediction method, developed and performed by Prof Dr Robert Konrat (University of Vienna), CEBINA selected already approved active substances for experimental testing in collaboration with Prof Dr. Ferenc Jakab (Virology National Laboratory, Szentágothai-Research-Center, University of Pécs, Hungary). This collaborative effort led to the identification of azelastine as a potent antiviral compound effective against SARS-CoV-2, a finding confirmed by now by several independent research groups. The potent anti-SARS-CoV-2 activity of azelastine was demonstrated in a reconstituted human nasal tissue model and was evident at a lower dose than present in commercially available nasal sprays .
A clinical trial has started on February 16th 2021 to verify whether the use of a nasal spray preparation containing azelastine can achieve a reduction in viral load in the the nasal cavity. The aim of the study is to show whether the anti-allergic medication Pollival® Nasal Spray, or a diluted version, can achieve a reduction in the viral load, therefore reducing transmission and positively influencing the course of the disease.
If positive results of the running clinical studies are demonstrated, URSAPHARM Arzneimittel GmbH and CEBINA GmbH believe this will be an important new approach to control viral spread and contain the current pandemic.
New York, NY, 2021-Jan-20 — /EPR HEALTHCARE NEWS/ — New York digital agency Code18 Interactive gives two health and wellness brands—Balmex Complete Protection and Balmex AdultAdvantage—custom websites that will provide peace of mind and relief for everyone from baby to grandpa. Both sites are fully responsive and built on the WordPress platform.
Code18 Interactive, a boutique digital agency based in New York City, announces the launch of new health and wellness websites for Balmex Complete Protectin and Balmex AdultAdvantage. Both are fully custom and fully responsive WordPress websites – https://balmex.com helps elevate and refresh a legacy brand while providing helpful diaper rash solutions and peace of mind for new parents, and https://balmexadult.com showcases over-the-counter relief for adults who experience skin irritation and chafing caused by incontinence or light bladder leakage. Both sites also feature e-commerce capabilities powered by WooCommerce, enabling the brands to offer Direct-to-Consumer sales for the first time.
The Balmex Complete Protection and Balmex AdultAdvantage brands are both part of the Randob Labs portfolio. Randob Labs is a private, family-held company that specializes in revitalizing and maintaining heritage brands on the OTC healthcare space. “Collaborating and working with Randob Labs has been an exciting adventure. Both Balmex and Balmex Adult provide big relief from common, irritating issues,” says Code18 Interactive founder Steve Pilon. “And providing relief and solutions to everyday problems is exactly what Randob Labs is all about. We’re thrilled to be a part of this process.”
As a well-established presence in the baby aisle, Balmex Complete Protection offers pediatrician-recommended diaper rash cream and multi-purpose healing ointment to help protect, soothe and heal baby’s delicate skin. “Many health and wellness websites only talk about what their product can do for consumers. However, Balmex is all about providing fast relief and reliable, proven solutions. Therefore, the website needed to clearly explain the causes of diaper rash and skin irritation, as well as provide simple steps parents can take to help prevent diaper rash in the first place,” says Pilon. “The brand’s willingness to go the extra mile for new parents is just one of the many reasons parents have been trusting Balmex for over 50 years.”
Clinically proven Balmex AdultAdvantage offers the same key benefits—a cream that protects, soothes and heals irritated and chafed skin—as its 50-year-old sibling brand. Available as a standalone skin relief cream or as part of an innovative on-the-go, 3-in-1 kit, Balmex AdultAdvantage helps older adults live life more comfortably. “For many older adults incontinence or bladder leakage controls their life, and unfortunately, many people just accept this fate,” says Pilon. “With the Balmex Adult website we really focused on awareness—awareness of this fantastic product, awareness of the benefits, and mostly, awareness that you can take back control of your life with Balmex AdultAdvantage.”
Code18 Interactive is a New York WordPress Agency that caters primarily to national consumer and media brands. The agency specializes in the design and development of enterprise-level WordPress and Magento 2 websites. They have the pleasure of working with many wonderful brands, including: GoGo squeeZ, Boursin Cheese, Public Radio International, The Laughing Cow, Grove Atlantic Publishing, C.O. Bigelow and many others.
SANTA BARBARA, CALIF. / STOCKHOLM, 27-Oct-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today introduced valuable new online resources for healthcare providers in France, Germany, Italy and Spain. By expanding its Deflux online presence to international audiences, Palette Life Sciences demonstrates its commitment to supporting the global paediatric community.
Deflux.fr is a French-language resource for healthcare providers in France. Deflux.com/de is a German-language site serving practitioners in Germany. Deflux.com/es and Deflux.it are English-language sites serving physicians in Spain and Italy respectively. These new sites offer best-in-class online resources, important information and education about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. All of the European sites provide physicians with access to the global Deflux Learning Center, a leading education platform that features information and training for paediatric urologists and their peers who treat VUR. The Deflux Learning Center includes clinical articles, educational videos, webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.
The Deflux Learning Center for each respective country also provides downloadable educational materials for parents and caregivers managing children with vesicoureteral reflux (VUR).
“My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence in patients who fail medical management, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for physicians, will help raise awareness of this treatment option in patients with primary VUR, troubled by recurrent febrile UTIs,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Service Lead for Paediatric Surgery at Chelsea & Westminster and Imperial College Hospitals.
“We are excited to offer these new online resources to the healthcare community in France, Germany, Italy and Spain,” said Rich Low, Head of Marketing at Palette Life Sciences. “We are confident they will benefit the global paediatric urology ecosystem and serve as valuable resources by providing critical information and access to educational resources through the Deflux Learning Center.”
SANTA BARBARA, CALIF., U.S.A. / BUDAPEST / STOCKHOLM, 5-Aug-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences AB (‘Palette’) with Gedeon Richter Plc. (‘Richter’), today announced that as a part of a decentralised regulatory procedure including thirty European Union Economic Area member states, Palette and Richter received national marketing authorization for LIDBREE™ in the United Kingdom (UK). The product is a novel, proprietary thermo gelling intrauterine formulation that can provide significant pain relief during common gynecological procedures.
LIDBREE’s marketing authorization is based on compelling data from clinical trials and investigations of sensory innervation in the reproductive area. In a pivotal clinical trial, LIDBREE treatment was associated with a significant reduction of pain and discomfort in women undergoing gynecological interventions.¹
“Our research group has detected pain nerves superficially throughout the uterus, which enable the use of local pain relief in many gynecological procedures such as insertion of an intrauterine device and sampling biopsies from the cervix and/or from the uterus – procedures that are currently routinely performed today without pain relief. LIDBREE is a novel gel containing the local anesthetic lidocaine which adheres to the mucosal tissue upon application to provide excellent analgesic effect”, says Gunvor Ekman-Ordeberg, MD PhD Professor at Karolinska Institute and founder of the LIDBREE program. “The gratification of observing the culmination of over 40 years of research into clinical practice via a new, simple, and effective treatment is a great privilege to share with all of my colleagues.”
In October 2017, Richter and Palette signed an agreement to commercialise LIDBREE, a novel innovative proprietary pain relief pharmaceutical formulation, in Europe and in certain other markets.
“We are very pleased with the approval of LIDBREE in the UK, it is a great accomplishment from everyone involved. This is an important milestone and allows us to address a significant unmet medical need in women’s health. We look forward to supporting LIDBREE’s product launch through our partner Gedeon Richter and pursuing additional markets, such as the U.S., in collaboration with future regional partners.” says Helena Jansson, Managing Director at Palette Life Sciences AB.
“We’ve been expecting this regulatory development and we are looking forward to successfully introduce LIDBREE to all of the territories covered by our agreement in order to further improve the quality of life of women experiencing pain during their gynaecological interventions,” stated Tibor Horváth, Commercial Director of Gedeon Richter Plc.
SANTA BARBARA, CALIF., U.S.A. / STOCKHOLM SWEDEN, 4-Aug-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced the launch of Deflux.com/UK as part of its global expansion. Deflux.com/UK is a best-in-class online resource developed specifically for healthcare practitioners in the United Kingdom, as well as parents and caregivers managing children with vesicoureteral reflux (VUR). VUR, sometimes referred to as urinary or bladder reflux, is a serious paediatric urinary condition in which urine flows from the bladder through one or both ureters toward the kidneys.
Deflux.com/UK features important information about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. Comprised of hyaluronic acid (HA) and dextranomer polysaccharides to form a gel, Deflux is a minimally invasive biocomopatible treatment for VUR. Endoscopic treatment with Deflux takes about 15 minutes in a day procedure setting, and generally allows the child to go back to normal activities the next day.
Deflux.com/UK also provides physicians with access to the Deflux Learning Center, a leading global education platform that features information and training for paediatric urologists and their peers who treat VUR as well as other paediatric urology conditions. The Deflux Learning Center includes clinical articles, educational videos and webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.
“Deflux is an effective, minimally-invasive treatment option that many caregivers simply aren’t aware of,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Clinical Director for Paediatric Surgery at Chelsea and Westminster Hospital. “My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for both physicians and caregivers, will help raise awareness and utilisation of this treatment option.”
“The entire Palette commercial team is excited to launch Deflux.com/UK, which we believe will help elevate the standard of care for VUR patients in the UK,” said Rich Low, Head of Marketing, Palette Life Sciences. “Deflux.com/UK will serve as a truly valuable resource for caregivers, providing critical information to paediatric urology healthcare professionals through the Deflux Learning Center, and to caregivers, connecting them to highly-trained specialists who provide high quality care.”
STOCKHOLM, SWEDEN / SANTA BARBARA, CALIF., USA, 15-Jun-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced global distribution expansion for two of Palette’s products, Deflux and Solesta. The expansion provides commercial access to more than 20 countries through five distributors around the globe, while adding direct sales in four additional countries: Cyprus, Greece, Hungary and Portugal.
KEBOMED, a leading European distributor of medical devices and equipment, will distribute the products in France, Sweden, Norway, Finland, Denmark and Iceland. Stratarium Sarl, will commercialize the products in Germany, Austria, Belgium, Luxembourg, Netherlands and Switzerland leveraging their urology focused subsidiary, RA Distribution. CJ Medical, a UK-based distributor of innovative technologies specializing in surgical and medical devices, will distribute the products in Ireland and the United Kingdom. Grifols, one of the leading companies in the production and sale of plasma-derived medicines and a top distributor of a broad range of products within their country will cover Spain, and GP Dermal, a specialist with deep ties across urology and pediatric call points will serve as the distributor in Italy and Malta.
“This enhanced distribution network allows Palette to ensure our customer and patient needs are adequately met across Europe,” said James Leech, Head of Corporate Development at Palette Life Sciences. “We have selected strong partners with deep experience and relationships in the urology and pediatric setting who will help us serve the product and education needs of physicians and hospitals. Palette and its network of partners are making significant investments within local markets to improve physician access to Palette resources, best management and treatment practices, and renewed product training.”
For more information or to place an order, please contact a Palette Life Sciences representative at email@example.com. Contact information for product orders or inquires by distributor are as follows:
Stratarium Sarl: firstname.lastname@example.org
CJ Medical: email@example.com
GP Dermal: firstname.lastname@example.org
Sacramento, California, 2019-Dec-10 — /EPR HEALTHCARE NEWS/ — American Hemp Processing (AHP) is excited to announce the design completion of their Mobile Hemp Extraction Unit (MEHU). This is a key step in AHP’s expansion to increase production to 400,000lbs of hemp per month that will be completed 1st quarter 2020. The mobility of the MEHU reduces overall processing costs, mitigates many of the risks associated to transportation, and increases transparency with farmers.
The MHEU units bring significant benefits to the farmer from both a financial and risk mitigation perspective. “Most hemp farms are not close to processing facilities. Transportation is a large cost and increases the risk of degradation and contamination. On top of that, farmers still have to deal with legal issues in states that aren’t familiar with hemp and mistake it for marijuana,” says Andrew Alvarez Co-Founder and Chief Technology Officer “Additionally, it increases transparency with farmers and helps educate them along the way to build synergistic relationships”.
“The design of the MHEU was Phase 2 of our strategy,” says Shick Park Co-Founder and Chief Operations Officer, “Phase 1 was developing a scalable extraction and remediation process enabling us to create high quality and compliant CBD oil, and Phase 3 is the roll-out of the mobile extraction units on to farms fall of 2020.”
“This caps off a 12 month design process by our engineers and now we go to the assembly phase. These units will take approximately 120 days each to build, and we plan to initially build 3,” says Co-Founder and CEO Tom Richardson. “This has been a very rewarding journey for us, from meeting farmers all over the country, to government legislators, to fine tuning the extraction process, to meeting other processors and sharing ideas, we feel very confident about the Cannabinoid Sector business.”
The training module received the distinction after PDA demonstrated to ICH that it meets the twelve eligibility criteria for the program. Among these are its mission to serve as a neutral convening platform to engage expert stakeholders from industry, academia, advocacy groups, non-profits, and/or regulatory agencies on critical regulatory topics, and its promotion of regulatory convergence to accelerate innovation and improve healthcare globally.
The free “ICH Q7 GMP for APIs” training module introduces and improves understanding of the ICH quality guideline, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The webinar is intended for pharmaceutical professionals working with APIs. More information on the webinar is available here: https://www.pda.org/global-event-calendar/ich-q7-gmp-for-apis.
BERLIN, 14-Aug-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have been invited to speak at the 2019 PDA Europe Biomanufacturing Conference, 3-4 September 2019 in Munich, Germany. The following health authorities have confirmed speakers:
Danish Medicines Agency
Dutch Medicines Evaluation Board
European Medicines Agency
European Directorate for the Quality of Medicines & Healthcare (EDQM)
Swedish Medicines Agency
Mats Welin, Medical Products Agency, Sweden, and Dolores Hernan, European Medicines Agency, will provide an opening plenary talk on Accelerated Access and discuss the results of a 2018 EMA/FDA workshop on quality considerations for early access approaches. Those intrigued by Accelerated Access can learn more in the follow-up session, moderated by Martjin van der Plas, Dutch Medicine Evaluation Board. Welin and Hernan will participate in a panel discussion ending that session.
After a the first-day luncheon, Nanna Kruse, Danish Medicines Agency, will peel away some of the mystery surrounding the forthcoming International Conference on Harmonization (ICH) Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. In a parallel track, the Austrian Agency for Health and Food Safety (speaker TBD) will intrigue the audience with a review of challenges regulators routinely face with the advent of new vaccines and innovative biologics.
Bright and early on 4 September, the EDQM’s Gwenael Cirefice and the Dutch Medicines Evaluation Board (speaker TBD) turn the attention to ICH and advances in test methodologies. In a parallel track, Martjin van de Plas returns to the podium to review regulatory ideas regarding quality by design and control strategies. Hernan takes the mic as the conference’s last speaker to discuss EMA’s 2025 regulatory science strategy.
The meeting will close with a panel discussion including all the regulatory representatives participating.
Lake Mary, Florida, United States, 2019-Aug-12 — /EPR HEALTHCARE NEWS/ — Personally Delivered, Inc., a leading expert in-home delivery of incontinence, skin care, ostomy, urological, and related supplies, is launching its new, competitively-superior line of Personally Delivered™ Premium-Plus Pull-On Protective Underwear in both Daytime and Overnight styles.
Leveraging 40+ years of listening to incontinence customers and helping them find the right products for their unique situations, Personally Delivered has incorporated the most advanced technologies to create a new unisex pull-on Protective Underwear available in both Daytime and Overnight styles. These state-of-the-art products offer superior absorbency and comfort to help users remain more comfortable, confident, and in control. Customers can now have industry-leading, superior products discreetly delivered right to their front door.
Made in the USA, Personally Delivered™ Pull-On Protective Underwear incorporates gentle cloth-feel stretch panels for maximum comfort and easy removal. A dual-core system plus super-absorbent polymers provide rapid absorbency and superior leak protection. A gel core locks in odors, prevents leaks, and keeps the wearer drier. Comfortable leg gathers deliver active protection and a secure fit. Combined, these features provide the new standard in incontinence comfort and absorbency.
“We speak with people every day who struggle with incontinence and provide real-life feedback on what works and what doesn’t when it comes to leak-free protection,” said Seth Segel, CEO of ConvaTec’s US Home Distribution Group, the parent company of Personally Delivered, Inc. “We understand what these individuals are going through. We listened to them and then went to work creating products to address their problems. Our new Personally Delivered™ Protective Underwear delivers optimal dryness and a leak-free experience.”
Personally Delivered™ Overnight and Daytime Protective Underwear are available exclusively through www.PersonallyDelivered.com. They are available in a range of sizes from Small to Extra-Extra Large.
BERLIN, 10-Jun-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in Amsterdam, The Netherlands, the new location of the European Medicines Agency, where industry and regulatory agencies will present their perspectives on the transformation unfolding in the pharmaceutical sector regarding the digitalization and automation of manufacturing processes.
From the Max Planck Institute for Human Development, Felix G. Rebitschek will deliver the keynote speech, “Decision-Making Under Uncertainty.” Following him, the opening plenary “Regulatory Updates – Current Situation” will discuss understanding regulatory frameworks in an atmosphere of rapid change and provide the opportunity to participate in conversation with regulators and industry representatives.
Regulatory agencies sharing industry updates include the European Medicines Agency, U.S. FDA, WHO, MHRA and HPRA, PIC/S.
A series of parallel tracks will offer the chance to learn about topics ranging from virtual reality, data quality management, manufacturing technologies and much more.
Learn more about the topics that will be examined in-depth.
BERLIN, 28-May-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is pleased to announce the speaker lineup for the 2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference, in Vilnius, Lithuania, June 4-5. Expert speakers representing industry, government and academia will cover the full breadth of scientific and regulatory considerations for successfully launching and manufacturing cell and gene therapies.
Lithuanian University of Health Science professor Romaldas Maciulaitis will get the meeting off to a quick start with his presentation, “Development and the Use of ATMPs in EU/Lithuania.”
Following him in the opening plenary session is Alistair Gibb from the UK Medicines and Healthcare Products Regulatory Agency, presenting “ATMPs System-wide Challenges from Innovation to Uptake – Pragmatic Supportive Regulation and Standards.”
The Paul-Ehrlich Institute’s Isabelle Bekeredjian-Ding takes the podium after her British counterpart with, “From Individualized to Standardized Microbiological Quality Control in ATMP Manufacturing.”
The PDA EU ATMP Conference comes just a month after PDA’s successful Cell and Gene Therapy Conference in Long Beach, Calif., May 6 – 7. That conference drew 200 participants. Earlier this year, PDA published Technical Report No. 81: Cell-Based Therapy Control Strategy.
RENNES, FRANCE, 2019-Apr-08 — /EPR HEALTHCARE NEWS/ — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors.
Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.
Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.
DUBLIN 2, Ireland, 18-Oct-2018 — /EPR HEALTHCARE NEWS/ — The European home diagnostics industry is realigning to foster integration with the broader customer-centric healthcare services. Growing consumer preference for home-based diagnostics, combined with innovation in online platforms, is creating sustained opportunities in this dynamic landscape. Riding on the coattails of these factors, the US$ 1.4 billion Europe home diagnostics market is likely to grow at 3.4% CAGR during the period 2018-2026.
Consumer Preference for Non-Invasive Glucose Monitoring Devices Still Remains Unmet
Glucose monitoring kits and devices remain the top-selling product, accounting for over 80% revenue share of the Europe home diagnostics market. The burgeoning demand for home-based glucose monitoring devices and kits can be attributed to growing prevalence of diabetes in Europe, which is increasing across all ages according to the WHO. The Fact.MR study opines that digital devices will remain the preferred choice over cassettes among European consumers.
The broader trends pertaining to non-invasive and painless diagnostics are driving innovation in glucose monitoring device development. According to the Fact.MR study, non-invasive glucose monitoring devices are likely to witness increasing penetration in Europe, albeit at a slow pace. The report also finds that broader innovation in non-invasive devices can drive healthcare consumerism across Europe.
The Fact.MR study remains optimistic on the future growth in Europe’s home diagnostics market, however, challenges prevail. “Self-testing, especially for people with type 1 diabetes, who require daily or frequent testing, remains a painful and inconvenient process. Over the decades, the innovation in glucose monitoring devices hasn’t really addressed the invasive part of the self-testing”, says Mr. Santosh Kumar, Senior Consultant at Fact.MR. “There is an urgent need for non-invasive glucose monitoring testing,” adds Mr. Kumar.
The Fact.MR study finds that home diagnostics manufacturers are aware of the evolving demand. Investment and research into developing minimally or non-invasive home diagnostics devices is gaining ground. “The realization that digital, and non-invasive devices are the future is dawning upon manufacturers. Market leaders, such as Siemens Healthcare and Abbott Technologies are leveraging wearable technologies and IoT to develop innovative products,” says Mr. Kumar.
Growth in Pregnancy and Ovulation Predictor Test Kits Sales Encouraging
Although glucose monitoring devices and kits will account for the majority of sales, encouraging trends in other self-test kits continue to complement market growth. Pregnancy test kits and ovulation predictor test kits are likely to witness surging demand, as an increasing consumer base feels confident about self-testing. Gains are also encouraging, albeit miniscule, in other home diagnostics products, such as urinary tract infection kits and male infertility test kits.
UK Maintains its Numero Uno Position, Germany and France Remain Lucrative
The Europe home diagnostics market remains concentrated in the UK, Germany, and France. These three markets collectively account for a market share of nearly 60% revenue share of the Europe home diagnostics market. The Fact.MR study opines that these three markets will witness increasing proliferation of next-gen home diagnostics devices.
Fact.MR study on the home diagnostics market brings interesting insights to the fore. According to the report, UK remains Europe’s largest market for home diagnostics, with revenues to the tune of US$ 280 million in 2017. The study opines that UK will maintain its numero uno position throughout the course of the forecast period 2017-2026. Germany and France will follow suit, however, sales will grow at a sluggish pace in the former.
The report also finds that home diagnostics devices that use urine and blood for testing will continue to remain pervasive in the Europe home diagnostics market. Samples devices and kits that use semen and breath are expected to witness growth during the course of the forecast period.
Marrongelli selected for her expertise in Botanical Drug Development
LONDON, Jun-16-2018 — /EPR Healthcare News/ — As a leading expert in her field, Dr. Christina Marrongelli, PharmD has been chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference: Exploring New Trends & Innovations in Pharmacology and Natural Compounds. The conference is being held in Paris, France on June 18, 2018.
Dr. Marrongelli, who is an adjunct professor at the Medical University of South Carolina in the department of drug discovery and biomedical sciences will also present “Developing and Marketing Botanical Drugs in the United States”.
The United States, which has the largest pharmaceutical market in the world, demonstrates a strong demand for the use of botanicals as medicine. However, to date only two prescription botanical drugs are currently approved for use in the USA: Veregen® (sinecatechins) and Mytesi™ (crofelemer).
Marrongelli attributes this disconnect between supply and demand to hidden barriers. She notes that with the worldwide herbal drug market is expected to reach nearly $86.74 billion by 2022, businesses must identify and address these barriers so that heterogeneous botanical drug products can obtain the approvals necessary to meet the consumers growing expectations and demands for botanical medicines.
To further explain the barriers to regulation of botanicals, Marrongelli points to the Botanical Drug Development Guidance for Industry from the U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) that was last updated in 2016. According to publication, regulation of botanicals in the U.S. is different from regulation in the rest of world. The U.S. does not have a separate regulatory category for traditional or herbal medicines: A botanical product may be classified as a food (including a dietary supplement), drug (including a biological drug), medical device, or cosmetic under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Whether an article is a food, drug, medical device, or cosmetic depends in large part on its intended use.
To learn more about the issues and barriers to the development of botanical drugs, please contact Dr. Marrongelli at Marronge@musc.edu or DrM@pharmD.expert.
LONDON, Dec-3-2017 — /EuropaWire/ — On December 5-6, 2017, 200 high-level experts from government, academia, biopharmaceutical developers and patient organisations convene in London (UK) to address the mounting challenge of accessibility and patient access to high-value, high-cost medical therapies.
The not-for-profit executive forum is organised by the London School of Hygiene and Tropical Medicine and analytica|LASER, a global research consultancy, to investigate topical questions around drug policy, global health systems sustainability and innovation funding through a combination of case studies, panel sessions, and roundtables. Delegations are registered from over 70 public and private organisations, including the World Health Organization, as well as health systems representatives from Belgium, England, Estonia, Croatia, France, Germany, Italy, Norway, Sweden, the United States and Wales. Multiple patient organisations support the meeting to ensure that the patient voice is reflected in all deliberations.
“Access to life-saving drugs is not a new challenge. The paradigm of accessibility was changed completely in the face of the deadly HIV epidemic. This time, however, accessibility concerns almost every domain of medicine such as cancer, auto-immune diseases and rare diseases. We must act now,” says Prof Peter Piot, Director of the London School of Hygiene & Tropical Medicine and former head of UNAIDS.
“There is an incredible challenge for the sustainability of health systems across the world”, says Prof. Lucien Abenhaim, London School of Hygiene & Tropical Medicine and Chairman of Analytica Laser. “It is critical that drug developers and health system engage on actionable proposals that address concerns around value, cost and overall access to innovation for the patients who need it. We are at an inflection point – the paradigms of the 1990’s can no longer guide us,” he adds.
The main plenary on December 6th features scheduled remarks by over a dozen authorities in the field, including Professor Baron Peter Piot (Director, London School of Hygiene & Tropical Medicine and former Head, UNAIDS), Dr. Olivier Brandicourt (Chief Executive Officer, Sanofi), Dr. Sarah Garner (World Health Organization), Prof. Dominique Le Guludec (President, French HAS), Sir Andrew Dillon (Chief Executive, National Institute for Health and Care Excellence UK) and Dr. Harold Paz (Chief Medical Officer, Aetna). The plenary is preceded by a scientific seminar on December 5th which gathers globally renowned academics to explore new frontiers on the methodology for the appraisal and valuation of high-value medicines.
Cambridge, England, 2017-Feb-14 — /EPR HEALTHCARE NEWS/ — Resveratrol and lycopene are the compounds known for anti-ageing and cardio-protective properties. Mediterranean diet based, among others, on consumption of big quantities of lycopene-rich vegetables coincides with a longer lifespan, lower incidence of CVDs and reduced occurrence of some forms of cancer among the population of Mediterranean region. High resveratrol consumption is considered a factor in “French Paradox”, where epidemiological data show low incidence of CVDs, despite high consumption of saturated fats. Consumers have enormous choice of food supplements including lycopene and resveratrol, but key information is often missing: what happens to the substance once consumed and how much of it is really absorbed?
Resveratrol – the powerful anti-ageing, antioxidant polyphenol
Resveratrol is a phytochemical from polyphenols family, compounds known for their antioxidant properties. It is produced by plants in response to different stresses from their surrounding environment and found mainly in the peel and seeds of red grapes, also in peanuts and berries. High resveratrol consumption is considered a factor in “French Paradox”, where epidemiological data show apparent disconnect between the incidence of cardiovascular diseases in French population and high consumption of saturated fats. It is thought to be related to high consumption of red wine that contains resveratrol. There is significant scientific research on the beneficial effects of resveratrol relating to anti-ageing and longevity – activation of sirtuin enzymes, support of mitochondrial metabolism, protection of telomeres, antioxidant properties. It also supports cardiovascular health and influences glucose metabolism management.
Lycopene – great contributor to healthy skin
Lycopene belongs to family of plant-derived substances – carotenoids. Due to their strong antioxidative properties carotenoids help protect plants from oxidative damage caused by various stressing factors. Scientific interest in lycopene originates from the phenomenon of the Mediterranean diet and its’ cardio-protective and longevity promoting properties. The Mediterranean diet is based, among others, on high consumption of tomatoes and other vegetables that contain high levels of lycopene and other carotenoids. The population of the Mediterranean region has a longer lifespan, lower incidence of cardiovascular diseases and lower occurrence of some forms of cancer. Because of its’ antioxidative properties lycopene helps fight against free radicals in the skin, reduces its’ sensitivity to UV radiation, reduces mitochondrial DNA damage, lowers the risk of heart diseases.
Carocelle® presents best in class lycopene and resveratrol anti-ageing supplement
The main challenge of resveratrol supplementation remains its’ bioavailability. As quickly as it is absorbed from intestinal tract to bloodstream most of it is transformed into inactive compounds. New Carocelle® Lycopene & Resveratrol formulation delivers superior bioavailability, proven in clinical trials. Carocelle® technology makes resveratrol over +500% more bioavailable than other products on the market and provides its’ outstanding concentration that would normally be difficult to obtain from other available sources.
Pharmacokinetic tests for Carocelle® Lycopene have also confirmed 2x higher concentration of lycopene in the bloodstream (bioavailability) in comparison to reference brand available on the market, with the same dosage of the compound.
Carocelle® Technology behind compounds’ superior bioavailability
Vesicle-micellisation helps carotenoids become more resistant to degradation in the highly acidic stomach environment. This ensures that more active lycopene and resveratrol can pass to the intestines and be absorbed. The vesicle-micelle format is easily transformed in the intestines by bile acids to the mixed micelles. This guarantees optimal absorption of fat-soluble ingredients, like lycopene and resveratrol. The result is increased delivery of active lycopene and resveratrol to the intestine for maximum absorption, improved bioavailability and remarkable bioactivity. Chaperone compounds in Carocelle® Lycopene & Resveratrol vesicle-micelles additionally contribute to increased bioavailability of both lycopene and resveratrol.
There are currently 3 SKUs within Carocelle® range:
Carocelle Cambridge Micelle Technology™ was founded in 2015 in collaboration with UK biotech firm Lycotec, headed by Dr. Ivan Petyaev. The company invents proprietary formulations and products that are scientifically tested and proven in laboratories in Cambridge, UK. Carocelle Cambridge Micelle Technology™ has its headquarters in Cambridge and operates a network of partnerships with research and commercial partners around the world.
DR. IVAN MIKHAILOVICH PETYAEV, MD, PHD
Dr. Petyaev is a medical doctor, researcher and author of scientific publications and inventions with applications in diagnostics, analytics, prevention and treatment of a variety of diseases. He spent his research years at MRS and Cambridge University in the Department of Pathology. To take his discoveries into innovative healthcare products he left University and set up his own company, Lycotec Limited. Dr Petyaev has wide experience of driving his innovations through the product development phase, clinical validation and in the setting up of industrial production of the successful prototypes. His projects have been supported by Cambridge University, the MRC, Papworth and Addenbrooke’s Hospitals, the British Heart Foundation, the Department for Trade and Industry and the Eurostars Eurica Project.
Systech will be part of Sharp’s panel discussion addressing delegates on the theme of “Serialization: Optimizing Your Supply Chain Means Optimizing Your Partners.” The presentation will explore the critical path to supply chain readiness, risk assessment, benchmarking and serialization risk mitigation options. The briefing will take place in the Pharma Insight Briefing room on Tuesday, 4 October 2016 at 11:30am CEST.
Systech will also showcase its UniSeries™ serialization software offered as an integrated solution within Autajon’s exhibit booth #2P16 (Hall 2).
CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, will host more than 36,000 visiting pharma professionals from 4-6 October at the Fira Gran Via, Barcelona, Spain. More than 2,500 exhibitors from 150+ countries gather at the event to network and take advantage of more than 100 free industry seminars. Every sector of the pharmaceutical market is represented under one roof, this year in a new location in Barcelona.
With thousands of implementations across the globe, Systech is the world’s most trusted brand protection expert, and its UniSeries offering is the industry standard for serializing products. UniSeries is offered as an integrated solution with both Sharp Packaging and Autajon Group’s hardware. Systech’s patented, configurable software offers manufacturers the flexibility to adapt to new regulations without extensive reworking or revalidation, thereby reducing implementation, training and support costs.
“We are recognized as the world leader in serialization and brand protection,” states Manfred Voglmaier, Senior Director Sales Europe, Systech International. “With more than 30 years of experience in providing highly configurable solutions for serialization across a variety of industries ― along with our partners Sharp Packaging and Sinel ― gives us a unique insight for this panel.”
Systech’s products are in greater demand than ever before since it is estimated that over 15,000 production lines for prescription medication in Europe must be fitted with a serialization system over the next three years. The European Commission adopted a regulation on October 2, 2015, under which the serialization of prescription medicine packages will become mandatory in all EU countries by 2019.
Show exhibit hours are on Tuesday, 4 October – Thursday, 6 October. Systech representatives will be available in the Sharp Packaging booth #3L56 (Hall 3) during the event, as well as in the Autajon booth #2P16 (Hall 2). They will showcase Systech’s software solutions on sample packaging lines and via live demos throughout the event.
Seattle, WA, San Francisco, CA and Moscow, Russia, 2016-May-25 — /EPR Healthcare News/ — R-Pharm and GenQual are pleased to announce a new collaboration focused on the development of novel predictive diagnostic tools in the area of Rheumatoid Arthritis and Autoimmune diseases.
The GenQual proprietary real-time PCR platform, when applied to the genes that are involved in the manifestation of several autoimmune diseases, allows us to detect and assess single nucleotide polymorphisms. Here, allelic determination is used as potential predictor of the treatment response by the novel anti-IL6 antibody, which is currently in development by R-Pharm.
GenQual Founder and CEO Jonathan Mirich said, “This partnership is exciting for GenQual as we advance in our goal to deliver predictive diagnostic tools for the treatment of autoimmune disorders. We are very excited about the possibilities in this space and are thankful to have quality partners in R-Pharm.”
R-Pharm CEO Vasily Ignatiev indicated the importance of the Autoimmune diseases as an area of the development and growth for R-Pharm, as well as the development of novel diagnostic tools aimed to increase the level of predictive response and efficiency of the upcoming treatment paradigm.
GenQual develops proprietary biomarker diagnostics for autoimmune and oncology indications. Our personalized medicine products are designed to facilitate early disease detection and diagnosis, and to improve treatment approaches at the molecular level. GenQual is a privately-held corporation based in Seattle, WA area, USA.
R-Pharm is a private Russian pharmaceutical company founded in 2001. It employs over 3,500 highly qualified specialists in 60+ branches. R-Pharm operates in Russia and CIS, USA, Germany, Japan, Turkey/MENA.
The company is involved in R&D, manufacturing (finished dosage forms, biotech and chemical APIs), marketing, sales and distribution of innovative pharmaceutical products in hospital/specialty care therapeutic areas.
R-Pharm collaborates with major international pharmaceutical companies and universities in the fields of drug discovery, development, clinical trials, manufacturing and commercialization. The company operates several GMP compliant manufacturing sites in Russia and Germany, research, BD/licensing and marketing affiliates in Japan, Germany, Turkey and US.
Marketed portfolio and pipeline features drugs used in oncology, hematology, autoimmune diseases, HIV, HCV, neurology, diabetes, cardiology, as well as antibiotics, contrast media and anesthesia agents.