Category Archives: Pharmaceuticals

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

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.

Learn more about the topics that will be examined in-depth and/or to register. https://www.pda.org/global-event-calendar/event-detail/biomanufacturing-conference

Members of the press are welcome to apply for a press pass. https://www.pda.org/about-pda/press-pass-request-form

SOURCE: EuropaWire

Personally Delivered, Inc., Introduces a New Line of Daytime and Overnight Adult Incontinence Pull-On Protective Underwear with Exceptional Absorbency and Comfort

Personally Delivered, Inc., Introduces a New Line of Daytime and Overnight Adult Incontinence Pull-On Protective Underwear with Exceptional Absorbency and Comfort

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.

Via EPR Network
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EMA, MHRA and U.S. FDA among regulatory agencies participating at PDA’s 4th Annual European Meeting in Amsterdam

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.

Registration (https://store.pda.org/Meetings/Login.aspx?ID=4520) can be completed until June 24.

Bona fide members of the press are welcome to apply for a press pass.

SOURCE: EuropaWire

2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference

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.

Go here to see the full speaker lineup.

Press passes are available here to bona fide members of the press.

SOURCE: EuropaWire

Mr RICHARD GUILLAUME IS APPOINTED TO THE DIAFIR BOARD OF DIRECTORS

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.

 

Via EPR Network
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Europe Home Diagnostics Market: Growth in Pregnancy and Ovulation Predictor Test Kits Sales Encouraging

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.

Request a sample of the report

https://www.factmr.com/connectus/sample?flag=S&rep_id=1892

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.

Request methodology behind the report

https://www.factmr.com/connectus/sample?flag=RM&rep_id=1892

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.

Buy the report

https://www.factmr.com/checkout/1892/S

SOURCE: EuropaWire

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

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.

SOURCE: EuropaWire

Prof. Lucien Abenhaim: There is an incredible challenge for the sustainability of health systems across the world

Prof. Lucien Abenhaim

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.

Please contact the organisers for more information on the programming and media access, or refer to www.accessibility-symposium.org

SOURCE: EuropaWire

Cambridge Micelle Technology in Carocelle® Lycopene and Resveratrol anti-ageing and cardio-protective formula

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® Lycopene & Resveratrol
Carocelle® Lutein & Zeaxanthin
Carocelle® Lycopene

For more information please visit www.carocelle-technology.com or contact us at contact@carocelle-technology.com

COMPANY PROFILE
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.

Via EPR Network
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Global leader in serialization solutions Systech to attend the annual pharmaceutical congress CPhI Worldwide in Barcelona, 4 – 6 Oct 2016

systech_international_slogo_europawireBRUSSELS, 28-Sep-2016 — /EuropaWire/ — Systech International, a global leader in brand protection technologies, will partner with Sharp Packaging and SINEL SYSTEMS, part of the Autajon Group, at CPhI Worldwide, the annual pharmaceutical congress held in Barcelona from 4 – 6 October 2016.

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.

SOURCE: EuropaWire

GenQual and R-Pharm collaborate to deliver predictive diagnostics for novel anti-IL-6 antibody for autoimmune diseases

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.

About GenQual
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.

About R-Pharm
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.

Contact

R-Pharm
info@rpharm.ru
www.r-pharm.com/en/

 

GenQual

info@genqual.com
206.659.7825
www.genqual.com

 

Via EPR Network
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Experimentica Ltd. licenses Akimba mouse model for diabetic retinopathy from Lions Eye Institute, Australia

Kuopio, Finland, December 18, 2014 — /EPR HEALTHCARE NEWS/ — The Lions Eye Institute (LEI) and Experimentica Ltd., a global ophthalmic contract research organization (CRO) announced today that they have entered into an exclusive license agreement for the Akimba mouse model for diabetic retinopathy for contract research. The license agreement was facilitated by Bio-Link Australia, a life sciences commercialisation company.

About Lions Eye Institute

The Lions Eye Institute (LEI) is the leading ophthalmic research institute in Australia. LEI employs scientists, clinicians and support staff to conduct first class scientific research into blindness and incorporates one of Australia’s largest ophthalmic practices. The Department of Molecular Ophthalmology (DMO) was founded by Professor Rakoczy in 1989 with the aim of using technological breakthroughs for the treatment of blindness. The Kimba mouse model have been successfully used in preclinical trials for a DMO developed gene therapy based treatment for wet-AMD that reached Phase I/II stage (www.lei.org.au;www.avalanchebiotech.com).

About Experimentica Ltd.

Experimentica Ltd. is a preclinical contract research organization (CRO) dedicated to develop and provide ocular disease models. Experimentica Ltd. is a global company and the largest ophthalmic CRO in Northern Europe, striving to provide scientific excellence by relying entirely on in-house expertise. Experimentica Ltd. is headquartered in Kuopio, Finland with offices in Tampere, Finland and Kansas City, MO, USA. For more information, visit www.experimentica.com.

About Bio-Link
Bio-Link Australia Pty. Ltd. is a life sciences commercialisation company which facilitates partnerships in the biopharma, medical device and diagnostic industries. Bio-Link has offices in Sydney and Melbourne, Australia, and clients including leading Australian and international biotechnology and medical device companies and medical research institutions. For more information, visit www.bio-link.com.

Contact details:
Experimentica Ltd/Giedrius Kalesnykas,
Microkatu 1, P.O.Box 1188,
70211 Kuopio, Finland.
E-mail: info@experimentica.com,
www.experimentica.com

Media enquiries:

For Experimentica:
Giedrius Kalesnykas, Ph.D.
Phone: +358 (50) 379-0275
US Toll Free: +1 (844) 393-4393
Email: gk@experimentica.com


For the Lions Eye Institute:

Francesca Robb
Communications and Media Officer
Phone: (+61 4) 09 102 556
francescarobb@lei.org.au

Via EPR Network
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HD Biosciences, Co., Ltd. and E. J. Corey Institute of Biomedical Research Reached Agreement for Drug R&D Collaboration

HD Biosciences Co., Ltd. (HDB) and E. J. Corey Institute of Biomedical Research (CIBR) announced that they have reached a risk-sharing agreement on collaborative drug discovery and development in the therapeutic areas of infectious diseases, metabolic diseases, and oncology. This joint effort will focus on both international and Chinese markets to provide innovative medicines for unmet healthcare needs. The agreement includes lead candidate selection pre-clinical development, IND filing, clinical trials, and NDA approvals. Both companies will share financial returns from any successes or products launches.

“We are delighted to enter this partnership. The collaboration will leverage HDB’s extensive capabilities in preclinical drug discovery and development, and create long term potentials for the company.” stated Xuehai Tan, Ph.D., President & CEO of HDB. “In combination of CIBR’s expertise in drug development, we are confident to deliver novel drug candidates over the next few years, and to make this partnership a success.”

“Working with HDB gives CIBR a unique opportunity to showcase its strength in innovative drug discovery and development,” said Wuyi Meng, Ph.D., President of CIBR. “This partnership further demonstrates CIBR’s commitment in the betterment of patient’s lives by bringing forward novel medicines. We will collaborate closely with HDB to accelerate the progress of our collaborative programs”

About HD Biosciences Co., Ltd.
HD Biosciences Co., Ltd. is a Shanghai-based, biology-focused preclinical drug discovery contract research organization (CRO). The company offers comprehensive service platforms around target validation, plate-based pharmacology, hit identification and lead discovery, therapeutic antibody discovery, in vivo pharmacology, as well as other research and development services. The company currently collaborates with eight of the ten largest pharmaceutical companies in the world and has established strategic partnerships on many key R&D areas with impacts to their portfolios. The strong scientific expertise, high quality and consistency in deliveries, constantly meeting or exceeding expectations, has earned the company a great reputation in the industry, and helped the company to build its widely recognized leadership in preclinical contract research services.http://www.hdbiosciences.com

About E. J. Corey Institute of Biomedical Research
Located in the Jiangyin High-tech Industry Development Zone in Jiangyin, Jiangsu, E. J. Corey Institute of Biomedical Research (CIBR) is a non-profit research organization founded by Nobel laureate Prof. E. J. Corey with the support from Jiangyin and Jiangsu government. CIBR is committed to scientific research in the broad biomedical field and to the development of novel therapeutics to meet the unmet medical needs of patients. In addition to its strong internal research and discovery capabilities in biomedical research and drug discovery, CIBR has established solid external capabilities in translational medicine and molecular toxicology to support drug development. Under the guidance of Nobel laureate Prof. Corey, CIBR is well poised to contribute to the discovery and development of novel medicines. http://www.cibrnobel.org

Contact Details:
HD Biosciences
Ms. Jessie Yang
Email: yangxiaojie@hdbiosciences.com

CIBR
Dr. Jiaquan Wu;
Email: jwu@cibrnobel.org

 

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HD Biosciences and Anchor Therapeutics Form Collaboration for Co-marketing Pepducin-mediated GPCR Technology

HD Biosciences Co., Ltd (HDB) and Anchor Therapeutics, Inc. today announced that they have formed a strategic collaboration to co-develop and co-market Anchor’s proprietary pepducin technology and provide novel drug development solutions to global pharmaceutical companies with drug discovery efforts focused on G-protein coupled receptors (GPCR).

Pepducins are proprietary lipidated peptide modulators for GPCR signaling. They may stabilize receptor conformation, promote or inhibit dimerization, and modulate interaction of GPCR with signalosome. As a strong research tool, pepducin technology enables high throughput screening (HTS) campaigns for the identification of special class of compounds and allosteric ligands, facilitates biophysical studies via stabilization of GPCRs in different activation states and functionally de-orphanizes GPCRs to provide tools for interrogation of pharmacology in vitro and in vivo.

As a key component of HDB’s plate-based pharmacology service capabilities, GPCR assays and screenings is one of the most active research and development areas that attracts global clients and partners in drug discoveries. With over 200 recombinant GPCR cell lines in house, some of which are orphan receptors, combining a variety assay formats with pepducin technology allows HDB to enhance its capabilities for supporting hit identification, lead discovery and receptor selectivity profiling. The collaboration is also designed to provide broader exposure and accessibility of pepducin technology across pharmaceutical and biotechnology industries through HDB’s global client base. HDB’s clients will gain unprecedented access to not only the pepducin screening platform but also HDB-Anchor’s joint expertise in GPCR research.

“Anchor’s pepducin technology has provided a novel approach to search very special GPCR related compounds that have potential to alter the receptor functions. We believe this technology will be very valuable in GPCR related drug discovery.” commented Dr. Xuehai Tan, President and Chief Executive Officer of HDB. “As one of the global leaders in biology focused contract research services, HDB emphasizes on innovative and scientific driven technologies in order to deliver extra value to our clients. The partnership between HDB and Anchor is a perfect example to demonstrate our commitment to grow the expertise and strengthen our leadership in GPCR R&D.” Dr. Tan continues his comments.

“Anchor Therapeutics is extremely pleased to partner its pepducin technology with HD Biosciences, one of the leading companies providing state of the art high throughput screening services to pharmaceutical and biotechnology clients,” said Thomas J. McMurry, PhD, Anchor’s Interim President. Dr. McMurry continued, “Through this collaboration, Anchor and HDB will expand the validation of pepducin high throughput screening probes in order to provide HDB’s clients with access to innovative screens designed to facilitate access to novel small molecule pharmacophores.”

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Peak Nutrition’s Nourkrin Woman Provides the Answer

It isn’t just men who suffer with hair loss and their hair thinning, woman also suffer and the effects of this can have a psychological effect on all women. Peak Nutrition, providers of a range of health and well-being supplements, may have the answer with Nourkrin Woman.

As a natural food supplement, Nourkrin tablets contain only natural ingredients such as Acerola Cherry Extract, Silica Kieselguhr and Horsetail extract which means there are no side effects to worry about. There are 4 stages to taking the product that take approximately six months.

Stage 1 is the slowing and stopping of hair loss; stage 2 is the process of strengthening the existing hair; stage 3 is when it promotes the growth of dormant hair and the final process involves the strengthening of the new hair.

Andrew Skipper, Managing Director of Peak Nutrition, said:

“We know that hair thinning and hair loss can really affect a woman’s confidence so we wanted to show that there is something customers can do about it. We hope Nourkrin Woman can not only give them some hair back but their confidence and self-esteem back. Although it has a new name, it is still the same great product!”

Nourkrin is suitable for both men and women and whilst there are no guarantees in life, the product has been clinically proven to promote the growth of existing hair and stop hair loss. Peak Nutrition also has other hair loss products available such as the Hairmax Lasercomb which has proven to be extremely popular recently.

Those that have used the tablets have seen some fantastic results and if there are people out there that are suffering with hair loss, why not give Nourkrin Woman a try; you may be surprised with the results.

Peak Nutrition also has a range of other products available to buy such as Pilfood,Nanogen and Orthomol, all available at www.peak-nutrition.co.uk

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Vital International Studies has Concluded that Aging can be Controlled

Middle aged Americans are terrified of becoming old and many say they are obsessed with coloring their gray hair. The findings of most people becoming self-conscience about aging, in spite of the old adage of “luring gray is distinguished”, are surprising findings of more than 12 months of ongoing studies, discussions and ramped up product sales of the company’s resveratrol.

In recent years, astounding results obtained in laboratories ion vertebrate and invertebrate mammals including mice and fish offer promises on many levels of health and wellness for humans. Consequently, Resveratrol has become the subject of more new scientific studies than almost any chemical compound on earth. …And for Americans, that seems to be more than suitable towards mitigating the signs of aging.

I have tried many products over the years but have never gotten the results that I am getting with your Resveratrol products!!! I have taken Vital-resV & Vital-flex as suggested -every day – two times per day for approx. 3 months.   At my recent medical checkup I got amazing results………HOORAY………THANK YOU

NICK “THE BEAR” KINZIGER

Resveratrol is a natural chemical compound found in the skin of red grapes, as well as a host of other plants and foods including mulberries, peanuts, and, of course, red wine.Resveratrol is a naturally powerful antioxidant that rids the body of free radicals. Laboratory studies have shown resveratrol protects the heart, may prevent cancer cells from forming, improves insulin sensitivity, increases the number of calories burned during exercise, and filters toxic minerals from the body.

Vital-resv.com provides consumer with the most effect form of resveratrol from its proprietary formula which includes Acai berry extract, Maqui berry extract and Grape seed extract. “The reason Vital-ResV is the most effective resveratrol, is amid the Company’s bio-enhanced technology for increased absorption”, says Chris Ingram, President at Vital International.

Vital International is working to provide consumers with a wider choice of supplements and multi-vitamin products. The Company’s Vital-ResV Resveratrol studies were comparatively mentioned on 60 minutes as featured on the Company’s website atwww.vital-resv.com.

If you’d like more information about this topic, or to schedule an interview with Chris Ingram, please call 877-500-1969 or email chris.ingram@vital-resv.com

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Vitamin D Pharmacy’s YouTube Video Surpasses the 2000 View Mark as Winter Sets in and the Hours of Vitamin D Producing Sunshine Decrease

New Life Pharmacy in Glasgow is on a mission to raise awareness of vitamin D deficiency and in turn, reduce the number of people suffering from its related health issues.

In April 2012 Elizabeth Roddick, Fellow of the Royal Pharmaceutical Society of Great Britain, pharmacist and owner of the New Life Pharmacy released a video on YouTube that explains the health risks of being deficient in vitamin D. Low levels of this important vitamin have been linked with diabetes, arthritis, high blood pressure, hypothyroidism and cancer.

More recently, studies have found that a high level of vitamin D in women under the age of 75 can decrease the risk of macular degeneration and the loss of central vision, which is a main cause of partial-blindness in people over 50 years old (Qureshah, 2012). Vitamin D deficiency can also lead to health issues and diseases such as rickets, multiple sclerosis, depression and respiratory tract infections.

Vitamin D is produced when ultra violet (UVB) rays coming from the sun hit the skin. It is then absorbed through the liver where it is converted to calcidiol. It then works to check the calcium and phosphate levels in the blood, which are important for maintaining healthy bones. Vitamin D can also be found in some foods such as eggs, oily fish and fortified cereals.

It is common knowledge that all people’s vitamin D levels drop during the winter (November to March) as the sun is weaker during this time. A recent study (Qureshah, 2012) found that during the winter 28 percent of women had deficient levels of vitamin D, and 33 percent of women had insufficient levels. Being regarded as deficient means the level of vitamin D is less than 20ng/mL, insufficient is having 20-29ng/mL. Compare this with the summer statistics where only 5% are deficient in vitamin D and the contrast is clear.

According to Roddick, the skin needs to be exposed at the hottest time of the day (between 10am and 3pm) for about 15 minutes. These are the hours where the UVB rays are strongest and so vitamin D is most prevalent. This of course completely opposes the advice given out by skin cancer charities who urge sun bathers and holiday makers to stay out of the sun during these peak hours. Roddick does add, “It is of course very important than the skin does not burn since that can lead to skin cancer.”

Roddick believes that, “supplementation is required for most people. Also, because there are certain people who shouldn’t take vitamin D and a wide range of doses are available it can be confusing. Advice needs to be available when purchasing the products.”

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Sprint Bioscience Strengthens Its Cancer Metabolism Portfolio

Sprint Bioscience, a Swedish company developing oncology therapeutics targeting cancer metabolism, announced today that it has raised money to strengthen its drug discovery portfolio.

The investment by Första Entreprenörsfonden and Almi Invest will enable the company to continue to build a pipeline of drug discovery projects within cancer metabolism.

“We are investing in Sprint Bioscience because we consider their entrepreneurial drive and their particular skills in drug development to be key success factors for the changing environment of the future pharmaceutical industry. Sprint Bioscience’s business strategy involves out-licensing or collaborating at an early stage of drug discovery to ensure that projects are developed with a focus on current and relevant market needs,” says Rune Nordlander, partner at Första Entreprenörsfonden.

Sprint Bioscience is a company founded by experienced drug hunters with an ambition to improve the drug discovery process. “We believe in small organisations with effective working procedures and collaborations throughout the sector,” says the company’s CEO and co-founder, Dr. Anders Åberg.

“Sprint Bioscience has developed an efficient, fragment-based drug discovery (FBDD) platform that can take parallel projects from initial idea to active molecules tested in cell-based systems in a very short time” Anders Åberg continues. Our goal is to align the early phase in the laboratory with pharmaceutical companies’ needs.

Targeting the metabolism in tumours provides exciting opportunities to develop drug therapies with novel mechanisms of action. This could be used to overcome the resistance that many cancer cells develop to current treatments.

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Boots UK and Macmillan Cancer Support launch new role to help millions access cancer information

According to new research* almost a third of people affected by cancer felt that they had insufficient information and support outside of their healthcare team. Boots UK and Macmillan have specially trained over 500 Boots Macmillan Information Pharmacists to help improve the lives of those affected by cancer**. They will be available in many Boots stores to help connect people to information and support in their local area.

The launch of the Boots Macmillan Information Pharmacist is the first time that the role of a pharmacist has been extended to include this type of cancer information and support. It is estimated that 2 million people are currently living with or beyond cancer in the UK and this is anticipated to increase to 4 million by 2030***. As the demand for cancer health care is set to rise, the launch of this innovative pharmacy role aims to help the millions of people affected by cancer access the information and support they need, in an accessible and trusted environment.

Ciarán Devane, Chief Executive of Macmillan, commented: “The Boots Macmillan Information Pharmacists are the next stage in what is already a strong and sector-leading partnership that we both are extremely proud of. Macmillan and Boots UK believe that by sharing expertise and working together, we can reach even more of the millions of people affected by cancer than we are currently.”

The research also showed that nearly three quarters (74%) of people living with cancer felt that the information and support they received outside of their healthcare team made them better equipped to understand their cancer experience:
– 92% felt it had a positive impact on their emotional, physical or financial well being
– 51% felt able to understand more about their cancer and their experience of it
– 48% felt able to make decisions that were right for them

Alex Gourlay, Chief Executive of Health & Beauty Division, Alliance Boots, added:
“The introduction of the Boots Macmillan Information Pharmacist means that for the millions of customers that visit Boots pharmacies across the country, they can access increased cancer information and support. The findings from this research highlight just how important accessing the right information at the right time can be for people affected by cancer and the role it can play in helping them to manage their condition.”

Visit www.boots.com/cancer to find your nearest Boots Macmillan Information Pharmacist. For cancer support contact Macmillan on 0808 808 0000 or visit www.macmillan.org.uk.

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BootsWebMD.com launches Baby Personality Quiz

BootsWebMD.com has launched a new, online Baby Personality Quiz which highlights several key traits to look out for when analysing a baby’s temperament.

With the help of the Baby Personality Quiz* on the BootsWebMD.com Children and Parenting Health Centre, users can identify their baby’s personality by answering a series of simple questions about their behaviour. The results of the quiz can then be analysed to identify their behaviour patterns. Essential information about the best approach in managing a child’s behaviour habits can also be found, with a simple step-by-step guide to keeping in sync with the baby. It could even help users to work in tandem with their child’s temperament and personality to make life easier for both parent and child.

Whether the child is feisty or easy-going, the answer to identifying its personality and behaviour patterns lies in a number of key areas. According to paediatrician Dr William Carey, author of ‘Understanding Your Child’s Temperament’, these include:

Activity/energy level – if the child has high or low energy levels, parents need to look for ways to keep them moving at a pace that’s comfortable for them Approach to newness – a naturally hesitant or shy baby will need extra reassurance and patience to overcome their shyness.

Intensity – if a baby is laid back, they can get lost in the shuffle of family life and vice versa. If the baby is intense they must be taught to deal with the curves of life

Sensitivity – if a baby has high sensitivity to lights, noise or texture, parents must be patient and look for ways to avoid sensory overload such as the lighting and the type of clothes the baby wears.

Regularity – if everything is unpredictable, potty, naps, moods, parents have to let go of their controlling ways and loosen up. Conversely, if a baby likes structure, parents might have to adhere to the schedule they crave

Persistence – puzzles are great tools to lengthen attention span, along with a daily dose of bedtime reading.

Overall mood – parents should take the time to observe their baby’s daily patterns and what makes them smile for a happier baby.

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