Category Archives: Biotech

University of Pretoria Prof. Mike Sathekge is First in South Africa to Treat Non-Melanocytic Skin #Cancer Patients with Rhenium-SCT®

Garching n. Munich, Germany, 26-Nov-2018 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today that Prof. Mike Sathekge from the University of Pretoria, Steve Biko Academic Hospital Nuclear Medical department and his clinical team has treated the first non-melanocytic skin cancer patients in South Africa with the innovative Rhenium-SCT® skin cancer treatment System. This next-generation radionuclide therapy technology applied by the nuclear medicine physician offers a new singles session, painless treatment for patients suffering from Basal Cell – and Squamous Cell Carcinomas (BCCs and SCCs).

The global incidence of non-melanoma skin cancers has drastically increased over the few past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. Approximately 80% of non-melanoma skin cancers are basal cell carcinomas or squamous cell carcinomas with South Africa having one of the highest incidence rates in the world.

Prof. Mike Sathekge and his team at the University of Pretoria, Steve Biko Academic Hospital are focused on providing patients with personalized care using state-of-the-art technology that can deliver high-precision therapy and diagnostics with minimal side effects. The specialized team of experts in the nuclear medicine and medical physics, work closely with other disciplines within the university hospital, referring physicians, and other institutions, to ensure patients receive the best possible treatment for their specific type of cancer.

Martin Magwaza, CEO of Tautomer (PTY) LTD Oncobeta®’s distribution partner for the Rhenium-SCT® in Africa, is dedicated to providing South Africans with new innovative and effective therapies across the continent, coordinating with representatives from all levels of government and state for the health care landscape.

“The start of the Rhenium-SCT® in South Africa is a significant milestone in the international expansion of our ground-breaking treatment for BCCs and SCCs.,” said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Our vision of bringing a revolutionary affordable skin cancer therapy to physicians and patients all over the world has come one step closer today”.

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™Â (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

Health Innovation Centre of Southern Denmark, Fraunhofer Institute Portugal and ProjectRay named the winners of the European Silver Economy Awards 2018

Winners of the first European Silver Economy Awards: Boaz Zilberman (ProjectRay), Anne Friis Hansen (Health Innovation Centre of Southern Denmark) and Ana Vasconcelos (Fraunhoder Institute Portugal)

BRUSSELS, Belgium, 20-May-2018 — /EPR Healthcare News/ — On Thursday May 3, the first edition of the European Silver Economy Awards has celebrated its winners under the patronage of Mariya Gabriel, Commissioner for Digital Economy and Society, and Markku Markkula, First Vice-President of the Committee of the Regions. The ceremony took place at the Committee of the Regions in Brussels and has been designed as an event that brings together key speakers and innovators from both the public and private sector.

The first prize in the category Public Authorities has been awarded to the Health Innovation Centre of Southern Denmark (Denmark) for their Generic Telemedicine Platform. The Fraunhofer Institute Portugal (Portugal) submitted a tool for fall prevention and detection (GoLive Solutions) and was the winning Non-for Profit Organisation. Introducing a smartphone solution (RAY Solutions) for visually impaired people, ProjectRay (Israel) has won in the category For Profit Organisation.

The Silver Economy Awards have been launched to recognise and reward innovative ICT solutions from all sectors, to raise awareness of the potentials of this section of the economy and to bring together European stakeholders under a common goal: supporting and improving the quality of life of older persons in society. On behalf of Commissioner Gabriel, Cabinet Member Manuel Mateo Goyet described the first Silver Economy Awards as representing a “milestone on our way towards becoming a truly age-friendly Europe”, and promoted the ceremony as “a unique occasion to send a very positive message on how we see the future of ageing” showing “the true value of collaboration in Europe”.

Celebrating the nine finalists and their dedication to making Europe an age-friendlier place, Markku Markkula, host and moral patron of the Silver Economy Awards, declares his acknowledgement: “I want them in my region”. More than 95 applications coming from 22 countries have been submitted for consideration in three awards categories referring to the type of organisation. Over 40 Silver Economy experts were involved in the three-staged evaluation process to determine Winner, Second and Third.

For more details on the winner entries and an overview of the final ranking of the first European Silver Economy Awards 2018 edition please visit www.silvereconomyawards.eu/sea/2017/awards#Winners.

SOURCE: EuropaWire

FINALLY, A REAL INNOVATION IN DENTAL CARE – THE ONLY DUAL MODE LIGHT THERAPY ELECTRIC TOOTHBRUSH LAUNCHES ON KICKSTARTER

Los Angeles, California, 2018-Mar-26 — /EPR HEALTHCARE NEWS/ — Bristl combines proven science of light therapy with sonic vibration to improve oral care. The company also offers a subscription service to replace brush heads, so having the best oral health is also convenient.

Available on Kickstarter on Monday, March 26th at 9am (PST)

The combination of Bristl’s features, convenience, and style make for true market disruption:

Gum Health
Visible Red light (620–750 nm in wavelength) has been clinically proven to heal gum tissue and prevent inflammation. The same technology is often used in skincare; Bristl is bringing it to the everyday tooth brushing routine.

Kill Bacteria
Visible blue light (450–495 nm in wavelength) has been clinically proven to kill and prevent oral bacteria that causes gingivitis and other gum disease. This safe and natural blue light is proven to be effective, and Bristl is proud to bring it to market.

Get Rid of Plaque
Bristl has three sonic vibration modes: regular, gentle, and off. Sonic vibration is recommended by dentists as it has the highest cleaning ability without damaging gums. The brush head is also particularly designed to reach in crack and crevices while letting light pass through the bristles.

A Few Stats
According to a study published in the Journal of Periodontology and Implant Science (Vol. 44: pp. 280-287), Bristl’s technology (even with only red light) was effective in achieving the following:

  • 86% reduction in bacteria that causes destruction of tooth supporting tissue
  • 117% improvement in PPD (Periodontal Pocket Depth) which indicates gum health
  • 80% improvement in CAL (Clinical Attachment Level) which is another metric for gum health

Why Us?
The Bristl Science team consists of a group of innovators and scientists looking to use advanced technology to improve everyday lives. While we of course wish to build a successful business, we are doing so responsibly; Bristl has committed to donating a percentage of every sale to America’s Toothfairy to provide underserved children with dental care. Whether a customer or an underserved child, we’re on a mission to maximize oral health everywhere.

This is just the beginning. The Bristl Science team will work tirelessly to innovate and build products that improve lives, maximize health, and promote good. The Bristl light therapy toothbrush is just the first step toward a healthier future.

Clinical backing, photos, founders quotes, and more information can be found in our Media Kit:
http://bit.ly/2HtKTJ8

Campaign Preview: https://www.kickstarter.com/projects/574806194/565862801?ref=450743&token=dbd4feaa

Via EPR Network
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Alliance Life Sciences to present expanded portfolio of pricing & market access services at the World Pharma Pricing and Market Access Congress 2018

SOMERSET, N.J. / LONDON, UK, 19-Mar-2018 — /EuropaWire/ — Alliance Life Sciences, a leading global life sciences consulting, pricing data and technology provider, announced that it is a sponsor at the World Pharma Pricing and Market Access Congress 2018 taking place March 20-21 in London, United Kingdom. As part of the largest pharmaceutical commercialization organization that services more than 300 of the industry’s top pharmaceutical, biotech and medical device companies, Alliance will present its expanded portfolio of pricing and market access services. The focus will be on pricing and reimbursement data managed by PricentricOne and pricing governance, reference and tender pricing software manage by PriceRight.

Now in its 12th year the World Pharma Pricing and Market Access Congress brings together the most innovative leaders and organizations to discuss all aspects of evidence, access and pricing. This year’s event will feature over 150 speakers and a greater range of topics being covered including Big Data & AI, rare diseases, advanced therapies and other emerging, innovative areas.

Alan Crowther, President of Global Markets noted “Alliance Life Sciences is pleased to be a sponsor of the World Pharma Pricing & Market Access congress, particularly this year. We have made a number of investments in our people and infrastructure in Europe. Our acquisition by Water Street partners in 2017 allowed us to offer enhancements in our Market Access offerings too. Europe continues to be our focus market and World Pharma Pricing & Market Access congress is a great venue to showcase our expended capabilities”.

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

MEDLAB Series Europe, 13-15 Sep 2017, will cover Point of Care Testing (POCT), Histopathology, Lab Management, Microbiology and Haematology

Spain, 04-May-2017 — /EuropaWire/ — After many years of operating successful MEDLAB events around Africa, Asia and the Middle East, Informa Life Sciences Exhibitions, the worlds leading publishing and exhibitions company, has announced that the MEDLAB Series will be expanding its presence into Europe. Taking place at the Barcelona Congress Centre in Barcelona, Spain, from 13-15 September 2017, more than 3,000 industry professionals are expected to attend Europe’s leading event for laboratory management and diagnosis.

With the European In-Vitro Diagnostics (IVD) market expected to reach USD 15.5 billion by 2024, a platform such as MEDLAB presents a huge opportunity for global laboratory industry leaders, including manufacturers, dealers and distributors, to make inroads into the European market. Housing international exhibitors and covering 2,000 sqm of exhibition space, MEDLAB Europe will give visitors from across the world an opportunity to access cutting-edge laboratory products, next-generation technology, innovative services and world-class educational content.

According to Tom Coleman, Group Exhibition Director, MEDLAB Series: “The launch of MEDLAB Europe is in line with our global expansion strategy for our MEDLAB series of events. The increasing prevalence of chronic diseases, rising geriatric population coupled with the rising awareness towards early diagnosis, has positioned the European IVD and medical laboratory market as a critical market for manufacturers, services providers, and dealers and distributors from across the globe. MEDLAB Europe will generate substantial value for our customers and partners by driving further product innovation and deeper engagement in these specific markets.”

Over the four-day event, MEDLAB Europe will also offer a multi-disciplinary congress tackling current challenges and developments key to the European market, and leveraging the true potential of laboratory testing to dramatically improve patient outcomes across the continent.

The conference programme covers five main tracks including Point of Care Testing (POCT), Histopathology, Lab Management, Microbiology and Haematology. From new methods of effective lab management to the development of techniques in detecting diseases, the conferences will also review the expanding role of the laboratory medicine and discuss partnership between a clinician and a lab professional in providing delivery of care to every patient.

“The scientific programme at MEDLAB has been carefully designed in collaboration with some of the brightest minds in the medical laboratory industry in order to have a real impact on improving the health and wellbeing of patients across the region,” said Coleman.

For more information about the MEDLAB Europe Exhibition & Congress, please visit: www.medlabeurope.com.

SOURCE: EuropaWire

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

Sway Medical’s app for sports concussion exam received European CE Mark as Medical Device

sway-concussiontest-is-a-validated-ios-app-based-concussion-management-system

TULSA, OK, 08-Sep-2016 — /EPR HEALTHCARE NEWS/ — Sway Medical is a US medical device company who’s software turns an iPhone or iPad into a mobile medical device that provides immediate medical grade, objective concussion measurement to medical professionals.

Sway Medical LLC (Sway) would like to announce its official availability in all European Union Countries. Sway was issued its CE Mark after being marketed in the United States and Canada for two years. This is significant because European sports organizations ranging from youth through pro level now have an affordable and convenient sideline assessment tool supporting concussion related medical decision making. Medical professionals and trained coaches can obtain a concussion assessment via an Apple mobile device (iPhone or iPad) and the Sway Balanceâ„¢ System web-portal. Acute objective measurements are obtained by performing a 1.5 minute balance and reaction time test protocol. Licensed athletic trainers, physical therapists and athletic therapists are able to join physicians in acutely managing the underserved market of youth sports, ages six and older.

Concussion injuries are very common in sports, often going un-reported or ignored until the obvious symptoms have incapacitated the athlete or draws the attention of a parent or coach. Second Impact Syndrome (SIS) is a serious medical condition with published mortality rates of up to 50%. SIS occurs when an athlete returns to play while still recovering from an initial concussion injury. During this time, the brain is highly susceptible to additional injury and complications. The Sway Balance™ System is able to accurately assess and track the acute and chronic outcome related to an athlete’s balance, motion reaction time and concussion symptoms. The Sway Balance™ System provides a graphical representation comparing suspicious injury event tests against a pre-injury “normative” or baseline score. The comparison of event tests against an established baseline is a common measurement for traumatic brain injury diagnosis and recovery tracking.

The Sway Balance™ System is available for purchase by licensed medical professionals involved in school, occupational or sports medicine through www.swaymedical.com. Additional protocols are available to assess an individual’s “Fall Risk” or “Functional Status”.

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

 

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Regenexx Announces the Publication of “Orthopedics 2.0 – How Regenerative Medicine and Interventional Orthopedics will Change Everything” on Amazon Kindle

Broomfield, CO, February 02, 2015 — /EPR HEALTHCARE NEWS/ — With more than 40,000 downloads, “Orthopedics 2.0 – How Regenerative Medicine and Interventional Orthopedics will Change Everything” is now available on Amazon Kindle. The third edition of the top-selling e-book is being offered as a free download through Jan. 6, 2015.

Written by Dr. Chris Centeno, this e-book delves into the human musculoskeletal system and explains how everything works together in concert to maintain our physical wellbeing. When a single component in this chain is damaged, it can lead to a cascade of joint, spine and connective tissue problems, resulting in chronic pain.

Using the Regenexx SANS approach, Orthopedics 2.0 walks you through a series of tests and exercises that you can do on your own to better understand where your own body is struggling to maintain proper stability and alignment, explaining the possible reasons and long term implications along the way. Orthopedics 2.0 also explores how Regenexx is pioneering the new field of Interventional Orthopedics, where the use of regenerative biologic treatments, such as adult stem cell therapy and platelet rich plasma, are being used to help repair and strengthen damaged tissues, as opposed to invasive surgeries that often remove important tissues when a joint or the spine becomes damaged.

With hyperlinks to more detailed information, related studies and commentary, this book condenses a vast amount of data and resources into an enjoyable and entertaining read.

About Regenexx
Since its genesis in 2005, Regenexx has been a world-leader in the use of adult stem cell treatments for orthopedic conditions, providing non-surgical, biologic therapies delivered with high accuracy through a needle. Regenexx has collected and published more data on stem cell patients than any other company and are dedicated to reinventing orthopedic care to help patients avoid invasive surgery.

Featured on television and media outlets such as the Doctors TV show, ABC News, Good Morning America and many others, Regenexx is taking orthopedic stem cell therapy to an exciting new level.

For more information about this e-book or to talk with a Regenexx Liaison, please call 888-525-3005 or email info@regenexx.com. Visit Regenexx online at:http://www.regenexx.com/

Contact-Details: Regenexx
Contact: Mark Testa
403 Summit Blvd., Suite 201
Broomfield, CO 80021
Phone: 888.525.3005
Email: info@regenexx.com
Web – http://www.regenexx.com/

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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

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ViroCarb’s anti HIV Crowd Funding Campaign

Toronto, Canada, December 01, 2014 — /EPR HEALTHCARE NEWS/ — ViroCarb Inc. has launched a worldwide crowd funding campaign to promote the development of its new HIV infection inhibitor.

WORLD AIDS DAY – Make a donation to save lives from AIDS! Support new treatment development at: https://www.indiegogo.com/projects/funding-a-new-therapy-against-drug-resistant-hiv/x/9240077

Despite the great progress made in HIV/AIDS treatment, there is still an urgent need for new drugs, particularly for people who have had to abandon existing treatments due to HIV drug resistance and side effects.

The current treatment of HIV/AIDS involves the use of three or more drugs from five main general classes, used in combination. While this antiretroviral therapy (ART) has helped to reduced morbidity and mortality from AIDS, long term toxicity and the emergence and transmission of drug resistant HIV strains limit the effectiveness. Thus, despite therapy which can render this a chronic, rather than acute fatal infection, development of new drugs to prevent infection and overcome drug resistant strains, is increasingly urgent.

ViroCarb Inc. is developing a novel technology that addresses infections by drug resistant HIV strains. Developed from the identification of a new, natural resistance factor against HIV infection by scientists at SickKids and Canadian Blood Services, ViroCarb’s inhibitor works against a previously overlooked target on the virus to block HIV from entering human cells, the very first step in the infection. It works against all HIV strains.

Funds are needed to aid in moving forward to support preclinical studies; therefore ViroCarb Inc. has started an international crown funding campaign to carry out these HIV model studies needed before conducting clinical trials.
Please support this new way to block HIV.

Contact-Details: Dr. Mario Huesca
479 Simonston Boulevard.
Thornhill ON.
L3T 4M4 Canada

Facebook: https://www.facebook.com/ViroCarb;
Website: http://www.virocarb.com

 

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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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The End of Alzheimer’s? A revolutionary scientific advance to the cure

Interface Dynamics Control Corporation (IDCC) has completed the first phase of its decade-long Advanced Therapeutic Interventions Project, with the result that a new approach to arresting and curing Alzheimer’s disease and the other neurodegenerative diseases has been produced and verified. IDCC is now launching the Project’s second phase, which will validate the first phase findings.

Alzheimer’s disease is the sixth leading cause of death in the United States, with more than 5.1 million Americans currently affected. The direct cost of Alzheimer’s is greater than $200 billion annually, a number expected reach between $1.2 and $1.5 trillion by 2050. Indirect costs are substantial: more than 15 million caregivers delivered some 17.5 billion hours of unpaid care valued at more than $200 billion.

IDCC has discovered the mechanism of and means to control the protein misfolding, abnormal aggregation, and degradation processes associated with the degenerative and prion diseases. That mechanism is also implicated in the failure to clear toxic intracellular proteins and in the dysfunction of apoptotic (programmed cell death) pathways. It underlies the adverse functions of the neuroglia (glial cells), including microglia, which provide immune defense to the central nervous system (CNS) and maintain homeostasis and protection for neurons in the brain and the peripheral nervous system.

The process of neurodegeneration has not been understood previously, which has precluded the production of any arresting or curative procedures or drugs. The Project’s findings, however, should lead to the realization of a new class of curative procedures and pharmaceuticals which can be engaged to defeat the disease-initiating neurodegenerative insult, thereby introducing the possibility of preventing these devastating diseases. There are direct implications for the human cancers, but verification of those implications must await further experiments.

The first major activity under the Project’s second phase will be the production of a new class of active imaging system. That system will be utilized to demonstrate the activities and accessible control points of the process pathways which, when certain abnormal events occur, trigger the incipient causal mechanisms of disease. The Project is currently developing the staff and capitalization required for execution of its second phase.

About IDCC 
IDCC was founded thirteen years ago to produce definitive solutions to seemingly intractable problems of social and technological significance. It is privately held and maintains its projects and client identities in strict confidence unless and until information releases are authorized by competent authority.

Contact Details: Peter W. Atkinson
IDCC
4655 Logsdon Drive
Annandale, VA 22003-3564 USA
+1.703.879.7065
Peter@InterfaceDynamicsControl.com

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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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Innovative Drug Discovery Business, Biosortia Pharmaceuticals, Lands Two Health Care Veterans

Kurt Dieck formerly SVP of Strategy and Business Execution at Cardinal Health, will lead early stage drug discovery business at Biosortia Pharmaceuticals. Dieck was named President and CEO in November 2012 and has quickly identified other key executives, including Dr. Guy Carter, former Natural Product head at Wyeth Pharmaceuticals, as his Chief Science Officer. In conjunction, other collaboration partners have joined the team, including NOAA (National Oceanic and Atmospheric Administration), NCI (National Cancer Institute) and key universities, to strategically accelerate the development of novel drug leads in the therapeutic areas of cancer, infectious diseases, inflammation and neurological disorders. Biosortia Pharmaceuticals has seen promising early results with dozens of novel compounds having already been requested, and are under evaluation with NCI and Eli Lilly.

Dieck has spent nearly 30 years in healthcare, including 18 years at Arthur Andersen as a global equity partner and then 10 years with Cardinal Health, a Fortune 20 public company, as a senior executive; there he worked with a broad spectrum of partners, including brand pharmaceutical manufacturers, throughout the supply chain. Dr. Guy Carter has over 30 years of experience working in pharmaceutical R&D, primarily in the discovery and development of microbial natural products. He previously was the leader of natural products drug discovery at Wyeth Research, as head of the Chemical Technologies Department.

“Kurt and Guy make a great team. Their complementary Pharma experiences and backgrounds create great opportunities to accelerate Biosortia’s objective to become the premier, aquatic natural products company with a primary focus in drug discovery,” says Ross Youngs, Biosortia’s Founder and Chairman. “Kurt and Guy bring a wealth of research and business experience along with deep industry relationships in building successful Pharma partnerships. Everyone involved with this young biotech is excited about the future.”

Industry observers have commented that late-stage R&D pipelines are not providing Pharma with the desired revenue growth the market is expecting. Therefore, large Pharma is evolving the way it performs R&D in order to optimize efficiency and to boost patent cliff defenses. These changes require shifting from relying solely on in-house chemistry-based R&D to acquiring and licensing external technologies and natural products based compounds in various stages of development. Biosortia’s ability to supply novel, highly active and potent compounds with drug-like characteristics will increase the productivity and success rate for Pharma as well as reduce the overall cost of the discovery process. The cost to discover, develop and launch a new drug is estimated to reach nearly $3B per drug by 2015. Biosortia’s business model is designed specifically to support Pharma’s needs.

“With nearly unlimited microorganisms (3.7 nonillion), the aquatic environment and its consortia represent an extraordinary opportunity…a new frontier, to access extremely potent and chemically diverse secondary metabolites with drug-like properties with unique mechanisms of action never researched before,” said Dieck. In describing the opportunity, Dieck goes on to say, “Biosortia is on the cutting edge of natural product discovery
and has the capabilities to deliver on its aspiration. Our powerful natural products research team, led by Dr. Guy Carter, in partnership with NOAA’s Dr. Peter Moeller, a leader in aquatic natural products research, has the experience and know-how to decipher the complex unexplored environment in a very efficient manner leveraging all the current state of the art instrumentation. The need for more efficient and effective approaches to drug discovery has never been more important. Biosortia’s innovative technologies, deep research skills and key relationships will efficiently provide thousands of unique natural products as candidates for drug discovery at a time when Pharma is in critical need for “high quality shots on goal.”

“Aquatic microbial consortia are a rich source of metabolically active organisms including microalgae, bacteria, fungi and their secondary metabolites,” states Carter. “Owing to the competitive nature of their habitat, chemical investigations of microbial consortia reveal unique structurally diversified natural products that are responsible for signaling and self-defense that have potential as therapeutics with novel mechanisms of action. Since they have been pre-optimized by nature, these compounds are typically closer to a drug candidate than a synthetic lead, thus requiring less optimization and shorter time when found as ‘hits’ in screening programs.”

The team has also focused on agreements with strategic collaboration partners as vital components to the strategy. Biosortia has recently entered into several collaboration agreements with NOAA, Analyticon and exclusive harvesting relationships, just to name a few. Several others will be advanced by the end of January. Biosortia’s cooperative research and development agreement (CRADA) with NOAA’s Center for Human Health Risk at Hollings Marine Laboratory provides a 5-year framework for research and development regarding the analysis and purification of novel bioactive compounds. According to NOAA’s Technology Partnerships Office, “Success will result in the commercial development of new and unique chemical compounds from the sea which have benefits to human health, either through disease prevention or new treatments for disease.”

Dr. Peter Moeller, NOAA’s Research Scientist who leads the Toxins Natural Products Program stated after analyzing fractions of Biosortia’s biomass, “Coupling NOAA’s mission of characterizing toxins affecting environmental and/or human health with Biosortia’s drug discovery focus turns one man’s toxin into another’s chemotherapeutic. The microorganisms analyzed in the Biosortia biomass identified more unique activity than I have seen in my 30 year career. The volumes achieved from a single harvest delivered an equivalent of 30 years of accumulation. This could materially change the landscape for natural products drug discovery research.”

As of December 31, 2012, Biosortia has identified more than 30 bioactive candidate compounds (hits) from a fresh water eutrophic lake consortium. Therapeutic areas of focus include treatments for cancer, infectious diseases, inflammation and neurological disorders. In addition, more than a dozen of its patent protected compounds are in initial evaluation stage within Eli Lilly’s Open Innovation Drug Discovery Program.

Dieck states, “Looking forward, it is with great optimism. We have a great team built around mutual respect, deep experience, and a desire to succeed and make a difference. We are aligning with the right partners and collaborators to execute our strategy with speed and discipline to provide Pharma with much high quality & diverse compounds vs. “me-too” drugs than they have had in the past 10 years. We are excited about what this company can accomplish, not only for its shareholders but also for the millions of people who have been diagnosed with various forms of chronic diseases who are looking for Pharma to identify better ways to help them extend their lives or live a more productive life. Biosortia can play a big role in identifying compounds that can help Pharma achieve these goals. I am looking forward to the challenge and opportunity to build an industry leading drug discovery company.”

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Microtissues® Inc. and Sigma-Aldrich® Sign Worldwide Supply and Distribution Agreement for the 3D Petri Dish®

Microtissues® Inc. announced today the signing of a Supply and Distribution Agreement with Sigma-Aldrich® Corporation (Nasdaq: SIAL) for the worldwide sales and marketing of the 3D Petri Dish®, a new technology for the culture of living cells in three dimensions (3D). Invented at Brown University, the 3D Petri Dish® maximizes cell-to-cell interactions critical for replicating the function of natural tissues and organs. Shown in numerous peer reviewed papers to work with over fifty different cell types, including cell lines, primary cells and stem cells, the 3D Petri Dish® has applications in cancer research, drug discovery, toxicity testing and regenerative medicine.

“Researchers are rapidly recognizing the importance of 3D cell culture and its ability to reliably mimic in vivo function” said Brian Morgan, Director of Business Development, Microtissues® Inc. “The 3D Petri Dish® creates a natural 3D environment without artificial scaffolds and we’re excited that this distribution agreement will bring our unique and innovative line of products to the worldwide research community.”

Unlike the conventional plastic Petri dish where cells are grown as a thin layer on the surface of the dish, the 3D Petri Dish® forms 3D aggregates of cells. Spheroid size is controlled by the number of cells seeded and hundreds of uniform sized spheroids are formed in a single pipetting step. Spheroids are formed in a well ordered array in a stable platform suitable for long term culture. All spheroids are positioned on the same optical plane making them easy to image (phase contrast, fluorescent). Spheroid size is controlled by the number of cells seeded and a mixture of cells forms mixed spheroids, suitable for investigating tumor-stroma interactions. Spheroids can be grown from single cells, applicable to the study of cancer stem cells. For histology, Western blots and RT-PCR, spheroids are harvested by simply inverting the 3D Petri Dish®. No need to dissolve or digest the gel. The 3D Petri Dish® is a new fundamental tool for the world wide industry of life sciences research.

About Sigma-Aldrich®: Sigma-Aldrich® is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich® customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 38 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich® is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich®, please visit its website at www.sigma-aldrich.com.

About Microtissues® Inc: Microtissues® Inc. is a privately held company located in Providence, RI, advancing technologies and applications of 3D cell culture. Microtissues®, Inc.’s products are designed to serve the needs of researchers in a wide range of areas including cancer research, stem cell biology, toxicity testing, developmental biology, drug discovery, regenerative medicine and tissue engineering. Microtissues®, Inc. has an exclusive worldwide license from Brown University to US and international patent applications on the 3D Petri Dish®. For more information on Microtissues®, Inc., please visit www.microtissues.com.

Sigma-Aldrich and Sigma are trademarks of Sigma-Aldrich Co. LLC registered in the US and other countries. Microtissues and 3D Petri Dish are registered trademarks of Microtissues, Inc.

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Is it a Moment or an Abuse: the Boom of iPSCs Research after 2012 Medicine Nobel Prize

On Creative Biomart website, we can read a report about the 2012 Nobel Prize in Physiology or Medicine regarding the two winners. They bring hope for organ or tissue repair for human or even for rejuvenation, i.e. for long life through induced pluripotent stem cells (iPSCs).

Since the first appearance in 2006, iPSCs became the hit and focus. But there are still lots of unknowns waiting for us before achieving the ideal status. Thus, numerous scientists, researchers and businessmen are struggling and investing for that goal. Here are some examples:

On Dec. 5, 2012, Roche (SIX: RO, ROG; OTCQX: RHHBY) and the Innovative Medicines Initiative (IMI) announced today the launch of StemBANCC, a new academic–industry partnership that unites ten pharmaceutical companies and 23 academic institutions. Initiated and coordinated by Roche and managed by Oxford University, StemBANCC aims to use human induced pluripotent stem cells as research tools for drug discovery with the goal of using this ground-breaking new technology to develop human disease models and enhance drug development.

On Oct. 29, 2012, on the PANS Journal there is an article about Cartilage tissue engineering using differentiated and purified induced pluripotent stem cells.

On Oct. 4, 2012, on Cell Stem Cell, there is a report with the title be Genome Sequencing of Mouse Induced Pluripotent Stem Cells Reveals Retroelement Stability and Infrequent DNA Rearrangement during Reprogramming.

On Jan. 30, 2012, on the PANS Journal, there is a report about modeling hepatitis C virus infection using human induced pluripotent stem cells, which make the individual and tailor therapy further.

Above are only a small part of such studies. People still wonder does it is the moment or an abuse on the iPSCs research. When someone reviewed one of the winners, Shinya Yamanaka, about his opinion on the challenge of iPSCs research, he said, “I have two research directions, the first is to establish human iPSCs bank that comply with clinical application standards. The second is to study the cell mechanism of iPSCs regenerating. And I think the current threat is still to be the safety problem as good research respects both scientific and ethical standards.”

But no one deny the great potential of iPSCs.

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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 Ã…berg.

“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 Ã…berg 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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