Tag Archives: Medicine

Exopharm: exosomes seen as an alternative to lipid nanoparticles (LNPs) and adeno-associated viral vectors (#AAVs) for targeted multi-dose delivery of modern medicines and vaccines

MELBOURNE, Australia, 3-Feb-2022 — /EPR HEALTHCARE NEWS/ — Australian technologist Dr Ian Dixon founded Exopharm in 2013 with the vision to harness the unique properties of exosomes as a new class of medicine. Dixon’s decisive early entry into exosome therapeutics is now bearing fruits.

Less than 10 years after its founding, Exopharm possesses a granted US patent for its key exosome manufacturing technology, LEAP™, and has run successful first-in-human clinical trials demonstrating the safety of its exosome products.

Exosomes have the potential to revolutionise medicine in many areas, including delivery of gene therapies into cell nucleus for rare and common genetic disorders, improving therapeutic window of small and large molecules by cell targeting, and by selective cellular delivery of next-generation DNA/RNA products.

In 2022, excitement around exosomes has converged on exosomes as an alternative to lipid nanoparticles (LNPs) and adeno-associated viral vectors (AAVs) for targeted multi-dose delivery of modern medicines and vaccines. Drug delivery accounts for a significant slice of the global pharmaceutical industry spend –around US$160b p.a. and growing strongly – and exosomes represent nature’s way to deliver a bioactive cargo into cells efficiently and safely.

Primed for growth

Dixon’s establishment of a specialist exosome medicines company has been followed by US based Codiak Biociences in 2015 (established by Arch Ventures) and Oxford based Evox Therapeutics in 2016. Today, only two dedicated exosome companies are listed on the public markets: Codiak (NASDAQ: CDAK) with a market cap of around US$200m; and Exopharm (ASX: EX1) with a market cap of around A$73m at the time of writing this article.

The field of exosome medicines is attracting the attention of financiers and pharmaceutical industry leaders. In late 2021, multinational pharmaceutical manufacturing services company Lonza jumped into exosome manufacture, a sign that they see big things over the horizon.

Over the past 9 years, Exopharm has grown and evolved but remains true to Dixon’s vision of exosome medicine development. The company now employs around 40 people most in its Melbourne, Australia, facility. Exopharm has built a toolbox of exosome technologies and knowhow which, in addition to the LEAP™ scalable exosome manufacturing platform, includes exosome analytical tools (Exoria) and technologies to load exosomes with a specific therapeutic cargo (LOAD) and target exosomes to select cells (EVPS).

Our business development team is attracting the attention of similar innovative biopharmaceutical and biomanufacturing companies, and validating the Exopharm technologies via collaboration research agreements.

Exopharm is not simply a technology company, however. Exopharm is pursuing a pipeline driven platform technology strategy, on the way to generating a revenue stream from technology out-licensing while developing its own exosome medicines for selected markets. More news on its pipeline products is expected to be ready for release later in CY ’22.

The Exopharm team has grown and changed to becoming more international in focus, improving on messaging and communications with the wider pharmaceutical industry. In 2021 Dr Jenn King joined the Board of Exopharm, bringing a wealth of big pharma and US biotech experience with her.

In 2022 we look to engage with more experts, as members of our advisory panels, as consultants, executives or Key Opinion Leaders. Please reach out to us if you want to be part of our vision.

At the company’s 10-year anniversary in late 2023, Exopharm will be a key part of the exosome medicines revolution.

SOURCE: EuropaWire

First Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany done by Dr. Lutz-Hendrik Holle

HANAU, Germany, 4-Oct-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that Dr. Lutz-Hendrik Holle, Medical Director of the interregional professional association for nuclear medicine in Hanau, has accomplished the first Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany. This state-of-the-art technology of local radionuclide therapy offers a painless and non-invasive treatment option for patients with basal cell carcinoma and squamous cell carcinoma (BCC and SCC) and the interregional professional association for nuclear medicine Hanau is the first center in Germany that offers the Rhenium-SCT®.

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods. The key argument for the expansion of the spectrum was that the Rhenium-SCT® is a new, painless and highly efficient treatment option that also delivers excellent cosmetic results. Besides being a painless alternative to other procedures, the Rhenium-SCT® also allows the treatment of numerous NMSC lesions consecutively in a single session, which was already realized during the first treatment in Hanau. This has also attracted international attention so that an American patient travelled to Hanau for the treatment.

“This therapy is particularly suitable for tumor localizations where good cosmetic results are to be achieved. The fact that the treatment is completely painless and can be performed in just one session is a great advantage”, says Dr. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are very happy and proud to be able to offer our revolutionary treatment to patients in Germany now. The interregional professional association of nuclear medicine in Hanau is an excellent partner for NMSC patients in the fight against NMSC”, said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Unfortunately, Germany is one of the countries that has experienced a drastic increase in newly diagnosed NMSC cases in recent years. Our highly qualified team strives to provide physicians and patients with a non-invasive and affordable solution to treat NMSC, while focusing on the needs of the patient.”

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In certain analyzed areas of Germany there was an increase in the incidence between the year 2005 and the year 2014 by about 30%1. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application in most of the cases, applied in one single session with excellent aesthetic outcomes.

Via EPR Network
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2019 Red Herring North America Top 100 Winner: New recognition of OncoBeta’s success in developing and providing an innovative therapy for non-melanoma skin cancer patients

Pasadena, CA, U.S.A., 6-Jul-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that it was honored as a Red Herring Top 100 North America Award winner recognizing the continent’s most exciting and innovative private technology companies. After being recognized with the Red Herring Top 100 Europe Award earlier this year, this is now the second recognition obtained by Red Herring.

The winners, celebrated at a special awards ceremony at the Westin Pasadena hotel, have been chosen from thousands of entrants, whittled down to hundreds making the trip to California. The ceremony, led by Red Herring chairman Alex Vieux, was preceded by two days of keynote speeches, discussions and finalist presentations.

Companies were judged by industry experts, insiders and journalists on a wide variety of criteria including financial performance, innovation, business strategy, and market penetration. Winners ran the gamut of verticals, from FinTech and Marketing to Security, IoT, and many more industries.

Red Herring’s editors have been evaluating the world’s startups and tech companies for over two decades. It gives them the ability to see through the industry’s hype to pick firms that will continue on a trajectory to success. Brands such as Alibaba, Google, Kakao, Skype, Spotify, Twitter and YouTube have all been singled out in Red Herring’s storied history.

“2019’s crop of Top 100 winners has been among our most intriguing yet,” said Vieux. “North America has led the way in tech for so many years, and to see such unique, pioneering entrepreneurs and companies here in California, which is in many ways the heartland of the industry, has been a thrilling experience.”

“What has excited me most is to see so many people forging niches in high-tech and cutting edge sectors,” added Vieux. “Some of the technical wizardry and first-rate business models showcased here at the conference has been fantastic to learn about. We believe OncoBeta® embodies the drive, skill and passion on which tech thrives. OncoBeta® should be proud of its achievement – the competition was incredibly strong.”

“Being named as one of the Red Herring’s Top 100 North America award winner in addition to the Top 100 Europe is a great honor for us.” states Shannon D. Brown III, CEO of OncoBeta®. “The spirit of the award aligns perfectly with our team’s mission in the fight against non-melanocytic skin cancer (NMSC) with the Rhenium-SCT®.”

The complete list of the 2019 Red Herring North America Top 100 Winners can be found here in alphabetical order: https://www.redherring.com/2019-rhna-top100-winners/

Red Herring’s press release is available online at https://www.redherring.com/red-herring-2019-top-100-north-america-winners-press-release/

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

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 Gorilla Releases Mobile Application for Doctors

Digital Health Leader Expands Marketplace Access with Mobility

SUNNYVALE, CA., 2014-8-20 — /EPR Healthcare News/ — Health Gorilla™, Inc., the first online healthcare marketplace to connect doctors and clinicians with over 9,000+ diagnostic labs and 35,000+ radiology centers, has announced today the release of Health Gorilla mobile.  Health Gorilla mobile provides access to the Health Gorilla Marketplace through the Apple® iPhone® and iPad™.

Today over 68% of doctors have standardized on the Apple platform to communicate with peers and patients. Doctors can now use their mobile devices to place electronic orders with Health Gorilla mobile to diagnostic labs, radiology centers, physical therapy, skilled nursing facilities (SNFs) and durable medical equipment (DME) and other medical providers nationwide with the ability to track and review the results instantly as they arrive.  Physicians can then forward electronic results within their practice or exchange them with peers and patients to streamline the process and improve quality of care.

According to a study published by the New England Journal of Medicine noted that approximately 59.3% of all of a primary care physician’s daily emails were for the interpretation of test results and 21.7% were responses to patients.  The use of email generally increases the risk for doctors and their patients as most email services are not HIPAA compliant.

Another study published in the Journal of the American Medical Association (JAMA) reported that researchers from the Michael E. DeBakey Veterans Affairs Medical Center in Houston conducted a survey of primary care practitioners and found that a third reported missing alerts about test results from an electronic health record notification system designed to inform them when a patient has abnormal test results.

Doctors are adopting iPad and iPhones as the platform of choice to communicate with peers and patients. Health Gorilla mobile integrated messaging greatly reduces the risk in communication between a doctor and their patients by offering a fully HIPAA compliant environment. Health Gorilla mobile enables a physician to securely and compliantly forward diagnostic test results, radiology images, admission and discharge summaries and other clinical documents to patients and care coordinators through secure messaging.

Benefits of Health Gorilla Mobile Include:

  • HIPAA compliant and ONC modular certified MU2 solution
  • Order in less time than it takes to use fax forms
  • Receive results faster wherever you are
  • Forward results to patients instantly
  • Immediately refer results to another doctor and send messages
  • Eliminate error prone paper processes
  • Mobile solution available at no charge for doctors and their teams

“We believe that the value proposition is clear and compelling for doctors and their teams.” said Steve Yaskin, Chief Executive Office, Health Gorilla, Inc.  “The existing process is heavily dependent on paper, fax and manual processing.  It is slow, cumbersome and prone to error.  Doctors can better manage their time, and the time of their administrative and care coordinating teams, by using the power of the marketplace through the Health Gorilla app.  Now they have one place to order from any diagnostic lab, radiology center, hospital, physical therapy, sleep center, SNF and other healthcare providers in the United States.  A doctor can start with us the first day and begin ordering through the marketplace immediately.  Health Gorilla is the first to deliver this capability.  No other vendor can provide this benefit.”

Health Gorilla mobile is available as an approved Apple® enterprise application and will be distributed to existing Health Gorilla Marketplace users via a secure link for the next month.  In September Health Gorilla mobile app will be available from the Apple® store and will be fully integrated with the Apple® Health app upon its release.

About Health Gorilla
Health Gorilla™ is the first online healthcare marketplace to connect all doctors and clinicians with over 9,000+ diagnostic labs and 35,000+ radiology centers.  Doctors and their teams can instantly place orders, get results, and completely eliminate paper faxes. Uniquely, our HIPAA compliant and ONC modular certified MU2 solution is available immediately at absolutely no charge for doctors and clinicians.

Watch our 2 minute video Intro to Health Gorilla: http://youtu.be/6Luo5eNG8-s
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Facebook: https://www.facebook.com/healthgorilla
LinkedIn: https://www.linkedin.com/company/2542523?
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Contacts

For additional information contact Joe Austin via jaustin@theventanagroup.com or call 818-332-6166.

Health Gorillaâ„¢ is a trademark of Health Gorilla, Inc.
Apple®, iPhone®, iPad mini™ are trademarks of Apple, Inc.

Health Gorilla Releases Mobile Application for Doctors
Health Gorilla Releases Mobile Application for Doctors

New Book, “Bush Medicine of the Bahamas” is the 2012 Recipient of Mary W. Klinger Book Award for Outstanding Book of the Year

Ethnobotanist, Jeffrey H. McCormack, Ph.D., says that what makes “Bush Medicine of the Bahamas” unique is its innovative, multi-faceted, cross-cultural approach that integrates oral history with botany, anthropology, and pharmacology. Its integrative approach and readable style make it especially appealing to Caribbean travelers, herbal practitioners, and educators. It also serves as a guide to medicinal flora.

The residents of the Bahamas practice a form of traditional medicine using tropical plants for curing diseases and treating ailments. On his website (http://www.bushmedicine.org) lead author, Jeffrey H. McCormack, Ph.D., writes that the enslaved African ancestors of the Bahamian people brought to the New World a practical knowledge of medicinal plants, and a legacy of “medicinal plant literacy” that helped them “read” and recognize the potential healing qualities of the many new and unfamiliar plants of the Bahamas. Under the influence of European and colonial practices, their diverse beliefs and healing practices were then simplified, distilled, transformed, reformulated, and further refined by generations of experimentation. This distinctive form of medicine is of value today for what it tells us of a unique culture, traditional healing, and the therapeutic value of their plants.

“Bush Medicine of the Bahamas” is the recipient of the 2012 Mary W. Klinger Book Award for outstanding book of the year, awarded annually by the Society for Economic Botany. The book has also been selected for the 19th annual Virginia Festival of the Book held in Charlottesville, Virginia, March 20-24, 2013.

Dr. McCormack says that the book is a comprehensive treatment of Bahamian bush medicine, dedicated to the preservation and continued use of this knowledge before it is lost. Chapters explore the cultural roots, principles, and practice of bush medicine. The materia medica covers 120 medicinal plants and 22 non-botanical remedies, including details of administration and dosage, pharmacology, and cross-cultural uses of bush medicine. Throughout the book, colorful oral histories provide details of the healers’ practices and glimpses of the culture of San Salvador Island in the Bahamas. What makes the book sing are the oral histories and personal stories. As internationally-celebrated nature writer Gary Paul Nabhan has written, “… what beautiful stories they are, some of them with healing power in their own right.”

This book can also serve as a field guide to medicinal flora and will therefore be of interest to nature-minded travelers throughout the Caribbean. Currently, it is available through several distributors in the Bahamas and U.S., and online at http://www.bushmedicine.org/orders-retail.html

Published by JHM Designs Publications, Charlottesville, VA, this is a large hardcover book (9” x 12” x 1”) of nearly 400 pages, including 161 illustrations (104 in color). Additional illustrations include photographs of bush medicine practitioners and island landscapes where they harvest their plant medicines. A dictionary of Bahamian dialect is included in the appendix. There are four indexes including common name, scientific name, subject index, and index of medicinal plants according to principal uses.

Excellent advance reviews from Gary Paul Nabhan, James A. Duke, Rosita Arvigo, and Roy Upton. For example: “This is the most comprehensive and richest ethnobotanical presentation on traditional bush medicine that I have seen …”

The lead author, Jeffrey Holt McCormack, Ph.D., is formerly a faculty member at Middlebury College, and the University of Virginia. Trained in natural products chemistry and physiological plant ecology he has worked in the fields of sustainable agriculture, genetic preservation, plant breeding, and ethnobotany. Co-author, Kathleen Maier, P.A., RH, is a nationally known herbalist, and recipient of the first Medicinal Plant Conservation Award bestowed by the United Plant Savers. Co-author, Patty Wallens, M.A., has a background in medical interviewing and home-based counseling.

Via EPR Network
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HGH Supplement Review Is Now Available Online

The website gives you the HGH Article and details regarding supplements that provide a great amount of energy to the body within a very short time period. The website gives the information regarding the material content of these hormones supplements and how they are useful to the health. The Gen F20 is such a hormone supplementary that is available now on the website.

HGH Supplement Review Is Now Available Online

MR James Smith just went to the website and find the best appropriate supplementary for himself. He believed on homeopathic medicine and he found something available on the website that can suit his need. He said that the” homeopathic supplementary available on websites are having no-side effects and it can be also easily diluted with water to reduce its effect so that it can be remain less effective for a person having problem regarding heavier dose”. Just go to the website and read the contents and reviews regarding the supplementary, these reviews will tell you that how much will this medicine is good for you or will it be beneficial for you using this supplementary? The Gen F20 gives you high amount of hormones which the pituitary glands are unavailable to produce. He also added that “These supplements can be taken irrespective of the age and sex of the person consuming it”. The website will offer all the details related to these and you will get the appropriate supplementary for yourself on the website with a special discount and a review regarding it.

The reviews regarding your supplementary can be easily found out at the website. For instant if you want to have the information regarding the C9Hgh then you can just go to the website and see the reviews of these medicines. The review also contains the experience of the people who have used this medicine and the effects they have got after using this medicine. The website reviews gives you the best deal that you can get online. The online website is made more users friendly and easier so that the person can easily interact and find the appropriate thing for himself.

Via EPR Network
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IS Clinical Improperly Using Phytoceuticals Inc Proprietary Research To Sell Products With Proven Quality Issues

PhytoCeuticals, Inc., strongly cautions its customers that some claims being made by IS Clinical about their products improperly uses scientific publications, clinical trials and research that are the exclusive property of PhytoCeuticals, Inc. and its founder, Dr. Mostafa Omar.

Dr. Mostafa Omar, PhytoCeutical’s president, is the highly respected developer and manufacturer of proprietary skin care formulations and the inventor of Stable Liquid L-Ascorbic Acid (Vitamin C).

PhytoCeuticals has developed several formulations, including stabilized liquid L-Ascorbic Acid in 1994. The company had distributed these products through Cellex-C, SkinCeuticals and IS Clinical. PhytoCeuticals permitted these companies the use of these scientific publications, clinical trials and research citations to support the marketing of PhytoCeuticals formulations.

PhytoCeuticals terminated its relationship (July 1, 2008) with IS Clinical by Innovation Skincare (Science of Skincare Inc.). Therefore IS Clinical no longer distributes any products using PhytoCeuticals formulations.

In addition, these companies surrendered the rights to use this materials for advertising and publicity claims. The only legal use of these studies is to support the sale of products formulated or developed by Dr. Omar and PhytoCeuticals, Inc.

PhytoCeuticals continues to retain the ownership of all its proprietary formulations, as well as the scientific research, publications, patents and grants from National Cancer Institute (NCI) and National Institute of Health (NIH).

Since the termination of the business relationship, PhytoCeuticals has received numerous requests from customers who have purchased IS Clinical products, (which do not contain PhytoCeuticals formulations) to exchange these IS Clinical products for genuine PhytoCeuticals PHYTO-C products.

Dr. Omar has stated that, “The acceptance of exchanges of IS Clinical new products for PhytoCeuticals PHYTO-C products was initially a courtesy to patients who thought they were still purchasing our formulations. It is my ethical duty to help and treat these patients – which is more important then making a profit. But we must be fair.”

NEW POLICY
Any purchaser of IS Clinical skincare products who is dissatisfied, should return these products to IS Clinical directly for refunds or substitute products. PhytoCeuticals has no responsibility and does not guarantee IS Clinical products.

PhytoCeuticals is currently is unaware of any controlled clinical testing, stability testing or research undertaken by IS Clinical with respect to the products it has been selling since July 1, 2008.

Dr. Mostafa Omar stated, “Normally a clinical study and testing of a new formulation takes at least 5 years or more before a product is launched into the marketplace. To the extent that IS Clinical claims that it has undertaken extensive research in connection with its products, customers should confirm that the research cited is genuine and not proprietary research using authentic PhytoCeuticals formulations.”

ABOUT PHYTOCEUTICALS
PhytoCeuticals, Inc. is the market leader in antioxidant skin care products. Established by Dr. Mostafa Omar and based in the United States, the company was awarded NCI grant #1 R43- CA83538-01A1 for “Prevention of UV Photoinjury in Skin by Antioxidants”, NCI Grant #1-R43-CA94484-01 for “Photoprotection of Skin by Topical Selenium” , Olive patent # 6,743,499 B2 and Aleoferon patent # 4861761 & NIH.

For further information, please visit www.phyto-ceutical.com or contact us directly at 201-791-2255 or info@phyto-ceutical.com.

Via EPR Network
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Innovative Medical Apparel Company Launches Men’s Lab Coats At Medica 2009 Conference

Medelita®, maker of breakthrough medical apparel, today announced the launch of its men’s lab coats, which are on display at Medica 2009, a leading international trade fair for the medical industry held in Dusseldorf, Germany. Medelita inaugurates its men’s collection with three varying lab coat styles, all named after distinguished figures in medicine: The Osler (44 in.), The Laennec (40 in.) and The Fleming (30 in.).

Men's Lab Coats

“Sophisticated, prestigious, innovative — these are words that medical professionals do not typically associate with lab coats,” said Lara Manchik, founder, Medelita.“But with the introduction of Medelita Men’s lab coats, male clinicians can now enjoy the same designer tailoring, high performance fabrics and upgrades that our female customers have raved about in our lab coats. The arrival of our men’s line is a natural evolution and we are thrilled to bring a product to market that’s long overdue.”

All Medelita lab coats are hand sewn in the U.S. using 100 percent pre-shrunk cotton, representing a significant improvement over traditional polyester/cotton blend lab coats with limited breathability. The lab coats feature a modern tailored fit, with finished inside seams and advanced fabric technology for unparalleled soil, stain, fluid and wrinkle resistance. While each style of Medelita Men’s lab coat is designed for a specific use, they are all available in contemporary menswear sizes 36-52.

The 44-inch Osler men’s lab coat is the modern version of the classic, full-length lab coat. Featuring five total pockets, including a concealed pocket for a PDA or Smartphone, the Osler lab coat is named after Sir William Osler, MD, CM, a Canadian physician, pathologist, educator, bibliophile, historian, and author, who is described as the Father of Modern Medicine.

The 40-inch Laennec lab coat is Medelita’s mid-length lab coat featuring abundant upgrades to this versatile physician lab coat. With a tailored, distinguished look and technically innovative features, this new men’s lab coat was named for René-Théophile-Hyacinthe Laennec, a French physician who invented the stethoscope in 1816, while working at the Hôpital Necker and pioneered its use in diagnosing various chest conditions.

The 30-inch Fleming lab coat is a hip-length lab coat, often called a “consultation” or “student” length lab coat. The Fleming is named after Sir Alexander Fleming, a Scottish biologist and pharmacologist who published many articles on bacteriology, immunology and chemotherapy. He is best-known for receiving the Nobel Peace Prize for the discovery of penicillin, which he shared with two colleagues.

About Medelita
Medelita has one purpose: to reinvent the way women and men of all healthcare professions present themselves at work by offering the highest quality, best fitting, and most comfortable medical apparel available, including women’s lab coats, men’s lab coats, embroidered lab coats and medical scrubs. Medelita caters to medical professionals who want their uniforms to embody the poise and confidence already displayed from within. For more information, visit our websites at http://www.medelita.com or http://www.medelita-mens.com, or call 877.987.7979.

Via EPR Network
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New 28-Inch Student-Length Lab Coat Answers Customer Demand For Shorter Style And Is Available For Pre-Order

Medelita®, maker of breakthrough medical apparel, today introduced the new Elizabeth B. lab coat to its collection of high performance women’s lab coats. Shorter than traditional coats, the Elizabeth B. is 28 inches in length and falls just below the hip on a woman of average height. The new, shorter-length lab coat is available for pre-order and will be available to purchase online November 6, 2009.

“The introduction of the Elizabeth B. lab coat is a significant milestone for us in that it answers countless customer requests, expressing the need for a lab coat with modern styling, sensible performance fabric features and long-lasting durability,” said Lara Manchik, founder, Medelita. “We chose to name the coat in honor of Elizabeth Blackwell, the very first female medical school graduate who paved the way for women in field of medicine. This appellation also honors customers of Medelita who continue to make significant contributions in their respective medical professions.”

At the turn of the 19th century, female doctors did not exist. But Elizabeth Blackwell changed that with her inspiring life’s work. Education played an important role for Blackwell, whose father moved the family from England to the U.S. Motivated by the desire to fill the unmet needs of women who preferred to consult with a female physician, Blackwell eventually sought a formal education during a time when medical schools simply did not allow women. Her application to the Geneva Medical College in New York was inadvertently accepted because students and the administration thought it was a practical joke.

Eventually, Blackwell’s persistence won her respect, admiration and the first U.S. medical degree awarded to a woman in 1849; however, she was barred from practicing in hospitals and set up a practice out of her own home. Among Blackwell’s many achievements was the establishment of women’s medical schools in the U.S. and in England. The educational institutions were the culmination of plans co-developed with Florence Nightengale, whom she met during the Civil War. Well into her later years, Blackwell continued to inspire and encourage women to study medicine. Today, women represent more than half of the students pursuing some form of medical education.

The Medelita Elizabeth B. lab coat is designed for those medical professionals who prefer technical advancements – not only in their clothing but also in their lifestyle. The fluid resistant lab coat is treated with Advanced Dual Action Teflon® fabric protector, which allows the fabric to repel and release stains, including blood, while maintaining a clean and crisp, polished appearance. Tailored for a feminine yet professional shape, the coats are sewn in the U.S. and feature the highest quality workmanship available in a medical uniform. Modern styling includes rounded lapels with complimentary pocket detailing, clean finishing of all seams, and a hidden inside pocket for transporting handheld devices and other useful medical tools.

Also called a consultation lab coat, the 28 inch lab coat is worn by students across numerous medical professions — medical school, dental school, physician assistant school — as well as by those medical professionals who simply prefer a hip length lab coat. Although the length is often a designation of a student, in some settings, the shorter coat is preferred or even required.

The new lab coat joins the Medelita collection of women’s lab coats, which range from the original, full-length Callia lab coat (38 in.), the Ellody (34 in.), to the Estie (38 in.) and Sophia (34 in.), all of which can be custom embroidered with name, title, and profession as preferred. For more information on the Elizabeth B. lab coat and all Medelita products, please visit www.medelita.com.

Via EPR Network
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Medelita Celebrates National Nurse Practitioner Week

Medelita®, maker of breakthrough medical apparel, celebrates National Nurse Practitioner Week this November 8 through 14. Nurse practitioners (NPs) are advanced practice nurses who provide high-quality healthcare services similar to those of a doctor. They diagnose and treat a wide range of health problems, and even prescribe medication. This year, nurse practitioners are celebrated for providing “125,000 solutions to the primary care shortage.”

“Nurse practitioners play a critical role in our healthcare system, providing much needed care that encompasses disease diagnosis and treatment, health education and helping patients to make wise choices and to become better advocates of their own health,” said Lara Manchik, PA-C and founder, Medelita. “Medelita is proud to be a partner to NPs, who combine strengths f r o m nursing and medicine to provide a holistic approach to personalized patient care.”

Most nurse practitioners have advanced degrees, such as master’s degrees, and training beyond their registered nurse credentials. Many even have doctorates in their areas of specialty. Since 1965, NPs have been practicing in all types of settings including clinics, hospitals, private physician or nurse practitioner offices, schools, urgent cares, colleges and public health offices, to name a few.

Every day, nurse practitioners are making a difference in the lives of patients and they are advancing the role of women in the healthcare professions. Medelita honors NPs this week and throughout the year, through its “Celebrating Women in Healthcare” campaign showcasing the talents, devotion and accomplishments of women all across the nation, just like Secor. The women selected for “Celebrating Women in Healthcare” each receive a lab coat or scrubs of their choice and are featured on the Medelita web site. Nominations that include photos and detailed descriptions of professional and personal accomplishments can be emailed to celebrating.women@medelita.com.

About Medelita
Medelita has one purpose: to reinvent the way women of all healthcare professions present themselves at work by offering the highest quality, best fitting, and most comfortable medical apparel available, including lab coats, embroidered lab coats and women’s medical scrubs. Medelita caters to professional women who want their uniforms to embody the poise and confidence already displayed f r o m within. For more information, visit our website at http://www.medelita.com or call 877.987.7979.

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Catalent Expands Capabilities In Testing For Melamine In Food And Medicinal Products

At a time when melamine-contamination has received global attention, Catalent Pharma Solutions continues its legacy of innovation by rapidly developing new FDA guidance-compliant tests for trace amounts of key contaminants in food and medicine. Incidents of melamine contamination in milk products, baby formula, dairy and non-dairy products manufactured in China have been widely reported, leading to product recalls and increased inspections by the FDA.

The current good manufacturing practice (CGMP) regulations require that all components (i.e. ingredients or raw materials) be tested before they are released for use in the manufacture or preparation of drug products (21 CFR 211.84). It is critical that all manufacturers determine whether they are using an at risk component for melamine contamination to manufacture or prepare a drug product.

In response to the FDA’s new guidance titled “Pharmaceutical Components at Risk for Melamine Contamination,” Catalent has successfully qualified a method for determining if suspect excipients are contamination-free to within 2.5 parts per million. The method is based on that provided by the FDA (Laboratory Information Bulletin No. 4423 “GC-MS Screen for the Presence of Melamine, Ammeline, Ammelide, and Cyanuric Acid”).

Catalent is now able to provide its customers successfully qualified and validated limits tests for trace levels of melamine, ammeline, ammelide, and cyanuric acid in lactose.

Melamine is a compound made of carbon, nitrogen and hydrogen and is typically combined with formaldehyde to produce a durable and moldable plastic that is fire and heat resistant. Trace amounts of melamine have recently been discovered to be toxic to dogs, cats, pigs, and chickens by veterinary scientists after kidney or renal failure occurred due to their food being contaminated with the chemical.

“Catalent is proud to have satisfied the demanding regulatory standards the US FDA has provided for detecting melamine,” said Kent Payne, Vice President and General Manager of Catalent’s Respiratory, Analytical and Biotechnology Services business. “Detecting trace levels of melamine in food and medicinal products at these levels is a challenging process, but is key to help avoid future public health crises. In order to support this critical public health need, Catalent can expedite this testing and provide results within 48 hours from receipt of samples

Fore more information on the US FDA guidelines, please visit:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176088.htm.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more information, visit www.catalent.com.

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Mountainside Cites That Heroin And Opiate Use Is On The Rise

The numbers of individuals entering inpatient drug rehab for heroin and opiate addiction continues to increase. In Afghanistan and Pakistan the opium (heroin) trade is tightly controlled by al Qaeda and the Taliban, and despite the war the efforts, the production of heroin and opium has dramatically increased – heroin is still dirt-cheap and readily purchased on the streets of Kabul and sold in short distance of military barracks. This phenomena has caused many analysts to be alarmed that our troops, reacting to the stress of war and ease of access of drugs, may develop drug habits like many of the soldiers in the Vietnam era.

The prevalence of cheap heroin has become a major issue in this country for teenagers who have begun experimenting with the drug as it is often cheaper and easier to buy than alcohol. Last year more than 46 people died from heroin overdoses in Nassau County, NY – this represents a 75 percent year over year increase. One of these individuals was Natalie Ciappa, a National Honor Society member at her high school on Long Island.

Recently, this past Wed, more than 1,000 parents gathered at a hosted forum in Smithtown, NY to voice their support and concern for the drug problem.

Directly correlated to the increase in heroin addiction has been the number of deaths by people using methadone. Many individuals who enter heroin rehab, also have tried methadone. A recent study published by the National Drug Intelligence Center (DIC indicates a 390% increase in deaths due to methadone since 1999. Increase in methadone deaths attributed to the drugs emerging popularity for use with chronic pain sufferers as well as increased diversion (stealing from legitimate sources and diverting to the street for illegal consumption).

The highest overdose rate was experienced among those between the ages of 15 – 24.

Opiate addiction or dependence which is recognized as a central nervous system disorder, can affect anyone from any walk of life. Opiate addiction is essentially what happens after someone intakes opiods such as Heroin, Oxycontin, Percocet and others for extended periods of time causing the brain to stop producing the vital chemical dopamine (the body’s natural response to pain as well as other physical activities) which in turn causes an uncontrollable urge for that person to have to ingest more of the drug they had been taking just to feel “normal”.

Opiate dependence while chemically the same as addiction more often occurs in people who have suffered from chronic or severe pain and have to be on this type of medication for an extended period of time. Normally to avoid any unpleasant effects the person’s physician will taper them off of the medication so the patient’s brain function has a chance to return to normal. Once the brain is actively producing dopamine and as long as the patient is no longer in pain, the medication is no longer medically needed.

Mountainside Drug Rehab and Alcohol Treatment Center has been helping people recover from alcoholism for over 12 years. Located in Connecticut, just north of New York City, its national program continues to help people from all over the country.

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Catalent To Present Webinar On Stabilities Studies In Pharmaceutical Development

Catalent Pharma Solutions will host a free Webinar featuring Senior Manager, Wei Pan, Ph.D. RAC and Kathy Waddle, Director, Stability QC Biology. The one-hour Webinar will cover stability studies as a critical part of the drug development process and the vital role they play for drug product marketing approval. The Webinar, titled “Stability Studies in Pharmaceutical Development,” will be held on Friday, November 20, 2009 at 2 p.m. (EST). To register for the Webinar please visit: https://www2.gotomeeting.com/register/280747146.

The presentation will address the principles and practices of stability studies in the drug development process. Pan and Waddle will discuss the framework of the FDA cGMP guidelines as expressed in 21CFR211. Additionally, the Webinar will provide a comprehensive review of ICH and WHO stability guidelines by discussing the strategy used in stability protocols designed to support global registration.

Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market. During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs. At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration. After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Mountainside Announces The Appointment Of A New Clinical Program Director

Mountainside Treatment Center announces the appointment of Wendi Shami MS, LCSW as the company’s Clinical Program Director. With more than 10 years of experience working in the mental health and addiction/alcoholism treatment field, Ms. Shami will be responsible for building and strengthening the therapeutic program, managing the treatment teams and introducing new evidenced based practices and identifying growth opportunities.

Ms. Shami brings extensive knowledge in the addiction treatment and therapeutic field and has an extensive career in the management of teams, cases and knowledge of therapeutic best-practices. She has helped many organizations to develop and execute initiatives including staff development and effective treatment team and efficient therapeutic case oversight.

Originally from Westchester she earned her Masters degree in Clinical Social Work at Columbia University in New York City and completed post graduate training in Family Counseling at the Ackerman Institute in New York City. Her areas of specialization include the treatment of addictions, co-occurring disorders, family therapy and counseling.

About Mountainside Treatment Center
Mountainside drug rehab is a comprehensive and innovative provider of treatment for individuals suffering from drug addiction and alcoholism.

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Senior Director of Biotechnology at Catalent To Present Industry Conferences

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be delivering workshops this October at two industry conferences.

The first will be a pre-conference workshop at Cambridge Health Institute’s Immunogenicity Summit. The event will take place in Philadelphia on Monday, October 26, 2009. The interactive workshop, titled “Technical Advice on Assay Development,” will begin at 8:30 a.m. and will enable attendees to develop an immunogenicity pre-clinical and clinical testing protocol for a therapeutic protein.

The second presentation by Menendez will be a seminar at San Francisco’s Biologicals to Devices (B2G) conference on October 27. The workshop will be called “Effective transfer of Complex Biological Methods in the GMP Environment.”

As part of Catalent’s Development and Clinical Services Segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menenedez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent`s broad range of drug and biologic development services, go to www.catalent.com/development.

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Pet Owners Save a Trip to the Animal Clinic and Find Pet Meds Online

Pet owners find themselves as contented as their cats and dogs with more time in their afternoon as they save a trip to the vet. As more and more consumers turn to the online community to find what they need, pet lovers find all their petmeds needs on the web. No longer do they have to make an extra trip to the pet clinic or pet store to find Frontline, Heartgard, Sentinel or any other pet need because they can get it just as easily on the Internet, never leaving their house or the company of their pet. All pet medications are USDA/EPA approved and exactly what they’d expect to find in a vet’s office or pet store.

The Internet creates convenience for everyone, including owners of animals who may find it difficult to work their animal’s needs for pet meds in with their busy schedules. Why should pet owners have to travel to meet the health needs of their pets when the Internet provides every pet medication conveniently at the fingertips? Online pet stores are only as far away as the nearest computer. More and more pet owners realize that the convenience of online pet supply outlets can ease a schedule and provide more time in the day.

The health needs of pets can vary widely and get considerably expensive. With online petmeds, all forms of pet medicine and treatments are available in one location at prices that are considerably lower than a pet shop or vet clinic. The online store saves money by having less real estate and employee expenses to contend with. These savings can then be passed onto the pet owner through lower prices. Not only can pet lovers find everything they need for their pets easier, but the pet meds also tend to be less expensive.

Shipping costs have deterred some potential online shoppers, but many online stores get around this by offering reduced or free shipping. At Petmeds, for example, shipping on all orders over $39 is completely free, adding to the savings with reduced overhead.

About the Author:

Sam Sheppard is a long time pet owner and blogger who finds it hard to find time in his schedule to get all his pet meds for the animals he loves. With online petmeds, Sheppard finds more time not only for writing but for quality lap time for all his furry friends as well.

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Free Joint Pain Relief Analyzer Launched

While some struggle to relieve daily joint pain, many are overcoming their joint pain quickly and easily. Largely, because they have mastered the proven (but little-known) methods of preventing joint pain from becoming overwhelming, before it’s too late.

That’s the opinion of Joint Pain Relief Today, online joint pain relief resource and designer of this new free tool, the Joint Pain Analyzer.

“Middle-aged individuals today need solid, reliable information on what works in relieving joint pain – and what doesn’t,” says Mary Ogden, joint pain specialist. “As an online joint pain specialist, I have hundreds of people contacting me, asking questions such as:

– How can I relieve my joint pain so I can get started with my day without being slowed-down by joint pain?

– How can I prevent and protect myself against significant joint pain in the first place?

“I designed the free Joint Pain Analyzer tool, to give these folks some of the answers. What makes this joint pain tool different is this: it’s not based upon theories or untested ideas. Each of the methods built into the joint pain analyzer tool has been thoroughly tested. The tool’s answers have been checked by medical professionals and in real-world joint pain relief.”

Unlike many of today’s joint pain services, Ogden points out, this new joint pain tool has been released at no charge. “A lot of organizations and individuals can’t afford to hire joint pain consultants or joint pain relief specialists. And it takes time to read an entire medical book, listen to a CD or attend a joint pain seminar,” notes Ogden. “This free joint pain analyzer has been created for them, and takes less than 2 minutes to get.”

Personal joint pain data analyzed in the free joint pain analyzer include:

– how joint pain is currently affecting the daily life of the patient
– why joint pain prevention is so important and what to do
– where to get effective, free help on boosting your joint pain relief

The Joint Pain Analyzer can be accessed online free, right now by visiting: Joint Pain Relief Today

The free joint pain relief analyzer is available to all individuals – both young and old, 24 hours a day, seven days a week.

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Medelita Joins AAPA in Celebrating National PA Week

Medelita®, makers of innovative high-quality scrub sets and lab coats for women in health care who excel in their profession and take pride in their appearance, joins the American Academy of Physician Assistants (AAPA) in celebrating National PA Week, October 6 – 12.

“National PA Week provides us the perfect opportunity to raise awareness of the central role PAs have in shaping the future of health care in this country, and across the world,” says Medelita founder Lara Manchik, who brings a decade of experience as a PA to her breakthrough line of medical apparel. “We’re honored to join AAPA in celebrating National PA Week and the professionals who deserve this recognition. AAPA is doing an outstanding job communicating the role of PAs in transforming health care — not just on the floor and by the patient’s bedside, but in our laws and legislation.”

Manchik points out that PAs have always responded to the changing needs of patient care. Launched in 1967 at Duke University Medical Center, the first PA program was developed to utilize the skills of returning Vietnam medics and fill a need for quality health care when and where it is needed most. Since then, PAs have continued to make cost-effective, quality health care accessible to more people who might otherwise have limited, or no, access.

Today, you’ll find PAs providing not only primary care, but also working with physicians across a spectrum of medical specialties. Says Manchik, ”Patients and physicians alike are recognizing the tremendous value that PAs, with their advanced training and knowledge, bring to patient care. They assume many of the same responsibilities of doctors, keep costs in check, and spend time with patients to completely understand their needs and goals. National PA Week allows us to acknowledge this contribution.”

During this year’s National PA Week, the AAPA is emphasizing the leading advocacy position PAs share in the current health care debate. Through grassroots efforts and awareness-raising campaigns, AAPA and its members are making sure legislators include PAs in the strategy to increase access to quality, affordable health care.

“National PA Week brings much deserved attention to these dedicated, extraordinary professionals,” adds Manchik. “Medelita applauds the AAPA and its members for their tremendous efforts and commitment to reform health care. We’re proud to provide PAs quality lab coats and scrub sets that reflect their exceptional dedication and professionalism.”

About Medelita
Medelita has one purpose: to reinvent the way women of all health care professions present themselves at work by offering the highest quality, best fitting, and most comfortable medical apparel available, including scrubs and women’s lab coats. Medelita caters to professional women who want their uniforms to embody the poise and confidence already displayed from within. For more information, visit www.medelita.comor call (877) 987-7979.

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