VIENNA, 24-Sep-2020 — /EPR BIOTECH NEWS/ — Eveliqure Biotechnologies GmbH, an Austrian biotechnology company, today announces the initiation of clinical testing for its ShigETEC vaccine candidate, with the dosing of the first subject in a Phase 1 safety and immunogenicity study in Europe. ShigETEC is an orally administered vaccine candidate targeting Shigella and Enterotoxigenic E. coli (ETEC), two of the major pathogens responsible for diarrhoeal diseases in travelers to endemic countries, as well as a major threat to children living in low- and middle- income countries.
Currently no effective vaccines against these two pathogens exist and previous attempts to develop vaccines against Shigella and ETEC have failed. Eveliqure has employed a radically innovative approach based on a live attenuated Shigella vaccine strain rationally designed to provide broad, serotype independent protection against both Shigella and ETEC, and is developing the vaccine for both travelers to endemic countries and for children living in resource-poor countries. Following this initial Phase 1 study run in Hungary, further clinical development of ShigETEC will include Phase 1 testing in non-endemic adults, immune characterization of vaccine responses, vaccine formulation studies and clinical testing of ShigETEC in the pediatric population in resource poor-countries. These activities are supported by the EU-funded SHIGETECVAX international consortium of world-leading vaccine organizations – the European Vaccine Initiative, Eveliqure Biotechnologies, University of Gothenburg, icddr,b and PATH.
“Entering clinical development with ShigETEC marks a major milestone for Eveliqure, culminating from our extensive preclinical work performed over the past five years” – commented Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure. “We believe that ShigETEC has the potential to reduce the burden of diarrhoeal diseases for travellers, while also saving hundreds of thousands of children in endemic areas of the world”.
“Initiating the Phase 1 study for ShigETEC in adult volunteers is a crucial step towards establishing safety and immunogenicity of our vaccine candidate, and will help us define a well-tolerated, and effective schedule of dosing for our planned Phase 2 human challenge studies”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure.
Compared to single pathogen approaches, ShigETEC has the potential to have a major impact on diarrheal diseases, protecting both travelers to the developing world and children in endemic populations.
SINGAPORE, 2020-May-22 — /EPR BIOTECH NEWS/ — Austrianova and Cells for Cells have just jointly published a ground breaking, peer reviewed, scientific publication on a novel, cost and time-saving method to generate extra-cellular vesicles (EVs) from encapsulated Mesenchymal Stem Cells (MSCs). These EVs are known to mediate many of the therapeutic effects of stem cells. The authors show that Austrianova’s proprietary Cell-in-a-Box encapsulation technology can be used to produce and deliver EVs from encapsulated MSC’s, as demonstrated using Cells for Cells proprietary MSCs. The publication, which was co-authored with their academic partners, the University of the Andes, Chile and the University of Veterinary Medicine Vienna, Austria appeared in prestigious international journal “Frontiers in Pharmacology” (Front. Pharmacol., 21 May 2020 | https://doi.org/10.3389/fphar.2020.00679https://www.frontiersin.org/articles/10.3389/fphar.2020.00679/full)
Currently, EVs have to be purified from cell culture conditioned media using tedious, costly and time-consuming protocols that are difficult to perform under Good Manufacturing Practices (GMP) conditions. The Cell-in-a-BoxÒ encapsulation technology allows efficient enrichment of EVs at high concentration since they are released from the encapsulated cells via the semipermeable pores, which selectively enable the release of small particles but not of the MSCs. Moreover, Cell-in-a-BoxÒ provides 3D culture conditions for the MSCs. The technology can be used in cell culture allowing GMP production. Alternatively, the encapsulated cells can be implanted into patients as a retrievable delivery device that shields the cells from clearance, whilst they continuously produce EVs, growth factors, hormones and other small therapeutically relevant molecules. Moreover, the EVs produced after encapsulation can themselves be used as drug-loaded delivery vehicles. This technology will be invaluable for the treatment of regenerative diseases and Inflammatory disease.
Maroun Khoury, CSO of Cells for Cells said “this is a multifaceted project bringing together different expertise to support the burgeoning field of EV-based therapies. It will be interesting to test in the near future, the continuous release of EVs in a in vivo context. At a personal level, it was a great way to stay connected with colleagues that I met while living in Singapore ”.
Brian Salmons, CEO of Austrianova said “we are pleased that these results representing the culmination of a long term project with our colleagues at Cells for Cells are finally publicly available. The encapsulation of stem cells as a means to produce exosomes using our Cell-in-a-BoxÒ is an exciting technological breakthrough that is applicable for all stem cell types.”
Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, recombinant proteins etc).
About Cells for Cells
Cells for Cells is a Chilean biotechnological company dedicated to the research, development and commercialization of innovative cellular therapies, complying with high standards of scientific, technological and international quality, through manufacturing processes certified under ISO 9001: 2015. Each therapy is produced in our labs with GMP standards, being the first biotech company, with such high-quality standards at Latin American level. Our therapies are applied by duly certified specialists.
Baltimore, MD, 2019-Sep-18 — /EPR BIOTECH NEWS/ — CoapTech LLC (Baltimore, MD) and Fidmi Medical, Ltd. (Caesarea, Israel) announced today that they will be collaborating on bringing to market a set of next-generation products for the initial placement and long-term maintenance of gastrostomy tubes (G-tubes). The collaboration between CoapTech and Fidmi will focus on integrating the company’s two technologies and expanding their collective market opportunities.
Gastrostomy tubes, which help patients receive long-term nutritional support, are typically placed endoscopically and need to be replaced every 3-6 months.
CoapTech’s PUMA-G System allows initial gastrostomy tube placement by non-surgeons/ gastroenterologists, outside of the endoscopy suite, using point-of-care ultrasound at the patient bedside. This novel approach can be performed in the ICU, emergency room, and eventually outside of the hospital setting, substantially reducing costs for tube placement.
Fidmi Medical’s innovative low-profile gastrostomy system is unique in that it can be utilized for both initial placement and replacement and has several features which make it more durable and comfortable for patients. Gastrostomy tubes very often get dislodged, clogged, or infected, and need to be replaced frequently. Fidmi’s improved low-profile gastrostomy tube is placed just like any standard PEG tube but has an easily replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures. This will result in fewer complications with patients’ g-tubes, therefore potentially reducing healthcare costs for payers and healthcare systems; as well as providing a substantial improvement in quality of life for patients and their caregivers.
Fidmi Medical Chairman, Lloyd Fishman, commented, “We are excited to collaborate with CoapTech in development and marketing. Both companies have developed cutting-edge technologies that will improve patient care and contribute to the ease, efficiency and confidence of clinicians’ work in the gastrostomy field.”
Dr. Steven Tropello, CoapTech’s founder and CMO said, “In combination these systems will be compatible with Push or Pull methods, be implantable in a wide variety of clinical settings, and require minimal readmission to the hospital and fewer visits to the ER. The synergy will reduce both front and back-end costs for hospitals and payers, and make care safer and more patient-centered.”
RENNES, FRANCE, 2019-Apr-08 — /EPR BIOTECH NEWS/ — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors
Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.
Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.
FREDERICA, DE, USA, 01-Nov-2018 — /EPR BIOTECH NEWS/ — ILC Dover, a global leader in flexible containment solutions for the pharmaceutical and biopharmaceutical industry is expanding its Irish production footprint by opening a location in Blarney, County Cork, Ireland.
The building will be operational in the first quarter of 2019 and outfitted with 4,000 square feet of
ISO 7 clean room capacity and 6,500 square feet of Class 8, both dedicated to the company’s pharmaceutical and biopharmaceutical product lines. When at full production, the company expects to hire 60-70 new ILC Dover employees. The company’s original operation in County Cork will be relocated to the Blarney site as part of the expansion project.
ILC Dover President and CEO Fran DiNuzzo expressed enthusiasm about the new launch: “The expansion of our production capabilities in Ireland will allow us to better serve our global customer base and strengthen our position as the leading single-use powder handling solutions provider to the global pharmaceutical and biopharmaceutical marketplace.”
In addition to production space, the new facility will contain state-of-the-art offices, meeting rooms and a product demonstration area for client visits. Curtis Gingles, Vice President and General Manager of the company’s Pharmaceutical Division, added, “Clients of ILC Dover will be happy to see that we’re focused on providing additional capacity located in the region with expanded technical resources. The market for our products is experiencing incredible growth and this expansion will ensure we can keep up with the growing demand for the high-quality products used in manufacturing lifesaving therapies.”
LJUBLJANA, Slovenia, 21-Sep-2018 — /EPR BIOTECH NEWS/ — The latest study published in the World Journal of Urology (Comparison between erbium‑doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence – https://doi.org/10.1007/s00345-018-2445-x) provides further confirmation that Fotona SMOOTH® laser technology is a safe, effective and minimally-invasive solution for stress and mixed urinary incontinence (SUI and MUI). The article, written by Dr. Nobuo Okui, compares Fotona’s minimally invasive IncontiLase® Er:YAG laser therapy with the more conventional TVT and TOT surgical sling procedures.
Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence
In the study performed by Dr. Okui, 50 Japanese women were treated either surgically (tension-free vaginal tape – TVT or transobturator tape – TOT) or with a Fotona laser. The 1-h pad test, ICIQ-SF, and overactive bladder-symptom score were used to assess the patients before and 12 months after treatment. Laser therapy was performed by first applying a local anesthetic to the vaginal wall and then inserting a probe into the vagina. Laser irradiation was performed for 20 min with an Er:YAG wavelength of 2940 nm (Dynamis XS, Fotona) for a total of three treatments (alternating every month). Results of the 1-h pad test and ICIQ-SF showed comparable improvements in SUI in the sling and laser therapy groups, while some of the patients with MUI in the TVT and TOT groups showed exacerbation. In conclusion, the TVT and TOT procedures and the laser therapy are comparable for SUI; however, laser therapy is superior in terms of MUI and complications. The study thus once again confirms the safety and efficacy of Fotona SMOOTH® laser therapy for urinary incontinence.
Urinary Incontinence Treatment Options
Conventional treatment options for urinary incontinence are surgical, and include TVT or TOT sling procedures, which involve inserting a synthetic material. Problems often arise with artificial meshes that require new treatment methods. With the Fotona SMOOTH® Er:YAG laser thermotherapy (also known as IncontiLase®), the goal is to provide a minimally invasive therapy based on vaginal collagen hyperthermia followed by collagen remodeling and new collagen synthesis, which results in overall regeneration of aged or stressed vaginal tissues and subsequently greater support to the bladder.
Unique Fotona SMOOTH® Technology for Maximum Safety
Patient safety is the primary concern and, for this reason, the patented Fotona SMOOTH® technology holds a very unique position within the spectrum of gynecological treatment options. It is a non-surgical procedure (no incisions) and without implants or appliances. The Fotona SMOOTH® method of dual-tissue regeneration is completely non-ablative and therefore minimally invasive to the vaginal wall. The treatment involves an additional superficial heat-shocking mechanism of tissue regeneration, and a unique self-regulating safety feature. These dual-tissue regeneration characteristics of the Fotona SMOOTH® Er:YAG laser allow for an exceptionally high degree of safety and efficacy in thermotherapy of the vaginal wall. This is what makes Fotona SMOOTH® a significantly safer alternative to many widely used and more-invasive procedures.
Evidence-Based Laser Medicine
Over the past few years numerous (over 35) other studies on Fotona SMOOTH® laser therapy have been published by distinguished gynecologists from around the globe in some of the most trusted and renowned international scientific journals, all with favorable results (https://www.laserandhealthacademy.com/en/practitioners/recommended-reading/gynecology/). One such noteworthy clinical paper published in March 2018 by Dr. Adolf Lukanovic and Dr. Mija Blaganje is the first randomized controlled trial study (on 114 premenopausal parous women) to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy as an alternative non-invasive treatment of SUI and the improvement of sexual gratification (published in the European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018 (224): 153-158). The results from this study indicate that a single session of IncontiLase® treatment improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo.
In another Asian study, Dr. Yi-Wen Tien et al. from the Chang-Hua Hospital in Taiwan examined the effects of laser treatment for female SUI on pad weight, urodynamics, and sexual function in 35 women (published in the International Urogynecology Journal. 2017; 28(3): 469-476). The study reveals that the effect of IncontiLase® treatment for mild SUI was moderate at the 6-month follow-up. Moreover, it improved LUTS, quality of life, and the sexual function of both partners. The authors conclude that the IntimaLase® procedure is very effective in the treatment of SUI and is not associated with any severe adverse effects.
Similarly, Dr. Yi-Hao Lin et al. from the Chang Gung Memorial Hospital in Taiwan obtained favorable results. Their study investigated the effects of non-ablative laser treatment on overactive bladder (OAB) syndromes, SUI and sexual function in 30 women with urodynamic stress incontinence (published in the Taiwanese Journal of Obstetrics & Gynecology. 2017 (56): 815-820). The results showed that IncontiLase® treatment can resolve SUI and coexistent OAB symptoms three months after therapy, while repeated laser therapy may be necessary after six months. The results also revealed that sexual gratification improved, while no major adverse effects were noticed.
The quantity and quality of the studies performed with Fotona SMOOTH® laser therapy is such that Fotona’s Dynamis has been cleared in the European Union for SUI (IncontiLase®), vaginal laxity – vaginal relaxation syndrome (IntimaLase®), genitourinary syndrome of menopause – GSM (RenovaLase®) and pelvic organ prolapse (ProlapLase®), giving women the option to choose a safer and less-invasive treatment alternative. In Asia, the Taiwan Food and Drug Administration has already cleared Fotona Dynamis for mild to moderate SUI, and the Singapore Health Sciences Authority has cleared the Dynamis for the treatment of SUI and GSM.
Los Angeles, California, 2018-Mar-26 — /EPR BIOTECH 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:
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.
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
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
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.
Yann Le Cam, CEO of EURORDIS-Rare Diseases Europe, an alliance of over 700 rare disease patient organisations, commented, “The majority of people living with a rare disease have delayed or no access to the medicine they need. Only through a collective engagement between all stakeholders involved, including industry, competent authorities, health ministries, academics and regulators, can we break the access deadlock.” Le Cam will be presenting a new four-pillar approach to improve access to rare disease therapies in Europe.
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.
New York, 2017-May-02 — /EPR BIOTECH NEWS/ — S-Acquisition Corporation is today commencing its tender offer for all 10,000,000 shares of Second Round financing of Common Stock of Astra Logics Inc., Hong Kong, at a price of US$7.00 per share, payable in cash. The offer, which has been unanimously approved and recommended by Astra Logic’s Board of Directors is being made pursuant to the agreement between the two companies.
The tender offer, which is currently scheduled to expire at 12:00 midnight EST on Thursday, June 1st, 2017 (unless extended) is subject to the tender by Astra Logic’s shareholders and would represent a majority of the outstanding shares on a fully diluted basis, as well as other customary conditions.
Astra Logics, Inc. aims to become a leader in advanced drug delivery systems with Graphine Oxide being the key component. After extensive research and testing the firm’s proprietary protocols are now nearing completion of initial phase clinical trials in Hong Kong. Ken Holland, Head of Corporate Affairs for Astra Logics said, “When completed, this tender offer provides the company with substantial cash reserves allowing for continued product development. Institutional sponsorship is critical to strengthening our market position for the long term”.
S-Acquisition Corp’s Director of Bio-Pharm Transactional Services, Mr. Craig Kirkman, stated “Astra Logics’ unique delivery platform offers tremendous upside potential in a sector providing boundless opportunity for return. Our firm shares the same long-term vision and commitment necessary to allow the company to progress”.
About S-Acquisition Corp.
S-Acquisition Corp. is a global corporate advisory with expertise in mergers and acquisitions, capital markets, financial restructuring, valuation, and strategic consulting. The firm serves corporations, institutions, groups and individuals worldwide and has its headquarters located in the United States.
About Astra Logics, Inc.
Astra Logics, Inc. is an independent biotech firm based in Hong Kong with a focus on the research and development of Nano-particle, bio-therapeutic drug delivery systems for the treatment of cancerous tumors, in particular lung cancer. The firm’s core objective is to deliver highly innovative cancer therapies that currently have few, if any, effective treatment options.
GERMANY, Mar-30-2017 — /EPR Biotech News/ — Ulcerative colitis and Crohn’s disease are the most common inflammatory bowel diseases (IBD). Globally, more than 4 million people suffer from recurring inflammation of the intestinal mucosa. To date, non-invasive methods have not been able to detect these forms of IBD reliably. Researchers at the University Hospital Erlangen (Germany) have now shown for the first time how Multispectral Optoacoustic Tomography (MSOT) can more reliably detect early stages of inflammation when compared with other non-invasive diagnostic methods. These results have recently been published in the New England Journal of Medicine.
Evaluating the inflammatory activity of the intestines early and accurately helps to prevent complications associated with IBD and guide an optimal therapy regime. Currently, doctors frequently rely on an invasive endoscopy procedure to assess the intestinal mucosa of patients with IBD. Additionally, non-invasive imaging methods are increasingly used in the clinic. For example, ultrasound allows clinicians to examine the structure, thickness and blood perfusion of the intestinal wall with changes in perfusion patterns indicating an onset of inflammation.
“With the MSOT procedure, we additionally use laser light, by which we can detect inflammation earlier than previously possible with ultrasound”, explains Prof. Dr. Maximilian Waldner, Professor at the University Hospital Erlangen. “The earlier we detect signs of an upcoming flare – i.e., a change in blood content – the quicker we can react and start a preventive treatment”. The MSOT technology was developed by iThera Medical in Munich, and was first used on IBD patients last year.
The researchers of the University Hospital Erlangen have recently published their results in the renowned New England Journal of Medicine. “We examined 108 patients with Crohn’s disease using the MSOT technology and compared the results to established non-invasive diagnostic procedures as well as endoscopy and histology”, says Prof. Waldner. “We were able to demonstrate that hemoglobin values in the tissue measured with MSOT indicate very accurately the inflammatory activity in the intestines. The method appears to be superior to other non-invasive procedures, as MSOT for the first time was able to detect even low levels of inflammation without having to perform endoscopy”.
Dr. Ferdinand Knieling, a physician at the University Hospital Erlangen, adds: “We are hoping that this principle can be applied to many applications and, in particular, also be used to enable safe evaluations of children and adolescents. With this new examination method, many of the currently invasive procedures might become obsolete.”
In optoacoustic imaging, the physician scans the intestines transabdominally through the skin, applying pulsed laser light in the near-infrared region. The energy of the light absorbed in tissue is converted into acoustic signals which are then acquired by an ultrasound detector. Christian Wiest, CEO of iThera Medical, comments: “MSOT is a new diagnostic imaging modality that can detect changes in tissue composition associated with a variety of diseases, without the use of contrast agents. The technology has already been applied in other clinical feasibility studies, e.g. for the detection of melanoma metastasis in sentinel lymph nodes or for the assessment of suspicious breast lesions”.
The results of the IBD study at the University Hospital Erlangen were published on March 30th 2017 in the New England Journal of Medicine (Volume 376, Issue 13, pg.1292-1294).
Allergan and Animal free Peptones for the use in culture media
Minnetonka, MN, 2016-Nov-14 — /EPR Biotech News/ — Today at Nu-Tek Bioscience announced the completion of an outside study comparing various protein sources on the enhancement of Cell growth using E. Coli. The study was completed by The University of St. Thomas.
Nu-Tek HSP (Hydrolyzed Soy Protein) and HPP (Hydrolyzed Pea Protein) peptones showed the least strain dependent variability in growth performance. In contrast to competitor peptones showed poorer performance. This has been an ongoing issue with media developers to minimize the variation from lot to lot in Peptones. Nu-Tek Bioscience has developed a technology that promotes reduction in variability.
Blending HPP (Nu-Tek’s Bioscience Hydrolyzed Pea Protein) with a weakly performing peptone supports growth of the weakly performing peptone to the level of performance of the HPP alone. The study has shown excellent growth performance results that compare favorably with soy peptones, pea peptones and yeast extracts. In addition, peptones have been shown to improve fermentations versus yeast extract “only” growth media.
Nov. 14, 2016 Availability
Nov. 14, 2016 is an update driven by customer feedback and is part of Nu-Tek Bioscience’s commitment to deliver the latest industry updates. Nov. 14, 2016 is available for immediately download at www.nu-tekbioscience.com
Founded in 2008, Nu-Tek Bioscience LLC is the worldwide manufacture and developer of specialty Peptones that have been designed to enhance Cell growth. The company offers a wide range of Peptones and Yeast Extracts designed to promote increased cell growth.
For more information, press only:
Seattle, WA, San Francisco, CA and Moscow, Russia, 2016-May-25 — /EPR Biotech News/ — R-Pharm and GenQual are pleased to announce a new collaboration focused on the development of novel predictive diagnostic tools in the area of Rheumatoid Arthritis and Autoimmune diseases.
The GenQual proprietary real-time PCR platform, when applied to the genes that are involved in the manifestation of several autoimmune diseases, allows us to detect and assess single nucleotide polymorphisms. Here, allelic determination is used as potential predictor of the treatment response by the novel anti-IL6 antibody, which is currently in development by R-Pharm.
GenQual Founder and CEO Jonathan Mirich said, “This partnership is exciting for GenQual as we advance in our goal to deliver predictive diagnostic tools for the treatment of autoimmune disorders. We are very excited about the possibilities in this space and are thankful to have quality partners in R-Pharm.”
R-Pharm CEO Vasily Ignatiev indicated the importance of the Autoimmune diseases as an area of the development and growth for R-Pharm, as well as the development of novel diagnostic tools aimed to increase the level of predictive response and efficiency of the upcoming treatment paradigm.
GenQual develops proprietary biomarker diagnostics for autoimmune and oncology indications. Our personalized medicine products are designed to facilitate early disease detection and diagnosis, and to improve treatment approaches at the molecular level. GenQual is a privately-held corporation based in Seattle, WA area, USA.
R-Pharm is a private Russian pharmaceutical company founded in 2001. It employs over 3,500 highly qualified specialists in 60+ branches. R-Pharm operates in Russia and CIS, USA, Germany, Japan, Turkey/MENA.
The company is involved in R&D, manufacturing (finished dosage forms, biotech and chemical APIs), marketing, sales and distribution of innovative pharmaceutical products in hospital/specialty care therapeutic areas.
R-Pharm collaborates with major international pharmaceutical companies and universities in the fields of drug discovery, development, clinical trials, manufacturing and commercialization. The company operates several GMP compliant manufacturing sites in Russia and Germany, research, BD/licensing and marketing affiliates in Japan, Germany, Turkey and US.
Marketed portfolio and pipeline features drugs used in oncology, hematology, autoimmune diseases, HIV, HCV, neurology, diabetes, cardiology, as well as antibiotics, contrast media and anesthesia agents.
Allergen free Peptones for the use in probiotic cultures
Minnetonka, MN, 2016-May-10 — /EPR BIOTECH NEWS/ — Nu-Tek’s Pea Peptone is an excellent alternative to Dairy and Soy Peptones for the production of probiotic cultures. Consumers with known food allergies rely on ingredient labeling for guidance. An Allergen Control Plan is a critical component of a food ingredient manufacturer’s safety initiatives. It not only protects the health and confidence of the consumer, but also the reputation and financial success of the company.
An advantage of allergen management strategies include ingredient selection that eliminates allergens without negatively affecting the performance of the product. Formulating growth media using Nu-Tek Pea Peptone provides such an advantage. Nu-Tek Pea Peptone HPP-A is an excellent source of natural nitrogen and necessary growth factors needed for optimum probiotic culture fermentations.
Our Kosher Pea Peptones are obtained through enzymatic hydrolysis of Animal free and Non-GM pea protein. Pea protein hydrolysates do not require special allergen labeling. Independent university trials have shown excellent growth performance results that compare favorably with soy peptones. In addition, peptones have been shown to improve fermentations versus yeast extract “only” growth media. Today at Nu-Tek Bioscience announced immediate availability of Pea Peptones, enabling developers of probiotics to either enhance their current culture growth rate.
Pea Peptones Availability
Pea Peptones is an update driven by customer feedback and is part of Nu-Tek Bioscience’ continuing development of new technologies.
Founded in 2008, Nu-Tek Bioscience LLC is the worldwide manufacture and developer of specialty Peptones that have been designed to enhance Cell growth. The company offers a wide range of Peptones and Yeast Extracts.
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SINGAPORE, January 26, 2016 — /EPR BIOTECH NEWS/ — Austrianova announced today that, having completed the set up of its new GMP facility, it is now offering clients a GMP cell banking (Master Cell Bank and Working Cell Bank) as well as a “Fill and Finish” service for cell therapy products, in addition to its encapsulation services and technology. Austrianova is able to offer the production of Master Cell and Working Cell Banks (MCB and WCB) at the size scale required for early (phase 1 and 2) stage clinical trials at highly competitive prices using its state of the art isolator based production facility, assuring that the highest quality standards are adhered to. The company can also fill bulk cell product into syringes or vials in its GMP facility. This new cell banking and filling service is called GMP4Cells. MCB’s and WCB’s are required for all cell therapy products such as stem cell therapies as well as biologics produced from cells such as vaccines, antibodies, recombinant proteins etc. Similarly, many companies, including those developing stem cell lines and products, are seeking high quality economic fill and finish for relative small lots.
“We see this as a natural add-on to our already established Cell-in-a-Box® cell encapsulation technology for which we have recently set up a GMP manufacturing facility in Thailand. This kind of MCB and WCB production as well as “Fill and Finish” services for cells are, however, stand alone services. Although these services are generally available to all customers, they should allow start up companies and academic based cell products, vaccines etc to enter clinical trials in a quality assured manner but at lower cost that other, more conventional, cell banking companies offer” stated Walter H. Gunzburg, Chairman and CTO of Austrianova.
“In addition to our state of the art facility, Austrianova offers services that comply with major international regulatory agencies using a customized German/Swiss based quality assurance system. Our team has many years experience with regulatory agencies around the world and has taken cell therapies into clinical trials” said Brian Salmons, CEO.
More information about the GMP4Cells cell banking but also the Cell-in-a-Box® and the related Bac-in-a-Box® encapsulation services can be found on our newly revamped website www.austrianova.com.
Austrianova, part of the SG Austria Group, is a biotech company with a global footprint and headquarters in Singapore. Austrianova utilizes a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications due to its ability for extending storage under lyophilized conditions and protection in stomach acid.
Long Island City, New York, January 15, 2016 — /EPR BIOTECH NEWS/ — Thursday of this week (January 14, 2016), BOC Sciences officially launched its analytical support service, aiming to provide all-round custom services on the base of its present services in pharmaceutical field.
The analytical service of BOC Sciences covers a wide range in almost every aspect of drug discovery from impurities identification, purity level testing, to right equipment suggestion for compound preparation with the aim of providing the best solutions for research conduction and maximizing the outcome with less waste in both time and cost.
Analysis service on inspecting the quality of compounds before, during, and after researches including their purity level, structure and degradation testing, final chemicals analysis, even involved equipment suggesting are available. “The launch of analytical service is an upgrade of the present customer services like drug design, compound manufacturing, but making the analysis outstand to meet pure needs in this aspect, with which the companies that carry out researches in a single direction can benefit from our comprehensive expertise network.” Said Daylen, the director of the newly funded business department, “and we will continue to optimize our professionalism in the field to serve more clients in such tailored needs.”
Besides, the analytical support (http://www.bocsci.com/analytical-support.html) additionally includes but not limited to mass spectrometry, nuclear magnetic resonance, and X-ray crystallography. Other technologies like chemistry synthesis and bioconjugation involved analysis needs can be also met at BOC Sciences
With the development of pharmaceutical industry, numerous studies and researches on material and new formulation are undergoing, the appearance of BOC Sciences’ analytical support services can be considered as an outsource route for companies that are not willing to spare more time and budget on some sub-matters, and such custom services can contribute to a purer research with no further distraction while obtain the highest level of expertise in related matters.
This form of analytical service will get furtherly developed as the general environment put more emphasis on the idea that professional problems should be done by professional people with the best result while keep efficient.
About BOC Sciences
BOC Sciences (http://www.bocsci.com) is original a chemical supplier on APIs, natural compounds, chiral compounds, inhibitors, GMP products and many other chemicals. But in recent years, the company gradually takes more effort on providing related custom services like synthesis, drug discovery and so on to be a comprehensive products and services supplier in the field.
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.
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.
VTU Technology to offer unique combination of technologies for the high-level production of proteins with human-like glycosylation using Pichia GlycoSwitch®
Tucson, Arizona and Grambach, Austria, December 03, 2014 — /EPR BIOTECH NEWS/ — VTU Technology and Research Corporation Technologies (RCT) announced today that they have entered into a development and commercialization agreement for VTU to combine both companies´ Pichia pastoris protein production technologies. Pichia GlycoSwitch® – a new expression system for the production of glycoproteins with human-like glycosylation patterns – and VTU´s yield enhancing Pichia pastoris expression platform are now available in one package from VTU. This unique combination of technologies acting synergistically is of great benefit for customers as it leads to a high performance production platform for recombinant glycoproteins with superior product yields and uniform Man5 – or other human-like glycoforms.
Under the terms of the agreement, RCT grants VTU Technology access to RCT´s Pichia GlycoSwitch® expression system for combination with VTU´s in-house high-yielding Pichia platform featuring different proprietary technologies such as AOX1 promoter libraries suited for both methanol-induced and methanol-free production. VTU Technology is now offering the combined technology suite as part of the company´s expression strain and corresponding bioprocess development contract services portfolio.
“We are delighted to offer Pichia GlycoSwitch® engineered with our broad portfolio of Pichia tools in this partnership with RCT and I am convinced that our yield enhancing technologies will give GlycoSwitch® an exciting extra edge for the production of glycoproteins with Man5 – or other human-like glycoforms”, states Thomas Purkarthofer, Ph.D., Head of Business Development of VTU Technology.
“Our partnership with VTU Technology brings together two technologies that will enable customers to uniquely tailor the glycosylation of their target protein and explore new biological functions. We are looking forward to working with VTU Technology to expand the potential of proteins manufactured in Pichia GlycoSwitch®”, states Kurt R. Gehlsen, Ph.D., Vice President and CSO of Research Corporation Technologies, Inc.
Pichia pastoris is a yeast widely used for recombinant protein expression. As a microbial eukaryotic organism, Pichia combines the post-translational modification systems similar to those found in mammalian cells, with the ease of use/manipulation of E. coli. Decades of processes development have been focused on efficiently growing Pichia to extremely high cell densities; and multiple generations of molecular biology tools have been created to engineer strains to produce tens of grams/liters of a recombinant protein product. Pichia can secrete high levels of properly folded, functional proteins into a simple, defined medium for easy purification. There have been more than 20,000 publications on the use of Pichia for the production of more than 5,000 proteins, with more than 70 products manufactured in Pichia on the market today. Pichia products include enzymes manufactured in 200,000-liter fermenters and two FDA-approved therapeutics.
Pichia GlycoSwitch® is a recombinant protein expression system that broadens Pichia’s applications to glycoproteins where N-linked glycosylation is important for biological function. Pichia GlycoSwitch® offers researchers the ability to control the glycosylation (sugar addition) of recombinant glycoproteins and explore the role of protein glycosylation and various glycan structures on protein function. Pichia´s typical high-mannose glycan patterns can also be eliminated to reduce immunogenicity caused by the unwanted hyperglycosylation. The Pichia GlycoSwitch® system consists of patents, strains and vectors that are useful for making proteins with a number of different human-like glycoforms.
VTU Technology, a leading contract research and development company, offers the broadest toolbox and most versatile technology platform available for Pichia pastoris recombinant protein expression / production enabling highest productivities delivering up to 22 g/L of secreted protein within a few weeks development time. VTU Technology´s powerful Pichia pastoris protein expression technology is based on its optimized gene design and cloning strategies, proprietary AOX1 promoter libraries & in-house expression platform and high-throughput screening & cultivation regime, combined with excellent know-how in fermentation and downstream process development.
Headquartered in Grambach/Graz, Austria, VTU Technology is a private company and a subsidiary of VTU Holding, an Austrian enterprise that combines several technology and engineering companies in chemistry, pharma & life science as well as power and fuel industry. For additional information about VTU Technology, please visit www.vtu-technology.com.
RCT is a Tucson, Ariz.-based technology investment and management company that provides early-stage funding and development for promising biomedical companies and technologies. RCT focuses on technology investments with origins from universities and research institutions worldwide. RCT’s technology portfolio includes platforms and tools that support the discovery, development and manufacturing of therapeutics. Current platform technologies include Pichia and E.coli protein expression systems and novel protein binding scaffolds. To learn more about RCT, see www.rctech.com and www.pichia.com.
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.
L3T 4M4 Canada
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
Ms. Jessie Yang
Axcellerate Pharma establishes CMO/CRO and API manufacturing facility in New Jersey, US. Focus will be small molecule and biologics PR&D, innovative technology platforms, filling vial and bag operations, peptide synthesis, oligonucleotide production and related areas.
Axcellerate Pharma LLC (“Axcellerate”) is a JV set up by TCG Lifesciences USA LLC, an affiliate of TCG Lifesciences Limited, a leading CRO engaged in drug development and clinical trial services; with Dilip Mehta, Founder & CEO of PANORAMA Consulting and Engineering, Inc., a leading developer of lab scale to GMP manufacturing facilities; and Alfagen Pharma LLC, an affiliate of AlfaGene Bioscience, Inc., an innovative biotechnology company. The facility houses state-of-the-art technology/equipment/ infrastructure and is supported by leading industry personnel from each of the partner firms.
“We will initially target specialized CMC and CMO activities that are time sensitive and high value in nature, that are desirable to be located geographically close to our clients. Axcellerate intends to leverage the strong scientific talent pool, end-to-end capabilities and PR&D/intermediate production facilities of TCG Lifesciences Limited in India to support its operations. This opportunity represents another significant milestone for TCG Lifesciences’ continued expansion,” commented Swapan Bhattacharya, Managing Director of TCG Lifesciences “as this strategic alliance will expand TCG Lifesciences’ geographic footprint and enable us to service clients in the US with a local presence while being supported globally”.
Dilip Mehta, CEO and co-founder of Axcellerate commented “we will engineer the facilities to provide the highest level of efficiency, technology and cost effectiveness to our customers, given PANORAMA’s broad involvement and experience in all facets of the pharma/biotech sector. We are pleased to join hands with TCG Lifesciences, who will bring in the scientific and technical know how and expertise in the cutting edge areas of drug discovery and development.”
“AlfaGene Bioscience has developed proprietary assay platforms in a range of therapeutic indications and has a scientific team with extensive experience in biologics and biomedical research. We also have a network of global relationships in the API arena to bring to bear for the success of Axcellerate”, remarked Mayur Doshi, President and CEO, AlfaGene Bioscience.