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Monthly Archives: October 2019
In Pursuit of Better Baby Formula | Innovation – Smithsonian.com
Posted: October 28, 2019 at 12:46 pm
Scan the aisles of any grocery store, and youll find a plethora of infant formula options, all designed to meet the nutrient needs of growing infants, who nearly triple their body weight in the first year of life. And yet researchers and companies are busy testing new formulations all the time.
Thats in part because much has changed in our understanding of breast milks complexities over the decades from early knowledge of its nutrient composition to modern revelations that its a living, bioactive substance that evolved not just to nourish babies, but also protect them from pathogens, train their immune systems and send signals between mother and baby.
Formula may never be able to replicate all this complexity, but science could guide development of better products, says Tony Ryan, a neonatologist and emeritus professor at University College Cork in Ireland, who coauthored an overview of baby formula R&D in the 2019 Annual Review of Food Science and Technology. Though breastfeeding is optimal, not every baby can be breastfed, and so we do need safe and effective formulas and with the maximum possible benefit, Ryan says.
But its also a fact that companies are apt to hype the benefits of added ingredients. The brain-nourishing promises made for supplementing formula with the omega-3 fatty acid DHA, starting in the early 2000s, are a case in point. DHA increased the cost of formula, and its now ubiquitous across brands, but whether its necessary is controversial; a 2017 review of the scientific literature, published by the international research network Cochrane, found no clear evidence that it benefits babies brain development.
As the understanding and the knowledge become more and more sophisticated, and we learn about new molecules and new things that are in breast milk, the goal would be to mimic that, says Susan Baker, a pediatric gastroenterologist at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences. But, she adds, ingredients should be added only if theres evidence theyre beneficial, not just to sell more formula or increase its price.
So how to separate the marketing from the science? Heres a look at some formula ingredients under study, many of them already on store shelves.
Throughout time, alternatives to breastfeeding have always had their place, for example when mothers had to work, didnt produce enough milk or died in childbirth. Until around 1900, wealthy families could hire a wet nurse, an arrangement that often compromised the health of the nurses own infant. Orphanages kept herds of lactating donkeys or goats, and babies would feed directly from their teats (which may have been safer than gambling with bacterial contamination of unpasteurized, unrefrigerated milk and hard-to-clean feeding vessels with nipples made from fabric or leather).
The emergence of formula, along with an understanding of germ theory, made feeding such infants simpler and safer. The earliest known patented formula was Justus von Liebigs soup for infants, introduced in Germany in 1865 and made from cows milk, potassium bicarbonate and wheat and malt flour. Similar products followed, but most people used homemade recipes with affordable ingredients such as canned milk and Karo syrup, and supplemented babies diets with orange juice and cod-liver oil to prevent scurvy and rickets.
By the mid-1900s, as nutrition science advanced, formula companies were making better, more complex products, tweaking the types of protein and fat to better match human milk and supplementing with required vitamins and minerals. Today, parents who cant or choose not to breastfeed can be assured that commercial formulas, governed by the nutrition and food safety requirements of the US Food and Drug Administration, are safe and meet a babys nutrient needs.
But there are detectable differences: Formula-fed babies are more likely to have gastrointestinal, respiratory and ear infections in early life, for example. Researchers and formula companies are still probing the suite of human milk molecules for new formula ingredients that might benefit babies health.
The third-most abundant component in human milk, after lactose and fat, is a large family of as many as 200 different sugar molecules called human milk oligosaccharides. Despite their prominence, they arent digestible by infants but instead serve as a food source for species of beneficial Bifidobacteria that dominate the gut microbiomes of breastfed babies, thus serving as prebiotics. The oligosaccharides also appear to act as decoys that can bind microbial pathogens and may prevent them from infecting the infant, and other antimicrobial and immune-modulating functions are being investigated by researchers.
As studies uncovered the importance of human milk oligosaccharides, so began attempts to mimic them in infant formula. But cows milk contains only a fraction of the oligosaccharides in human milk, and until recently the technology to synthesize large amounts didnt exist. And so formula manufacturers instead added different, easier-to-make indigestible carbohydrates such as galacto-oligosaccharides and fructo-oligosaccharides, which also act as prebiotics for Bifidobacteria species.
But these molecules are structurally very different from human milk oligosaccharides and are unlikely to recapitulate their diverse functions, says Lars Bode, a nutrition scientist at the University of California, San Diego. Im always a bit skeptical when something is added to infant formula that is not inherently in human milk, he says, because you never know what these things do, really. Bode points to rare reports of severe allergic reactions in children and adults from galacto-oligosaccharides and the fact that, overall, theres little evidence that these prebiotics are beneficial. A 2018 review of 41 randomized controlled trials of prebiotic-supplemented formula concluded that while the products seemed safe, they didnt lead to tangible health benefits.
Several human milk oligosaccharides are now commercially available, their synthesis in bulk made possible by genetic engineering of yeast and bacteria. In a Nestl-funded trial of a formula containing two of these, 2-fucosyllactose and lacto-N-neotetraose, babies receiving the substances had a lower rate of bronchitis than babies receiving unsupplemented formula (10 percent vs. 28 percent), as well as lower rates of lower respiratory tract infections (19 percent vs. 35 percent) and antibiotic use (42 percent vs. 61 percent) in the first year of life, although the authors say these potential benefits need to be confirmed in larger studies.
Bode says this is a step in the right direction but that formula makers need to look beyond one or two oligosaccharides and also consider the importance of balance. If you only give one oligosaccharide and if you start doing that in higher doses, you might get some effects that would otherwise be kept in check by adding other oligosaccharides as well, he says.
In 2018, for example, he and colleagues reported that higher levels of 2-fucosyllactose, lacto-N-tetraose and a third oligosaccharide in breast milk of mothers in India were associated with a greater incidence of symptomatic rotavirus infections in their babies, and that in cell culture experiments, the oligosaccharides increased the infectivity of a virus strain that causes severe gastrointestinal infections in infants.
Other studies suggest that specific oligosaccharides or mixtures of them in breast milk correlate with excessive weight gain and risk of allergies in breastfeeding infants. There could be potential in designing mixtures of five or 10 oligosaccharides that would benefit infant health, but more research is needed to identify which molecules to pick, and in what ratios.
Studies also have investigated adding different strains of bacteria, or probiotics, directly to formula. And here, too, results have been mixed, with some strains appearing to lower rates of diarrhea, and others leading to softer stools, but most showing no measurable benefit. Were on a very exciting pathway, Ryan says but with much more work still to do.
Lactoferrin is a protein found in high concentrations in human milk. It fights pathogens by binding to the iron they need to grow, and punches holes in the membranes of some bacteria. Lactoferrin concentrations are much higher in human milk than cows milk, and appear to rise in mothers milk when the baby gets sick.
A couple of studies find benefits of adding lactoferrin to formula: One in China reported a decrease in the incidence of respiratory and diarrhea-related illnesses by 32 percent and 35 percent, respectively, and a small US study reported 70 percent fewer lower-respiratory tract infections. But the largest published study, conducted by Enfamil and enrolling 480 US infants, found that while lactoferrin-supplemented formula was safe and well-tolerated, it didnt decrease infections or allergy symptoms. Even so, Enfamil now includes lactoferrin as an immune-supporting protein in one of its most expensive products.
When milk fat is secreted from the mammary gland, its packaged in a triple-layer membrane made of phospholipids, cholesterol and a multitude of proteins (including lactoferrin). Synthesis of these milk fat globule membranes is orchestrated by one of the most well-conserved parts of the mammalian lactation genome, says food scientist Bruce German of the University of California, Davis. Yet the membranes are discarded during manufacture of infant formula, which is based on nonfat milk powder with vegetable oils added as a fat source. Evolution thought it was real important, German says of the milk fat globule material. Then we just threw it away.
Researchers are now experimenting with adding the bovine version of milk fat globule membranes often made from byproducts of dairy processing, such as butter- or cheese-making to infant formula. This is probably a good idea, German says, but chronic underfunding of basic lactation research means theres very little known about the role of the membranes in human milk, so its hard to know how to measure the effects of this addition. Embarrassingly, we dont even know the composition, much less the mechanistic function, he says.
Trials of formula supplemented with bovine milk fat globule membranes have shown confusing results. One study, conducted in France and Italy and funded by Nestl, found that babies grew normally and tolerated the ingredient, but they were no less likely to get sick. And there was a concerning outcome: Babies consuming one of the two experimental formulas were four times more likely to have eczema (13.9 percent vs. 3.5 percent in the standard formula group) inflamed, itchy skin that often precedes the development of food allergies, hay fever and asthma.
But a Swedish study testing the same ingredient in a different formula recipe found no such effect. Funded in part by Swedish formula manufacturer Semper, it found that babies consuming the formula had fewer ear infections (1 percent vs. 9 percent in the standard formula group) in the first 6 months of life. And at 12 months, babies getting the supplement tested 4 points higher on a cognitive scale than those receiving standard formula, and the same as a breastfed group. Formula with milk fat globule membranes is now marketed in the US with the claim that it supports cognitive development similar to breast milk."
Steven Abrams, a neonatologist at Dell Medical School at the University of Texas at Austin and chair of the American Academy of Pediatrics Committee on Nutrition, cautions against getting excited about these results. The cognitive scale used in the Swedish study, called the Bayley Scales of Infant and Toddler Development, wasnt designed to measure small differences among a group of normally developing infants, he says, and you cant determine from a tiny difference on a Bayley at 12 months whether or not that child will actually be more likely to make it in to MIT.
Despite the potential for advances in infant formula and the claims of benefits made for these new formula ingredients, a skeptical eye is in order, researchers and clinicians say. Abrams, for his part, is not convinced that these new ingredients have been adequately studied, especially over the long term. Most studies in this area are funded by the formula industry, he adds, raising concerns of bias and making the case for more federal funding of infant nutrition research.
In 2015, Abrams published a commentary in the Journal of Pediatrics suggesting a moratorium on new formula ingredients until more research could be conducted. He notes that the Food and Drug Administration requires little clinical data on effectiveness or long-term safety before allowing addition of new ingredients. Since then, the issue has gotten bigger, not smaller, he says with more new ingredients accompanied by vague, structure/function claims, such as immune-supporting and brain-building, based on minimal evidence. The FDA drafted guidance in 2016 that would require companies to show more meaningful clinical outcomes before making such claims, but the new guidelines havent yet been finalized and an agency spokesperson was unable to provide an estimate for completion.
Helen Hughes, a pediatrician at Johns Hopkins School of Medicine, says she doesnt usually recommend any formula product over another, including those touting ingredients that mimic bioactive molecules in breast milk. A coauthor of a 2017 commentary in JAMA Pediatrics urging a higher bar for evidence for claims on formula labels, she worries that the claims may persuade parents to unnecessarily switch formulas or choose more expensive products premium formulas with the newest ingredients can cost more than 50 percent more than standard products from the same companies.
I, as a physician, would love to see more evidence about what they do before theyre added into formula, Hughes says. Its hard as a parent, she adds, to say Im going to buy the formula thats not for brain health. "
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4 Innovative Solutions Fostering Advanced Cancer Treatment – Medical Tech Outlook
Posted: October 28, 2019 at 12:44 pm
Medical technologies like smart pills, vaccines personalization, and more are opening newer ways for cancer treatment.
FREMONT, CA: Treatment options for cancer have massively evolved and improved in recent years. Today, care providers continue to explore new possibilities for cancer treatment with the help of advanced technologies. Treatments like radiation therapy, personalization of cancer vaccines, and nano-medicines, experience rapid adoptions by care providers for cancer treatment.
1. Radiation Therapy
Health care providers use radiation therapy, highly effective cancer treatment. This treatment aims accurately and directly at the cancer cells, resulting in the killing or reduction of the tumor-affected cells and tissues in the patients. The high-energy rays prove to be highly effective in reducing the risk of cancer and recurrence of common cancer, such as breast cancer, bowel cancer, and prostate cancer, and helps the surgeons remove or kill the cancer-affected tissues. The latest medical technologies for cancer integrated with radiation therapy are making the treatments more quick, accurate, and effective.
2. Ingestible Sensors and Smart Pills
Ingestible technology in the healthcare field is used to help the patients manage their medications. The new technology allows the care providers to ensure their cancer patients are taking medications as prescribed. Ingestible sensors offer close monitoring of patients' health conditions, which include sensing the growth of tumors and instantly guiding the smart pills towards precise tumor locations and heart rate, activity level, and sleep cycle of the patients. The digital pills enable real-time transmission of health information to a small patch on the patients' skin, which can be connected to a mobile app that both the patients and their doctors can access.
3. Personalized Cancer Vaccines
Developments in personalized cancer vaccines enable the next-generation cancer treatment method. The advanced vaccine is used with the computational pipeline, which can precisely identify tumor-unique mutations and successfully induce immune responses in cancer patients, helping them fight their diseases. The technique follows cell-based immune therapies that provide the patients with tumor-attacking T cells, and the delivered neo-antigens in the patients body create vaccines to stimulate the T cells. The advanced vaccines are given in the form of messenger RNA that produces a particular protein according to the patients physiological requirements.
4. Nano-Medicines
The innovative and promising technology, nano-medicine provides many advantages over conventional cancer therapies and new opportunities for early detection, improved treatment, and diagnosis of cancer. The benefits of nano-medicines for cancer treatment attract care providers, as the unique physical, chemical, mechanical, and optical properties of these medicines are easier to access with more efficiency. The innovative medicine uses nano-carriers to deliver therapeutic molecules, such as drugs, proteins, or nucleic acids. The nano-structures for the cancer treatment can also be exploited to favor the delivery of immune agents and represent therapeutic tool.
Technology leads the cancer treatment sector towards a bright future, where the increasing advantages of innovative cancer treatment solutions can be accessed easily across the world. Nanotechnology, targeted radiation, personalized vaccines are revolutionizing the medical technology industry, promising the possibilities of more solutions that can successfully fight cancer and prevent its reoccurrence. The ever-evolving field of cancer treatments consistently puts effort into exploring innovative diagnostics and treatments, leading to more creative solutions like molecular cancer diagnostics, identify genetic and lifestyle causes of diseases, and perform precision surgery.
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Thought Leadership & Innovation Foundation to Expand Its Regenerative Medicine Program Through New Collaboration with RenovaCare – Business Wire
Posted: October 28, 2019 at 12:43 pm
MCLEAN, Va.--(BUSINESS WIRE)--The Thought Leadership & Innovation Foundation (TLI) announces today plans to build on its existing Regenerative Medicine Program through a research collaboration with cellular therapy industry leader RenovaCare. As part of TLIs efforts to conduct vital research in regenerative medicine and chronic disease, this initiative aims to innovate methods for reducing complications from burn and diabetic wounds across large populations.
Our research base, collaborative institutions and long history of innovation align with RenovaCares commitment to breakthrough biomedical technologies, says Bill Oldham, founder and chairman of the Board, TLI. The patented RenovaCare SkinGun technology and its ability to ultra-gently spray stem cells could present a special opportunity for investigations and applications in a wide range of regenerative therapies. Working together, our overall goal is to improve the quality, efficiency and effectiveness of patient care by not only developing new treatment methods, but also by making thoughtful and systematic changes to healthcare and health systems.
TLIs Regenerative Medicine program seeks to adapt new strategies based upon sound scientific evidence, utilizing its infrastructure to support the continuation of scientific and medical work, as well as the development of grant-funded research and other initiatives.
Dr. Robin A. Robinson, who is a TLI Fellow, Vice President of Scientific Affairs, RenovaCare, and named one of the top 100 innovators in medicine by Medicine Maker in 2018, states, This exciting collaboration between RenovaCare and TLIs Regenerative Medicine Program is the first step toward the development of meaningful and quality therapeutic treatments that will benefit patients around the world.
About TLI Foundation:
TLI Foundation is a nonprofit foundation focused on driving innovative thinking and action on global issues relating to health, education and economic empowerment. The organization is committed to fostering transformative change and improving the health and well-being outcomes of communities around the world. Visit https://www.thoughtfoundation.org/
About RenovaCare:
RenovaCare, Inc. is a biotechnology company focused on developing first-of-their-kind autologous (self-donated) stem cell therapies for the regeneration of human organs. Initial products under development target the bodys largest organ, the skin. Investigative clinical use of their flagship technology has shown to be promising new alternatives for patients suffering from burns, and chronic and acute wounds. https://www.renovacareinc.com.
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Regenerative Medicine Market 2019 overview, segmentation, top key companies, market size and trends by 2025 – Health News Office
Posted: October 28, 2019 at 12:42 pm
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Cynata Therapeutics awarded grant to progress stem cell therapies for coronary artery disease – Proactive Investors Australia
Posted: October 28, 2019 at 12:42 pm
The company is an Australian clinical-stage stem cell and regenerative medicine corporation focused on the development of therapies based on Cymerus a therapeutic stem cell platform technology.
() has been awarded a Federal GovernmentInnovations Connections grant to advance development of therapies based on itsCymerus technology platform for the treatment of coronary artery disease (CAD).
CAD, which is the narrowing or blockage of the arteries in the heart, causes the majority of heart attacks and about one-third of all deaths in people over the age of 35 in developed countries.
The Innovations Connections grant of $50,000 is supported by the Australian Governments Department of Industry Innovation and Science.
These funds will be used to support the continuation of research at the University of NSW in Sydney under the leadership of Associate Professor Kristopher Kilian, ARC future fellow at the UNSW School of Chemistry and School of Materials Science and Engineering.
Cynata's chief operating officer Dr Kilian Kelly said: We are very pleased to receive this non-dilutive funding which enables us to further our research into the development of customised MSCs that address CAD before a heart attack occurs.
Associate Professor Kristopher Kilian and his team have already demonstrated the potential value of this approach and we now look forward to generating further data in support of a future clinical trial.
Thisfurther research leads on from a collaborative project with this group which started in 2018 and identified optimal cell culture matrices to stimulate the growth of new blood vessels.
These positive effects were demonstrated in a well-established in vitro assay and were maintained after the cells were frozen and then thawed, which is important from a commercialisation perspective.
The additional project, which is expected to complete by the end of 2020, seeks to build on the previous findings by profiling the pro-angiogenic factors released from the primed MSCs, establish the ability of primed cells to promote new blood vessel formation in vivo, followed by in vivo safety and efficacy in a preclinical model.
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Regenerative Medicine Market Industry Outlook, Growth Prospects and Key Opportunities – Health News Office
Posted: October 28, 2019 at 12:42 pm
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Awareness among people regarding the disposal of medical waste, and taking care of their safety from harmful medical waste are the major trend currently driving the market growth. Regulated waste disposal generally costs more than unregulated waste disposal. Growth of the overall medical and healthcare industry is driving the demand for medical waste management systems. In the U.S. and European countries, due to strict regulations, most medical waste management service providers require government permits, approvals, certificates from all jurisdictions in which they operate. In India, the Ministry of Environment and Forests (MoEF), Government of India, declare the Medical waste management and Handling Rules, 1998 and the Bio-Medical Waste (Management and Handling) (Amendment) Rules, 2003, to provide legal and mandatory guidelines for healthcare and medical waste management industry
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The new study study of Medical Waste Management Market anticipated to reach US$ XXX Million with a significant CAGR of 5.3% in the forecast period of 2015-2025. The growing population across the globe is expanding the number of patients, resulting in the rising volume of medicinal waste. Also, the increasing prevalence of diseases such as cancer & other chronic disorders and increasing geriatric population result in higher demand for these propelled the medical waste management market. The Central Pollution Control Board has additionally issued guidelines on the Central Bio-medical Waste Treatment Facilities (CBWTF). The expanding number of innovative initiatives by the government authorities is driving the medical waste management market. The developing trend of government R&D in technological research are the prime aspects that are straightforwardly responsible for driving the global medical waste management market. The Asia Pacific is anticipated to open growth prospects for the medical waste management market in the forecast period of 2019-25 in the healthcare sector.
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Overview and highlights of product and application segments of the global Medical Waste Management Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.
Explore about Sales data of key players of the global Medical Waste Management Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the Medical Waste ManagementMarket.
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Describe Medical Waste Management Market Findings and Conclusion, Appendix, methodology and data source;
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FDA Approves Medicines360’s LILETTA (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Six Years, the Longest…
Posted: October 28, 2019 at 12:42 pm
"Our mission has always been to meet the diverse and unique health needs of all women, and this approval of LILETTA for up to six years means women have even greater flexibility and choice when it comes to their reproductive health," said Jessica Grossman, M.D., CEO of Medicines360. "Studying our products in robust clinical trials, like ACCESS IUS, ensures we can provide quality birth control that works for a broad range of women in the U.S., something we take pride in for leading the way."
The FDA approval was based on a review of additional efficacy and safety data from the largest ongoing Phase 3 clinical trial of an intrauterine system in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 U.S. women receiving LILETTA. LILETTA proved to be more than 99 percent effective in preventing pregnancy for up to 6 years in a diverse population of women. The study population in the ACCESS IUS trial included women of various ages, races, and body mass index (BMI).
"I hear all the time from women that they want a reliable and long-term option for birth control that is reversible," said Carolyn Westhoff, M.D., MSC, chief of the Division of Family Planning, Sarah Billinghurst Solomon Professor of Reproductive Health, Department of Obstetrics and Gynecology, Professor of Population and Family Health and Epidemiology, Columbia University, and investigator in the ACCESS IUS study. "This groundbreaking trial has given healthcare providers the ability to confidently offer women the option of pregnancy prevention for up to six years."
LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to six years. The system should be replaced after six years if continued use is desired. Medicines360 received initial approval of LILETTA in February 2015. Since then, Medicines360 and Allergan have continued to invest in the product, which has led to the introduction of the single-handed inserter and, now, the extended duration of use for up to six years.
LILETTA is commercially available in the U.S., and through Medicines360's unique mission-driven model, LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.
"Our partnership with Medicines360 helps to ensure that women can obtain an effective, long-term birth control option," said David Nicholson, Ph.D., Allergan's Executive Vice President and Chief Research and Development Officer. "Our goal is to provide a variety of contraceptive options for women so they and their healthcare providers can choose what is best for them. We are proud to deliver a product that now provides women with an even longer duration of pregnancy prevention."
ABOUT LILETTA
Indication
LILETTA (levonorgestrel-releasing intrauterine system) 52mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 6 years.
Important Risk Information About LILETTA
LILETTA does not protect against HIV or STDs.
Available by prescription only.
Please see full Prescribing Information for LILETTA.
About Medicines360
Medicines360, located in San Francisco, California, is a nonprofit global women's health pharmaceutical company with a mission to remove cost as a barrier to health by developing and providing affordable Women's Health products. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit http://www.medicines360.org
About Allergan Women's Healthcare
Allergan is a leader in women's healthcare that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women's healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women's HealthCare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website atwww.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
SOURCE Medicines360
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FDA Approves Medicines360's LILETTA (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Six Years, the Longest...
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The Bounce is On in Predictive Technology Group Inc (OTCMKTS:PRED) – The Oracle Dispatch
Posted: October 28, 2019 at 12:42 pm
As we head into the fresh weekof trading, note the action on Friday in shares of Predictive Technology Group Inc (OTCMKTS:PRED). The rally looks tobe related to news of an uplist onto the OTCQX tier of the OTC market. But wewould also point out the companys announcement that a team mostly from PRED(including Kenneth Ward, M.D., laboratory director of Predictive Laboratoriesand chief executive officer of Juneau Biosciences; Rakesh Chettier M.S.,director of biostatistics of Predictive Laboratories; and Hans Albertsen,Ph.D., chief scientific officer of Juneau Biosciences) has received the 2019Endometriosis Special Interest Group (EndoSIG) Prize Paper in the Best inClinical/Population Science category.
According to the release, Dr. Albertsens presentation entitled Cytoskeletal and extracellular matrix genes are key contributors in the pathogenesis of endometriosis was delivered at the American Society for Reproductive Medicine (ASRM) 2019 Scientific Congress & Expo in Philadelphia on October 16. EndoSIG is a member group of ASRM aimed at fostering increased interest in the biology, pathophysiology and clinical management of endometriosis.
Predictive Technology Group Inc (OTCMKTS:PRED) promulgates itself as a company that, together with its subsidiaries, develops and commercializes discoveries and technologies involved in novel molecular diagnostic and pharmaceutical therapeutic/human cells, tissues, and human cellular and tissue-based products (HCT/Ps).
The company operates through two segments, Regenerative Medicine Products and HCT/Ps, and Diagnostics and Therapeutics. It offers ARTguide, a genetic diagnostic and prognostic test for women experiencing infertility as a result of endometriosis and other health concerns; and regenerative medicine products, including AmnioCyteT, AmnioCyte PlusT, PolyCyteT, and CoreCyteT.
The company was formerly knownas Global Enterprises Group, Inc. and changed its name to Predictive TechnologyGroup, Inc. in July 2015. Predictive Technology Group, Inc. was founded in 2005and is headquartered in Salt Lake City, Utah.
According to companymaterials, Predictive Technology Group aims to revolutionize patient carethrough predictive data analytics, novel gene-based diagnostics and companiontherapeutics through its subsidiaries Predictive Therapeutics, PredictiveBiotech, and Predictive Laboratories. These subsidiaries are focused onendometriosis, scoliosis, degenerative disc disease and human cell and tissueproducts. The subsidiaries use genetic and other information as cornerstones inthe development of new diagnostics that assess a persons risk of illness andtherapeutic products designed to identify, prevent and treat diseases moreeffectively.
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As noted above, PRED just announced that a team mostly from the company has received the 2019 Endometriosis Special Interest Group (EndoSIG) Prize Paper in the Best in Clinical/Population Science category.
Weve witnessed 28% tacked on to share pricing for the name in the past week. In addition, the stock has witnessed a pop in interest, as transaction volume levels have recently pushed topping 120% over what the stock has registered over the longer term.
We are honored to receive this prestigious award from the ASRM Research Committee, said Dr. Albertsen. As endometriosis is generally characterized as a hormonal and inflammatory disease, current therapies often come with significant debilitating side effects. The scientific breakthroughs reported in these award-winning discoveries provide Predictive with insights into new non-hormonal therapies.
At this time, carrying acapital value in the market of $475M, PREDhas a bankroll ($1.8M) of cash on the books, which is balanced by about $14.1Min total current liabilities. One should also note that debt has been growingover recent quarters. PRED is pulling in trailing 12-month revenues of $43.5M.In addition, the company is seeing major top-line growth, with y/y quarterlyrevenues growing at 88%. You can bet we will update this one again as newinformation comes into view. Sign-up forcontinuing coverage on shares of $PRED stock, as well as other hot stock picks,get our free newsletter today and get our next breakout pick!
Disclosure: we hold no position in $PRED, either long orshort, and we have not been compensated for this article.
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The Bounce is On in Predictive Technology Group Inc (OTCMKTS:PRED) - The Oracle Dispatch
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Reviewing vTv Therapeutics Inc. (VTVT)’s and Asterias Biotherapeutics Inc. (:)’s results – MS Wkly
Posted: October 27, 2019 at 7:46 am
vTv Therapeutics Inc. (NASDAQ:VTVT) and Asterias Biotherapeutics Inc. (:) are two firms in the Biotechnology that compete against each other. Below is a comparison of their institutional ownership, analyst recommendations, profitability, risk, dividends, earnings and valuation.
Valuation and Earnings
We can see in table 1 the earnings per share, top-line revenue and valuation of vTv Therapeutics Inc. and Asterias Biotherapeutics Inc.
Profitability
Table 2 provides the return on equity, net margins and return on assets of the two firms.
Analyst Ratings
In next table is delivered vTv Therapeutics Inc. and Asterias Biotherapeutics Inc.s ratings and recommendations.
vTv Therapeutics Inc. has a 224.68% upside potential and a consensus target price of $5.
Insider & Institutional Ownership
The shares of both vTv Therapeutics Inc. and Asterias Biotherapeutics Inc. are owned by institutional investors at 7.3% and 13.75% respectively. 69.32% are vTv Therapeutics Inc.s share owned by insiders. Insiders Competitively, owned 40.53% of Asterias Biotherapeutics Inc. shares.
Performance
Here are the Weekly, Monthly, Quarterly, Half Yearly, Yearly and YTD Performance of both pretenders.
Summary
vTv Therapeutics Inc. beats Asterias Biotherapeutics Inc. on 6 of the 9 factors.
vTv Therapeutics Inc., a clinical-stage biopharmaceutical company, discovers, develops, and sells orally administered small molecule drug candidates worldwide. The companys drug candidate for the treatment of Alzheimers disease comprise azeliragon (TTP488), an orally administered, small molecule antagonist targeting the receptor for advanced glycation endproducts, which is in Phase III clinical trials. Its type 2 diabetes drug candidates include TTP399, an orally administered, liver-selective glucokinase activator that has been completed Phase IIb clinical trials; and TTP273, an orally administered, non-peptide agonist that targets the glucagon-like peptide-1 receptor, which is in Phase II clinical trials. The company has a license and research agreement with Calithera Biosciences, Inc. to develop and commercialize its hexokinase II inhibitors for therapeutics, prophylactic, preventative, or diagnostic use. vTv Therapeutics Inc. was founded in 2015 and is headquartered in High Point, North Carolina. vTv Therapeutics Inc. operates as a subsidiary of M&F TTP Holdings Two LLC.
Asterias Biotherapeutics, Inc., a clinical-stage biotechnology company, focuses on developing and commercializing novel therapies in the fields of cell therapy and regenerative medicine. The company develops therapeutic products in the areas of neurology and oncology. Its clinical stage programs include AST-OPC1, a therapy derived from pluripotent stem cells that has completed a Phase I clinical trial for the treatment of thoracic spinal cord injuries; and that is in Phase I/IIa clinical trial for treating cervical spinal cord injuries, as well as for the treatment of multiple sclerosis and white matter stroke. The company also develops immunotherapeutic programs, such as AST-VAC1, an autologous product candidate that has completed a Phase II clinical trial for the treatment of acute myelogenous leukemia; and AST-VAC2, which is in a Phase I/IIa clinical trial, an allogeneic and cancer vaccine candidate designed to stimulate patient immune responses to telomerase. The company was formerly known as BioTime Acquisition Corporation and changed its name to Asterias Biotherapeutics, Inc. in March 2013. Asterias Biotherapeutics, Inc. was founded in 2012 and is headquartered in Fremont, California. Asterias Biotherapeutics, Inc. is a subsidiary of BioTime, Inc.
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Reviewing vTv Therapeutics Inc. (VTVT)'s and Asterias Biotherapeutics Inc. (:)'s results - MS Wkly
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Reviewing BioCryst Pharmaceuticals Inc. (BCRX)’s and Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI)’s results – MS Wkly
Posted: October 27, 2019 at 7:46 am
Both BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) and Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) are each others competitor in the Biotechnology industry. Thus the compare of their institutional ownership, earnings and valuation, profitability, risk, dividends, analyst recommendations.
Earnings & Valuation
Demonstrates BioCryst Pharmaceuticals Inc. and Brainstorm Cell Therapeutics Inc. earnings per share, gross revenue and valuation.
Profitability
Table 2 represents BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) and Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI)s net margins, return on assets and return on equity.
Volatility and Risk
A 2.02 beta means BioCryst Pharmaceuticals Inc.s volatility is 102.00% more than Standard and Poors 500s volatility. Brainstorm Cell Therapeutics Inc.s 1.19 beta is the reason why it is 19.00% more volatile than Standard and Poors 500.
Liquidity
1.8 and 1.8 are the respective Current Ratio and a Quick Ratio of BioCryst Pharmaceuticals Inc. Its rival Brainstorm Cell Therapeutics Inc.s Current and Quick Ratios are 1 and 1 respectively. BioCryst Pharmaceuticals Inc. has a better chance of clearing its pay short and long-term debts than Brainstorm Cell Therapeutics Inc.
Analyst Ratings
The next table highlights the given recommendations and ratings for BioCryst Pharmaceuticals Inc. and Brainstorm Cell Therapeutics Inc.
BioCryst Pharmaceuticals Inc.s average price target is $16, while its potential upside is 580.85%. Meanwhile, Brainstorm Cell Therapeutics Inc.s average price target is $9, while its potential upside is 147.25%. Based on the analysts view we can conclude, BioCryst Pharmaceuticals Inc. is looking more favorable than Brainstorm Cell Therapeutics Inc.
Institutional & Insider Ownership
BioCryst Pharmaceuticals Inc. and Brainstorm Cell Therapeutics Inc. has shares owned by institutional investors as follows: 98.7% and 11.4%. Insiders owned roughly 0.2% of BioCryst Pharmaceuticals Inc.s shares. Comparatively, Brainstorm Cell Therapeutics Inc. has 0.6% of its share owned by insiders.
Performance
In this table we provide the Weekly, Monthly, Quarterly, Half Yearly, Yearly and YTD Performance of both pretenders.
For the past year BioCryst Pharmaceuticals Inc. had bearish trend while Brainstorm Cell Therapeutics Inc. had bullish trend.
Summary
BioCryst Pharmaceuticals Inc. beats on 7 of the 12 factors Brainstorm Cell Therapeutics Inc.
BioCryst Pharmaceuticals, Inc., a biotechnology company, designs, optimizes, and develops small molecule drugs that block key enzymes involved in the pathogenesis of diseases. The company markets peramivir, an intravenous neuraminidase inhibitor, which is approved for uncomplicated seasonal and acute influenza in the United States and Canada under the name RAPIVAB, in Japan and Taiwan as RAPIACTA, and in Korea as PERAMIFLU. It also has various ongoing development programs, including BCX7353 and second generation oral inhibitors of plasma kallikrein for hereditary angioedema; and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is indicated to treat filoviruses, as well as forodesine, an oral purine nucleoside phosphorylase inhibitor for use in oncology. It has collaborative relationships with Mundipharma International Holdings Limited for the development and commercialization of forodesine; Shionogi & Co., Ltd. and Green Cross Corporation for the development and commercialization of peramivir in Japan, Taiwan, and South Korea; Seqirus UK Limited for the development and commercialization of RAPIVAB worldwide, except Japan, Taiwan, Korea, and Israel; and the University of Alabama at Birmingham for the development of influenza neuraminidase and complement inhibitors. BioCryst Pharmaceuticals, Inc. was founded in 1986 and is headquartered in Durham, North Carolina.
Brainstorm Cell Therapeutics Inc., a biotechnology company, develops adult stem cell therapies for neurodegenerative disorders that include amyotrophic lateral sclerosis, multiple sclerosis, Parkinsons disease, and others. The company holds rights to develop and commercialize its NurOwn technology through a licensing agreement with Ramot of Tel Aviv University Ltd. Its NurOwn technology is based on a novel differentiation protocol, which induces differentiation of the bone marrow-derived mesenchymal stem cells into neuron-supporting cells and secreting cells that release various neurotrophic factors, including glial-derived neurotrophic factor, brain-derived neurotrophic factor, vascular endothelial growth factor, and hepatocyte growth factor for the growth, survival, and differentiation of developing neurons. The company was formerly known as Golden Hand Resources Inc. and changed its name to Brainstorm Cell Therapeutics Inc. in November 2004 to reflect its new line of business in the development of novel cell therapies for neurodegenerative diseases. Brainstorm Cell Therapeutics Inc. was founded in 2000 and is headquartered in Hackensack, New Jersey.
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