VANCOUVER, British Columbia, Feb. 20, 2018 (GLOBE NEWSWIRE) -- Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce commencement of its clinical trial and first patient enrollment. These clinical studies are designed to measure the safety and effectiveness of the HeartSentry technology for cardiovascular health diagnosis.

HeartSentry is a new non-invasive diagnostic device that is designed to measure and monitor cardiovascular health by assessing the function of a patient’s vascular endothelium, the vital innermost lining of the cardiovascular system. The core technology of HeartSentry was developed at the University of California Berkeley over a fifteen-year research and development period involving an award winning scientific team dedicated to solving the holy grail of cardiovascular medicine, being able to cost effectively predict the development and progression of cardiovascular disease. The early research studies and product iterations resulted in a portfolio of multiple pending and issued patents being licensed to the Company.

Read more: https://globenewswire.com/news-release/2018/02/20/1361972/0/en/Lexington-Begins-HeartSentry-Clinical-Trial.html

FRAMINGHAM, Mass., Feb. 20, 2018 /PRNewswire/ -- Alira Health, an international healthcare and life science advisory firm, announced that it has acquired Clinical Assistance Programs (CAP), a contract research organization providing a full range of clinical trial management and consulting services.

The purchase will strengthen Alira Health's scientific and clinical core. The combined organization will provide a full range of services across regulatory, clinical research and medical affairs. This expansion reinforces Alira Health's commitment to simplifying their clients' complex journey through the healthcare and life science product lifecycle.

Read more: https://www.prnewswire.com/news-releases/alira-health-acquires-clinical-assistance-programs-300601166.html

In the latest of its growing list of biomedical partnerships, Ionis Pharmaceuticals will get $30 million upfront from drug giant AstraZeneca to commercialize a drug for a genetic form of kidney disease.

Up to an additional $300 million may be available to Ionis in milestone payments as the drug progresses through clinical testing, Carlsbad-based Ionis said Monday. And if the drug reaches the market, Ionis will get “low double-digit royalties.”

The drug, called Ionis-AZ5-2.5Rx, uses an improved version of the company’s antisense technology, which treats diseases by modifying or blocking production of the disease-related proteins. This “generation 2.5” technology makes more potent drugs, and enables them to reach more regions of the body, Ionis says.

Antisense can reach disease targets other drug technologies can’t and also reduces drug side effects.

Read more: http://www.sandiegouniontribune.com/business/biotech/sd-me-ionis-deal-20180220-story.html

ROCHESTER, Minn. -- When people are suffering from a chronic medical condition, they may place their hope on treatments in clinical trials that show early positive results. However, these results may be grossly exaggerated in more than 1 in 3 early clinical trials, reports a new study led by Mayo Clinic and published today in Mayo Clinic Proceedings.

"This phenomenon of exaggerated early results was present in a whopping 37 percent of the studies we reviewed," says Fares Alahdab, M.D., lead author of the study and a research fellow in Mayo Clinic's Evidence-Based Practice Center. "Physicians and patients should be cautious about new or early clinical trial evidence. Exaggerated results could lead to false hope as well as possibly harmful effects."

Read more: https://www.eurekalert.org/pub_releases/2018-02/mc-erf021918.php

BRIDGEWATER, N.J., Feb. 19, 2018 — Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a privately-held specialty pharmaceutical company developing novel central nervous system (CNS) treatments utilizing its proprietary osmotic drug delivery platform, announced today that the U.S. Food and Drug Administration (FDA) has approved OSMOLEX ER™, an amantadine extended release tablet, for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms are known side effects of many common medications.
“The FDA’s approval of OSMOLEX ER provides a new treatment option for those patients suffering from Parkinson’s disease and adults who have extrapyramidal reactions, or movement disorders, that are caused by certain medicines. We are eager to make OSMOLEX ER available to physicians and patients in the U.S.,” stated Brian Markison, Chief Executive Officer of Osmotica.

Read more: http://bit.ly/2CbqCcU

A not-for-profit organisation dedicated to encouraging life sciences R&D has launched a new tool to help companies in the sector design better apps and digital tools.

The Pistoia Alliance announced it had launched the User Experience (UX) for Life Science (LS) Toolkit to improve user experience of programs in line with other global industries.

Containing user experience case studies, methods and metrics, the toolkit will enable life science companies to design and implement better, more intuitive and usable digital products.

Read more: http://bit.ly/2GtPISn

Astellas will bolster its regenerative medicine arm through the acquisition of pluripotent stem cell maker Universal Cells.
Read more: HTTPS://WWW.BIOPHARMA-REPORTER.COM/ARTICLE/2018/02/20/ASTELLAS-ADDING-OFF-THE-SHELF-STEM-CELL-TECH-IN-102.5M-ACQUISITION

NEW YORK, NY / ACCESSWIRE / February 19, 2018 / Dr. Joel Singer announces that he plans to fund and start a double-blind study on the use of autologous, adipose derived stem cells for the treatment of osteoarthritis of the knee. The Park Avenue Stem Cell Medical Director also says the study is designed to determine the efficacy of intra-articular autologous adipose derived stem cells in the treatment of osteoarthritis of the human knee. It will be the first prospective, randomized, controlled, double-blind study of this kind.

The safety and efficacy of autologous stem cell treatment

Ever since the discovery by Zuk et al in 2001 of the presence, abundance, and significance of adult pluripotential mesenchymal stem cells as part of the structure and function of human adipose tissue, clinical applications have expanded exponentially all over the world.

There has been ample evidence in peer-reviewed medical literature of the safety of autologous stem cell treatment, including Chang et al in 2013, Centeno et al in 2016, and Berman et al in 2017 comprising more than 3500 patients. Stem cell therapy is considered safe because the stem cells used come from the patient. This minimizes any risk of negative consequences.

Numerous peer-reviewed publications suggest the efficacy of intra-articular injections for osteoarthritis of the knee and other joints in humans. Clinical evidence has been mostly anecdotal but is corroborated by changes in arthroscopy and X-rays.

Researchers believe that when stem cells are injected into an arthritic joint, they develop into cartilage cells, suppress the inflammation that makes the arthritis worse and releases cytokines that slow down cartilage degeneration.



Read more: http://www.digitaljournal.com/pr/3663592#ixzz57eK3Dedz

By genetically modifying bacteria, a new startup from the University of Basel known T3 Pharmaceuticals AG want to develop new cancer therapies. Scientists actually took inspiration from nature and they are adapting it to find alternatives to chemotherapy.

Scientists are consolidating two understood regular wonders: that microbes can colonize tumours, and those specific microscopic organisms can infuse independent protein atoms into human cells. To do this, they utilize an ultra-fine needle known as a “type III secretion system”.

The real plan is to reprogram the bacteria in order to transform the desired proteins into the tumour cells. Through this approach, scientists make it possible to introduce therapeutically effective proteins directly into the cancerous cells.

Read more: http://bit.ly/2GscNoC

In March 2015, Hanmi signed an exclusive license agreement with the US-based drug maker to grant rights to HM71224 in a deal that could generate up to $640 million

Korea’s Hanmi Pharma recently announced that its partner Eli Lilly has discontinued the clinical study for HM71224, an experimental Bruton’s tyrosine kinase inhibitor for the treatment of rheumatoid arthritis because it is “unlikely to meet the primary efficacy endpoint in the ongoing phase 2 trials.”

Shares of Hanmi Pharmaceutical dropped sharply on Feb. 19 after Eli Lilly decided to stop clinical trials, according to the country’s local press reports.

In March 2015, Hanmi signed an exclusive license agreement with the US-based drug maker to grant rights to HM71224 in a deal that could generate up to $640 million.

Read more: http://bit.ly/2CyoKGO

Researchers at the University of Georgia have developed a new stem-cell-based treatment for strokes. When tested in animal models, the technique was found to reduce brain damage and help the brain heal itself faster, and the results have been promising enough that human clinical trials may follow as soon as next year.

A particularly promising line of treatment involves stem cells. A few years ago, a London study used a certain set of CD34+ stem cells to trigger the growth of new brain tissue and blood vessels. Later, a Stanford study managed to restore mobility in the limbs of stroke victims after injecting stem cells into the brain.

The new study, conducted by researchers from the University of Georgia's Regenerative Bioscience Center and spinout startup ArunA Biomedical, also uses stem cells. Dubbed AB126, the treatment uses exosomes, tiny tube-shaped structures generated by neural stem cells. Since these structures are smaller than cells, they're able to cross certain barriers that cells can't, carrying and delivering multiple doses of regenerative therapeutics to where they're most needed.

Read more: http://bit.ly/2EUAHMe

The Internet of Things (IoT) has the potential to revolutionize the pharmaceutical sector with its practical applications. It may facilitate and automate remote monitoring of patients and the discovery and access of drugs. IoT, combined with the spread of digitalization of data in pharmaceuticals, brings in several new opportunities.

• Changing the fundamentals of the Pharmaceutical sector
With the increasing demand for easy and immediate access to healthcare, it becomes essential for pharmaceutical companies to find quicker means for transportation of drugs and to regulate their transit and delivery. IoT-driven technology has proved useful in several areas like manufacturing, distribution, monitoring, and control, while maintaining quality and avoiding wastage.

Read more:http://bit.ly/2EIkCdh

The race is on to be the first company to market with a drug developed by artificial intelligence (AI), with Irish start-up Nuritas among those leading the charge.
Addressing attendees at an event at Dogpatch Labs in Dublin’s docklands recently, Nuritas founder and chief scientific officer Nora Khaldi outlined the impact AI will have on life sciences and how her company is helping to lead a revolution in health.
“AI has achieved a lot in many areas but very little so far in life sciences and true biology. I believe, though, that biology is the area where AI will have the largest impact over the next few years,” she said.

“I think it would be great for everyone who works in AI or computer science to focus on this area because it will be the most impactful for humankind,” Ms Khaldi added.
Nuritas uses data mining of molecules in food and food byproducts to identify supplements and new drugs. The company was founded by Ms Khaldi, a TCD-trained mathematician and bioinformatics specialist, in 2014 and was subsequently spun out of NovaUCD’s VentureLaunch accelerator programme.

Read more: http://bit.ly/2GfOBWd

KTH researchers reported a nanoengineering innovation that offers hope for treatment of cancer, infections and other health problems – conductive wires of DNA enhanced with gold which could be used to electrically measure hundreds of biological processes simultaneously.
While DNA nanowires have been in development for some time, the method developed at KTH Royal Institute of Technology and Stockholm University produces a unique three-dimensional biosensor for better effectiveness than flat, two-dimensional sensors. “Our geometry makes it much easier to measure several biomolecules simultaneously, and is also 100 times more sensitive,” says KTH Professor Wouter van der Wijngaart.

“This is the first out-of-plane metallic nanowire formation based on stretching of DNA through a porous membrane,” van der Wijngaart says.

The DNA nanowires, treated with gold to make them conductive, are created only in the presence of specific biomarker molecules in the patient sample and transmit evidence of their presence, even when such molecules are low in concentration. The conductive wires short-circuit both sides of the membrane, which makes them easy to detect.

Read more: http://bit.ly/2o1wblo

(CNN)The US Food and Drug Administration has, for the first time, approved a blood test to help detect concussion in adults.

The Brain Trauma Indicator test measures two biomarkers: proteins known as UCH-L1 and GFAP that are released upon injury to the brain and pass through the blood-brain barrier. Elevated levels of the proteins can be detected within 15 or 20 minutes of injury. The test can be taken within 12 hours of injury, and results can be obtained within three or four hours.
Patients are currently diagnosed with concussion based on a combination of symptoms as well as imaging. However, CT scans don't always detect concussion.

"Over 90% of CT scans (for concussion) are negative. And you get 200 times the radiation of a chest X-ray. It's expensive; it's not terrific," said Hank Nordhoff, chairman and CEO of Banyan Biomarkers, maker of the new test. It can help determine whether a patient further needs a CT scan, based on a physician's concerns.

"Today's action supports the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging -- an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose," FDA Commissioner Dr. Scott Gottlieb said in a statement Wednesday.
The test could also help reduce costs significantly. Where a CT scan can cost $800 to $1,500, Nordhoff predicts that the new test would cost closer to $150.
The test would be available to hospitals, Nordhoff said, and he hopes a handheld sideline device could be commercially available in the near future.

Read more: http://cnn.it/2EEyDYT

There may yet be hope in the fight against growing antibiotic resistance—while antibiotic efficacy has fallen as pathogens are increasingly developing resistance, antibiotic discovery has slowed in the last few decades, thanks to drugmakers shifting their focus to developing pharma products geared for managing chronic diseases, most of which are either genetic or lifestyle diseases. Researchers at the Rockefeller University in New York have discovered a new class of antibiotics, which they have named malacidins, which can be extracted from soil bacteria that are notoriously difficult to culture in labs and study. The findings of the research, published in Nature Microbiology, are encouraging. The new antibiotics fought off many common infections in lab and mice tests, eliminating some microbes that have become resistant to existing antibiotics. The researchers used genetic sequencing and combed through genetic material from 1,500 soil samples to identify and isolate the new antibiotics.

Read more: http://bit.ly/2HiCWas

A new study has successfully reversed both the biological and behavioral hallmarks of Alzheimer's disease in mouse models. The research found that slowly depleting the presence of a certain enzyme can reverse the formation of amyloid plaques in the brain. Illustrating the tricky path current Alzheimer's research faces, the study was published literally hours after giant pharmaceutical company Merck announced the cancellation of a Phase 3 clinical trial surrounding a drug that targets the exact same enzyme.

The new study from a team at the Cleveland Clinic Lerner Research Institute focused on an enzyme called BACE1 (aka beta-secretase), which is known to contribute to the formation of the toxic amyloid proteins that congregate as plaques on the brain, and are hypothesized to be the source of most Alzheimer's symptoms.

Completely blocking BACE1 in previous mouse models has resulted in major brain defects, as the enzyme controls several fundamental developmental processes. So the team engineered a mouse model that gradually lost the enzyme as it grew older and then bred those mice with rodents that were engineered to develop amyloid plaques from an age of 75 days.

This allowed the researchers to simulate both the age-related progression of Alzheimer's disease, and an associated progressive reduction in BACE1 activity. The results were remarkably positive, with the reduction in BACE1 activity not only stalling the development of amyloid plaques in the mice, but actually removing the deposits that had already formed. At 10 months of age the mouse models were found have no amyloid plaque deposits at all.

Read more: http://bit.ly/2EuNVMw

OAKBROOK TERRACE, Ill., Feb. 14, 2018 /PRNewswire/ -- A recent study has found that corn oil lowers cholesterol compared with coconut oil. The findings, released as part of Heart Health Month, highlight consumer misperceptions of coconut oil, which has grown in popularity in recent years.

The study was conducted by MB Clinical Research, and sponsored by ACH Food Companies, Inc. Researchers tested participants' cholesterol, insulin and C-reactive protein (a marker of inflammation) while they consumed either corn oil or coconut oil as part of their daily diet for 4 weeks. Results of the double-blind study showed adding corn oil to one's diet resulted in lower cholesterol levels than coconut oil, supporting corn oil's superiority over coconut oil when it comes to this indicator of heart health.1

"There is a lot of confusion about the effects of coconut oil on indicators of heart health," noted Kevin C Maki, PhD, Chief Science Officer of MB Clinical Research. "This study helps to show that coconut oil raises cholesterol levels compared with corn oil."

One in four deaths in the U.S. is due to heart disease. 2 Controlling risk factors like high cholesterol is critical to maintaining heart health,2 but when it comes to impact on cholesterol, not all cooking oils are created equal. A previous study published in The Journal of Clinical Lipidology found that corn oil can also help lower cholesterol more than extra virgin olive oil.3

Corn oil contains plant-based compounds called plant sterols, which are also found in fruits, vegetables, nuts, cereal, and legumes. Plant sterols help block the absorption of cholesterol in the gut and work to lower LDL ("bad") cholesterol in the blood stream.4 Corn oil contains 10 times more cholesterol-blocking plant sterols than coconut oil, four times more than olive oil, and 1 1/2 times more than canola oil. 4

Read more: http://prn.to/2EFP86S

FDA advocates on all sides applauded the request to increase funding significantly for FDA under the Trump administration’s budget for fiscal year 2019, which seeks more than $400 million in additional outlays for oversight of drugs, biologics, and medical devices. The Alliance for a Stronger FDA praised the budget plan for recognizing the important work of FDA in advancing innovative drugs and medical devices, while Friends of Cancer Research noted the $20-million allocation to support FDA’s Oncology Center of Excellence, which had not received full funding previously.

Read more: http://bit.ly/2EIefpy

UCLA Health has received certification to provide a therapy that genetically modifies patients’ own cells to attack cancer, the university announced Friday.

The Food and Drug Administration approved the treatment, marketed as Yescarta, in October for patients with a type of blood cancer called large B cell lymphoma. UCLA is one of about two-dozen medical centers nationwide certified to offer the therapy.

The treatment is a form of chimeric antigen receptor T cell therapy, in which a synthetic gene is added to T cells that recognize infectious substances and mount an immune response. The added gene enables CAR T cells to recognize cancer cells.

Joshua Sasine, a clinical instructor of medicine and director of the CAR T program, said doctors could no longer detect cancer in patients after providing a single dose of CAR T cells in clinical trials. Before CAR T cell therapy, the patients had conditions that worsened or spread despite previously receiving at least two traditional treatments, such as chemotherapy or bone marrow transplant.

Read more: http://bit.ly/2GeYR1d

SAN FRANCISCO--(BUSINESS WIRE)--Fitbit, Inc. (NYSE: FIT) the leading global wearables brand, today announced that it will acquire Twine Health, an innovative, proven health coaching platform that empowers people to achieve better health outcomes and helps health systems, health plans and workplace health providers lower healthcare costs. A HIPAA-compliant connected health platform, Twine Health delivers an engaging and user-friendly experience to help people manage chronic conditions, such as diabetes and hypertension, and aid in lifestyle interventions, such as weight loss and smoking cessation, by making it easy for care teams of providers, coaches, friends and family to collaborate on care plans. The Twine Health platform brings a scalable approach to health coaching, allowing a single coach to work with a large number of patients, driving efficiencies while helping more people reach their goals.

With this acquisition, Fitbit further extends its reach into healthcare and lays the foundation to expand its offerings to health plans, health systems and self-insured employers, while creating opportunities to increase subscription-based revenue. The acquisition will combine the power of the Fitbit platform to drive lasting behavior change with Twine Health’s clinical expertise and proven ability to help patients better manage their care through a highly scalable platform and coaching model. In the longer term, Fitbit will have the opportunity to extend the benefits of the Twine platform to its more than 25 million users and expand into new condition areas.

Read more: http://bit.ly/2CjAfBW

LONDON & CAMBRIDGE, United Kingdom & BOSTON--(BUSINESS WIRE)--Cancer Research UK and Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform, announced today that the first patient has been dosed in their Phase I/IIa trial evaluating BT1718 in patients with advanced solid tumors. BT1718 is a first-in-class Bicycle Toxin Conjugate being developed by Bicycle Therapeutics that targets Membrane Type 1 Matrix Metalloproteinase (MT1-MMP/MMP-14), which has been shown to be highly expressed in solid tumors.

“The initiation of this study is a landmark event for the company and for our technology,” said Maria Koehler, M.D., Ph.D., Chief Medical Officer of Bicycle Therapeutics. “BT1718 is the first clinical candidate from our pipeline of Bicycles, a brand-new class of chemically synthesized medicines. We believe that Bicycles, because of their small size and exquisite selectivity, could provide meaningful efficacy to patients suffering from cancer and avoid the toxicities associated with other classes of highly potent anti-cancer drugs. We are delighted to be exploring its potential in collaboration with Cancer Research UK.”

Read more: http://bit.ly/2EnDtWN

This press release was orginally distributed by SBWire

Brooklyn, NY -- (SBWIRE) -- 02/13/2018 -- Qyresearchreports include new market research report Global Pharmaceutical Contract Manufacturing & Contract Market Size,Status and Forecast 2025 to its huge collection of research reports.

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Compiled after an extensive research phase, the report presents findings that are reliable as well as verifiable. Using standard analytical tools such as Porter's Five Forces and SWOT analysis, profitability of new ventures and investments in the market as well as positioning of key players is presented herein.

Get Report Sample and Customization: https://www.qyresearchreports.com/sample/sample.php?rep_id=1507390&type=S

Read more: http://bit.ly/2o9hvQK

Aphasia is a communication disability, most often caused by stroke, which occurs when the language centres of the brain are damaged. Pharmacists and healthcare professionals should be aware of how the communication needs of people with aphasia vary based on the severity of the condition, and how they can best provide support with medicines optimisation.

Aphasia is a disorder caused by damage to the portions of the brain responsible for understanding and using language; it has been defined as the loss or impairment of the power to use or comprehend words, usually resulting from brain damage[1]. The term is sometimes used interchangeably with dysphasia, which is more commonly used in Europe.

Read more: http://bit.ly/2GdcePq

US based drug makers lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) has complained that the positive signals given by India in terms of greater intellectual property protection and market access opportunities are yet to translate into real policy actions and practical changes.
In its annual submission to the United States Trade Representative (USTR), PhRMA highlighted unpredictable patent environment, regulatory data protection failures, high tariffs and taxes on medicines, discriminatory and nobn-transparent market access policies, and unpredictable environment for clinical research as the key challenges before US companies that operate or wish to tap the Indian market.
The lobby group wants India to remain on the Priority Watch List in the 2018 Special 301 Report of USTR until India addresses their concerns.

Read more: http://bit.ly/2EHD0SK