FDA authorises emergency Zika Virus Test

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US-based company, Nanobiosym has announced that the U.S. Food and Drug Administration (FDA) has authorised use of their handheld diagnostic machines, the Gene-RADAR®, to identify Zika Virus.  The fully portable, chip-based diagnostic platform can recognize Zika Virus RNA in just minutes, without the need for lab infrastructure, trained healthcare personnel, electricity or running water.

The system uses nanotechnology to build a miniature testing lab on a thumbnail-size chip, capable of detecting Zika, Ebola, HIV and a range of other serious diseases. Nanobiosym aims to bring the XPRIZE-winning Gene-RADAR® platform technology to over four billion people on the planet that currently lack access to basic healthcare.

In addition to the Gene-RADAR® Zika Virus Test that has been granted an Emergency Use Authorization by the FDA, the Company is developing expanded clinical sample input options to include other body fluids such as whole blood and urine . Currently, the Gene-RADAR® Zika Virus Test has only been authorized for the detection of RNA from Zika virus in human serum, not for any other body fluids or any other viruses or pathogens.

According to the Centers for Disease Control (CDC), more than 43,000 people in the U.S. and its territories have already been infected by the Zika virus, including at least 4,750 pregnant women. One of the greatest threats of Zika infection occurs during pregnancy, potentially resulting in significant neurological problems in the developing baby, such as severe microcephaly, decreased brain tissue and brain damage.

“This FDA EUA represents a major milestone towards realizing our deeper vision: to decentralize, personalize, and mobilize the next generation of healthcare, much like cell phones transformed the telecommunications industry,” said Dr. Anita Goel, M.D., Ph.D., Chairman and CEO of Nanobiosym and a Harvard-MIT trained physicist and physician. “The FDA’s prompt feedback has accelerated our journey from winning the first XPRIZE for healthcare to bringing this new technology to patients and providers battling Zika on the front lines.”

Currently, Zika virus RNA has been detected in serum up to 13 days post-symptom onset in non-pregnant patients, up to 62 days post-symptom onset in pregnant patients and up to 53 days after the last known possible exposure in an asymptomatic pregnant woman.

“Access to this important new testing technology represents an important breakthrough in ‘real-time’ Zika testing and partnering with Nanobiosym allows us to bring cutting-edge Gene-RADAR® testing to our patients here in Florida,” said Dr. D.T. Jayaweera, M.D., Executive Dean for Infectious Disease Research at the Miller School of Medicine at the University of Miami, which has signed a Memorandum of Understanding with Nanobiosym to evaluate the real-world clinical and operational utility of the Gene-RADAR® platform. “Mitigating the further spread of Zika virus infection in Florida and effectively managing the spectrum of neurological problems in newborn babies and adults is a top priority for us.”  

The Nanobiosym Research Institute focuses on creating breakthrough scientific insights and developing transformational technologies that emerge from the convergence of physics, nanotechnology, and biomedicine. Nanobiosym has been awarded several prestigious peer-reviewed awards and grants from U.S. federal agencies, including DARPA, NSF, DOD, DOE, CASIS (in affiliation with NASA), and USAID. Dr. Goel and Nanobiosym are harnessing the science of nanobiophysics to develop and clinically validate a pipeline of novel “apps” for the Gene-RADAR® Platform as well as enhance the mobility and other performance metrics of the underlying platform.

In the future, as the company releases diagnostics for further illnesses and applications, it is likely the Gene-RADAR® Platform will be a major breakthrough in what is a multi-trillion dollar industry. The out-dated, expensive and bulky PCR blood test machines used in major hospitals could be a thing of the past in years to come, making way for this cost-effective, mobile and quick diagnostic device.

A mobile diagnostic device which identifies multiple illnesses at the point of care for a fraction of the price will revolutionise healthcare. It will be interesting to see how the company develops. 

SOURCE: www.nano-magazine.com/news

Winning with analytics in the pharmaceutical industry

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With the global pharma market set to be worth as much as $1.6 trillion by 2020, the opportunities for companies to improve the efficiency of drug launches using analytics are manifold.

The route to success in the pharmaceutical sector is rapidly changing. The negotiating power of buyers and providers had dramatically increased, declining physician access is restricting the accountability of care organisations and increasingly stringent regulatory measures mean selling and marketing healthcare products has never been more difficult than it is today. This is just the tip of the iceberg.

To keep pace in such a fast-moving industry, stakeholders are being forced to deploy a variety of new tactics to maintain a competitive advantage. Some are embracing smaller drug launches to diversify and reduce sales attrition risks, while others are focusing on understanding patient needs and treatment providers’ expectations better, to reduce drug failures.

Regardless of the chosen method, one thing has become crystal clear – improving operational efficiency and reducing costs is vital to counter shrinking industry profitability. While there is no one-stop solution to achieve that, pharma businesses worldwide are increasingly turning to data analytics for help.

The opportunities are endless.

The opportunities for pharmaceutical companies to make use of analytics are manifold – from analysing patient demographics and medical histories to optimising drug launches, through to identifying physician behaviour and establishing their likelihood to adopt new drugs.

Yet, a recent survey by WNS DecisionPoint highlighted that of all the functions within a pharmaceutical company, it is the marketing and sales teams that use them most often. Seventy-one percent and eight-two percent of sales and marketing teams respectively use analytics either ‘extensively’ or ‘a lot.’ That’s in contrast to strategy (69%) and R&D functions (60%).

Data analytics being used so extensively in marketing and sales teams is unsurprising. Applications generally revolve around optimising sales force design and planning, as well as territory management, allowing pharma companies to work out how to improve sales and balance the workloads of their representatives.

Yet, given the significant opportunities for innovation and growth, there is still work to be done to ensure analytics is implemented more widely and evenly across the entire business.

For example, there could be great gains made if R&D teams used analytics to improve the efficiency of clinical trials by utilising data from a wider range of sources such as social media, and taking more criteria (such as genetic information) into account to make trials smaller, shorter and cheaper.

SOURCE: www.information-age.com/winning-analytics-pharmaceutical-industry-123465730

Rebiotix microbiome drug success against C diff infection

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Patients suffering from a recurrent infection with the C difficile bacteria have benefited from a microbiome treatment from Rebiotix.

The results from the open label phase 2 trial confirm that Rebiotix’s drug, RBX2660, is the frontrunner among a coming wave of new microbiome treatments.

The Minnesota-based company is focused on developing drugs which use ‘good bacteria’ to help restore a healthy balance of bacteria in a patient’s body, based on the growing understanding of how the ‘microbiome’ helps to regulate health.

A serious and common condition related to imbalanced gut bacteria is recurrent C difficile infection, RBX2660 has shown success in an open label phase 2 trial.

RBX2660 has been granted Orphan Drug status, Fast Track status and gained Breakthrough Therapy Designation from the FDA in October 2015 for its potential to prevent recurrent C. diff. infection.

This puts it at the head of a growing field of drugs looking to tap into the power of the microbiome. Companies are focusing on gastrointestinal conditions first, but the potential for treatments is also being investigated in conditions such as multiple sclerosis and depression.

RBX2660 was well-tolerated and achieved its primary endpoint of preventing C. diff. recurrence; patients treated with RBX2660 exhibited a treatment success rate of 78.8% compared with a historical control of 51.8% (p<0.0001).

RBX2660 is a broad-spectrum microbiota suspension designed to rehabilitate the human microbiome by delivering live microbes into a patient’s intestinal tract.

Lee Jones, president and CEO of Rebiotix, said: “The 78.8% treatment success achieved in this open-label Phase 2 trial demonstrates the potential of RBX2660, a broad spectrum microbiota drug product, to rehabilitate the gut microbiome and break the cycle of C. diff. recurrence.

Jones said these results, coupled with safety and efficacy data observed in a prior Phase 2b and Phase 2 clinical trials, would allow the company to advance RBX2660 into Phase 3 clinical development.

She added that it consolidated its position as “the most clinically advanced microbiome company in the industry.”

Rebiotix’s development pipeline includes multiple formulations targeting several disease indications and is built around its pioneering Microbiota Restoration Therapy (MRT) platform. MRT is a standardised, stabilised drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.

There are plenty of other companies investing in the field. Janssen (J&J’s pharma division) is particularly convinced that the approach will be an important part of medicine in the future, and has established its own Janssen Human Microbiome Institute (JHMI).

Focusing on the discovery, development and commercialisation of generation microbial products, it has established a number of research collaborations, but these are generally less advanced that Rebiotix’s work. The JHMI has a collaboration with DayTwo Ltd. and the Weizmann Institute of Science in Rehovot, Israel, to pursue microbiome-based health solutions targeting metabolic disorders.

Caelus Health has become a portfolio company of Johnson & Johnson Innovation – JJDC, Inc. (JJDC) a start-up development unit run by the company. Amsterdam-based Caelus is developing an entirely new class of microbiome therapeutics for the reduction of insulin resistance and prevention of type 2 diabetes in people with metabolic syndrome.

SOURCE: pharmaphorum.com/news

Exova acquires SL Pharma Labs

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Acquisition demonstrates Exova’s expanding testing capabilities to meet CMC product development.

Testing, calibration and advisory services provider, Exova, has acquired SL Pharma, a US-based pharmaceutical business.

SL Pharma provides pharmaceutical Chemistry, Manufacturing and Controls (CMC) product development and quality control testing services, focused primarily on parenteral, ophthalmic, intranasal and topical drug products

The business supports clients in North America, Australia, Europe and Japan to gain regulatory approvals and meet commercial timelines and budgetary requirements.

James Scull, Vice President, Health Sciences Americas, said: “The addition of SL Pharma is a demonstration of our expanding testing capabilities to meet CMC product development.”

Waheed Sheikh, President, SL Pharma, said: “Becoming part of a global testing and advisory business is a great move for SL Pharma and our customers as it gives us access to new capabilities and expertise.”

SOURCE: www.manufacturingchemist.com/news

Love it or hate it – Vitamin B12 may give the brain a boost

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Trying to explain to someone outside of the UK or Australia and New Zealand what Marmite is can be a little tricky – the savoury spread has the consistency of tar and tastes like a mixture of salt and bark. However, there may be a big reason now to encourage those uninitiated to taste the yeasty spread and that is the potential vitamin B12 has to give the brain boost.

A new study by researchers from York University, presumably all big fans of the spread, found that the high concentration of vitamin B12 and glutamate in the product increases the levels of gamma-amino-butyric acid (GABA) chemicals in the brain. GABA chemicals are thought to protect the brain against neurological disorders.

The study tested a sample of 28 volunteers by randomly allocating them to either to take a teaspoon of marmite or of peanut butter as part of their everyday diet. The groups were then tested to judge their neurological response to the visual stimuli of flickering images.

The test measured the groups’ ability to estimate the difference in contrast between two wave forms. The volunteers were all aged in their twenties and none had epilepsy.

The results of the experiment found that the group that had consumed Marmite displayed a 30% reduction in neurological response to the stimulus compared with the control group. It is not known exactly what caused this reaction but GABA chemicals are known to act to dampen over-active brain cells, reducing symptoms of anxiety or fear. GABA activity is already harnessed in anti-anxiety drug benzodiazepine, which functions by bolstering GABA efficacy.

Research emerging last month has also suggested that children with lower levels of vitamin B12 struggled on cognitive tests. The tests included completing puzzles, recognising letters and interpreting other children’s feelings.

The major caveat to the research is that funding came from the Wellcome Trust and Leverhulme Trust. Leverhulme Trust was set up by the Lever Brothers, a company that later went onto become Unilever – the multinational company that produces Marmite. It should be taken with a handful of salt that research funded by the company that produces the product would find it beneficial for health. However, the findings into the impacts of vitamin B12 intake and the reaction of the brain could still provide a platform for further research.

It is not yet known whether the researchers will have to stand before an ethical committee after designing a study that encouraged the participants to eat a teaspoon of unadulterated Marmite.

SOURCE: www.pharmafile.com/news

Johnson & Johnson moves for Irish medical firm

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An Irish company which treats stroke patients has been acquired by a subsidiary of Johnson & Johnson.

Founded in 2009, Galway-based Neuravi has invested extensively in scientific research on the varieties of clots that cause acute ischemic strokes, and has translated its learnings into the EmboTrap Revascularization Platform.

The device is engineered to restore blood flow to the brain by retrieving a clot. It has already been used to treat more than 3,000 patients in Europe.

Codman Neuro is behind the deal, as the acquired business as it complements its existing portfolio of products for hemorrhagic and ischemic stroke. DePuy Ireland Unlimited Company, an affiliate of Codman Neuro, is the acquiring entity.

“Rapid restoration of flow is of utmost importance when treating stroke patients,” said Shlomi Nachman, company group chairman of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions.

“The EmboTrap platform was designed to address this critical need and we are excited to combine Neuravi’s expertise in clot research with Codman Neuro’s global resources to accelerate innovation in acute ischemic stroke treatment.”

SOURCE: www.insidermedia.com/insider/ireland/johnson-johnson-moves-for-irish-medical-firm

Huge doses of vitamin C found to boost cancer treatment

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It may sound like the kind of science that would raise eyebrows than interest but recent research has found that raised levels of vitamin C alongside cancer treatment could aid the body to kill the cancerous cells. The levels of vitamin C are not possible through eating a few oranges a day, as those administered to patients were in infusions of 800 to 1,000 times the recommended daily dose – you would need to eat a thousand oranges per day to reach such levels.

The researchers at the University of Iowa were keen to determine whether high doses of patients were tolerable and safe in patients being treated for cancer. Vitamin C was introduced three times a week for nearly two months and patients receiving the doses did not report any adverse events as a result.

Beyond being safe, however, the researchers noticed some remarkable results in those undergoing cancer treatments. In a small group of 14 patients suffering from non-small cell lung cancer, 93% of those patients responded to treatment that compares with 40% as the usual rate of response. Of this 93%, 30% showed signs that their tumours were reduced in size.

The main aim of the trial was to determine safety and the results were positive; patients did not report serious adverse events, with the most serious cases being infrequently observed high blood pressure spike following infusion. Other than this, there were side effects that included frequent urination and dry mouth.

At the moment, there is a certain degree of speculation as to why vitamin C produces these improved results in cancer cells – it is thought that, even in high doses, vitamin C is not toxic to healthy cells. It is considered that the impacts are only felt in tumour cells as a result of the high levels of iron in tumour cells, which then reacts with vitamin C to form hydrogen peroxide – effectively killing off the tumour cell in a targeted way.

“This is a significant example of how knowing details of potential mechanisms and the basic science of redox active compounds in cancer versus normal cells can be leveraged clinically in cancer therapy,” says co-senior author Douglas Spitz. “Here, we verified convincingly that increased redox active metal ions in cancer cells were responsible for this differential sensitivity of cancer versus normal cells to very high doses of vitamin C.”

The research is currently going through Phase 2 trials and the full understanding of how beneficial the vitamin C doses will be better determined once these complete.

SOURCE: www.pharmafile.com/news/513815

Komodo dragon blood could hold secret to new antibiotic

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The urgency to find new antibiotics has led researchers into the mouths of Komodo dragons. In particular, the researchers were interested as to why, despite harbouring bacteria in their mouths that lead to blood poisoning on biting its victims, the reptiles are not harmed by the bacteria.

This fact suggested that the dragons had immunity from the bacteria and, if this were the case, it pointed the way towards potentially utilising this for therapeutic uses.

It is becoming common knowledge that antibiotic resistance is on the rise and so any new leads into a potential new therapy is important news. In this case, the researchers were able to find a particular peptide in the dragons’ blood, called VK25, which stood out as potentially useful therapeutically. Early tests on the peptide found that it was able to kill bacteria, clear away biofilms and promote healing.

Biofilms are bacteria that are able to clump together in colonies, which are much more difficult to combat than single bacterium and are able to stick together on a surface, such as a wound. This makes them particularly dangerous in hospital setting where they are able to transfer to biomedical devices, such as heart valves and catheters.

To test their hypothesis, the researchers changed the structure of the peptide, VK25, to boost its efficacy and then tested the peptide in mice. In wounds that were infected with biofilms, the tweaked compound, named DRGN-1, was able to heal wounds over the course of 11 days and completely removed the bacteria. In mice acting as the control, either treated with unchanged VK25 or nothing, the wounds had not healed.

The success of the peptide opens up the possibility of the peptide being administered as a form of topical cream to patients that have biofilms that are potentially serious. The next stage will be to conduct larger safety and efficacy studies before considering trials in humans.

SOURCE: www.pharmafile.com/news

Boots launches HPV vaccination service

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Boots UK is launching a new private human papilloma virus (HPV) vaccination service which it says offers parents the chance to protect their sons as well as their daughters from contracting the virus.

School HPV vaccinations were introduced in the UK back in 2008 for girls aged 12 to 13 years, but campaigners are currently seeking to expand the scope of the immunisation programme to include boys.

While the need to protect against the virus is typically considered as a female issue, four out of five sexually active men and women will be infected with it at some point during their lives, leaving both sexes at risk of developing certain cancers.

“HPV is a common virus with over 100 different types, most of which are harmless, but some can lead to cervical cancer, and other associated cancers including anal, penile and head and neck in men and other HPV types can cause genital warts,” noted Dr Christian Jessen.

“The virus is spread by close skin to skin or sexual contact with another person already carrying the virus, which is why I encourage boys and girls to get vaccinated prior to being sexually active.”

Peter Baker, Campaign Director at HPV Action, says the NHS HPV vaccination programme should be extended to all teenage boys. “Without this, almost 400,000 more boys each year are being left at risk from HPV-related cancers. In the meantime, it’s important that parents and carers who want their sons to be vaccinated have the option of taking them to pharmacies”.

Boots UK is offering its HPV vaccination service in 68 stores, for both males and females aged 12-44 years old, at a cost of £300 for a course of two vaccinations and £450 for those aged 15 and over who will need a series of three vaccinations.

“We are delighted to be able to extend our HPV vaccination service, ensuring more men and boys across the UK have access to this important vaccination,” said Richard Bradley, pharmacy director, Boots UK. “This is a fantastic example of how community pharmacists can use their clinical skills to support patients’ health in locations and at times that are convenient to them.”

SOURCE: www.pharmatimes.com/news

Vaccination to reduce infant mortality

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New study shows 3M adjuvant boosts immune response and potentially reduces side effects

Protecting newborns and young infants from life-threatening infectious diseases, such as pneumococcus or pertussis, is a complex challenge.

Their unique immune systems typically mount weak antibody responses to most vaccines, leaving them highly vulnerable to potentially fatal illnesses.

Now, researchers at Boston Children’s Hospital report achieving strong vaccine responses in newborn animals by adding adjuvants – compounds that boost the immune response.

The new studies, led by David Dowling, cap a decade of research in the laboratory of Ofer Levy, aimed at tailoring vaccines to newborns’ unique immune systems.

Pneumococcal vaccine was used because it can cause potentially fatal pneumonia, meningitis, and sepsis in infants.

It’s conceivable that you could get protection with one shot.

In the first study, Newborn Rhesus monkeys were given a series of three shots with the existing Prevnar 13 pneumococcal vaccine.

This vaccine is already packaged with an adjuvant (Alum) but half the monkeys were randomised to also receive a toll-like receptor agonist adjuvant called 3M-052.

At day 28, the animals were much quicker to develop an antibody response.

Moreover, their antibody levels were 10–100 times greater than that with Prevnar 13 alone — high enough to ensure protection against infection.

“The protective antibody response we saw was so strong that it’s conceivable that you could get protection with one shot,” said Levy.

“This is critical because, in many parts of the world, birth is the most reliable point of healthcare contact. After birth, it becomes challenging to bring children in for repeated clinic visits.”

The adjuvant works by stimulating a set of receptors on white blood cells, known as Toll-like receptors, to induce a strong antibody response.

Studying white blood cells derived from newborn animals’ umbilical cords, the researchers also saw robust T helper 1-cytokine production when given 3M-052 alone. When it was added to Prevnar 13, the response was synergistic.

”We need better vaccine formulations against a range of early life infectious pathogens.”

Mark Tomai, head of 3M TLR and Microstructured Transdermal Systems (MTS) Business Development, said:

“Many adjuvants are not very effective in newborns. The fact that 3M-052 was effective in newborn monkeys shows the potential for using this adjuvant in immunising the young.”

The 3M-052 adjuvant is designed to minimise side effects; it is configured chemically with a lipid “tail” that mixes poorly with water which makes it insoluble in aqueous formulations.

This configuration keeps it from getting into the bloodstream, where it could cause inflammation and flu-like symptoms.

“Rather than distributing throughout the body, when you inject the 3M-052 adjuvant, it is retained at the injection site in the muscle and enhances the immune response to the vaccine,” said Levy.

He plans to work with collaborators to work towards eventual human trials.

“There’s not a long list of vaccines that can be given at birth and we need better vaccine formulations against a range of early life infectious pathogens,” Levy said.

SOURCE: www.manufacturingchemist.com/news