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Rescooped by Mario Hugo Genero from Pharma Biotech Industry Review (Krishan Maggon)
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FDA New Drug Approvals 2014

FDA New Drug Approvals 2014 | NGS | Scoop.it

The FDA has approved 41 new  drugs (NCE/NME) in 2014, which is a 18 years high. The approval of new drugs has picked up in December with 9 new drugs approved and 6 in one week, a record for the FDA.

 

The CHMP of EMA recommended approval of 82  new medicines in 2014, out of which 57 were approved by the EC for marketing in the EU and the others are pending.

 

 

to be updated ASAP.

 

 


Via Krishan Maggon
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Krishan Maggon 's curator insight, January 9, 2014 3:18 AM

For a free updated ongoing review of new drugs (NCE/NME) approved by the FDA in 2014 with a list of new NDA/BLA filings, PDUFA dates. 

 

FDA first approved drug Farxiga (dapaglifozin, Astra Zeneca, BMS) to treat type 2 diabetes is reviewed with links, references,

clinical data and regulatory history and its competition with J&J first approved SGTP2 inhibitor Invokana. 

 

Approvals of generics, combination products or new formulations is not covered.

Rescooped by Mario Hugo Genero from Pharma Biotech Industry Review (Krishan Maggon)
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Personalized medicine: Time for one-person trials

Personalized medicine: Time for one-person trials | NGS | Scoop.it
Precision medicine requires a different type of clinical trial that focuses on individual, not average, responses to therapy, says Nicholas J. Schork.

 

Every day, millions of people are taking medications that will not help them. The top ten highest-grossing drugs in the United States help between 1 in 25 and 1 in 4 of the people who take them (see 'Imprecision medicine'). For some drugs, such as statins — routinely used to lower cholesterol — as few as 1 in 50 may benefit1. There are even drugs that are harmful to certain ethnic groups because of the bias towards white Western participants in classical clinical trials2.


Via Krishan Maggon
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Krishan Maggon 's curator insight, April 30, 2015 12:27 AM

Studies that focus on a single person — known as N-of-1 trials — will be a crucial part of the mix. 


Gleevec (imatinib) was found to double survival rates of leukaemia patients4with a chromosomal abnormality in their tumours called the Philadelphia translocation.  Erbitux (cetuximab) improves the survival of people with colorectal cancer whose tumour cells carry a mutated EGFR gene but not a mutated KRAS gene5.

Rescooped by Mario Hugo Genero from Digital Health
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IBM's Watson computer can now do in a matter of minutes what it takes cancer doctors weeks to perform

IBM's Watson computer can now do in a matter of minutes what it takes cancer doctors weeks to perform | NGS | Scoop.it

Fourteen US and Canadian cancer institutes will use International Business Machines Corp.'s Watson computer system to choose therapies based on a tumor's genetic fingerprints, the company said on Tuesday, the latest step toward bringing personalized cancer treatments to more patients.

 

Oncology is the first specialty where matching therapy to DNA has improved outcomes for some patients, inspiring the "precision medicine initiative" President Barack Obama announced in January


Via Alex Butler
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Art Jones's curator insight, May 6, 2015 7:36 PM

#TheFutureofHealthcare

Rescooped by Mario Hugo Genero from NGSS Resources
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Scientists have discovered a new state of matter, called 'Jahn-Teller metals'

Scientists have discovered a new state of matter, called 'Jahn-Teller metals' | NGS | Scoop.it

An international team of scientists has announced the discovery of a new state of matter in a material that appears to be an insulator, superconductor, metal and magnet all rolled into one, saying that it could lead to the development of more effective high-temperature superconductors.

 

Why is this so exciting? Well, if these properties are confirmed, this new state of matter will allow scientists to better understand why some materials have the potential to achieve superconductivity at a relativity high critical temperature (Tc) - "high" as in −135 °C as opposed to −243.2 °C. Because superconductivity allows a material to conduct electricity without resistance, which means no heat, sound, or any other form of energy release, achieving this would revolutionise how we use and produce energy, but it’s only feasible if we can achieve it at so-called high temperatures.

 

As Michael Byrne explains, when we talk about states of matter, it’s not just solids, liquids, gases, and maybe plasmas that we have to think about. We also have to consider the more obscure states that don’t occur in nature, but are rather created in the lab - Bose–Einstein condensate, degenerate matter, supersolids and superfluids, and quark-gluon plasma, for example. 

 

By introducing rubidium into carbon-60 molecules - more commonly known as 'buckyballs' - a team led by chemist Kosmas Prassides from Tokohu University in Japan was able to change the distance between them, which forced them into a new, crystalline structure. When put through an array of tests, this structure displayed a combination of insulating, superconducting, metallic, and magnetic phases, including a brand new one, which the researchers have named 'Jahn-Teller metals'. 

 

Named after the Jahn-Teller effect, which is used in chemistry to describe how at low pressures, the geometric arrangement of molecules and ions in an electronic state can become distorted, this new state of matter allows scientists to transform an insulator - which can’t conduct electricity - into a conductor by simply applying pressure.

 

There’s a whole lot of lab-work to be done before this discovery will mean anything for practical energy production in the real world, but that’s science for you. And it’s got people excited already, as chemist Elisabeth Nicol from the University of Guelph in Canada told Hamish Johnston at PhysicsWorld: "Understanding the mechanisms at play and how they can be manipulated to change the Tc surely will inspire the development of new superconducting materials".


Via Dr. Stefan Gruenwald, Diane Johnson
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Rescooped by Mario Hugo Genero from Amazing Science
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Specialized brain cells of the entorhinal cortex are behind a 'sense of direction'

Specialized brain cells of the entorhinal cortex are behind a 'sense of direction' | NGS | Scoop.it
After wandering around an unfamiliar part of town, can you sense which direction to travel to get back to the subway or your car? If so, you can thank your entorhinal cortex, a brain area recently identified as being responsible for our sense of direction. Variation in the signals in this area might even explain why some people are better navigators than others.

The new work adds to a growing understanding of how our brain knows where we are. Groundbreaking discoveries in this field won last year's Nobel Prize in Physiology or Medicine for John O'Keefe, a neuroscientist at University College London, who discovered “place cells” in the hippocampus, a brain region most associated with memory. These cells activate when we move into a specific location, so that groups of them form a map of the environment.

O'Keefe shared the prize with his former students Edvard Moser and May-Britt Moser, both now at the Kavli Institute for Systems Neuroscience in Norway, who discovered “grid cells” in the entorhinal cortex, a region adjacent to the hippocampus. Grid cells have been called the brain's GPS system. They are thought to tell us where we are relative to where we started.

A third type—head-direction cells, also found in the entorhinal region—fires when we face a certain direction (such as “toward the mountain”). Together these specialized neurons appear to enable navigation, but precisely how is still unclear. For instance, in addition to knowing which direction we are facing, we need to know which direction to travel. Little was known about how or where such a goal-direction signal might be generated in the brain until the new study.

A team of researchers, led by Hugo Spiers of University College London, asked 16 volunteers to familiarize themselves with a virtual environment consisting of a square courtyard with a landscape (such as a forest or a mountain) on each wall and a unique object in each corner. They then scanned the participants' brains while showing them views from the environment and asking them to indicate in which direction different objects lay.

The entorhinal region displayed a distinct pattern of activity when volunteers faced each direction—consistent with how head-direction cells should behave. The researchers discovered, however, that the same pattern appeared whether the volunteers were facing a specific direction or just thinking about it. The finding suggests that the same mechanism that signals head direction also simulates goal direction. How, exactly, the brain switches back and forth is unclear, but the researchers think the brain probably signals which direction you are facing until you consciously decide to think about where you want to go, at which point the same cells then run the simulation.

Via Dr. Stefan Gruenwald
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Rescooped by Mario Hugo Genero from PARP Inhibitors Cancer Review
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In Silico Prescription of Anticancer Drugs to Cohorts of 28 Tumor Types Reveals Targeting Opportunities: Cancer Cell

In Silico Prescription of Anticancer Drugs to Cohorts of 28 Tumor Types Reveals Targeting Opportunities: Cancer Cell | NGS | Scoop.it

Summary

Large efforts dedicated to detect somatic alterations across tumor genomes/exomes are expected to produce significant improvements in precision cancer medicine. However, high inter-tumor heterogeneity is a major obstacle to developing and applying therapeutic targeted agents to treat most cancer patients. Here, we offer a comprehensive assessment of the scope of targeted therapeutic agents in a large pan-cancer cohort. We developed an in silico prescription strategy based on identification of the driver alterations in each tumor and their druggability options. Although relatively few tumors are tractable by approved agents following clinical guidelines (5.9%), up to 40.2% could benefit from different repurposing options, and up to 73.3% considering treatments currently under clinical investigation. We also identified 80 therapeutically targetable cancer genes.


Via Krishan Maggon
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Krishan Maggon 's curator insight, April 12, 2015 4:23 AM
Highlights

 

•Driver genes are comprehensively identified across a large pan-cancer cohort•In silico prescription links approved or experimental targeted therapies to patients•Up to 73.3% of patients could benefit from agents in clinical stages•80 therapeutically unexploited targetable cancer driver genes are identified
Rescooped by Mario Hugo Genero from Pharma Biotech Industry Review (Krishan Maggon)
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Personalized medicine: Time for one-person trials

Personalized medicine: Time for one-person trials | NGS | Scoop.it
Precision medicine requires a different type of clinical trial that focuses on individual, not average, responses to therapy, says Nicholas J. Schork.

 

Every day, millions of people are taking medications that will not help them. The top ten highest-grossing drugs in the United States help between 1 in 25 and 1 in 4 of the people who take them (see 'Imprecision medicine'). For some drugs, such as statins — routinely used to lower cholesterol — as few as 1 in 50 may benefit1. There are even drugs that are harmful to certain ethnic groups because of the bias towards white Western participants in classical clinical trials2.


Via Krishan Maggon
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Krishan Maggon 's curator insight, April 30, 2015 12:27 AM

Studies that focus on a single person — known as N-of-1 trials — will be a crucial part of the mix. 


Gleevec (imatinib) was found to double survival rates of leukaemia patients4with a chromosomal abnormality in their tumours called the Philadelphia translocation.  Erbitux (cetuximab) improves the survival of people with colorectal cancer whose tumour cells carry a mutated EGFR gene but not a mutated KRAS gene5.

Rescooped by Mario Hugo Genero from Amazing Science
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Artificial muscles created from gold-plated onion cells

Artificial muscles created from gold-plated onion cells | NGS | Scoop.it

Just one well-placed slice into a particularly pungent onion can send even the most seasoned chef running for a box of tissues. Now, this humble root vegetable is proving its strength outside the culinary world as well -- in an artificial muscle created from onion cells. Unlike previous artificial muscles, this one, created by a group of researchers from National Taiwan University, can either expand or contract to bend in different directions depending on the driving voltage applied. The finding is published this week in the journalApplied Physics Letters, from AIP Publishing. "The initial goal was to develop an engineered microstructure in artificial muscles for increasing the actuation deformation [the amount the muscle can bend or stretch when triggered]," said lead researcher Wen-Pin Shih. "One day, we found that the onion's cell structure and its dimensions were similar to what we had been making." Shih lead the study along with graduate student Chien-Chun Chen and their colleagues.


The onion epidermis -- the fragile skin found just beneath the onion's surface -- is a thin, translucent layer of blocky cells arranged in a tightly-packed lattice. Shih and his colleagues thought that onion epidermal cells might be a viable candidate for the tricky task of creating a more versatile muscle that could expand or contract while bending. To date, Shih said, artificial muscles can either bend or contract, but not at the same time.


The researchers treated the cells with acid to remove the hemicellulose, a protein that makes the cell walls rigid. Then, they coated both sides of the onion layer with gold. When current flowed through the gold electrodes, the onion cells bent and stretched much like a muscle. "We intentionally made the top and bottom electrodes a different thickness so that the cell stiffness becomes asymmetric from top to bottom," said Shih. The asymmetry gave the researchers control over the muscle's response: a low voltage made them expand and flex downwards, towards the thicker bottom layer. A high voltage, on the other hand, caused the cells to contract and flex upwards, towards the thinner top layer.


"We found that the single-layer lattice structure can generate unique actuation modes that engineered artificial muscle has never achieved before," said Shih. To demonstrate their device's utility, the researchers combined two onion muscles into a pair of tweezers, which they used to pick up a cotton ball. In the future, they hope to increase the lifting power of their artificial muscles. "Our next step is to reduce the driving voltage and the actuating force," said Shih.


Via Dr. Stefan Gruenwald
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Rescooped by Mario Hugo Genero from Genetics - GEG Tech top picks
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Transposon mutagenesis identifies genetic drivers of BrafV600E melanoma - Nature Genetics

Transposon mutagenesis identifies genetic drivers of BrafV600E melanoma - Nature Genetics | NGS | Scoop.it

 

 


Via BigField GEG Tech
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BigField GEG Tech's curator insight, May 13, 2015 8:33 AM

The scientists show that Sleeping Beauty (SB) transposon-mediated mutagenesis drives melanoma progression in BrafV600E mutant mice and identify 1,232 recurrently mutated candidate cancer genes (CCGs) from 70 SB-driven melanomas.


www.geg-tech.com/Vectors

Rescooped by Mario Hugo Genero from Future Visions And Trends! Lead The Way And Innovate.
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Innovation: The next big thing | Computerworld Hong Kong

Innovation: The next big thing | Computerworld Hong Kong | NGS | Scoop.it
RT @CIO_Adam: #Innovation: The next big thing http://t.co/2e7XKeeDUf #CIO #CTO

Via Pekka Puhakka
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