Diabetes and high estrogen levels raise dementia risk for women

Women aged 65 and over who have both diabetes and high estrogen levels are 14 times more likely to develop dementia than women who have neither condition.

Breakthrough: Scientists create embryonic stem cells without embryos

It may not be necessary to create an embryo to acquire embryonic stem cells. Research findings demonstrate that creation of an autologous pluripotent stem cell - a stem cell from an individual that has the potential to be used for a therapeutic purpose - without an embryo, is possible.

The fate of adult cells can be drastically converted by exposing mature cells to an external stress or injury. This finding has the potential to reduce the need to utilize both embryonic stem cells and DNA-manipulated iPS cells.

Multiple Sclerosis Linked to Higher Cancer Risk

A new nationwide cohort study from Taiwan suggested that patients with multiple sclerosis may have an increased risk of developing cancer, particularly breast cancer.

FDA Issues Safety Warning for Sodium Phosphate for Constipation

The US Food and Drug Administration (FDA) is warning about possible harm from exceeding the recommended dose of over-the-counter (OTC) sodium phosphate products to treat constipation.

There have been reports of severe dehydration and changes in serum electrolyte levels from taking more than the recommended dose of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases resulting in death.

Pfizer to assess Akili game as Alzheimer's biomarker

Pfizer is launching a clinical study to assess the potential of Akili Interactive Labs’ Project EVO gaming platform as a biomarker or cognitive endpoint for people at risk of Alzheimer’s disease.

Akili is a US-based company developing mobile video games as potential therapeutics for neurological disorders or as tools for remote monitoring of core cognition.

The Akili platform is designed to quantify and improve the ability of individuals to deal with cognitive interference affecting their ability to pay attention, plan or make decisions. These deficits are common symptoms of a number of degenerative diseases such as Alzheimer’s, as well as psychiatric conditions like attention deficit hyperactivity disorder (ADHD), autism and depression.

Researchers discover potential drug targets for early onset glaucoma

Using a novel high-throughput screening process, scientists have for the first time identified molecules with the potential to block the accumulation of a toxic eye protein that can lead to early onset of glaucoma. Researchers have implicated a mutant form of a protein called myocilin as a possible root cause of this increased eye pressure. Mutant myocilin is toxic to the cells in the part of the eye that regulates pressure.

Eisai's amatuximab gets orphan status in Europe 

European regulators have assigned Eisai's amatuximab with an orphan drug designation (ODD) for the treatment of malignant mesothelioma.

Malignant mesothelioma is a rare and aggressive form of lung cancer caused by exposure to asbestos, affecting around 1 in 50,000 people per year in Europe.

Although there has been a dramatic decline in the use of asbestos since the mid-1970s, incidence of the difficult-to-treat condition is expected to rise. 

Breakthrough announced in treatment of patient with rare type of leukemia 

A team of scientists from the University of Leicester has demonstrated a novel treatment for Hairy Cell Leukaemia (HCL), a rare type of blood cancer, using a drug administered to combat skin cancer. The research, published in the New England Journal of Medicine, indicates Vemurafenib, a BRAF inhibitor that has been approved as a treatment for advanced melanomas, is also successful in treating leukaemia.

FDA Asks Doctors to Limit Acetaminophen in Prescription 

The US Food and Drug Administration (FDA) is asking healthcare professionals to stop prescribing combination prescription pain relievers that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit, citing the risk for liver damage.
The action targets prescription analgesics that contain both acetaminophen and another ingredient, typically opioids such as codeine, oxycodone, and hydrocodone. Some of these combination products now have as much as 750 mg of acetaminophen per dose.

Clever chemistry and a new class of antibiotics

As concerns about bacterial resistance to antibiotics grow, researchers are racing to find new kinds of drugs to replace ones that are no longer effective. One promising new class of molecules called acyldepsipeptides - ADEPs - kills bacteria in a way that no marketed antibacterial drug does - by altering the pathway through which cells rid themselves of harmful proteins.

ADEPs kill bacteria by a mechanism by that is distinct from all clinically available anti-bacterial drugs. They work by binding to a protein in bacterial cells that acts as a "cellular garbage disposal,”. This barrel-shaped protein, called ClpP, breaks down proteins that are misfolded or damaged and could be harmful to the cell. However, when ClpP is bound by an ADEP, it's no longer so selective about the proteins it degrades. In essence, the binding by ADEP causes the garbage disposal to run amok and devour healthy proteins throughout the cell. For bacteria, a runaway ClpP is deadly.

Chinese Herbs Reduce Progression to Diabetes by a Third

Tianqi, a capsule combination of 10 Chinese medicinal herbs, reduces progression from impaired glucose tolerance to type 2 diabetes by 32% over 12 months.

Researchers develop artificial bone marrow

Artificial bone marrow may be used to reproduce hematopoietic stem cells. A prototype has now been developed by scientists of KIT, the Max Planck Institute for Intelligent Systems, Stuttgart, and Tübingen University (Germany). The porous structure possesses essential properties of natural bone marrow and can be used for the reproduction of stem cells at the laboratory. This might facilitate the treatment of leukemia in a few years.

Infant probiotic use 'reduces risk of gastrointestinal disorders'

Probiotics are microorganisms that are believed to play an important role in regulating intestinal function and digestion by balancing the microflora of the gut.

Driving a change of colonization during the first weeks of life through giving lactobacilli may promote an improvement in intestinal permeability; visceral sensitivity and mast cell density and probiotic administration may represent a new strategy for preventing these conditions, at least in predisposed children.

Infants who received a probiotic supplement each day in the first 3 months of life appeared to have a reduced risk for gastrointestinal disorders.

Successful phase 3 trial for ST10 shows promise for the treatment of iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD)

Iron deficiency anaemia is a real problem for many of my patients. Unfortunately patients often struggle with GI side effects caused by conventional ferrous iron salts. Currently we offer such patients intravenous iron in hospital. This is costly to administer, inconvenient for patients and associated with a small but significant risk of anaphylaxis. The exciting AEGIS Phase 3 data suggests that ST10 will provide an effective, safe and more convenient alternative to intravenous iron for this group of patients as demonstrated by ST10 keeping our patients out of the infusion room by correcting and maintaining their haemoglobin in the normal range.

FDA approves new drug for treatment of type 2 diabetes

The US Food and Drug and Administration has announced the approval of a drug called Farxiga (dapaglifozin) to help treat adults with type 2 diabetes. The tablets, in combination with diet and exercise, are said to improve control of blood sugar levels.

Farxiga, a sodium-glucose co-transporter 2 inhibitor (SGLT2), works by preventing the kidney from reabsorbing glucose. This increases the excretion of glucose and reduces blood sugar levels.

Protein destroys migrating cancer cells on contact

Metastasis is where cancer cells from a first tumor detach and spread to other parts of the body.

Surgery and radiation are usually quite effective for treating primary tumors, but once cancer cells start migrating the chances of successful treatment worsen considerably, partly because they are difficult to track down. The vast majority of deaths from cancer are due to metastasis.

Now, a new study suggests it is possible not only to locate these migrating cancer cells, but to annihilate them before they have a chance to set up secondary tumors.

Cancer cells 'kill themselves' when in contact with TRAIL-coated white blood cells. Together the two proteins formed a sticky coating around leukocytes - white blood cells found everywhere in the bloodstream. They found that once cancer cells came into contact with the sticky white blood cells, they imploded.

One surprising factor was that the chaotic environment of a flowing medium, the bloodstream, actually improved the chances this would happen. When they tested the approach in a still medium, it was not as effective. And targeting the cancer cells directly with proteins, was not as effective either. It seems the best way was to turn the white blood cells into sticky carriers of the killer TRAIL protein. 

For instance, when they targeted the cancer cells in saline directly with the proteins, the success rate was 60%. But when they tried again with a model of flowing blood that has forces, mixing and other conditions similar to the human body, the kill rate shot up to 100%.They discovered that by knocking out a protein in a class of cells that leads the migration, they could render them incapable of carrying out the first crucial step of metastasis.

US FDA Provides 510(k) Communication Timeline

  

The US Food and Drug Administration recently added a new timeline to its 510(k) premarket notification webpage that summarizes typical communications between agency reviewers and medical device applicants between submission and final clearance.

The FDA published its new chart to meet 510(k) performance goals set up by the Medical Device User Fee Amendments of 2012 (MDUFA III). The chart indicates a 90-day timeframe for most 510(k) clearance decisions, and spells out what manufacturers can expect in terms of possible communications with FDA reviewers during their US medical device registration process.

Coffee Consumption and Chronic Liver Disease: The New Best Prescription?

Coffee consumption is a part of daily life in most areas of the world. As such, a number of studies have evaluated the chemical composition and related effects that this enjoyable beverage may have on health and disease.

For many years, healthcare providers have advised patients to avoid excessive consumption because of a concern about caffeine dependence. Several recent studies, however, suggest that regular coffee consumption may modulate the risk for fibrosis in chronic liver disease.

Tropical plant inspires super-slippery coating for medical use

Chemical engineers have turned to exotic meat-eating plant life for inspiration in creating materials that have potential for use as a coating on medical devices.

The pitcher plant - which is carnivorous by trapping and digesting animals in leaves that resemble trumpets or small pitchers - has a highly slippery surface that stops its prey from escaping. This surface can repel liquids and contaminants, the scientists from Harvard University found, and it has self-healing properties when scratched.

They mimicked these effects in their work to develop a transparent coating they call SLIPS (slippery liquid-infused porous surface). Taking inspiration from the pitcher plant's inner surface to develop the properties of the new material, however, has meant that it could be used to coat the insides of medical tubing, such as catheters and blood transfusion systems, improving the flow and sterility of fluids through them.

The scientists created their super-slippery surface by infusing a "nano/micro-structured porous material" with a lubricating fluid.

The chemical engineers list a number of remarkable properties to their new material, which can:

- Repel various simple and complex liquids (water, hydrocarbons, crude oil and blood)

- Quickly restore liquid-repellency after physical damage (in under 1 second)

- Resist ice adhesion, and

- Function at high pressures (up to about 680 atmospheres).

"By mimicking the pitcher plant's skin structure, this new coating self-heals almost instantly, even if scraped with a knife or blade.

It is capable of operating in extreme temperatures and high pressure, and can be applied to surfaces ranging from metals and semiconductors, to paper and cotton fabric."

New imaging technology set to reveal secret life of virus in cells

One of the challenges of unlocking the secret lives of tiny biological agents - like viruses inside living cells - is how to get close up without disturbing their structure and behavior.

Now, using high-end imaging, a team from the US has found a way to label and study the respiratory syncytial virus (RSV) and its activity in living cells that could become a general method for unlocking the secrets of many important RNA viruses.

With the new approach, the scientists could study how the RSV virion or infective virus particle enters cells, how it replicates, how many genomes it inserts into its hosts, and perhaps discover why some types of lung cells manage to avoid infection.

This new imaging technique brings together multiply-labeled tetravalent RNA imaging probes (MTRIPS) and direct stochastic optical reconstruction microscopy (dSTORM) - to probe the life of RSV in living cells.

Sushmitha of Batch-18, gave an excellent presentation on the topic of SUSARs (Suspected Unexpected Serious Adverse Reactions).
http://acriindia.com

Prakruthi and Mohammad Vaseem of batch-18, gave a good overview on the regulations in Denmark with regards to drugs and devices.

Nisha and Ashok of batch-18, presented a topic on Russian regulatory authority. This presentation focused on the regulations of new drugs and medical devices and procedures for online submissions.