With a rise in the number of dengue cases, health minister Suresh Shetty directedBrihamumbai Municipal Corporation (BMC) officials on Tuesday to take up a cleanliness drive against the disease.

He also wants it to ensure that dengue-causing mosquitoes are eradicated from places with water logging by identifying such areas.

BMC officials were asked to carry out an awareness drive among citizens to educate them about the importance of cleanliness. Health department officials were instructed to make sure that drugs were properly stocked.

As the state and BMC are gearing up to combat dengue, doctors feel that the number of cases will soon drop, but are instead seeing a rise in malaria cases. Dr Pratit Samdhani, consultant physician, Jaslok Hospital, said, "Malaria cases are slightly on a rise."

Moreover, in a education committee meeting on Tuesday, the BMC decided to fumigate all schools in the city, including private ones, to deal with dengue.

Congress corporator Ajanta Yadav raised a point of order and said, "There is a possibility that school premises have breeding spots. So, an anti-mosquito drive is needed."

Committee chairman Vitthal Khartmol said that all municipal schools should be surveyed to verify this possibility.

"The BMC should take immediate preventive measures and submit a report to the committee next month," he said.

All generic drug makers, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories and Lupin, are now required to pay a fee to the US drug regulator while seeking permission to launch their products in the world's largest drug market.

The US Food and Drugs Administration (US FDA) recently made amendments to its law to introduce a generic drug user fee. According to the new law - The Generic Drugs User Fee Amendment (GDUFA) of 2012 - companies will have to pay a fee ranging between $17,435 and $51,520 an application to seek an approval. The fee, in force since October 1, is also for applications pending without a tentative approval.

Besides, drug makers will also have to pay for inspection of their facilities by the FDA outside the US, and for supplying active pharmaceutical ingredients (APIs) for manufacturing generic drugs in the US.

However, the current rates are in effect only till September 30, 2013, and will be revised every year.

According to US FDA, companies will have to pay $17,434 per generic drug application pending without tentative approval till October 1. For applications seeking generic drug approval on or after October 1, companies will have to pay $51,520, whereas for Drug Master File (DMF-filed for supplying API or raw material for generic drugs), companies are required to churn out $21,340.

However, a firm has to pay only a one-time fee on DMFs whenever they supply it for a new generic drug.

"The DMF fee is a one-time fee, incurred on first reference of the DMF on or after October 1, 2012. This fee is not incurred every time a DMF is referenced," the FDA said.

It added, "GDUFA specifies that the amount of the fee for a facility located outside the United States and its territories and possessions shall not be less than $15,000 and not more than $30,000 higher than the amount of the fee for a domestic facility. The differential amount is designed to reflect the higher costs of inspections funded, in part, through GDUFA."

Before this, FDA did not charge any fee for generic drug applications. However, under the Prescription Drug User Fee Act (PDUFA), the regulator collects a fee from companies for any newly innovated medicine.

While the move is expected to have a financial impact on generic drug makers with various companies already making quarterly provisions, US FDA claims that both patients and the industry would benefit as the fee would enable the regulator to do faster approvals.

"GDUFA will deliver greater predictability and timeliness to the review of generic drug applications, slashing review times and saving industry time and money," the FDA said.

According to the FDA estimates, during the five-year period from financial year 2013 through 2017, the generic drug industry will provide FDA an inflation-adjusted $299 million each year through user fees, supplementing the agency's allotted budget for assessing the safety of generic drugs.

The proposed generic user fee is expected to give FDA the additional resources required to expedite and improve the review of drugs. Currently, it takes the regulator an average of 30 months to review an application; it aims to reduce the review time to 10 months by 2017.

The development is significant as a large number of Indian companies are targeting various generic launches in the US, in the wake of expiring patents.

"We have a number of launches planned and we have a total of 178 fillings with the US FDA, so we have made a provisioning for the generic user fee," says Vinita Gupta, Chief Executive, Lupin Pharmaceuticals Inc.

Even companies like Ranbaxy, Cipla Sun Pharma and Glenmark have a huge pipeline of drugs pending with the US FDA for approval.

In 2011, the ANDA fillings in the US went up to 946, against 793 in 2006. This led to a sharp increase in the backlog of processing ANDAs. Analyst estimates show 2,696 generic drug applications were pending with the FDA as of December 2011, as compared to 1,216 in December 2006.

The US generic market, 70-75 per cent of the total US pharmaceutical market, is currently estimated at $350 billion and seen to grow at 3 to 5 per cent yearly. Sales by Indian companies make up for around 10 per cent of the US market.

Around 1,000 generic applications are filed in the US market every year by Indian drug companies.

Pancreatic cancer, which tops mortality rates of all cancers, with Apple`s founder Steve Jobs being its most famous victim, is many diseases rolled into one, says new research.

A large-scale analysis done by the Institute for Molecular Bioscience (IMB), University of Queensland, defines the complexity of underlying mutations responsible for pancreatic cancers in more than 100 patients.

The analysis, Australia`s contribution to the International Cancer Genome Consortium (ICGC), brings together the world`s leading scientists to identify the genetic drivers behind 50 different cancer types, the journal Naturetoday reported.

"We found over 2,000 mutated genes in total, ranging from the KRAS gene, which was mutated in about 90 percent of samples, to hundreds of gene mutations that were only present in one or two percent of tumours," said professor at the IMB, Sean Grimmond, according to an IMB statement.

"So while tumours may look very similar under the microscope, genetic analysis reveals as many variations in each tumour as there are patients," Grimmond said.

"This demonstrates that so-called `pancreatic cancer` is not one disease, but many, and suggests that people who seemingly have the same cancer might need to be treated quite differently."
Pancreatic cancer is one of the few for which survival has not improved substantially over the past 40 years.

Andrew Biankin, professor at Garvan Institute of Medical Research, along with Grimmond, led an international team of more than 100 researchers who sequenced the genomes of 100 pancreatic tumours and compared them to normal tissue to determine the genetic changes that lead to this cancer.

"In this study, we found a set of genes, the axon guidance pathway, that is frequently damaged in pancreatic cancer patients and is associated with a potentially poorer outcome for those patients. It is a new marker of pancreatic cancer that can be used to direct prognoses and treatments," said Biankin.

"`Personalised medicine`, where the molecular profile of a patient is matched to the best treatment, is the way the world is moving for many diseases, not just cancer."

"The challenge now will be in moving from population healthcare and a `one drug fits all` model to personalised healthcare.

"First we must take the time to develop the necessary genetic knowledge and implement health systems to translate that knowledge effectively," added Biankin.

Biankin and Grimmond acknowledged the vital assistance of the Australian Pancreatic Cancer Genome Initiative, a network of more than 20 hospitals and research institutions Australia-wide, with over 200 members - surgeons, pathologists, nurses and researchers - that all contributed to the project.

Children with serious anger problems can be helped by a simple video game that hones their ability to regulate their emotions, a pilot study at Boston Children's Hospital has found.

Noticing that children with anger control problems are often uninterested in psychotherapy, but
very eager to play video games, Jason Kahn, PhD, and Joseph Gonzalez-Heydrich, MD, at Boston Children's Hospital developed "RAGE Control" to motivate children to practice emotional control skills that they can later use in challenging life situations.

The fast-paced game involves shooting at enemy spaceships while avoiding shooting at friendly ones. As children play, a monitor on one finger tracks their heart rate and displays it on the computer screen. When heart rate goes above a certain level, players lose their ability to shoot at the enemy spaceships.

To improve their game, they must learn to keep calm.

"The connections between the brain's executive control centres and emotional centres are weak in people with severe anger problems," explained Gonzalez-Heydrich, chief of Psychopharmacology at Boston Children's and senior investigator on the study.

"However, to succeed at RAGE Control, players have to learn to use these centres at the same time to score point," he noted.

The study, led by first author Peter Ducharme, MSW, a clinical social worker at Boston Children's, compared two groups of 9- to 17-year-old children admitted to the hospital's Psychiatry Inpatient Service who had high levels of anger. To qualify for the study, the children had to have a normal IQ and not need a medication change during the five-day study period.

One group, with 19 children, received standard treatments for anger including cognitive-behavioural therapy, presentation of relaxation techniques and social skills training for five consecutive business days. The second group, with 18 children, got these same treatments, but spent the last 15 minutes of their psychotherapy session playing RAGE Control.

After five sessions, the video gamers were significantly better at keeping their heart rate down. They showed clinically significant decreases in anger scores on the State Trait Anger Expression Inventory-Child and Adolescent (STAXI-CA), and specifically on: the intensity of anger at a particular time the frequency of angry feelings over time, expression of anger towards others or objects.

The gamers also had a decrease in suppressed, internalized anger that reached marginal statistical significance. In contrast, the standard-treatment group showed no significant change from baseline on any of the above measures.

The video gamers gave their therapy experience high marks for helpfulness (5 to 6 on a scale of 7).

"Kids reported feeling better control of their emotions when encountering day to day frustrations on the unit. While this was a pilot study, and we weren't able to follow the kids after they were discharged, we think the game will help them control their emotions in other environments," said Ducharme.

The research team plans another clinical trial to test whether letting children take RAGE Control home, to play with parents and siblings, will increase its effect.

In addition, Kahn is spearheading a team effort to develop toys to enhance emotional regulation skills in children too young for RAGE Control. These toys include racing cars that stop if a child gets too excited and, for even younger children, a cooperative game where children try to help each other stack blocks (if heart rate goes up, the table becomes wobbly and the blocks topple).

Results were published online October 24 in the journal Adolescent Psychiatry.

Just two glasses of wine a day could be harmful to the brain, new research suggests.

Even moderate drinking can decrease the production of adult brain cells by as much as 40 per cent, researchers from Rutgers Unviersity in the US have found.

The researchers said the findings showed there is a fine line between moderate and binge drinking.

Lead author Megan Anderson said: 'Moderate drinking can become binge drinking without the person realising it.

'In the short term there may not be any noticeable motor skills or overall functioning problems, but in the long term this type of behaviour could have an adverse effect on learning and memory.'

Ms Anderson, a graduate fellow in the department of neuroscience and cell biology, used rats to model moderate to heavy drinking in humans.

Creating a blood alcohol level of 0.08 per cent in the rats, the legal driving limit in the US, they found this disrupted the production of brain cells.

This level of alcohol intake was not enough to impair the motor skills of the rats or prevent them from associative learning in the short-term.

But the number of nerve cells in the hippocampus of the brain were reduced by nearly 40 percent compared to those in the sober group of rodents.

This substantial decrease in brain cell numbers over time could have profound effects on the adult brain, said Ms Anderson.

That's because these new cells communicate with other neurons to regulate brain health.

'If this area of your brain was affected every day over many months and years, eventually you might not be able to learn how to get somewhere new or to learn something new about your life,' said Ms Anderson.

It's something that you might not even be aware is occurring.

The study is available online in the journal Neuroscience.