Friday 30 March 2012

Natco Pharma bags licence to sell Bayer's cancer drug Nexavar



The government has allowed a local drugmaker to make and sell a patented cancer drug at a fraction of the price charged by Germany's Bayer AG, setting a precedent for more such efforts by Indian firms and heightening the global pharmaceutical industry's anxiety over the use of the controversial compulsory licensing provision.
The outgoing patent controller of India, PH Kurian, on Monday granted the country's first compulsory licence to Hyderabad-based Natco Pharma, permitting it to manufacture and market a generic version of Nexavar, a medicine used for treating liver and kidney cancer, in India for just 3% of the patented drug's price in return for paying 6% royalty on sales to Bayer.

LIST OF DRUGS APPROVED BY FDA-2012



Dermatology/Plastic Surgery
Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012
Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012
Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012
Endocrinology
Bio-T-Gel (testosterone gel); Teva Pharmaceuticals; For the treatment of hypogonadism, Approved February 2012
Jentadueto (linagliptin plus metformin hydrochloride); Eli Lilly; For the treatment of type II diabetes, Approved February 2012
Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with endogenous Cushing’s syndrome, Approved February 2012
Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012
Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012
Gastroenterology
Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012
Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012
Hematology
Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012
Immunology/Infectious Diseases
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Nephrology/Urology
Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012
Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012
Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012
Neurology
Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012
Obstetrics/Gynecology
Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer HealthCare; For the treatment of heavy menstrual bleeding, Approved March 2012
Oncology
Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012
Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012
Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012
Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012
Ophthalmology
Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February 2012
Otolaryngology
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Pediatrics/Neonatology
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012
Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012
Pharmacology/Toxicology
Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012
Pulmonary/Respiratory Diseases
Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 2012
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012

Caring for a Chemical Burn


A chemical burn should be treated immediately and with care, since traditional skin remedies -- such as an antibiotic lotion -- can react with the chemical and actually worsen the burn.
The American Academy of Family Physicians offers these suggestions to care for a chemical burn:
  • Carefully flush the area with lots of cool water.
  • Promptly remove any jewelry or clothing that may have come in contact with the chemical.
  • Carefully wrap the area with a clean cloth or a piece of sterile, dry gauze.

Wednesday 28 March 2012

Dietary Do’s and Don’ts of Ayurveda


Certain dietary do’s and don’ts serve to maintain balance of specific doshas (vata, pitta and kapha) and promote sound health. An appropriate diet can not only enhance wellness but can also be used to neutralize toxins in the body. According to the science of Ayurveda, the root cause of any disease or malfunction is the accumulation of toxic substances (Ama, i.e. the improperly digested food particles) in the body. The toxic accumulation depletes the cells of its oxygen and energy and promotes ill heath.

Ayurveda lays down extensive guidelines for a healthy lifestyle. Focus on nutrition is one of its essential components. Some of the essential ayurvedic guidelines on nutrition are as mentioned below.


 
Eating in sync with the prakriti:


The vata dosha has cold, dry and light qualities. So, an individual with vata prakriti should avoid dry and light food items to counterbalance the excess of these qualities. Lubricating substances such as oily, sweet, sour and salty items are advised. Leafy veggies, mushrooms and potatoes are okay for people with vata prakriti. Tomato is best consumed in low quantity or better still if avoided. 

An individual with pitta dosha has hot, oily and liquid qualities. Excess stomach acid can be formed if the hot quality is combined with the liquid quality. So, cold items having sweet, bitter and astringent taste should be preferred over oily, spicy and sour foods. 

A person with kapha prakriti should avoid sweet, sour (e.g. pickle) and salty foods that increase the bulk and moisture in the body, and prefer hot, spicy foods since kapha qualities include cool, heavy and wet. 

Quantity of food consumed:

One has to always eat a little less than the full stomach. If the food taken is properly digested in time without impairing health, it is the proper quantity. Heaviness, pain in the abdomen, lethargy, is an indication of overeating.

Eating in excess of the required amount produces ama and leads to disorders like obesity, hypertension, diabetes, joint disorders and heart diseases. 

Light foods such as green gram dal, dalia, khichdi, plain curds, rice all stimulate the digestive fire (agni). They are harmless foods and can be consumed in quantities till it satisfies one’s appetite. On the other hand, heavy foods such as sesame, nuts, flour preparations, black gram, meats, fish and eggs are heavy to digest and do not stimulate the gastric fire. For that matter, banana is also a heavy food according to Ayurveda and it should be consumed in moderation or avoided. 

The time of food consumption:

In Ayurveda, emphasis is laid on the fact that food should only be consumed once the food taken earlier is digested. This is experienced by -

 A pure feeling – not acid or pungent taste
 Feeling of enthusiasm
 Proper passage of urine, flatus and feces
 Feeling of lightlessness in the body
 Feeling of hunger and thirst

There should be a gap of three hours between two meals as it affects digestion. At the same time, food should be consumed within six hours of earlier food intake.

Kind of food eaten:

Certain food articles in Ayurveda are beneficial for all types of prakritis. They are -

 Red shali rice (rice with red colored bran) among grains
 Green gram or moong dal among pulses
 Directly collected rain water among waters
 Cow milk among milks
 Ghee from cow milk among ghee
 Sesame oil among oils
 Grapes among fruits
 Rock salt among salts
 Ginger among bulbs
 Barley, wheat, honey, amla, pomegranate, amaranth, and snake gourd among other foods

 source: medindia

Monday 26 March 2012

Bacteria From Mouth Can Lead to Heart Inflammation


A type of bacteria from the mouth can cause blood clots and lead to serious heart problems if it enters the bloodstream, a new study indicates.
The bacteria, called Streptococcus gordonii, contributes to plaque that forms on the surface of teeth. If the bacteria enters the bloodstream through bleeding gums, it can cause problems by masquerading as human proteins, the researchers found.
The study authors, from the Royal College of Surgeons in Ireland and the University of Bristol in the United Kingdom, discovered that S. gordonii can produce a molecule on its surface that enables it to mimic the human protein fibrinogen, which is a blood-clotting factor.
This activates platelets (cells that are found in blood and involved in clotting) and causes them to clump inside blood vessels. The resulting blood clots encase the bacteria, protecting the invader from the immune system and from antibiotics used to treat infection.
Platelet clumping can result in growths on the heart valves (endocarditis) or blood vessel inflammation that can block blood supply to the heart or brain.
The findings, to be presented at a Society for General Microbiology meeting in Dublin this week, could help lead to new treatments for infective endocarditis, said study author Dr. Helen Petersen.
"In the development of infective endocarditis, a crucial step is the bacteria sticking to the heart valve and then activating platelets to form a clot," Petersen said in a society news release. "We are now looking at the mechanism behind this sequence of events in the hope that we can develop new drugs which are needed to prevent blood clots and also infective endocarditis."
The researchers stressed that it's important to keep the gums healthy and get regular dental care.
"We are also trying to determine how widespread this phenomenon is by studying other bacteria related to S. gordonii," Petersen said. "What our work clearly shows is how important it is to keep your mouth healthy through regular brushing and flossing, to keep these bacteria in check."
Because this study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.
More information
The U.S. National Heart, Lung, and Blood Institute has more about endocarditis.

Weight-loss surgery cut blood sugar more than drugs


 
Weight-loss surgery did a better job of controlling type 2 diabetes in overweight and moderately obese patients than the most advanced medical treatment for the disease, researchers said on Monday.
The study, conducted at the Cleveland Clinic and presented at the annual scientific sessions of the American College of Cardiology in Chicago, showed that patients who underwent surgery were more than three times more likely to gain control over their diabetes after one year than the group that was treated with drugs.
Uncontrolled diabetes is a major risk factor for heart problems, including heart attack.
"Within days and hours of surgery -- before there's any measurable weight loss -- we saw dramatic changes. A majority of(surgery) patients left the hospital with normal blood sugars. However, this was not as effective for people who had diabetes for many years," said Dr. Philip Schauer, director of Bariatric and Metabolic Institute at the Cleveland Clinic, who led the clinical trial.
Shauer called the findings, which were published in the New England Journal of Medicine, "a potential paradigm change" for how some patients should be treated for diabetes.
In the study, dubbed STAMPEDE, researchers randomly assigned 150 patients -- three-quarters of them female -- with a body mass index between 27 and 43 into one of three groups.
There were two surgery groups -- laparoscopic gastric bypass, a surgery that reroutes the digestive system and allows food to bypass part of the small intestine, and sleeve gastrectomy, a procedure that reduces the stomach to about one- quarter of its original size.
The two surgery groups were compared with a third group that got the most advanced non-insulin treatment for diabetes, such as liraglutide, marketed by Novo Nordisk under the brand name Victoza.
The research was primarily funded by Johnson & Johnson's Ethicon Endo-Surgery Inc, a maker of surgical instruments used for bariatric surgery.
REACHING GOAL
The main goal of the study was to reduce blood-sugar levels as measured by a test called HbA1c, a standard tool used to determine blood-sugar control in patients known to have diabetes. The America Diabetes Association recommends an HbA1c goal of less than 7 percent.
Patients in all groups had an average HbA1c level of 9 percent. The study measured those patients who achieved levels 6 percent or lower after one year.
Researchers reported that 42 percent of patients who underwent gastric bypass surgery achieved that goal, compared with 37 percent of patients who got the sleeve gastrectomy. Just 12 percent of the patients in the drug group achieved that goal.
"This study shows, in this group of patients who have poorly controlled diabetes, surgery is more effective than medication alone," Schauer said in an interview. "More doctors who treat diabetes are going to think about surgery for these patients.
"The implication is that insurance companies might need to reconsider coverage. Right now, there's a brick wall at 35," he said, referring to the BMI threshold where insurers will cover surgery.
A BMI is a number that is calculated from a person's weight and height and provides a reliable indicator of body fat for most people.
About 80 percent of the 23 million Americans living with type 2 diabetes are overweight or obese.
Not surprisingly, weight loss was five times greater among those who underwent surgery than those who did not.