Domestic pharmaceutical market grows over 13% in July

MUMBAI: The domestic pharmaceutical retail market estimated at Rs 6883 crore for July, reported a growth of 13.5%, according to research firm, IMS.

After a rather subdued first half, the market seems to be reviving in the second half of the year. The upsurge during the month is in line with expectations, as July had a robust monsoon resulting in a strong growth of 14.6% in the acute segment. The chronic segment continued its double digit growth at 10.7%.

Improvement in macro factors ( forecasts of favourable monsoon, clarity on pricing policy) should result into progressive improvement in the pharma market, and thus into a growth between 11-13% in the FY 2013, as forecast in the IMS market prognosis report.

For the period MAT (moving annual total) July 2013, the pharmaceutical market was valued at Rs 75,542 crore, with a growth of 10.8%, over the same period last year.

The big challenge which remains is the implementation of DPCO 2013. While bigger pharma companies would take the major brunt of the erosion due to those drugs under the NLEM, they would be able to mitigate some of the drop by higher volumes, due to greater market reach and brand value, according to IMS.

Cases of Depression in India are on rise........

   New Delhi, August 23, 2013: There are no long term population based studies in India to suggest that the number of cases of depression and consumption of antidepressant drugs are increasing in the country. However, as per a study conducted simultaneously at 11 centres in India, it was determined that the chance of an individual developing an episode of depression during the life time was 9% (life time prevalence). The study also revealed that the chance of developing an episode of major depression at any point of time in any 12 month period is 4.5% (period prevalence). 

Health being a State subject, the details of number of people suffering from depression, state-wise/UT wise are not centrally maintained in this Ministry. However, no single factor can be attributed for depression. Depression can be caused under a variety of circumstances such as genetic, biological, psychosocial and other stress related situations like marital stress, unemployment, profession related stress etc. 

To address the huge burden of mental disorders, the Government of India has introduced the National Mental Health Programme (NMHP) in the country since 1982. A total of 123 districts in 30 States/ UTs have been covered under the District Mental Health Program (DMHP) to provide detection, management and treatment of mental disorders/ illness. With the objective to address the shortage of mental health professionals in the country, 11 Centres of Excellence in Mental Health and 27 PG training departments in mental health specialties to increase the PG training capacity in mental health as well as improving the tertiary care treatment facility have been funded. Besides, three Central Institutions viz. National Institute of Mental Health And Neuro Sciences, Bangalore, LokpriyaGopinathBordoloi Regional Institute of Mental Health, Tezpur and Central Institute of Psychiatry, Ranchi have been strengthened for augmenting the human resources in the area of mental health and for capacity building in the country. During the 11th Five Year Plan, the National Mental Health Programme has been restructured to include additional components like suicide prevention services, work place stress management, life skills training and counselling in schools and colleges. It also provides for upgradation of Psychiatry wings of Govt. Medical Colleges/ General Hospitals, modernization of State run Mental Hospitals, support for Central/ State Mental Health Authorities, Research and Training and Information, Education and Communication (IEC) activities. 

The Information, Education and Communication activities are integral part of NMHP to generate awareness among the masses towards mental illness. Awareness messages in local newspapers and radio, street plays, wall paintings etc. are the different IEC activities that are organized under DMHP. 

Drug shortage looms as pharma policy hurts margins

MUMBAI: A shortage of essential medicines is looming across major parts of the country, with drug companies reporting lower orders from wholesalers, mainly on account of reduction in trade margins due to the new pharma policy. Drug companies say that wholesalers have stopped the purchase of widely prescribed medication like painkillers, anti-infectives, cardiac and antibiotics — part of the national list of essential medicines — mainly in states including Gujarat, Karnataka, Tamil Nadu, West Bengal and Jharkhand, but other states may also be impacted.

While seeking the help of drug regulatory authorities across states to prevent such a shortage, the industry says that consumers may soon be hit by the lack of availability of these medicines. 

Interestingly, the government has not clearly specified margins to wholesalers as per the new Drug Price Control Order 2013 while it mentions that retailers will get a 16% mark-up on the notified ceiling price, down from 20% which they received earlier. According to the DPCO 1995, margin to wholesalers was 10% of the maximum retail price, which now has been interpreted by companies to reduce it to 8%. 
"We are witnessing a reduction in orders (from trade)", an executive with a pharma company said, adding "there is panic in the market, but it may not lead to a shortage of medicines". 

The three industry associations — Indian Pharmaceutical Alliance, Organisation of Pharmaceutical Producers of India and Indian Drug Manufacturers Association — have in a recent communication to state drug regulatory authorities of the states concerned, saying that there may be a potential shortage of essential medicines on account of lower orders placed by distributors. 

"Wholesalers and retailers have stopped purchases of NLEM products citing various issues, including the margin specified under Para 7 of the DPCO 13," the letter says. 


The impact was visible in July, with the basket of products where ceiling prices were announced showing a drop of 2.2% as against a 10.8% growth for the balance drugs, according to research firm AIOCD Awacs. 

Sources in retail trade said that they have started keeping a lower inventory as a strategy to rationalize costs. As against an inventory of 45 days, now we keep stocks for 14 to 21 days, said a chemist, who is part of AIOCD, an organization which represents over seven lakh chemists. 

Experts termed this as a "mere tussle" between pharma companies and trade, with both trying to get the better of the other. 

The industry bodies have asked the state drug commissioners to determine availability of medicines in their states so as to prevent a shortage. 

An AIOCD official had earlier told TOI: "The industry should maintain margins at the existing level, especially for drugs in which ceiling prices are unchanged. There are 100-odd formulations in which the prices have not gone up." 

There may be a little disruption in certain medicines or chemists may also shift to keeping brands and companies which offer high margins, if not resolved soon. Fearing that their drugs may not be picked up by trade, certain companies like Blue Cross and Win Medicare have said that they would maintain status quo in margins, which is 20% to retailers and 10% to wholesales, sources said.

New Moms, the Obese Prone to Flu Complications, Analysis Finds

A new analysis finds that new mothers and obese people are at higher risk of complications from severe cases of the flu.

Both groups have not been previously recognized as vulnerable, the researchers said.

However, the global analysis, sponsored by the World Health Organization, also found that pregnant women aren't especially threatened by complications of influenza. For that reason, the researchers said, pregnant women don't need to get special priority for vaccinations.

"Policy makers and public-health organizations need to recognize the poor quality of evidence that has previously supported decisions on who receives vaccines during an epidemic," study author Dr. Dominik Mertz, an assistant professor of medicine at McMaster University's Michael G. DeGroote School of Medicine, in Hamilton, Ontario, Canada, said in a university news release.

"If we can define the risk groups, we can optimally allocate vaccines, and that is particularly important when and if there is vaccine shortage -- say during a new pandemic," he said.

The researchers reached their conclusions after reviewing 239 studies conducted between 1918 and 2011. They examined complications of influenza, including hospital admission, pneumonia, assistance with breathing via respirator, and death.

"These data reinforce the need to carefully define those conditions that lead to complications following infection with influenza," study senior author Dr. Mark Loeb, a microbiologist and professor of medicine at McMaster University, said in the news release.

The study was published in the Aug. 23 issue of the journal BMJ.

More information

For more about influenza, try the U.S. National Library of Medicine.

Urine Test May Show Risk of Mental Decline in People With Type 2 Diabetes

THURSDAY Aug. 29, 2013 -- A simple urine test may be able to identify type 2 diabetes patients at increased risk for mental decline, according to a new study.

This study of nearly 3,000 type 2 diabetes patients, average age 62, found that those who had persistent protein in their urine over four to five years had greater declines in their brain's information-processing speed than those with no protein in their urine. The decline in patients with persistent protein in the urine was greater than 5 percent.

The findings suggest that protein in the urine -- a condition called albuminuria -- may be an early warning sign of future mental decline, according to the study, which was published online Aug. 29 in the Clinical Journal of the American Society of Nephrology.

"Our finding was a subtle change in cognition," Dr. Joshua Barzilay, of Kaiser Permanente of Georgia and the Emory School of Medicine, said in a journal news release. "However, were this decline to continue over 10 to 15 years it could translate into noticeable cognitive decline by the age of 75 to 80, when [mental] impairment generally becomes clinically evident."

People with diabetes are 50 percent to 60 percent more likely to suffer mental decline than those without diabetes, according to the news release.

"Given how common albuminuria and diabetes are in the older population, these findings have a great deal of importance from a population point of view," Barzilay said. "Moreover, albuminuria is also common among older people with hypertension without diabetes."

Although the study linked protein in the urine with a sign of mental decline in older adults with type 2 diabetes, it did not establish a cause-and-effect relationship.

More information

The American Academy of Family Physicians outlines ways to look after your brain.

Delhi HC extends relief period for pharma cos in drug pricing case ET Bureau Aug 28, 2013, 04.00AM IST

NEW DELHI: The Delhi High Court on Tuesday extended relief for pharma firms, including Sun Pharma and Cipla, on relabeling of their existing stock under the new drug pricingregime on the condition that they comply with the interim order and posted the case for next hearing on September 23.he two companies along with a dozen other drug firms had challenged the government on specific provision under Drug Price Control Order 2013 which makes it mandatory upon the companies to label revised prices within 45 days of the price notification.

Other companies that have approached the court include Micro Labs, Lupin, Wockhardt, Intas Pharma, Alembic Pharma and Emcure Pharma.

The two cases of Sun Pharma, represented by Ajay Bhargava, partner, Khaitan & Co and Cipla, represented by Prathiba Singh of Singh & Singh have been made lead cases in the matter.

The Delhi High Court, in the interim order had asked the government not to take coercive measures against Sun Pharma and Cipla among other drugmakers who had moved the court on similar grounds till the next hearing.

 

Anti-Fungal Drug Not Tied to Most Birth Defects: Study

WEDNESDAY Aug 28, 2013 -- Although some reports have shown that high doses of the anti-fungal drug fluconazole (Diflucan) may raise the risk of birth defects, a new Danish review finds that more commonly prescribed lower doses of the medicine do not carry the same dangers.

Yet, in spite of this reassurance, experts may remain reluctant to prescribe the drug for expectant mothers who have yeast infections, since it is still linked to an increased risk of a rare congenital heart problem called tetralogy of Fallot.

"Many pregnant women suffer from a yeast infection called vaginal candidiasis, or vaginal thrush, which is the most common clinical indication for use of oral fluconazole," explained lead researcher Ditte Molgaard-Nielsen, an epidemiologist at the Statens Serum Institute in Copenhagen.

First-line treatment for vaginal candidiasis during pregnancy is vaginal preparations of topical anti-fungal drugs, she noted.

"However, in cases when topical treatment is ineffective this study provides comprehensive safety information, and may help inform clinical decisions when treatment with oral fluconazole is considered in pregnancy," Molgaard-Nielsen said.

Specifically, the researchers looked at 15 birth defects linked to fluconazole and found it was not associated with an increased risk for 14 of them, she said.

"However, we did see an increase in the risk of tetralogy of Fallot, an uncommon congenital heart defect, but the number of exposed cases were few and this association should be confirmed in other studies before anything can be concluded with any certainty," Molgaard-Nielsen added.

The report was published Aug. 29 in the New England Journal of Medicine.

Dr. Scott Berns, senior vice president and deputy medical officer for the March of Dimes, said that "when pregnant it is important to avoid taking any medicines unnecessarily."

"I would chose the topical drug to treat a yeast infection. That is my first line," he said. "If I had to use oral fluconazole, this study is reassuring that most of the time the baby is going to be fine. But, there is that small chance of tetralogy of Fallot. So, why take that chance?"

Another expert doesn't think these findings will change clinical practice.

"Ob/Gyns are still going to be reluctant to prescribe this drug," said Dr. Kecia Gaither, director of maternal fetal medicine at Brookdale University Hospital and Medical Center in Brooklyn, N.Y.

Gaither prefers to use natural methods for treating yeast infections. "One of them is increasing the use of yogurt intake," she said. "There is certain bacteria in yogurt that prevents yeast infections. I have not run into a person who continues to have recurrent yeast infections after that is done."

For the study, Molgaard-Nielsen's team collected data on more than 7,300 women who took fluconazole during their pregnancy, among whom 210 infants were born with birth defects, and compared them to a control group of more than 968,000 unexposed women, among whom more than 25,000 babies were born with birth defects.

In both groups, the risk for having an infant with a birth defect was 0.6 percent, the researchers found.

Moreover, fluconazole wasn't linked to a significantly increased risk for 14 of 15 birth defects to which the drug had been previously linked, they added.

These include craniosynostosis (a defect in the baby's skull), middle ear defects, cleft palate, cleft lip, limb defects, an abnormal number of finger or toes, fused fingers or toes, diaphragmatic hernia, heart defects and shifting of a lung.

There was, however, a significantly increased risk of tetralogy of Fallot, with seven cases (0.10 percent) among women who took fluconazole, compared with 287 cases (0.03 percent) in unexposed women, the researchers found.

According to the U.S. National Institutes of Health, tetralogy of Fallot is a rare, complex birth defect where four different areas of the heart are malformed and the heart cannot pump enough blood or oxygen to the rest of the body. Surgery is usually required shortly after birth, although the long-term outlook for these patients has improved greatly in recent years.

More information

For more on vaginal candidiasis, visit the U.S. Centers for Disease Control and Prevention.

Posted: August 2013

High Cholesterol May Be Particularly Bad for Middle-Aged Men

TUESDAY Aug. 27, 2013 -- Middle-aged men with high cholesterol levels are at greater risk for a first heart attack than similar women are, Norwegian researchers report.

In a study of more than 40,000 men and women under the age of 60, men with high cholesterol had more than three times the risk of having a heart attack, compared to women with high cholesterol.

"In middle age, our results suggest that high cholesterol is much more detrimental for men than for women, and that prevention and treatment of high cholesterol in middle-aged men have a great potential to reduce the occurrence of heart attacks among men," said lead researcher Dr. Erik Madssen, from the department of circulation and medical imaging at the Norwegian University of Science and Technology, in Trondheim.

Men under 60 should be diagnosed and treated for high cholesterol more aggressively than what often is the case today, he added.

To reduce the risk of heart attack, men should be counseled about making lifestyle changes, such as diet and exercise, as well as taking medication such as statins like Lipitor, to lower their cholesterol levels. "This is especially true in males that have a family history of heart attacks and in smokers," Madssen said.

Why there is this difference in risk between men and women isn't clear, but Madssen thinks it may have to do with the protective effects of hormones like estrogen, which is why they limited their study to women and men under 60.

"We believe that females below 60 years of age may be protected against some of the cardiovascular consequences of having high cholesterol due to female sex hormones such as estrogen," he said.

The report was published in the September issue of Epidemiology.

One expert said it is important for both men and women to keep their cholesterol in check.

"It is well established [that] men have a higher risk for heart attacks at an earlier age than women, with an approximately 10-year risk differential, but over a lifetime the cardiovascular risk in women exceeds that of men," said Dr. Gregg Fonarow, spokesman for the American Heart Association and a professor of cardiology at the University of California, Los Angeles.

In addition, it has been shown that higher cholesterol levels are an independent risk factor for men and women, with both sexes deriving similar benefits in terms of protection from cardiovascular disease with statins, he added.

"The use of lifestyle modification and statin therapy is one of the most effective, cost-effective and high-value therapeutic approaches to prevent cardiovascular events and prolong life in men as well as women," Fonarow said. "Attention to cholesterol levels and other risk factors remain vital for both men and women."

For the study, Madssen's team collected data on 23,525 women and 20,725 men who were younger than 60 when they took part in the second Nord-Trondelag Health Study. In that survey, which was done in 1995-1997 across Norway, participants had blood samples taken and analyzed.

Over 12 years of follow-up, 522 men had a first heart attack, compared with 157 women.

The researchers also looked at heart attacks among 20,138 people aged 60 and older at the time of the survey. However, among these participants there was no gender difference in the risk for heart attacks, they noted.

More information

For more on cholesterol, visit the American Heart Association.

Posted: August 2013

New Review Article Discusses Treatment of the Obese Patient in Primary Care

MOUNTAIN VIEW, Calif., Aug. 27, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that a review article has been published online in Postgraduate Medicine examining the treatment of obesity in the primary-care setting. This manuscript presents available medical treatment options, including Qsymia(R) (phentermine and topiramate
extended-release) capsules CIV, to assist clinicians in addressing the medical needs of their patients who are overweight or obese.

  Authors:       George Bray, MD, MACP, MACE; Michelle Look, MD, FAAFP; Donna Ryan, MD

  Title:         "Treatment of Obesity in Primary Care: Targeting and Meeting Goals and Expectations (narrative review)"

According to the article, the primary-care provider should not only manage the common comorbidities related to obesity, but obesity itself must be recognized as a physical and physiologic state, requiring effective therapy and ongoing management.

About Qsymia

Qsymia(R) (phentermine and topiramate extended-release) capsules CIV is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.

The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.

Important Safety Information

Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.

Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

About VIVUS

VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. For more information about the company, please visit www.vivus.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," "intend,"
"likely," "may," "plan," "potential," "predict," "opportunity" and "should," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS's Form 10-K for the year ending December 31, 2012, as amended by the Form 10-K/A filed on April 30,
2013 and by the Form 10-K/A filed on June 12, 2013, and periodic reports filed with the Securities and Exchange Commission.

New Drug Combo Helps Hard-to-Treat Hepatitis C

TUESDAY Aug. 27, 2013 -- Combining an old drug with an experimental one may cure many cases of hard-to-treat hepatitis C -- without the harsh side effects of the standard regimen, a U.S. government study finds.

Experts said the study, reported in the Aug. 28Journal of the American Medical Association, is an important research step. It focused on patients who often do not respond well to the current hepatitis C drug regimen because they already had liver damage, harbored a particularly stubborn strain of the virus or had other "unfavorable treatment characteristics."

In other words, they were the patients who often are left out of clinical trials.

"This was the real world, and the treatment response was really quite good," said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases and one of the researchers on the work.

Of the 60 patients in the trial, 48 percent to 68 percent had the virus cleared from their bodies, depending on the drug dose.

The therapy included one older hepatitis C drug, called ribavirin, and one currently being considered for approval in the United States and Europe, called sofosbuvir. Most important, the regimen excluded interferon -- an injection drug that is part of the current standard treatment for hepatitis C.

Interferon is difficult to take and can cause side effects including sleep problems, depression, nausea, diarrhea, muscle pain, fever and fatigue. Researchers are working on various interferon-free drug regimens for hepatitis C.

There are dozens of drugs under development, with several expected to be on the market within the next year or two.

That means the best is yet to come, said Dr. Eugene Schiff, a liver disease expert who was not involved in the new trial.

"This is an important paper," said Schiff, who directs the Center for Liver Diseases at the University of Miami. "But these results reflect an interim experience. It's a treatment that will be out there for only a short time."

Schiff said that in the next year and a half, there should be new oral drug combinations that allow hepatitis C patients to skip not only the interferon, but also ribavirin -- which can have substantial side effects of its own, including anemia.

"We're in the middle of an exciting time," Schiff said. "I'm very optimistic."

The current study included 60 hepatitis C patients with factors that make standard interferon-based treatment unlikely to work.

Most had a genetic strain of the virus that does not respond well to interferon. Many also had liver fibrosis -- scarring of the organ that can progress to more severe damage, known as cirrhosis, and possibly liver cancer. And most participants were black, a group that traditionally has not fared as well with hepatitis C regimens compared to whites.

All of the patients were given sofosbuvir, an oral drug, plus either low-dose ribavirin or a dose adjusted to their weight. After 24 weeks of treatment, 68 percent of those given the weight-based ribavirin had a "sustained virologic response," which equates to a cure, Schiff said.

Of the patients in the low-dose group, 48 percent were cured.

Headache, anemia, fatigue and nausea were the most common side effects, affecting anywhere from 16 percent to 33 percent of the patients. But none dropped out of treatment due to side effects, the researchers said.

Fauci agreed that drug regimens that bypass both interferon and ribavirin are the wave of the future. "The ultimate goal is to have a drug combination that would be nontoxic and have a high cure rate," he said.

The drugs under development also are expected to cut the treatment time from up to 48 weeks to 12 weeks or less, Schiff said.

More than 3 million Americans are living with chronic hepatitis C, but most don't know it, Fauci said. "That's why there's a big push for screening," he said.

U.S health officials recommend that all baby boomers (people born from 1945 to 1965) get tested for chronic hepatitis C infection. The virus is mainly transmitted through infected blood, and injection-drug use is the top risk factor. But people who had a blood transfusion before 1992 also are at risk, because that predated widespread screening for hepatitis C.

In a small number of cases, the virus is passed during sex.

Schiff agreed that people would need to be screened for the new drug regimens to effectively prevent cases of liver cirrhosis and cancer. Only a small number of people with chronic hepatitis C develop those complications, but there is no way to predict any one person's course.

Treating all those people with the new drugs coming to market will be expensive, Schiff said. "But it's highly likely they'll be cured," he added. "And you'll be curing a disease that causes cirrhosis and cancer."

More information

The U.S. Centers for Disease Control and Prevention has more on hepatitis C.

Health Highlights: Aug. 27, 2013

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Girl Who Got 2 Lung Transplants Goes Home

The 10-year-old Pennsylvania girl whose lung transplant sparked a national debate over organ-transplantation policy left the hospital and returned home Tuesday, the Associated Press reported.

Sarah Murnaghan, of Newtown Square, has end-stage cystic fibrosis and received two transplants of adult-sized lungs, even though current organ-transplant policy states that children only receive child-sized lungs.

However, Sarah's parents took her case to the courts. A federal judge intervened on her behalf, ordering that she be allowed an adult lung transplant.

The first set of adult lungs the child received failed within hours of transplant, but a second set, transplanted three days later, seem to have worked.

Sarah's mother, Janet Murnaghan, said in a Facebook page posting late Monday that Sarah would be leaving Children's Hospital of Philadephia on Tuesday. On Sunday, Janet Murnaghan said her daughter had been taken off oxygen but does get some breathing support from a machine. She is now able to walk around the hospital using a walker, and has gone outside for brief periods, the AP reported.

-----

Music Star Linda Ronstadt Has Parkinson's Disease

Singer Linda Ronstadt, a music star for more than four decades, has been diagnosed with Parkinson's disease, which has robbed her of the ability to sing.

"No one can sing with Parkinson's disease," the 67-year-old Ronstadt said in an interview withAARP Magazine. "No matter how hard you try."

Ronstadt said she was diagnosed eight months ago and "can't sing a note." She said she initially experienced symptoms about eight years ago, but thought her singing problems were caused by a tick disease, the Associated Press reported.

She said she was "completely shocked" when a neurologist diagnosed her with Parkinson's disease. "I wouldn't have suspected that in a million, billion years."

Ronstadt sold tens of millions of records starting in the late 1960s. Some of her earlier hits included "You're No Good" and "When Will I Be Loved." She later sang pop standards and mariachi music, the AP reported.

Ronstadt now uses poles to walk on uneven ground and a wheelchair when traveling, the AARP story said.

The U.S. National Institute of Neurological Disorders and Stroke says Parkinson's disease is part of a group of conditions called motor system disorders that are caused by the loss of certain key brain cells. Typical symptoms include tremors, or trembling in the hands, arms, legs, jaw, and face; stiffness of the limbs and trunk; slowness of movement; and problems with balance and coordination. As symptoms become more severe, some patients may have trouble with walking, talking or other simple tasks. The disease usually affects people 50 and older.

There's no cure for Parkinson's, but a variety of medications can provide significant relief from the symptoms, according to the institute.

FDA warns 2 Indian companies for manufacturing lapses

In its latest action against Indian drug makers, the US health regulator FDA has red-flagged "significant deviations" from good manufacturing practices at two Indian pharmaceutical companies.

In the case of Hyderabad-based Posh Chemicals, the US Food and Drug Administration said that lapses found at its manufacturing facility may cause the Active Pharmaceutical Ingredients (APIs) manufactured by it to get adulterated.

During an inspection of the company's facilities, FDA found failure to protect computerised data from unauthorised access, failure to ensure that test procedures are scientifically sound and failure to follow and document quality-related activities at the time they are performed.

With regard to the second company, Himachal Pradesh-based Sentiss Pharma (formerly Promed Exports), the FDA said the company failed to establish adequate systems for monitoring environmental conditions and for cleaning and disinfecting the room and equipment in aseptic processing areas.

Besides, Sentiss allegedly failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, FDA has alleged.

In separate warning letters issued to the two companies, the FDA said that their deviation from "good manufacturing practices" could cause their products to be adulterated as per the US regulations.

The FDA said it may withhold approval of any new applications or supplements of the two companies, until they put in place necessary corrective measures and get those corrections approved as per the US regulations.

At least six Indian drug makers have been issued such warning letters so far this year by the FDA, which has also ordered recall of certain drugs manufactured in India.

Wockhardt and Fresenius Kabi received warning letters last month, while Hospira Healthcare India and RPG Life Sciences got such letters in May.

Besides, the FDA recently also clamped down on 15 companies globally, including Gujarat-based Amrutam Life Care, for illegal sale of drugs labelled as dietary supplements and ayurvedic products for treating diabetes.

Others having faced FDA action for non-compliance with various US regulations include Ranbaxy, Dr Reddy's Labs, Sun Pharma, Cadila, Aurobindo Pharma and Glenmark.

Known for making cheaper generic versions of expensive well-known drugs, India enjoys about 10 per cent share in the finished-dose product market in the US.

Bharat Biotech launches typhoid conjugate vaccine

Bharat Biotech, Hyderabad-based vaccine and biotherapeutics company, will in two weeks from now hit the Indian market with what it claims is the world's first "clinically proven typhoid conjugate vaccine".

A conjugate vaccine is typically one which provides coverage for a longer period - at least for about five years.

There are typhoid vaccines in the market, including one manufactured by Bharat Biotech itself, but they provide immunity from the disease for three years. These are called polysaccharide vaccines.

While Bharat Biotech claims this vaccine is the only one that is clinically proven and unique, this may not be the only conjugate vaccine. Bio-Med also has a conjugate vaccine for typhoid.

Launching the new vaccine in Hyderabad on August 26, Bharat Biotech Chairman and Managing Director Krishna M. Ella said it could be used across age groups, "starting from six months old infants to older children and adults."

He said that the price was still being worked out. Bharat Biotech invested Rs 65 crore on the project.

Bharat Biotech, with revenues of Rs 300 crore, expects the new vaccine to take the company's total revenues from the typhoid segment to around Rs 100 crore from around Rs 40 crore.

The 14-year-old company also makes Hepatitis B and polio vaccines, among others. In May, it also announced plans to launch a rotavirus vaccine developed in association with the Department of Biotechnology and four US organisations: National Institutes of Health, the Centers for Disease Control and Prevention, Stanford University School of Medicine, and the non-governmental organisation PATH.

DCGI asked to check quality of drugs sold by Ranbaxy: Govt

The government has ordered the Drug Controller General of India (DCGI) to check the quality of drugs produced by Ranbaxy Laboratories and to check if the firm is following standard manufacturing norms at its various manufacturing plants.

In May this year, Ranbaxy had pleaded guilty to "felony charges" in the US Court of Maryland for manufacture and distribution of certain drugs not in conformity with the GMP regulation, which are considered as adulterated drugs as per the US law, and as a result agreed to pay a fine of $500 million.

The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India.

"The DCGI has already been ordered to review the good manufacturing practices compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities," Minister of State of Chemicals and Fertilisers Srikant Kumar Jena said in a written reply in Rajya Sabha.

To a query whether the company is selling "some of the medicines" in the country for which it was penalised in the US, Jena said as per the US law, any drug is considered adulterated if it is not manufactured, processed, packed in conformity with the current good manufacturing practice (GMP) regulations of the US Food and Drug Administration (USFDA).

"However, as per Drugs and Cosmetic Act and Rules, in India, manufacturing of drugs not in conformity of with GMP is viewed non compliance to GMP," Jena said.

Boston launches COGNIS cardiac resynchronization therapy defibrillator in Chinese market

Boston Scientific Corporation has launched COGNIS cardiac resynchronization therapy defibrillator (CRT-D) in the Chinese market. Professor Farong Shen in Zhejiang Lucheng Hospital and Professor Wei Hua in Beijing Fuwai Hospital have implanted COGNIS cardiac resynchronization therapy defibrillator in its first patient from China’s Zhejiang province and Beijing successfully.

Cardiac resynchronization therapy is a treatment option for some heart failure patients that can help the heart pump more efficiently. A CRT-D system can also defibrillate the heart when an arrhythmia occurs.

COGNIS offers Electronic Repositioning, with six pacing configurations, to manage high pacing thresholds and unwanted diaphragmatic muscle stimulation. SmartDelay AV Optimization provides individualized therapy without the need for a time-consuming echocardiogram. COGNIS also offers HF Perspectiv, a proprietary suite of diagnostics, including Heart Rate Variability Footprint which gives clinicians an objective view of patients’ response to therapy. These features are paired with three left ventricular leads designed to reach and remain in the target vessel. Boston Scientific ENDOTAK RELIANCE defibrillation leads have a 98.5 per cent survival probability at 10 years, the highest in the industry.

The COGNIS CRT-D is the thinnest in the world with exceptional longevity. COGNIS battery technology is the culmination of seven years of research and is unique to Boston Scientific. The projected life expectancy of COGNIS products reaches more than eight years, which is much longer than similar CRT-Ds on the market. Longer-lasting CRT-Ds may significantly reduce the risk of a secondary operation and lessen the financial burden incurred from device replacement.

As for the first implantation of COGNIS in China, Professor Shu Zhang, chairman of the Chinese Cardiac Pacing and Electrophysiology Society and director of the Cardiac Arrhythmias Treatment Centre of Beijing Fuwai Hospital, said, “The successful introduction of COGNIS CRT-D once again demonstrates that Boston Scientific, a leading enterprise in the pacing and electrophysiology industry, introduces advanced medical technologies and products.”

Professor Wei Hua, chief physician of cardiovascular department in Fuwai Hospital, also commented, “The Boston Scientific CRT-D System provides clinicians with many implantation choices, including different forms of the left ventricular lead, which I believe drive a  high success rate of CRT-D implantation.”

“COGNIS is small and thin, but it has a long service life,” said Professor Farong Shen, executive hospital director and head of the cardiology center in Lucheng Hospital. “I believe that it is indeed a groundbreaking CRT-D product for patients.”

Boston Scientific provides advanced less-invasive medical products and services to its customers and patients and transforms lives through innovative medical solutions that improve the health of patients around the world.

DMA received an In-Principle approval for its Pharma SEZ

Hyderabad:The Drugs & Pharmaceuticals Manufacturers Association has received in-principle approval for its proposed special economic zone for pharmaceuticals, bulk drugs, active pharmaceutical ingredients (APIs) and formulations to be located at Nakkapalli mandal in Visakhapatnam district.


This is formal approval granted by the Board of Approval of the Special Economic Zones.

Lupin is setting up a new formulation plant at MIHAN

Lupin is setting up a new manufacturing plant at the MIHAN special economic zone (SEZ) in Nagpur, The project entailing an investment of Rs 400 crore over a period of five years.


The new formulation manufacturing facility at the Multi- modal International Cargo Hub and Airport (MHIAN) SEZ will be completed in a year.

The biopharmaceutical industry is firmly committed to enhancing public health

The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information. In July 2013, PhRMA joined with the European Federation of Pharmaceutical Industries and Associations (EFPIA) in adopting joint Principles for Responsible Clinical Trial Data Sharing.

[Read the joint press release announcing the Principles]
 
The Principles reflect the biopharmaceutical sector’s strong support for responsible data sharing that recognizes the importance of protecting patient privacy, respects the integrity of national regulatory systems, and maintains incentives for continued investment in biopharmaceutical research.
 
Biopharmaceutical companies already routinely collaborate with academic researchers, publish clinical research, and share clinical trial information on public websites such as ClinicalTrials.gov.  The Principles will enhance those efforts by making additional information available to the public, the patients who volunteer to participate in clinical trials, and qualified researchers.
 
PhRMA firmly believes that continuing to augment the amount of information available to researchers, patients and the public will expand research and scientific knowledge, foster a collaborative scientific discovery process, and support patient care – all with the ultimate goal of improving public health.
 
Under the Principles, PhRMA and EFPIA member companies commit to enhance data sharing with qualified researchers, share results with the patients who participate in clinical trials, enhance public access to clinical study information, and reaffirm their commitment to publish clinical trial results. 
 
Implementation of the commitments in the Principles for Responsible Clinical Trial Data Sharing begins on January 1, 2014.  At that time, companies will begin reviewing requests from researchers.  Releases of patient-level data must take into account informed consent and patients who volunteered in earlier clinical trials may have not consented to such release. Biopharmaceutical companies will certify on a publicly available website that they have established policies and procedures to implement them.
 
These new Principles supplement PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results which help assure that clinical research conducted by America’s biopharmaceutical research companies continues to be carefully conducted and that meaningful medical research results are communicated to healthcare professionals and patients. These Principles include enhanced standards for medical research authorship and improved disclosure to better manage potential conflicts of interest in medical research.

Intas Pharma is planning to raise R2. 50Cr PE investment for expansion

Intas Pharma is planning to raise R250Cr private equity investment for expansion.


Intas Pharma filed DRHP to raise upto R425Cr through fresh issue of shares.

The company planning to use the funds raised through fresh issue for product registration (R108.5Cr), capital expenditure (R218.75Cr) and for other corporate purposes.

Novartis to increase its stake in Indian subsidiary

The Swiss company Novartis is set to increase stake in its Indian subsidiary to nearly 90 per cent from the existing 51 per cent.


The company said it would go in for a tender offer to acquire an additional stake of about 39 per cent in its majority-owned Indian subsidiary, Novartis India Ltd, from public shareholders at a price of Rs 351 a share. The offer represents a total value of up to Rs 440 crore.

Novartis stock price shot up 20 per cent to Rs 330, following the announcement on the BSE, early Wednesday.

The Indian arm is the only listed entity Novartis has, outside its headquarters in Basel.

The decision will help consolidate Novartis� economic ownership, an investment banking source said, adding that there was nothing �diabolical� about the timing of the offer. Other multinational companies too have their only listed entity in India, in keeping with regulatory requirements.

Explaining the valuation, he said, the price of Rs 351 was last visited by the Novartis stock in January 2008, when the stock market was at its peak.

The stock is infrequently traded, he said, adding that an average of about 5,420 shares was traded a day in the last six months. Novartis AG�s offer is at a premium of 27 per cent to the closing share price of Rs 275.6 of Novartis India Ltd on March 24, which was the last trading day before this announcement. It also represents a premium of 35 per cent over Novartis India Ltd�s average share price during the last month.

Also, at present there has been no decision taken on delisting locally. The note from Novartis AG too does not state as much.

However, if the company�s public float falls below 25 per cent, as it would if the parent�s equity increases to 90 per cent, that could be a violation of the Takeover Code and Listing Agreement, a regulatory expert said. Unless, the public float itself is 10 per cent, the expert added, asked whether Novartis was headed for a delisting.

Mr Ranjit Kapadia of PCG-Prabhudas Lilladher observed that the offer price did not reflect the fair value of the share price. The cash-on-book and brand valuation together exceeds the offer price, he added.

Novartis has Rs 475 crore cash on its books and it has good brands like the Rs 140-crore painkiller Voveran, he said. There is a possibility of delisting at a later date, he added, as it brings in less accountability to shareholders.

Ranbaxy gets approval for drugs treating seizures

New Delhi: Ranbaxy Laboratories has received approval from the US Food and Drug Administration (USFDA) to market and manufacture a generic drug for treating seizures.


The company has received approvals for Topirimate tablets which have the same therapeutic effect as that of the reference listed drug, Topamax by Ortho McNeil Janssen Pharmaceuticals Inc.

The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, New Jersey, USA.

Ohm is a wholly owned subsidiary of Ranbaxy Laboratories Ltd. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system. Facing data falsification charges from the USFDA at one of its Indian facilities, Ranbaxy is now relying upon the drug making capabilities of its US subsidiary, Ohm Laboratories.

This is the fourth drug approval received by Ranbaxy after the USFDA banned drugs from the company�s plant in Paonta Sahib. It had earlier got approval to market cardiovascular drug � Ramipril Capsules, generic version of Pfizer�s blood pressure drug Accuretic and GSK�s blockbuster migrane medicine, Imetrix.

First pre-clinical gene therapy study to reverse Rett symptoms

AstraZeneca and Bristol-Myers Squibb today announced they have resubmitted to the U.S. Food and Drug Administration (FDA), a New Drug Application (NDA) for dapagliflozin for the treatment of adults with type 2 diabetes. The NDA resubmission, which is pending acceptance by the FDA, includes several new studies and additional long-term data (up to four years' duration) from previously submitted studies.

About dapagliflozin
Dapagliflozin, an investigational compound, is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently of insulin. It is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico and New Zealand. About Type 2 Diabetes

In 2012, diabetes was estimated to affect more than 370 million people worldwide. The prevalence of diabetes is projected to reach more than 550 million by 2030. Type 2 diabetes accounts for approximately 90 to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease characterised by insulin resistance and dysfunction of beta cells in the pancreas, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to further progression of the disease. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

First pre-clinical gene therapy study to reverse Rett symptoms

The concept behind gene therapy is simple: deliver a healthy gene to compensate for one that is mutated. New research published today in the Journal of Neuroscience suggests this approach may eventually be a feasible option to treat Rett Syndrome, the most disabling of the autism spectrum disorders. Gail Mandel, Ph.D., a Howard Hughes Investigator at Oregon Health and Sciences University, led the study. The Rett Syndrome Research Trust, with generous support from the Rett Syndrome Research Trust UK and Rett Syndrome Research & Treatment Foundation, funded this work through the MECP2 Consortium.

In 2007, co-author Adrian Bird, Ph.D., at the University of Edinburgh astonished the scientific community with proof-of-concept that Rett is curable, by reversing symptoms in adult mice. His unexpected results catalyzed labs around the world to pursue a multitude of strategies to extend the pre-clinical findings to people.

Today's study is the first to show reversal of symptoms in fully symptomatic mice using techniques of gene therapy that have potential for clinical application.

Rett Syndrome is an X-linked neurological disorder primarily affecting girls; in the US, about 1 in 10,000 children a year are born with Rett. In most cases symptoms begin to manifest between 6 and 18 months of age, as developmental milestones are missed or lost. The regression that follows is characterized by loss of speech, mobility, and functional hand use, which is often replaced by Rett's signature gesture: hand-wringing, sometimes so intense that it is a constant during every waking hour. Other symptoms include seizures, tremors, orthopedic and digestive problems, disordered breathing and other autonomic impairments, sensory issues and anxiety. Most children live into adulthood and require round-the-clock care.

The cause of Rett Syndrome's terrible constellation of symptoms lies in mutations of an X-linked gene called MECP2 (methyl CpG-binding protein). MECP2 is a master gene that regulates the activity of many other genes, switching them on or off.

"Gene therapy is well suited for this disorder," Dr. Mandel explains. "Because MECP2 binds to DNA throughout the genome, there is no single gene currently that we can point to and target with a drug. Therefore the best chance of having a major impact on the disorder is to correct the underlying defect in as many cells throughout the body as possible. Gene therapy allows us to do that."

Healthy genes can be delivered into cells aboard a virus, which acts as a Trojan horse. Many different types of these Trojan horses exist. Dr. Mandel used adeno-associated virus serotype 9 (AAV9), which has the unusual and attractive ability to cross the blood-brain barrier. This allows the virus and its cargo to be administered intravenously, instead of employing more invasive direct brain delivery systems that require drilling burr holes into the skull.

Because the virus has limited cargo space, it cannot carry the entire MECP2 gene. Co-author Brian Kaspar of Nationwide Children's Hospital collaborated with the Mandel lab to package only the gene's most critical segments. After being injected into the Rett mice, the virus made its way to cells throughout the body and brain, distributing the modified gene, which then started to produce the MeCP2 protein.

As in human females with Rett Syndrome, only approximately 50% of the mouse cells have a healthy copy of MECP2. After the gene therapy treatment 65% of cells now had a functioning MECP2 gene.

The treated mice showed profound improvements in motor function, tremors, seizures and hind limb clasping. At the cellular level the smaller body size of neurons seen in mutant cells was restored to normal. Biochemical experiments proved that the gene had found its way into the nuclei of cells and was functioning as expected, binding to DNA.

One Rett symptom that was not ameliorated was abnormal respiration. Researchers hypothesize that correcting this may require targeting a greater number of cells than the 15% that had been achieved in the brainstem.

"We learned a critical and encouraging point with these experiments - that we don't have to correct every cell in order to reverse symptoms. Going from 50% to 65% of the cells having a functioning gene resulted in significant improvements," said co-author Saurabh Garg.

One of the potential challenges of gene therapy in Rett is the possibility of delivering multiple copies of the gene to a cell. We know from the MECP2 Duplication Syndrome that too much of this protein is detrimental. "Our results show that after gene therapy treatment the correct amount of MeCP2 protein was being expressed. At least in our hands, with these methods, overexpression of MeCP2 was not an issue," said co-author Daniel Lioy.

Dr. Mandel cautioned that key steps remain before clinical trials can begin. "Our study is an important first step in highlighting the potential for AAV9 to treating the neurological symptoms in Rett. We are now working on improving the packaging of MeCP2 in the virus to see if we can target a larger percentage of cells and therefore improve symptoms even further," said Mandel. Collaborators Hélène Cheval and Adrian Bird see this as a promising follow up to the 2007 work showing symptom reversal in Rett mice. "That study used genetic tricks that could not be directly applicable to humans, but the AAV9 vector used here could in principle deliver a gene therapeutically. This is an important step forward, but there is a way to go yet."

"Gene therapy has had a tumultuous road in the past few decades but is undergoing a renaissance due to recent technological advances. Europe and Asia have gene therapy treatments already in the clinic and it's likely that the US will follow suit. Our goal now is to prioritize the next key experiments and facilitate their execution as quickly as possible. Gene therapy, especially to the brain, is a tricky undertaking but I'm cautiously optimistic that with the right team we can lay out a plan for clinical development. I congratulate the Mandel and Bird labs on today's publication, which is the third to be generated from the MECP2 Consortium in a short period of time," said Monica Coenraads, Executive Director of the Rett Syndrome Research Trust and mother of a teenaged daughter with the disorder.