Rahul Gandhi alleges hospitals discriminate against poor IANS [ Updated 09 Aug 2014, 08:09:32 ]

Gurgaon: Congress vice-president Rahul Gandhi on Friday said that hospitals in India discriminate against the poor.

Inaugurating the Indira Gandhi Eye Hospital in Raipur village near Sohna, 26 km from Gurgaon, Rahul said the hospital would provide access to quality eye care to the marginalized section of society and to low and middle income groups from both rural and urban areas.

"I had visited a hospital in Delhi a few months back and was shocked to see a line written there saying 'Poor are not allowed'," Rahul said.

He, however, did not mention the name of the hospital or say whether it was a government or a private one.

The Congress leader said both poor and rich people would get similar treatment in this hospital with a 16-bed facility.

He said a team of doctors would visit far-flung areas and check people's eyesight.

Rahul said the parents of a little girl, Mohsina, thought she was mentally disabled. When doctors examined her, she was found to have poor eyesight. She was treated and ‘now her life has completely changed’.

This would be the third Indira Gandhi Eye Hospital run by the Rahul Gandhi Charitable Trust. The other two are in Amethi and Lucknow.

Over 15 lakh patients have been treated and cataract operations performed on two lakh patients in these two hospitals, he said.

http://www.indiatvnews.com/news/india/rahul-gandhi-alleges-hospitals-discriminate-against-poor-40280.html

Fruit flies can help unlock mysteries of human diabetes: Study Publish Date: 09 Aug 2014, 10:38 AMLast Updated: 09 Aug 2014, 10:38 AM

By : Jagran Post News Desk | Jagran Post Editorial

For the first time, the tiny fruit fly can be used to study how mutations associated with the development of diabetes affect the production and secretion of the vital hormone insulin.

The new technique devised by researchers at the Stanford University School of Medicine allows scientists to measure insulin levels in the insects with extremely high sensitivity and reproducibility.

The experimental model is likely to transform the field of diabetes research by bringing the staggering power of fruit fly genetics, honed over 100 years of research, to bear on the devastating condition, researchers said.

Until now, scientists wishing to study the effect of specific mutations on insulin had to rely on the laborious, lengthy and expensive genetic engineering of laboratory mice or other mammals.

In contrast, tiny, short-lived fruit flies can be bred in dizzying combinations by the tens of thousands in just days or weeks in small flasks on a laboratory bench.

Developed by Research associate Sangbin Park, lead author of the paper, the new technique uses a chemical tag to label an insulin-like peptide called Ilp2 in fruit flies.

The tag allows researchers to use an antibody-based assay to measure insulin concentrations in the insect's blood and cells at the picomolar level the level at which insulin concentrations are measured in humans.

Using the technique, the researchers were able to quickly identify what a mutation associated with type-2 diabetes in humans actually does. It regulates insulin secretion, but not production.

Parsing the effect of each mutation on the way the body produces, secretes and responds (or not) to insulin is critical to further understand the disease and to devise new therapeutic approaches.
http://post.jagran.com/fruit-flies-can-help-unlock-mysteries-of-human-diabetes-study-1407560935

Stem cell behaviour of human bowel uncovered PTI | London | Published: Aug 09 2014, 11:05 IST

They found the stem cell biology of human bowels have significant similarities to mice bowels.

SUMMARYScientists have uncovered stem cell behaviour of human bowel.

For the first time, scientists have uncovered stem cell behaviour of human bowel, providing vital clues about the earliest stages in bowel cancer development.

The study, led by Queen Mary University of London (QMUL), discovered how many stem cells exist within the human bowel and how they behave and evolve over time.

It was found that within a healthy bowel, stem cells are in constant competition with each other for survival and only a certain number of stem cells can exist within one area at a time (referred to as the 'stem cell niche').

However, when investigating stem cells in early tumours, the researchers saw increased numbers of stem cells within each area as well as intensified competition for survival, suggesting a link between stem cell activity and bowel cancer development.

The study involved studying stem cells directly within the human body using a specially developed 'toolkit'.

The toolkit worked by measuring random mutations that naturally accrue in ageing stem cells. The random mutations recorded how the stem cells had behaved, similarly to how the rings on a tree trunk record how a tree grew over time.

The techniques used were unique in that scientists were able to study the human stem cells within their natural environment, giving a much more accurate picture of their behaviour.

Until this research, the stem cell biology of the human bowel has remained largely a mystery. This is because most stem cell research is carried out in mice, and it was uncertain how research findings in mice could be applied to humans, researchers said.

They found the stem cell biology of human bowels have significant similarities to mice bowels.

This means researchers can continue investigating stem cell activity within mice with the knowledge it is representative of humans - speeding up bowel cancer research.

These new research methods can also now be applied to investigate stem cells in other parts of the human body such as skin, prostate, lung and breast, with the aim of accelerating cancer research in these areas too.

The study was published in the journal Cell Reports.

http://www.financialexpress.com/news/stem-cell-behaviour-of-human-bowel-uncovered/1277843

Union Health Ministry seeks synergy in fragmented healthcare industry Saturday, 9 August 2014 - 7:55am IST | Place: Mumbai | Agency: DNA

The health ministry is working towards bringing all the healthcare related departments under one fold over the next five year period and put in place a health policy in the near term to increase healthcare access for the people, a senior government official said on Friday.

Rajendra Pratap Gupta, advisor in public policy, economy, rural development, healthcare, retail, innovation, on the sidelines of healthcare access summit organised by the Organisation of Pharmaceutical Producers of India in Mumbai, said, "One of the biggest lacuna is that the health industry is spread across different departments and the best way to bring synergy is to conversion of related departments under one. I think the health ministry is also thinking the same."

However, Gupta said that bringing all departments will not be done immediately, but it will happen over a five years term. He also said that a health policy is also underway.

Gupta, who has authored the manifesto of the new government, said the first step is to have a health policy in place. The other requirement is to bring down the out-of-pocket spending, increase in the healthcare access, increase in the quality of care and the use of new technology. The other major thrust would be on upgrading the government hospitals and provision of latest technology and diagnostics. He also said that the government would set up the National e-Health Authority but that depends on which phase it gets rolled out.

On the recent decision of National Pharmaceutical Pricing Authority (NPPA) to bring more drugs under price control, Gupta said, "It is very clear that the patient interest will be above everyone and whatever it takes to be there will be there."

However, Shailesh Ayyangar, president, OPPI and managing director, India & vice president, South Asia, Sanofi, said, "When the price regulator decided on bringing a list of essential medicines under price control in 2013, it organised a discussion with all the industry stakeholders. If there could be a discussion then, why not now? The issue is it was done unilaterally, without having any discussion with the industry."

While the case is now subjudiced after some of the industry stakeholders including IPA, OPPI moving court against NPPA's recent decision to bring 108 more formulations under price control, manufacturing of these products may have to stop unless there is the court decision.

Said Ranjit Shahani, vice chairman and managing director, Novartis, "I think companies will stop manufacturing, otherwise stocks would be there and you have to re-label them. Which means there is a gap and there is uncertainty over the court decision, uncertainty over what the government might do and so there's going to be certain disruptions some way or the other."

While Shahani said that till a court decision or a consensus is reached, the medicines will be sold at the old price, Aijaz Tobaccowala, managing director, Pfizer, said, "As far as I know, till there is a change, it's on the go. I think we don't have a choice."

http://www.dnaindia.com/money/report-union-health-ministry-seeks-synergy-in-fragmented-healthcare-industry-2009264

Allow pharmacists as medical practitioners in rural areas: IPA | Business Standard News

Pharma's Top 11 Marketing Settlements June 26, 2012 By Tracy Staton and Eric Palmer

The Justice Department is growing more and more impatient. For more than a decade, its lawyers and investigators have been slapping drugmakers around for their marketing misdoings. They've insisted on bigger and bigger penalties, especially during the last several years, with penalties and payments commonly topping $500 million. And yet the whistleblower lawsuits and off-label settlements keep coming.

Consider what's happened since 2004, when Pfizer ($PFE) inked a $430 million settlement with the feds for its misbegotten promotions of the seizure drug Neurontin. In 2005, Serono agreed to a $704 million deal for conspiring to market its AIDS-wasting drug Serostim off-label. Two years later, Purdue Pharma and Bristol-Myers Squibb ($BMY) wrapped up their investigations for a combined $1.15 billion. By 2009, the penalties had skyrocketed: Pfizer and Eli Lilly's ($LLY) settlements together amounted to $3.7 billion.

The deals show no sign of stopping. At the end of 2011 came Merck's ($MRK)$950 million Vioxx deal. Abbott Laboratories' ($ABT) $1.6 billion Depakote deal was finalized earlier this year. GlaxoSmithKline ($GSK) finalized its $3 billion settlement, which covers off-label and safety-related claims. More marketing settlements are expected by year's end, too: Johnson & Johnson ($JNJ) is reportedly very close to a settlement of at least $1.6 billion, perhaps as much as $2.2 billion, covering its marketing of the antipsychotic Risperdal and a handful of other products.

In fact, as our ranking of the top 11 marketing settlements of the past 10 years shows, these drugmakers agreed to pay more than $11 billion for their misbehavior. And that doesn't include the smaller off-label deals that didn't make the list: Novartis' ($NVS) $422.5 million Trileptal deal, inked in 2010. Cephalon's ($CEPH) $425 million settlement. Schering-Plough's $435 million agreement. Pfizer's well-known $430 million in Neurontin penalties. AstraZeneca's ($AZN) long-ago, $355 million Zoladex settlement. Or Forest Laboratories' ($FRX) $313 millionor Elan's $203 million. Add all that in, and the total is close to $14 billion.

A few other drugmakers have disclosed government probes. More than 900 whistleblower suits were filed last year. Historically, about 10% of whistleblower claims involve drugmakers, and only a small number of those will end up attracting the attention and backing of the Justice Department. Still, it's a steady stream of allegations. And some involve companies that previously stepped over the line, paid their fines and promised to stay clean. A few, more than once.

So, government prosecutors are brainstorming additional penalties to deter bad behavior. Since 2010, federal officials have been threatening action against pharma executives, not just their companies, perhaps under the "responsible corporate officer" doctrine. Another idea: Yanking disobedient drugmakers' patent rights.

The patent-loss idea wouldn't apply to settlements expected in the near term, only to infractions under investigation now. That means J&J and Amgen ($AMGN), all expected to finalize their settlements in 2012, won't likely be affected.

Some notes about our top settlements list: It includes deals wrapped up during the last decade, ranked by the total of criminal and civil payments. Johnson & Johnson's impending deal is included, and ranked based on the range of reported settlement amounts. Whether on the low end or high end of that range, theRisperdal deal fits firmly in second place.

Amgen's settlement could shake up the rankings, though. The company said itearmarked $780 million to settle allegations of kickbacks and other marketing infractions designed to boost sales of its anemia drugs. So, we'll update the list accordingly as deals are announced.

http://www.fiercepharma.com/special-reports/top-10-pharma-settlements/top-10-pharma-settlements?utm_medium=nl&utm_source=internal

Pfizer to pay $35 million to U.S. states to settle Rapamune claims BY JONATHAN STEMPEL NEW YORK Wed Aug 6, 2014 7:32pm BST

(Reuters) - Pfizer Inc (PFE.N) agreed to pay $35 million (20.7937 British million pounds) to 41 U.S. states and Washington, D.C. to settle claims that its Wyeth unit illegally marketed the drug Rapamune, and encouraged doctors and hospitals to prescribe it for off-label uses.

The settlement was announced on Wednesday, just over one year after Pfizer agreed in July 2013 to pay $490.9 million to resolve U.S. Department of Justice claims over the marketing of the drug.

Pfizer bought Wyeth in October 2009, and the alleged improper conduct predated that purchase.

Rapamune was approved in 1999 to help people who received kidney transplants keep their immune systems from rejecting the new organs.

Regulators said Wyeth encouraged its sales force to promote Rapamune for other uses not approved by the U.S. Food and Drug Administration, including by people who received heart, liver and lung transplants, and in combination with other drugs.

New York Attorney General Eric Schneiderman said the settlement also restricts how Pfizer markets other drugs.

"Patients and consumers need to have confidence in the truthfulness of claims made to them by medical providers without having to worry about drug companies manipulating the doctor-patient relationship," Schneiderman said in a statement.

In 2013, Pfizer, which is based in New York, generated $350 million of revenue from Rapamune. Neither Pfizer nor Wyeth admitted wrongdoing or liability in agreeing to settle.

"Pfizer and its subsidiaries take compliance very seriously and the company is committed to ensuring that its promotional practices meet or exceed all legal requirements and the expectations of the people we serve," the company said.

(Reporting by Jonathan Stempel in New York; Editing by David Gregorio)

New Hepatitis-C drug 99% cheaper in India Rupali Mukherjee, TNN | Aug 6, 2014, 05.04AM IST

MUMBAI: There is some hope for hepatitis C patients in India. Amid mounting criticism over the eye-popping price of Sovaldi, the first breakthrough treatment for hepatitis C virus, US pharma firm Gilead Sciences has offered to introduce the drug in India at nearly 99% discount of the US price.

The blockbuster hepatitis C drug will cost about $900 (around Rs 54,000) in India for a 12-week course of treatment. That would be a fraction of the $84,000 (over Rs 50 lakh) price tag for the same treatment in US.

Gilead Sciences will adopt a tiered pricing structure here, like the one for HIV treatment in developing countries like India.

"The pricing of Sovaldi in India at $300 per bottle, is our low income pricing, similar to the price negotiated with Egypt for its government-run programme. We hope with local production by our partners in India, higher volumes and continued research & development on the drug will lead to a further reduction in prices at a later stage", Gregg Alton, executive V-P (corporate & medical affairs), Gilead Sciences told TOI in a telecon from the US.

"We have set three basic pricing tiers (based on a country's per capita income and hepatitis C prevalence) that serve as the starting point for negotiations with national governments. The tiers are low-income, low middle-income and upper-middle income," Alton said.

The pricing and launch of the breakthrough treatment of hepatitis C is crucial for India, which has one of the highest incidence of the virus, with over 12 million chronically infected, according to WHO.

However, even at $900, many patients will still not be able to afford the therapy in India. The cost will escalate for those who are prescribed a six-month treatment.

Alton said existing treatment in India is more expensive than the one his company will offer. Also, Sovaldi prices are expected to fall with generic competition and local manufacture.

Existing hepatitis C treatment in India is expensive (Rs 3,75,000 or $6000), complex (24-48 weeks of injectables) and has serious side-effects.

Gilead also plans to license its new therapy to Indian generic manufacturers, who will then supply lower cost versions of the drug in the country, and across global markets. It is in talks with its HIV drug pasrtners -- Ranbaxy, Mylan, Strides Arcolab -- to finalise an agreement for Sovaldi. The licensee agreements could be finalised by September, Alton said.

At present, the company has initiated clinical trials of the drug in India, with results expected in 2015-end. While Gilead Sciences has applied for multiple patents in India on sofosbuvir, even before its grant the company is already embroiled in a fight. A patient group, Delhi Network of Positive People, and UK-based intellectual property law firm, Initiative for Medicines Access and Knowledge, have together filed an opposition to prevent Gilead from gaining a patent in India.

http://timesofindia.indiatimes.com/india/New-Hepatitis-C-drug-99-cheaper-in-India/articleshow/39719323.cms

Overprescription of antibiotics, sedatives rampant despite Sch H1 norms Shardul Nautiyal, Mumbai Friday, August 08, 2014, 08:00 Hrs [IST]

Even when Maharashtra Food and Drug Administration (FDA) is trying to implement Schedule H1 Rules, city based chemists rue that around 25 per cent of antibiotics, sedatives and pain-killer drugs are overprescribed by doctors and are purchased in bulk for drug addiction and substance abuse.

Chemists say that dispensing these drugs come with an added burden of maintaining detailed records and prescriptions albeit with a low margin. Medicines are not dispensed at times if the patients do not have valid prescriptions as in some cases doctors don't write clear prescriptions and with even longer validity ranging from over a year to six months. Says a city based physician, "Chemists have stopped stocking sedatives and pain-killers which are covered under Schedule H1 as they are most often irrationally consumed."

Besides this, as per new government notifications, the inclusion of drugs in Schedule H has drastically increased whereas those included in Schedule X have reduced due to some omissions. FDA has also recently recommended the Drugs Controller General of India (DCGI) for inclusion of Codeine, other narcotic drugs and psychotropic substances in Schedule X of the Drugs and Cosmetics Act, 1940. Codeine, other narcotic drugs and psychotropic substances are currently listed under narcotics and psychotropic substances act 1985.

Prescribed mostly for insomnia and anxiety, diazepam containing drugs are extremely cheap and thus chemists don't profit much from them. With the FDA's stringent rules pertaining to schedule H1 drugs, some chemists prefer to keep minimal stocks or no stocks at all. The shortage is artificial, since the drugs are otherwise available with pharma companies.

These low cost drugs fall under the price range of Rs.13.86 for a strip of 10 tablets to the most expensive one costing Rs.40 for a strip of 10 tablets. Pharma companies like Cipla, Ranbaxy, Sun Pharma, Sanofi Aventis etc are some of the companies manufacturing these drugs.

Schedule X comprises of 15 drugs currently as compared to 17 earlier. meprobamate, methylphenidate and amphetamine are some of the drugs which can be misused. Schedule H of the drug and cosmetics act contains a list of 536 drugs which are required to be dispensed on the prescriptions of a registered medical practitioner. In order to have separate regulation to check unauthorised sale of antibiotics, a separate schedule as Schedule H1 has also been introduced under the Drugs and Cosmetics Rules to regulate sale of 46 drugs exclusively.

Drugs covered under narcotic drugs in Narcotic Drug and Psychotropic Substances Act, 1985 are also included in Schedule H of the Drugs and Cosmetics Act like alprazolam, chlordiazepoxide and clobazam which are habit forming drugs.

The 46 drugs under Schedule H1 are sold under more than 3,300 brand names and are available in over 20,000 different combinations. According to experts, "Taking the present scenario into consideration, it has been observed that there is a rapid rise in the research and development activities resulting in the emergence of more new drugs and formulations. This has resulted in categorising these drugs in various schedules of Drugs and Cosmetics Act 1940 and the Rules thereunder."

http://www.pharmabiz.com/NewsDetails.aspx?aid=83414&sid=1

Diabetes drug 'benefits life expectancy'

http://www.tv3.ie/entertainment_article.php?locID=1.803.1098&article=142313

A new study has found that taking a drug prescribed for those suffering with type 2 diabetes could help us live longer.

New research has suggested that a diabetes drug could help us all live longer.

Metformin, which is used to treat type 2 diabetes by controlling glucose levels, has also been found to help stave of cardiovascular disease and cancer even in those who are not diabetic.

Findings were published in the journal Diabetes, Obesity and Metabolism and scientists studied more than 180,000 people.

They found a "small but statistically significant improvement in survival" in those that were taking metformin compared with those given an older anti-diabetic drug and also a group without diabetes.

Cardiff University's School of Medicine's Professor Craig Currie, who was lead author of the new study, commented that further research on healthy people taking the drug was merited particularly as it had minor side effects. Metformin is also inexpensive, costing a little over ten pence a day for the highest prescribed dose.

"Surprisingly, the findings indicate that this cheap and widely prescribed diabetic drug may have beneficial effects not only on patients with diabetes but also for people without," Professor Currie said.

"Metformin has been shown to have anti-cancer and anti-cardiovascular disease benefits. It can also reduce pre-diabetics' chances of developing the disease by a third."

He added that those who suffer with type 2 diabetes would see their health decline regardless of what drug they took, stating that averagely around eight years are lost from one's life expectancy. Keeping lean with moderate exercise is the best way to avoid diabetes he advised.

The data used in the study come from the UK Clinical Practice Research Datalink, from which researchers identified 78,241 patients prescribed metformin as a first-line therapy and 12,222 patients prescribed a sulphonylurea as a first-line therapy.

These were then matched against a patient that was not suffering with diabetes, using criterias such as age, gender, smoking status and life expectancy compared.

The findings demonstrated that average survival time was 15 per cent lower in healthy people compared with diabetics on metformin, and 38 per cent lower in diabetic patients on older drugs.

© Cover Media Group 2014

CTI BioPharma's myelofibrosis drug pacritinib receives fast track designation from US FDA Seattle Friday, August 08, 2014, 15:00 Hrs [IST]

The US Food and Drug Administration (FDA) has granted Fast Track designation to CTI BioPharma's pacritinib for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on other JAK2 therapy.

Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3. The drug candidate is currently being evaluated in two phase 3 clinical trials, known as the PERSIST programme, for patients with myelofibrosis.

"We are very pleased that the pacritinib development programme in myelofibrosis has been granted Fast Track designation, and we look forward to continuing to work closely with the FDA on this important drug candidate," stated James A. Bianco, M.D., president and chief executive officer. "We believe that pacritinib's unique profile has the potential to serve an unmet medical need that currently exists in this patient population, particularly for those patients with disease or therapy-related low platelet counts."

The Fast Track process is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. An unmet need is a condition whose treatment or diagnosis is not addressed adequately by available therapy. The purpose of the Fast Track designation is to make important new drugs available to the patient earlier. The Fast Track programme also enables a company to submit sections of the NDA on a rolling basis as data becomes available. This enables the FDA to review sections of the NDA as they are received, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the company has submitted the entire application to the FDA. A drug programme with Fast Track designation enables the company to have early and frequent communication with the FDA in the development and review of the product candidate, often leading to faster drug approval and access by patients.

Based on pacritinib's efficacy and tolerability profile demonstrated to date, CTI is pursuing a broad approach to advancing this therapy for patients with myelofibrosis by conducting two phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the PERSIST-1 trial, and the other in patients with low platelet counts, the PERSIST-2 trial.

In July 2014, CTI completed enrollment in the PERSIST-1 trial that was designed to enroll approximately 320 patients and is a randomised, open-label, multicentre trial comparing the efficacy and safety of pacritinib with that of best available therapy, other than JAK inhibitors, in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, without exclusion for low platelet counts. The primary endpoint is the percentage of patients achieving a greater than or equal to 35 percent reduction in spleen volume measured by MRI or CT from baseline to 24 weeks of treatment.

In March 2014, CTI announced the initiation of the PERSIST-2 trial, which will evaluate pacritinib compared to best available therapy, including approved JAK2 inhibitors that are dosed according to product label, in patients with myelofibrosis whose platelet counts are less than or equal to 100,000/uL. The trial is designed to enroll up to 300 patients in North America, Europe, Australia and New Zealand. In October 2013, CTI reached agreement with the FDA on a Special Protocol Assessment (SPA) for the PERSIST-2 trial, which is a written agreement between CTI and the FDA regarding the planned design, endpoints and statistical analysis approach of the trial to be used in support of a potential NDA submission. Under the SPA, the agreed upon co-primary endpoints are the percentage of patients achieving a 35 percent or greater reduction in spleen volume measured by MRI or CT scan from baseline to 24 weeks of treatment and the percentage of patients achieving a Total Symptom Score (TSS) reduction of 50 percent or greater using six key symptoms as measured by the modified Myeloproliferative Neoplasm Symptom Assessment (MPN-SAF TSS 2.0) diary from baseline to 24 weeks.

Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukaemia and lymphoma. Pacritinib may offer an advantage over other JAK inhibitors through effective treatment of symptoms while having less treatment-emergent thrombocytopenia and anaemia than has been seen in currently approved and in-development JAK inhibitors.

In November 2013, CTI and Baxter International (Baxter) entered into a worldwide license agreement to develop and commercialise pacritinib in which CTI and Baxter will jointly commercialise pacritinib in the US and Baxter has exclusive commercialisation rights for all indications outside the US.

Myelofibrosis is classified as a myeloproliferative neoplasm and is a chronic bone marrow disorder. Myelofibrosis is caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response, scarring the bone marrow and limiting its ability to produce red blood cells, prompting the spleen and liver to take over this function. Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue and pain.

CTI BioPharma Corp. is a bio-pharmaceutical company focussed on the acquisition, development and commercialisation of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83423&sid=2

US FDA approves Orbactiv to treat adults with skin infections Maryland Friday, August 08, 2014, 17:00 Hrs [IST]

The US Food and Drug Administration (FDA) has approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.

Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is administered intravenously.

Orbactiv is the third new antibacterial drug approved by the FDA this year to treat ABSSSI. The agency approved Dalvance (dalbavancin) in May 2014 and Sivextro (tedizolid) in June 2014.

“The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs.”

Orbactiv is also the third new drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Orbactiv was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection.

As part of its QIDP designation, Orbactiv was given priority review, which provides an expedited review of the drug’s application. Orbactiv’s QIDP designation also qualifies it for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug, and Cosmetic Act.

Orbactiv’s safety and efficacy were evaluated in two clinical trials with a total of 1,987 adults with ABSSSI. Participants were randomly assigned to receive Orbactiv or vancomycin. Results showed Orbactiv was as effective as vancomycin for the treatment of ABSSSI.

The most common side effects identified in the clinical trials were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs and diarrhoea. Orbactiv’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin, a drug used to prevent blood clots.

Orbactiv is marketed by The Medicines Company, based in Parsippany, New Jersey.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83425&sid=2

Largest ever genomic study set to revolutionize cancer treatment | Business Standard News

CBI can’t probe medical colleges under MCI, rules HC - The Hindu

CBI can’t probe medical colleges under MCI, rules HC - The Hindu

In a landmark judgment, the Madras High Court has ruled that the Central Bureau of Investigation has no jurisdiction to investigate the affairs of any medical institution within the purview of the Medical Council of India (MCI).

MPs unaware they are part of district health panels - The Hindu

MPs unaware they are part of district health panels - The Hindu

Union Health Minister Dr. Harsh Vardhan reminded members in the Lok Sabha on Friday that all MPS are chairpersons of patient welfare committees at the district level in their respective States.

CDSCO implement uniform regulatory procedures for COPP & GMP inspections

(6th August, 2014); Central Drugs Standard Control Organization (CDSCO) ensuring uniform procedures in regulatory inspection for issuance of Certificates of Pharmaceutical Products (COPP) and other Good Manufacturing Practices (GMP) inspections. These procedures were discussed in 47^thDrugs consultative committee (DCC) meeting.

http://www.pharmatutor.org/pharma-news

Wish to see a body pledging revolution in India: Harsh Vardhan | Business Standard News

Wish to see a body pledging revolution in India: Harsh Vardhan | Business Standard News

Union Health Minister Dr Harsh Vardhan has announced a fresh government initiative to ensure that organs and tissues are collected scientifically from donors and distributed to patients-in-need at minimum cost.

Stress may shorten pregnancy in coming generations

oronto: Have you experienced childbirth complications and delivered a premature baby even after taking all de-stressing measures during pregnancy?

This could well be owing to stress in your mothers, grandmothers and beyond, suggests a study.

Inherited epigenetic effects of stress could affect pregnancies for generations

"We show that stress across generations becomes powerful enough to shorten pregnancy length in rats and induce hallmark features of human preterm birth," said Gerlinde Metz from University of Lethbridge in Canada.

"A surprising finding was that mild to moderate stress during pregnancy had a compounding effect across generations. Thus, the effects of stress grew larger with each generation," Metz added.

For the study, the researchers examined the length of pregnancies in rats because in general there is very little variation between them.

A first generation of rats were subjected to stress late in pregnancy. The following two generations were then split into two groups that were either stressed or not stressed.

The daughters of stressed rats had shorter pregnancies than the daughters of those who had not been.

Remarkably, the grand-daughters of stressed rats had shorter pregnancies, even if their mothers had not been stressed.

The researchers believe that these changes are due to epigenetics - the arrangement and expression of our genes.

The study appeared in the journal BMC Medicine.

Breast cancer gene mutation raises risk Thu, 07 Aug 2014 10:07 AM

A newly discovered gene mutation significantly raises a woman's risk of breast cancer and may be considered the third such inherited gene flaw known to science, researchers said Wednesday.

Women with mutations in the PALB2 gene face a one in three chance of getting breast cancer by age 70, said the findings in the New England Journal of Medicine.

The other two known gene mutations associated with breast cancer risk, BRCA1 and BRCA2, have been linked to a 55-65 percent likelihood of developing breast cancer by age 70.

"Since the BRCA1 and BRCA2 mutations were discovered in the mid-90s, no other genes of similar importance have been found and the consensus in the scientific community if more exist we would have found them by now," said lead author Marc Tischkowitz from the Department of Medical Genetics at the University of Cambridge.

"PALB2 is a potential candidate to be 'BRCA3'."

Most cases of breast cancer are not passed down in families.

Only about five to 10 percent of all breast cancer has been linked to BRCA1 and BRCA2 gene mutations, according to the National Cancer Institute.

It remains unclear how prevalent PALB2 is in the general population, but researchers suspect it is rare.

The research in the New England Journal of Medicine was part of an international collaboration between 17 different institutions in eight countries.

Scientists analyzed data from 154 families without BRCA1 or BRCA2 mutations, which included 362 family members with PALB2 gene mutations.

Women with rare mutations in PALB2 were found to have on average a 35 percent chance of developing breast cancer.

Individual risk varied, however. Those with more cases of breast cancer in the family found themselves at higher risk.

PALB2 was first linked to breast cancer in 2007.

"Now that we have identified this gene, we are in a position to provide genetic counseling and advice," added Tischkowitz.

"If a woman is found to carry this mutation, we would recommend additional surveillance, such as MRI breast screening."

AFP

Zydus Cadila gets United States Food and Drug Administration nod for kidney stones tablets

NEW DELHI: Drug firm Zydus Cadila has received the final approval from the US health regulator to market Potassium Citrate ER tablets used in prevention of kidney stones.

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Potassium Citrate ER tablets in the strengths of 5 mEq, 10 mEq and 15 mEq, said the Zydus group's listed entity, Cadila Healthcare, said in a statement.

"The estimated sales in 2014 for Potassi ..

Diabetic? Eat pistachios daily for super health

New York: Love pistachios? You have another reason to have these tree nuts if your sugar levels are high as eating pistachios may reduce vascular response to stress in type 2 diabetes.

“In adults with diabetes, two servings of pistachios per day lowered vascular constriction during stress and improved neural control of the heart,” said Sheila G. West, a professor of biobehavioral health and nutritional sciences at Pennsylvania State University.

Although nuts are high in fat, they contain good fats, fibre, potassium and antioxidants.

“Given the high risk of heart disease in people with diabetes, nuts are an important component of a heart healthy diet in this population,” West added.

During the investigation on patients with type 2 diabetes about the effects of pistachios, researchers randomised patients to one of two test diets.

Test diets included a standard heart-healthy diet - 27 percent fat and seven percent saturated fat - and a diet containing two servings per day of pistachios - about 3 ounces or 20 percent of calories from pistachio nuts.

The typical research participant consumed about 150 pistachio nuts per day.

The pistachio diet contained 33 percent fat and 7 percent saturated fat.

“After the pistachio diet, blood vessels remained more relaxed and open during the stress tests,” West said.

They found that systolic blood pressure during sleep was particularly affected by pistachios.

“Average sleep blood pressure was reduced by about four points and this would be expected to lower workload on the heart,” West noted.

The researchers also recorded improvements in heart rate variability, a measure of how well the nervous system controls heart function.

The results appeared in the Journal of the American Heart Association.

http://zeenews.india.com/news/health/health-news/diabetic-eat-pistachios-daily-for-super-health_29105.html

Threefold surge in male teenage drinking in India: Study

NEW YORK: In an alarming trend, the proportion of men in India who start to drink alcohol in their teens has surged more than threefold over the past few decades, a new study has warned.

The trend is more likely among those living in urban areas and poorer households, researchers said.
Researchers questioned just under 2000 randomly selected 20-49 year old men from rural and urban areas in Northern Goa about the age at which they first started to drink alcohol, how much they drank, and whether they had sustained any injuries as a result of their drinking.

Levels of psychological distress were also assessed using a validated questionnaire (GHQ).

"The proportion of men who started drinking in their teens rose from 20 per cent for those born between 1956 and 196 ..

Drinks with high acidity content can damage teeth within 30 sec | Business Standard News

FDA Approves Jardiance For Type 2 Diabetes - the third product from the Boehringer Ingelheim-Eli Lilly Diabetes alliance

http://www.bidnessetc.com/23539-fda-approves-jardiance-for-type-2-diabetes/Published: August 4, 2014 at 8:18 am ESTBy: Hannah Ishmael
On Friday, the US Food & Drug Administration (FDA) approved Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Co.’s (LLY) drug Jardiance (empagliflozin) as an add-on to diet and exercise to improve glycemic control (blood sugar levels) in adults with type 2 diabetes (T2D). The approval comes after the FDA had earlier rejected empagliflozin because of manufacturing deficiencies at Boehringer’s facility, where the drug is manufactured.The drug got approval once the company reported that the issue had been resolved.

Jardiance, available in two dosage strength types i.e. 10 mg or 25 mg, is a once-daily oral medication. It works by blocking the reabsorption of glucose in kidneys and by increasing glucose excretion to lower blood glucose levels in adults with T2D. The drug is not for people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

FDA approval for Jardiance is based on data from more than 10 multinational clinical trials and 13,000 adults with T2D, which revealed that the drug reduced hemoglobin A1C and blood sugar levels significantly after 24 weeks, in isolation or in combination with other treatments like metformin, sulfonylureas, insulin and pioglitazone. Modest weight loss was also observed in the trials; the drug, however, is not approved for weight loss. Common adverse reactions witnessed with Jardiance include urinary tract infections and vaginal yeast infections.

According to president of Lilly Diabetes Enrique Conterno: “Today'sFDAapproval of Jardiance provides an exciting new option in the treatment of adults with type 2 diabetes and demonstrates our commitment to these patients, as it marks the third diabetes medicine to emerge from our alliance pipeline.”

About 382 million people worldwide and 29 million Americans have diabetes. Type 2 diabetes, which is the most common, accounts for 85% to 95% of all cases.

Health experts at loggerheads with Government over Rotavirus vaccine 0 BY NANDHAKUMARIN HEALTH — 6 AUG, 2014

http://www.thenewsreports.com/health-experts-loggerheads-government-rotavirus-vaccine/7648/nandhakumar

The Narendra Modi Government’s in-principle decision to introduce Rotavirus vaccine in the Universal Immunisation Programme (UIP) is being much debated with one group of public health researchers supporting and another opposing it.

Those against the move are questioning the vaccine’s efficacy and safety. Among those who are opposing the move is Jacob Puliyel, head of paediatrics at the St Stephens Hospital in Delhi.

Opposing the move, he said, “The vaccines in the USA, tested on more than 10,000 children, were found to cause excess cases of intussusceptions – a complication wherein parts of the intestine are devoid of blood supply. The Indian vaccine was tested on 4,500 children for two years and data for the second year has not yet been made public.”

Rotavirus is notoriously the most common reason for diarrhoeal death in children and takes an annual toll of 80,000. In addition, 8, 00,000 children are hospitalised for treatment every year.

Acting under pressure from the PMO (Prime Minister’s Office), the vaccine is planned for introduction in UIP beginning this year in select district. Initially, it is planned to procure 10 million doses, sources say. Earlier the National Technical Advisory group on immunisation has approved the inclusion of the vaccine in the programme.

According to a study in the journal Vaccine, introducing a third dose of the DPT along with the vaccine can prevent approximately 44,500 under-five deaths in the country each year in addition to saving Rs 14 crores for each 10 lakh of vaccinations.