Brain 'switch' controlling blood sugar levels discovered by researchers

http://www.firstpost.com/living/brain-switch-controlling-blood-sugar-levels-discovered-researchers-1640799.html

Possibly new generation of anti-diabetic drug - stops diabetes in its tracks and reverses insulin insensitivity with no side effects By PharmaTutor News - Posted on 17 July 2014

(17th July, 2014); Researchers from Salk discovered new and more effective diabetic drug which could lead for safe & new generation of anti-diabetic drugs. They injected single injection of the protein FGF1 which is enough to restore blood sugar levels to a healthy range for more than two days.

The team found that sustained treatment with the protein doesn't merely keep blood sugar under control, but also reverses insulin insensitivity, the underlying physiological cause of diabetes. Equally exciting, the newly developed treatment doesn't result in side effects common to most current diabetes treatments.

"Controlling glucose is a dominant problem in our society," says Ronald M. Evans, director of Salk's Gene Expression Laboratory and corresponding author of the paper. "And FGF1 offers a new method to control glucose in a powerful and unexpected way."

Type 2 diabetes, which can be brought on by excess weight and inactivity, has skyrocketed over the past few decades in the United States and around the world. Almost 30 million Americans are estimated to have the disease, where glucose builds up in the bloodstream because not enough sugar-carting insulin is produced or because cells have become insulin-resistant, ignoring signals to absorb sugar. As a chronic disease, diabetes can cause serious health problems and has no specific cure. Rather it is managed—with varying levels of success—through a combination of diet, exercise and pharmaceuticals.

In the liver tissue of obese animals with type 2 diabetes, unhealthy, fat-filled cells are prolific (small white cells, panel A). After chronic treatment through FGF1 injections, the liver cells successfully lose fat and absorb sugar from the bloodstream (small purple cells, panel B) and more closely resemble cells of normal, non-diabetic animals.

Image: Courtesy of the Salk Institute for Biological Studies

Diabetes drugs currently on the market aim to boost insulin levels and reverse insulin resistance by changing expression levels of genes to lower glucose levels in the blood. But drugs, such as Byetta, which increase the body's production of insulin, can cause glucose levels to dip too low and lead to life-threatening hypoglycemia, as well as other side effects.

In 2012, Evans and his colleagues discovered that a long-ignored growth factor had a hidden function: it helps the body respond to insulin. Unexpectedly, mice lacking the growth factor, called FGF1, quickly develop diabetes when placed on a high-fat diet, a finding suggesting that FGF1 played a key role in managing blood glucose levels. This led the researchers to wonder whether providing extra FGF1 to diabetic mice could affect symptoms of the disease.

Evans' team injected doses of FGF1 into obese mice with diabetes to assess the protein's potential impact on metabolism. Researchers were stunned by what happened: they found that with a single dose, blood sugar levels quickly dropped to normal levels in all the diabetic mice.

"Many previous studies that injected FGF1 showed no effect on healthy mice," says Michael Downes, a senior staff scientist and co-corresponding author of the new work. "However, when we injected it into a diabetic mouse, we saw a dramatic improvement in glucose."

The researchers found that the FGF1 treatment had a number of advantages over the diabetes drug Actos, which is associated with side effects ranging from unwanted weight gain to dangerous heart and liver problems. Importantly, FGF1—even at high doses—did not trigger these side effects or cause glucose levels to drop to dangerously low levels, a risk factor associated with many glucose-lowering agents. Instead, the injections restored the body's own ability to naturally regulate insulin and blood sugar levels, keeping glucose amounts within a safe range—effectively reversing the core symptoms of diabetes.

"With FGF1, we really haven't seen hypoglycemia or other common side effects," says Salk postdoctoral research fellow Jae Myoung Suh, a member of Evans' lab and first author of the new paper. "It may be that FGF1 leads to a more 'normal' type of response compared to other drugs because it metabolizes quickly in the body and targets certain cell types."

The mechanism of FGF1 still isn't fully understood—nor is the mechanism of insulin resistance—but Evans' group discovered that the protein's ability to stimulate growth is independent of its effect on glucose, bringing the protein a step closer to therapeutic use.

"There are many questions that emerge from this work and the avenues for investigating FGF1 in diabetes and metabolism are now wide open," Evans says. Pinning down the signaling pathways and receptors that FGF1 interacts with is one of the first questions he'd like to address. He's also planning human trials of FGF1 with collaborators, but it will take time to fine-tune the protein into a therapeutic drug.

"We want to move this to people by developing a new generation of FGF1 variants that solely affect glucose and not cell growth," he says. "If we can find the perfect variation, I think we will have on our hands a very new, very effective tool for glucose control."

Journal Reference: Jae Myoung Suh, Johan W. Jonker, Maryam Ahmadian, Regina Goetz, Denise Lackey, Olivia Osborn, Zhifeng Huang, Weilin Liu, Eiji Yoshihara, Theo H. van Dijk, Rick Havinga, Weiwei Fan, Yun-Qiang Yin, Ruth T. Yu, Christopher Liddle, Annette R. Atkins, Jerrold M. Olefsky, Moosa Mohammadi, Michael Downes, Ronald M. Evans. Endocrinization of FGF1 produces a neomorphic and potent insulin sensitizer. Nature, 2014; DOI: 10.1038/nature13540

LIVE:Life imprisonment for selling fake medicines - patrika.com

ndore. Milavtkhori to prevent government has strict legal provisions. Law and Legislative Affairs Department of Criminal Law bills streams through 2014 IPC and CrPC has been publishing the proposed amendment. Now according to these adulterated foods or unpleasant loss from the sale of counterfeit medicines being found guilty, could be sentenced to life imprisonment and fines. So far in this episode was punishable by 6 months.

This amendment is certain, now Milavtkhori punishment in the state have similar provisions. Neither the police department or the Food and Drug Administration to take any action, contaminants harmful to life imprisonment upon conviction shall be punished. It would apply to all foods and medicines.

The discrepancy was far
adulterated foods in the state were inconsistencies in the provisions of the punishment. Adulteration of Food Safety and Standards Act, the law of cause of death was to be a life sentence. However, the provision of IPC was sentenced to 6 months. In such case Milavtkhor police were made only six months left. This will not happen now.

- See more at: http://www.patrika.com/news/life-imprisonment-for-selling-fake-medicines/1020756#sthash.yduSybEQ.dpuf

Limited-competition products boost Dr Reddy's performance | Business Standard News

Sugary drinks in teenage can impair memory, says study PTI | Washington | Published: Jul 30 2014, 16:53 IST

Daily consumption of beverages sweetened with high-fructose corn syrup or sucrose can impair the ability to learn and remember information, particularly when used during adolescence, a new study has warned.

Both adult and adolescent rats were given daily access to sugar-sweetened beverages that mirror sugar concentrations found in common soft drinks.

Adult rats that consumed the sugar-sweetened beverages for one month performed normally in tests of cognitive function; however, when consumption occurred during adolescence the rats were impaired in tests of learning and memory capability.

"It's no secret that refined carbohydrates, particularly when consumed in soft drinks and other beverages, can lead to metabolic disturbances," said the lead author, Dr Scott Kanoski from the University of Southern California.

"However, our findings reveal that consuming sugar-sweetened drinks is also interfering with our brain's ability to function normally and remember critical information about our environment, at least when consumed in excess before adulthood," said Kanoski.

In addition to causing memory impairment, adolescent sugar-sweetened beverage consumption also produced inflammation in the hippocampus, an area of the brain that controls many learning and memory functions.

"The hippocampus is such a critical brain region for memory function," said Kanoski.

"In many ways this region is a canary in the coal mine, as it is particularly sensitive to insult by various environmental factors, including eating foods that are high in saturated fat and processed sugar," Kanoski said.

The research will be presented at the Annual Meeting of the Society for the Study of Ingestive Behaviour (SSIB) in Seattle.

http://www.financialexpress.com/news/sugary-drinks-in-teenage-can-impair-memory-says-study/1275137?rhnews

Sun, Ranbaxy get show-cause notice from CCI fe Bureau | New Delhi | Published: Jul 31 2014, 01:27 IST

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Maintaining that Sun Pharma’s takeover of Ranbaxy in April in an all-stock transaction valued at over $3.2 billion needs greater scrutiny, the Competition Commission of India (CCI) has issued a show-cause notice to both the companies to provide more details to prove that it would not lead to a monopolistic situation. The companies will have to respond within 30-days, sources said.

However, CCI at this stage has not taken a decision either way — to approve or block the deal — which would be taken once the companies respond in detail to its notice.

Explaining the Competition Act, a CCI official explained that prima facie where it feels that a transaction needs a greater scrutiny, a show cause notice is issued to the concerned parties. In such cases, the concerned parties need to explain the transaction and its resultant impact in greater detail after which a final decision is taken by the CCI. “At the show cause stage, it doesn't mean that we have taken a decision either way,” the official said.

CCI has sought more details related to market share of various drug formulation currently spread between Sun Pharma and Ranbaxy in order to get a better clarity on whether the proposed acquisition will comply with the competition laws and not lead to abuse of dominance of the merged entity, sources added.

According to experts, if CCI is not satisfied with the details, it has the powers to order a probe by its director general of investigation. The probe, if ordered, will need to establish whether the proposed deal will have any adverse impact on competition vis-a-vis the market share of various drug categories, experts said.

According to industry estimates, the deal between two large generic drugs makers, who will collectively control 46 drug formulae, will create India’s largest drug manufacturer with an 8.5% market share in India's pharmaceutical marker estimated to be over R76,000 crore.

Subsequent to the acquisition in April, Sun Pharma had approached the CCI for clearance as CCI's approval is required as per the combination regulations when the enterprises value of the entities are more than R1,000 crore or the combined turnover is more than R3,000 crore.

“Since presently both large Indian companies are competing with each other, the proposed acquisition is likely to raise competition concerns, that is, “Unilateral Effects” leading to 'single firm dominance' like situation in certain select drugs formulations, CCI fears. Currently

both companies hold 50-90% of market share in many drug segments,” explained MM Sharma, head of competition law and policy at Vaish Associates, a leading law firm.

According to Gautam Shahi, senior associate in J Sagar Associates, this may be one of the most exciting cases that CCI has dealt with till date when a combination notice is filed. “It will be interesting to see how CCI defines the relevant market in this industry as a demand substitutability analysis will lead to multiple relevant market definitions and then CCI will have to analyse the presence of Sun Pharma and Ranbaxy in each of these relevant markets”, Shahi said.

CCI’s approval is required as per its combination regulations when the enterprise value of the Indian entities concerned is more than Rs 1,500 crore or the combined turnover is more than Rs 4,500 crore. The Sun Pharma-Ranbaxy deal satisfies this criteria for CCI scrutiny.

According to competition law experts, the Sun-Ranbaxy filings to CCI under the combination regulations were made through what is called a Form-II filing which is the longer version of form requiring greater level of reporting on any proposed M&A deals.

Global anti-obesity drugs market forecast to expand at 10.9% CAGR between 2014 and 2020

According to medical experts, obesity is expected to become an indirect but leading cause of mortality and morbidity. It is a chronic medical condition that results in hypertension, type 2 diabetes mellitus, dyslipidemia, coronary heart disease and insulin resistance. Such factors contribute towards cardiovascular disease, which is a leading cause of death. These metabolic factors also significantly raise the risk for myocardial infarction, stroke and angina.

Non-life threatening conditions linked to obesity include osteoarthritis, sleep apnea, gout and gallstones. Subsequent development of a broad set of complications - including atherosclerosis, dyslipidemia, hypertension, and type 2 diabetes - lead to an increased mortality rate. In addition, obesity predisposes to prostate, breast, and colorectal cancers.

Global human antifungal therapeutics market continues its upward trajectory

Recent estimates by Switzerland's Global Action Fund for Fungal Infections (GAFFI) indicate that over 300 million people worldwide are affected by serious fungal infections. Out of these, around 25 million are at high risk losing their sight or dying.

Such infections can be acute, in particular diseases such as Pneumocystis pneumonia and cryptococcal meningitis, which result in an annual combined death total of 680,000. On top of this, chronic diseases such as chronic pulmonary aspergillosis cause an additional 500,000 deaths per annum.

Global antibiotics market: Antibiotic-resistant bacteria is one of the top global risks

2004, a report published by the Infectious Diseases Society of America (IDSA) warned that "infections that were once easily curable with antibiotics are becoming difficult, even impossible, to treat, and an increasing number of people are suffering severe illness - or dying - as a result."

There is currently a gap between multidrug-resistant bacteria and the development of new antibacterial agents. This gap is particularly significant, given that antibiotic research and development is characterised by long lead times. In this context, public health experts are expressing concerns regarding a possible return to the pre-biotic era. The recent Global Risks Report, published by the World Economic Forum, describes antibiotic-resistant bacteria as an existential threat and one of the top 50 global risks faced by humanity today.

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The discovery of the first antibiotic nearly a century ago revolutionized the global healthcare industry, reducing the incidence of the morbidity and mortality due to dangerous infectious diseases. The global antibiotics market is estimated to have been $39.6 billion in 2013 and is expected to reach $41.2 billion in 2018. The global aging population and the increased prevalence of hospital-acquired infections are the primary factors driving the growth of the antibiotics market. Economic conditions and cost-containment issues have compelled North American and European antibiotic manufacturers to explore new regions, such as India, China and Brazil, for growth opportunities.

There has been a paradigm shift in the regulatory framework, causing a positive impact on the overall growth of the antibiotics market; however, the economic slowdown and the patent expiry of major antibiotics during the forecast period will limit the growth of the market. In order to keep abreast of this change, antibiotic manufacturers are using various novel technologies to reduce antibiotic resistance in order to yield novel antibiotics.

It is expected that this trend will continue with the aim of solving the current challenges and fulfilling the unmet needs of the market. North America accounted for the largest market in 2013 followed by Europe. However, Asian countries represent the fastest-growing markets due to the increasing aging population, increasing GDP rate and increasing awareness about healthcare.

The leading players in the global antibiotics market include Pfizer Inc. (U.S.), Merck and Co. (U.S.), Eli Lilly and Co. (U.S.), Sanofi-Aventis (France), AstraZeneca (U.K.), Cubist pharmaceuticals (U.S.), Johnson & Johnson (U.S.) and GlaxoSmithKline PLC (U.K.).

Global metabolomics market sees entry of new players

Metabolomes refer to small molecules produced by cells, which offers a mechanism for understanding how biochemistry relates to cellular phenotype. Advances in spectrometry and nuclear magnetic resonance offer the opportunity to measure thousands of metabolites from minimal amounts of biological material.

Through the process of global metabolite profiling, researchers are able to make new discoveries, linking cellular pathways to biological mechanisms. In this context, recent advances in bioinformatic tools and instrumentation enable the systematic analysis of cellular metabolites without bias

Global diabetes therapies market sees expansion in the Asia Pacific region

Global diabetes therapies market sees expansion in the Asia Pacific region

Diabetes is a chronic disease in which there are high levels of sugar in the blood. The World Diabetes Foundation estimates that there will be 438 million people with diabetes by the year 2030. The global market for products in the management of diabetes currently stands at $41 billion and is on pace to grow to over $114 billion by 2018. Oral anti-diabetics were the leading category of drugs in 2010 and showed a growth rate of 6.3% from the total global sales. The total sales for insulin products increased significantly as well.

Anti-diabetic products include glucose meters, lancets, test strips, continuous blood glucose meters, insulin, insulin pumps, syringes and other insulin delivery devices and anti-diabetic drugs. The bulk of product revenues come from three segments - test strips, insulin and anti-diabetic drugs - which will remain the largest sources of product revenues over the next ten years. The most significant growth, however, will come from the nascent segment of continuous blood glucose monitors, which provide significantly added clinical benefit at only a modestly higher cost compared to standard blood glucose meters.

the key players in the global market for diabetes therapies include Eli Lilly, Novo Nordisk and Merck. Anti-diabetic products include insulin, insulin delivery devices, test strips, blood glucose meters and anti-diabetic drugs. The majority of product revenues emanate from just three segments - insulin, test strips and anti-diabetic drugs. It is expected that these three segments will remain the most important sources of product revenues over the next decade.

Global Vaccine Market

Source : Global Vaccine Market

The demand by countries for local production of vaccines is increasing. As a result such bioproducts tend to lead the way in terms of adopting of modern bioprocessing technology and services in less developed economies. In this context, the potential of emerging economies as major players on the global vaccine market is being recognised. Historically, the global vaccine manufacturing space was dominated by the "triad" - Japan, USA and European Union. In contrast, the emerging and less-developed markets have been, at least initially, focussed on local generics businesses. This was due to a number of factors, one being a lack of a congruent legislative framework for intellectual property protection.

Indian sports drink market led by Lucozade and Gatorade

June 2012 the Food Safety and Standards Authority of India (FSSAI) announced that energy drinks will be renamed as "caffeinated beverages". The permissible limit of caffeine in carbonated beverages according to FSSAI is 145 parts per million. Brands, such as Red Bull and Burn, surpass this limit. Hence according to FSSAI they should be named as caffeinated beverages.

Growing interest in attending gyms and keeping fit is supporting demand for sports drinks in the country. The majority of sales are from energy drinks which are growing due to changes in consumer lifestyles, especially in metros and mini-metros. Long erratic working hours and changing consumer lifestyles are some of the factors leading to volume growth of energy drinks.

The key consumer groups of sports and energy drinks are people who exercise and work-orientated young generations in India. While products in sports drinks are seen as an important complement to outdoor exercise, products within energy drinks are popularised as essential for parties and useful to sustain an active lifestyle.

Red Bull enjoyed a large lead over its competitors to record a 72% off-trade value share within sports and energy drinks in 2012. PepsiCo ranked second registering an 11% off-trade value share.

Due to the regulatory changes in sports and energy drinks in the country in 2012, category leader Red Bull, was not allowed to sell its Tamil Nadu brand during the year, which was one of the reasons for the decline in Red Bull's volume sales in 2012.

In terms of individual categories, the Red Bull brand held an 86% off-trade value share in energy drinks while Gatorade dominatedsports drinks with an 82% share in 2012.

Cloud 9,Tzinga and Burn, from Goldwin Healthcare, Hector Beverages and Coca-Cola respectively, are the other notable brands in energy drinks while Lucozade Isotonic Drink and 100 Plus Isotonic Drink from GlaxoSmithKline and ATC Beverages, respectively, were the only significant competitors to Gatorade in sports drinks.

For more information on the Indian sports drink market, see the latest research: Indian Sports Drink Market

Pharma cos refuse to cut prices of 108 products despite NPPA order on July 10 Shardul Nautiyal, Mumbai Thursday, July 24, 2014, 08:00 Hrs [IST]

http://www.pharmabiz.com/NewsDetails.aspx?aid=83114&sid=1

Although National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 108 formulation packs of 50 non scheduled drugs in antidiabetic and cardiovascular segments effective from July 10, 2014 in the wider public interest, the revised prices of these formulations have not been implemented as yet by the pharma manufactures in the country.

While the industry feels that prices of drugs are not in the interest of their business, NPPA maintains that companies have a mandate to abide by the new gazette notification failing which they will be held liable in contravention to the provisions of Drug Price Control Order (DPCO) - 2013.

The government’s move to put a cap on the pricing of cardiovascular and diabetes drugs are likely to impact bigger brands which were charging more for the same drug molecules.

Pharma companies feel that NPPA action may lead to a business loss of Rs. 600 crore which can impact the annual turnover to the tune of Rs. 6000 crore under the diabetes and cardio-vascular segments. The drugs that will become cheaper would include atorvastatin, gliclazide, glimepiride, heparin, metolazone propranolol, ramipril, rosuvastatin, simvastatin, telmisartan, terazosin, torasemide, trimetazidine and valsartan among others.

Retail trade associations inform that they have not received any revised price list of 108 non scheduled formulations from the manufacturers, the state drug regulator says that it is awaiting an intimation from the government on its implementation.

Though the industry associations are against invoking Para 19 of DPCO by NPPA for extending price control to non-schedule products, Para 19 of DPCO, 2013 authorises NPPA in extraordinary circumstances to fix the ceiling price or retail price of any drug for such period as it deems fit.

The industry argues that if NPPA is allowed to pursue this course of action, every drug will be under price control, making National List of Essential Medicines (NLEM) redundant. As per the Drug Price Control Order (DPCO) 2013, the government currently controls the prices of 652 essential drug formulation listed in the NLEM.

It is estimated that around Rs. 5,500 crore of the pharma market will be impacted, with the range of prices being reduced from 10 to 15 per cent to as high as 35 per cent, with the average reduction of around 12 per cent.

According to experts, it is a rare invocation of a lesser used provision in the Drug Price Control Order (DPCO). The development is significant as NPPA has fixed prices of those medicines which are not listed under the national list of essential medicines (NLEM).

The total market of cardiac medicines under price control, including the earlier ones, stands at 58 per cent besides 21 per cent of the anti-diabetic market that comes under the drug control purview. Sanofi is likely to see the maximum impact of this price capping in India. Companies like Ranbaxy, Emcure, Zydus Cadila and Glenmark Pharma will also get impacted by the new pricing regime. Respiratory will be a major therapy area witnessing the impact with companies like Cipla, Lupin and GlaxoSmithKline Pharmaceuticals (GSK).

The three public sector units producing primary vaccines might have resumed operation, but they are hardly making any contribution to the vaccines procured for the Universal Immunisation Programme (UIP).

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The three public sector units producing primary vaccines might have resumed operation, but they are hardly making any contribution to the vaccines procured for the Universal Immunisation Programme (UIP). In 2012-13, the PSUs' share in UIP procurement worth Rs 887 crore was just 2.4% and in 2013-14, it was just 3.6%.

According to the health ministry's reply to an RTI application in January 2014, the PSUs accounted for well over a quarter of the money spent on vaccine procurement for UIP before being shut down in 2008. They produced almost the entire requirement of BCG, DTP and TT vaccines in the country.

The UPA's tenure has witnessed the country's vaccine security being destroyed with the three largest PSUs supplying vaccines being shut down. The government failed to advance vaccine research and upgrade manufacturing capabilities of its PSUs which led to the shut down. The promised modern vaccine park in Chennai, which was meant to replace these PSUs by 2010, is expected to complete its first phase in March 2015.

Meanwhile, the country remains totally dependent on the private sector for its UIP vaccines even as the prices of vaccines have been steadily rising over the years, most having doubled in this period. India's UIP is one of the largest in the world that targets 2.7 crore infants and 3 crore pregnant women every year.

According to the RTI reply, in 2013-14, BCG Guindy resumed production and supplied over a third of the demand for BCG vaccine. The resumption of operation of the PSU seems to have brought the price down from Rs 3 to Rs 2.80. PSUs beginning to supply DPT in 2010-11 also stopped the steady climb in its price, even though the PSU price hovered around the same level as that of the private sector — about Rs 2.30 per dose.

"PSUs play a crucial role in keeping prices in check. Despite the parliamentary standing committee on health urging the government to make the PSUs functional, the government has been dragging its feet as is obvious from the amount being supplied by them," said Dr K V Babu, who had filed the RTI query.

The then health minister, Anbumani Ramadoss, shut down these units supplying the bulk of primary vaccines for UIP in January 2008 claiming that a World Health Organisation team's inspection had found that the institutes were not complying with good manufacturing practices (GMP).

When the units were shut down, the health ministry claimed that a new vaccine park planned near Chennai would be functional by February 2010. Since then, the deadline for the park has been extended several times. The entire UIP demand for BCG vaccines, meant for tuberculosis, was being supplied by BCG Vaccine Laboratory (BCGVL) in Chennai, established in 1948. This government-run laboratory helped the country achieve self-sufficiency in BCG vaccine production from the year 2000, after which import through UNICEF was stopped. The entire demand for Tetanus Toxoid (TT) vaccine was being supplied by two PSUs — the Pasteur Institute of India (PII), Coonoor, Tamil Nadu and the Central Research Institute, Kasauli, Himachal Pradesh. These two institutes were also supplying almost 90% of the DPT vaccine needed for the UIP.

It was known that the institutes were not GMP-compliant right from 1997, when an attempt was made to upgrade these institutes. Since then, neither funds nor effort seem to have been expended on upgrading them and after over a decade, Ramadoss shut them down instead of ensuring they became GMP-compliant.

These PSUs were also producing yellow fever vaccine, anti-snake venom and antirabies vaccine. All through 2008, 2009 and 2010, different parts of the country suffered acute shortage of various UIP vaccines which disrupted routine immunization of thousands of children. There has also been acute shortage of yellow fever vaccine, antisnake venom and anti-rabies vaccine which has led to hundreds of deaths.

-Timesofindia

Maha FDA writes to NPPA to bring medical devices under DPCO to curb profiteering :

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Maharashtra Food and Drug Administration (FDA) has recommended to the Drug Controller General of India (DCGI) and National Pharmaceutical Pricing Authority (NPPA) to bring medical devices including drug eluting stents (DES) under the Drug Price Control Order (DPCO) 2013 to make it affordable to the patients.

Medical devices including drug eluting stents (DES) are notified as drugs under the Drugs and Cosmetics Act, 1940 but is not included under the DPCO. Therefore, the prices of medical devices cannot be monitored and controlled as of today.

The recommendation comes in the wake of studies conducted by the FDA which has revealed that manufacturers in connivance with importers, distributors and hospitals are fixing the MRP of medical devices arbitrarily which is then passed on to the gullible patients. It was observed from the studies that the Maximum Retail Price (MRP) of the imported drug eluting stents is exhorbitantly high and patients have no option to bargain.

FDA, therefore, recommends that in order to monitor and control the prices of medical device including DES, the term medical device including DES should be included under the new DPCO regime.

The MRP of DES is fixed by the importing company. As the manufacturers of these devices are located overseas, it is difficult to study the manufacturing cost and export prices of these devices. Besides this, the startling fact is that the cost of DES is immediately recovered from the patients but payments to the distributors are made after a period of 60 to 120 days. The payments of applicable taxes of the concerned sale transactions, to the state government are made only within 51 days by the distributors.

The study showed that DES manufactured by Medtronic Inc and imported by India Medtronic Pvt Ltd, Bhiwandi in Thane at Rs.30,848 has a MRP of Rs.1,62,000. This was sold to a distributor Bhalani Biomedicals Pvt Ltd, Mumbai at a price of Rs.67,000. The said distributor sold this DES to Jaslok Hospital, Mumbai at a price of Rs.1,06,050 which was passed on to the patient.

In yet another case of profiteering, DES manufactured by Abbott Vascular Devices Holland BV at Netherlands and imported by Abbott Healthcare Pvt Ltd, New Delhi at Rs.40,710 and having MRP of Rs.1,50,000 was sold to Sinocare, Mumbai at a price of Rs.73, 440. The said distributor sold this stent to P D Hinduja Hospital, Mumbai at a price of Rs.1,13,400 and the patient paid a price of Rs.1,19,070.

DES manufactured by Cordis Inc at GMED Healthcare BVBA Brussels and imported by Johnson & Johnson, Mumbai at Rs 45,115 with MRP of Rs.1,35,000 was sold to Pack Deal, Mumbai at Rs.76,886. The said distributor sold the DES to Jaslok Hospital at a price of Rs.98,800 which was passed on to the patient.

Patients were being forced to pay double or even triple the price for medical devices at hospitals. As most of these are not available in the open market, patients can't check prices and are held hostage by the hospitals, which force them to buy at the price they quote.

However, experts also opine that having an MRP has not prevented profiteering in medicines, with the MRP being fixed high enough to accommodate commissions since there is no limit on what the MRP can be. Moreover, while MRP is mandatory on everything manufactured in India, many devices are imported and escape this stipulation. In most hospitals, if two devices are more or less equal, the choice of which one is used depends on which fetches the hospital a bigger cut.

-Pharmabiz

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ANDA Approval Reports ANDA (Generic) Drug Approvals - Previous Years

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Understanding Generic Drugs Facts About Generic Drugs Infographic

Understanding Generic Drugs Facts About Generic Drugs Infographic

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm

Understanding Generic Drugs

Generic drugs are important options that allow greater access to health care for all Americans. They are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.

Generic Drugs: Questions and Answers

What are generic drugs?

A generic drug is identical -- or bioequivalent -- to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

Is there a generic equivalent for my brand-name drug?

To find out if there is a generic equivalent for your brand-name drug, use Drugs@FDA, a catalog of FDA-approved drug products, as well as drug labeling.

You can also search for generic equivalents by using the "Electronic Orange Book." Search by proprietary "brand" name," then search again by using the active ingredient name. If other manufacturers are listed besides the "brand name" manufacturer when searching by the "active ingredient," they are the generic product manufacturers.

Since there is a lag time after generic products are approved and they appear in the "Orange Book," you should also consult the most recent monthly approvals for "First Generics".

Are generic drugs as effective as brand-name drugs?

Yes. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.

FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.

Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.

How are generic drugs approved?

Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA's approval process.

New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.

What standards do generic drugs have to meet?

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

contain the same active ingredients as the innovator drug(inactive ingredients may vary)
be identical in strength, dosage form, and route of administration
have the same use indications
be bioequivalent
meet the same batch requirements for identity, strength, purity, and quality
be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

Inhaled Insulin Afrezza Gets FDA Approval - By MikeH on June 29, 2014

Huge news, D-Friends: the new rapid-acting inhalable insulin known as Afrezza has just obtained FDA approval!

The third time’s the charm for this new formulation of inhalable insulin, the second-ever to make it through the U.S. regulatory process after Pfizer’s failed Exubera the better part of a decade ago.

On Friday, the California biotech company MannKind Corp. finally obtained regulatory clearancefor its Afrezza device.

Twice before, regulators turned down Afrezza asking for more clinical study data to appease concerns about safety and effectiveness.

Now, after resubmitting Afrezza in October 2013, MannKind has finally convinced the FDA it’s ready to get into the hands of adults with diabetes!

We’re told by MannKind’s top executives that they’re working to find a pharma partner to manufacture and distribute Afrezza, and the product could be made available as soon as January, or end of the first quarter of 2015.

In the FDA news release issued on Friday, Dr. Jean-Marc Guettier of the agency’s Division of Metabolism and Endocrinology Products, states: “Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.”

Here’s the 411 on Afrezza, for those who don’t know:

Afrezza’s an ultrarapid-acting insulin in powder form that’s designed as a pre-meal insulin for adults (not yet for kids) with type 1 or type 2 diabetes. It’s aimed at post-meal blood sugar spikes, meaning used with existing insulin treatment and not meant to be a stand-alone insulin treatment.

The powdered insulin is administered via a whistle-sized inhaler called the Dreamboat, which was developed after the first FDA round and caused delays because the agency wanted more clinical studies using that new inhaler. The powder dissolves immediately when inhaled into the lungs, and the insulin’s then quickly dumped into the bloodstream to start working. Afrezza peaks within 12 to 15 minutes and is out of the system within an hour, compared to current short-term insulins that usually take at least 20 minutes to kick in, peak at 2-3 hours, and can stay in the system for as long as five hours.

Here’s a video of how the Afrezza Dreamboat inhaler works, posted by a clinical study participant last year:

Source: YouTube

MannKind has spent years trying to gain approval for this treatment, first submitting a new drug application in May 2009. And now, Afrezza appears to be ready for primetime, having cleared the FDA.

Of course, the biggest appeal is that it requires no needles, but just a little hand-held inhaler that really does look like a whistle. The Dreamboat is meant to be thrown away after 15 days to prevent any powder buildup inside that could clog the device. Unlike traditional insulin, it needs no refrigeration, but rather is kept at room temperature. Each single-use cartridge would hold either 4 or 8 units, and by the time Afrezza is commercialized, there could be a 12-unit cartridge available.

Here’s how you might dose for it, converting current insulin injection or bolus amounts into an Afrezza-friendly inhalable dose:

From Page 4 of the MannKind Afrezza medication guide

Personally, that doesn’t seem like a lot of insulin to cover some of the meals I eat that require higher doses… I’d be going through a whole bunch of those little cartridges. So for some PWDs, this device may present a logistical challenge in terms of easily dosing the amounts we need…? But then again, this may be a good tool for knocking down stubborn high blood sugars with correction dosing.

In a phone conversation late Friday, MannKind’s president Hakan Edstrom told us the company hasn’t yet finalized any deals with potential partners in order to manufacturer and distribute Afrezza. But it’s getting close, and in talks with a number of companies to finalize a partnership as soon as possible.

Costs remain TBD (a lot depends on the potential partnership), but Edstrom says they expect prices to be in the same range as what we patients typically pay now for insulin pens in the U.S.

This approval is a HUGE development, and it’s been a long time coming, eight years since this quest began by Alfred Mann — the man who founded Minimed before it was eventually bought by Medtronic. We’ve been following the Afrezza story for years here at the ‘Mine — from the initial FDA filing days when MannKind had its initial clunkier design, to the more recent coverage on how Afrezza’s being used in Artificial Pancreas clinical trials.

So far it’s cost a whopping $1.8 billion (!) to get Afrezza to this point, and much of that money was used to pay for 60+ clinical trials that have involved 6,500 patients. Wowza!

Before last fall’s FDA resubmission, we heard MannKind boast about its Phase III clinical studieslast summer that included 500+ type 1 PWDs in the U.S. and globally, which indicated the company was poised to try its hand again with the FDA.

All that said, it’s still a bit of a surprise that Afrezza got the FDA’s approval, considering the agency’s own staff review had raised conce

rns about the product’s safety and effectiveness. There were initial concerns that long-term exposure of the lungs to insulin could cause lung cancer, since clinical trial data showed more cases of lung cancer among those who received Afrezza than others in control groups. But the numbers were small and far from definitive, and MannKind was required to undertake a long-term study to assess that risk.

The advisory committee that met on April 1 of this year voted 13 to 1 that Afrezza was safe and effective enough for approval as a treatment for type 1 diabetes, with the lone dissenter David Cooke voting that the risks outweighed the benefits for type 1s. He pointed to the internal FDA review that showed some patients taking Afrezza stopped treatment after developing bronchial spasms, coughing, and a decline in the functioning of their lungs. But none of those concerns came up during the voting on Afrezza for type 2 use, and the committee decided unanimously in favor with a 14-0 vote.

In approving Afrezza, the FDA has attached a number of safety, effectiveness and patient use stipulations:

It’s not recommended for people with diabetes who smoke, nor for treating diabetic ketoacidosis (DKA).
Afrezza is only approved for adults, not kids. However, the agency’s asking for a post-market clinical trial to evaluate the safety and use in pediatric patients.
The FDA is requiring a Boxed Warning, advising that some people with asthma and chronic obstructive pulmonary disease (COPD) who’ve used Afrezza have experienced acute bronchospasm. As a result, those with chronic lung disease, asthma or COPD, should not use Afrezza because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
Part of the approval requirements are a Risk Evaluation and Mitigation Strategy, which must include a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza. That’s mean to ensure that the benefits outweigh the potential risks of using Afrezza.
Other post-market studies are required on Afrezza, such as: clinical trial to evaluate the potential risk of pulmonary malignancy with use (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function); and two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability.

Edstrom told us they are planning to start pediatric trials as soon as possible, which will realistically begin sometime in mid-2015. That means Afrezza might not be approved for kids with diabetes until 2017, and that regulatory process may vary depending on what the post-market studies and adult-use experience shows in the meantime.

And despite the FDA green light, there’s no guarantee Afrezza will see commercial success or that PWDs will flock to use it. As noted, MannKind has not yet secured any pharma partners ready to sell Afrezza. But if MannKind’s earnings call in May is any indication of what’s coming soon, a potential partnership may not be far off.

From the investor point of view, many are skeptical based on the failed Exubera inhaled insulinthat has shaped much of the discussion about Afrezza over the past several years. That joint Pfizer-Sanofi product was pulled from the market in 2007 after more than a year’s worth of subpar sales — resulting in a record-breaking $2.8 billion loss for the vendors.

Of course, MannKind claims that Afrezza is significantly different, mainly because Exubera used a clunky foot-long inhaler and was linked to a higher lung cancer risk that Pfizer just couldn’t overcome.

We’ll see what the D-Community thinks now with Afrezza, especially with all the AP clinical trial attention it’s had more recently. Whether that’s enough to convince the masses is yet unclear…

Inhale the news for now, and we’ll see how long it takes for us all to exhale and turn this excitement into actual sales and widespread use.