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COPYRIGHT 2005 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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For more information, visit www.pharma.us.novartis.com and click on “Prescribing Information.”
COPYRIGHT 2006 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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An estimated 3 million patients worldwide take Diovan for high blood pressure. Heart failure, or progressive weakening of the heart muscle, is the fastest-growing cardiovascular disease in the world and has reached epidemic proportions in industrialized nations. Twenty million people worldwide have heart failure, and the condition is the most common reason why patients aged 65 or older are hospitalized.
COPYRIGHT 2001 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2008 Gale, Cengage Learning

DiovanDiovanDiovan dosesFDA approves DiovanNew indication for diovan

> Exforge has received regulatory approval as a treatment for patients with high blood pressure. Manufacturer Novartis AG notes that the product combines in one tablet the two most commonly prescribed hypertension medicines in their categories: Diovan and Norvasc. The new product is expected to be available in the United States in late September pending expiration of patent protection for amlodipine besylate (Norvasc).
COPYRIGHT 2007 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

What causes heart failure?

Heart failure has many different causes. Sometimes the exact cause can’t be found. The most common causes of heart failure are listed below:

Coronary artery disease (narrowing of the blood vessels to the heart)
Problems with the heart muscle itself (known as cardiomyopathy)
High blood pressure (also known as hypertension)

Any disorder that directly affects the heart can lead to heart failure, as can some disorders that indirectly affect the heart. Some disorders cause heart failure quickly; others do so only after many years. Some disorders cause systolic dysfunction, others cause diastolic dysfunction, and some disorders, such as high blood pressure and some heart valve disorders, can cause both types of dysfunction.

Symptoms of Heart Failure

Many symptoms of heart failure result from the congestion that develops as fluid backs up into the lungs and leaks into the tissues. Other symptoms result from inadequate delivery of oxygen-rich blood to the body’s tissues. Since heart failure can progress rapidly, it is essential to consult a doctor immediately if any of the following symptoms are detected.

Heart failure on the left

Heart failure on the left side can also make you breathless. This can happen at any time but often happens when you are active or laying in bed. During the night you may feel the need to sit up in bed or even to get some fresh air.

Blood “backs up” in the pulmonary veins (the vessels that return blood from the lungs to the heart) because the heart can’t keep up with the supply. This causes fluid to leak into the lungs.

To make matters worse, any or several of these conditions may coexist along with congestive heart failure.

Heart Failure Treatment

If you have heart failure, your doctor will monitor you closely. This means having follow up appointments at least every 3 to 6 months, figuring out any underlying cause and treating it, and periodic testing of your heart function. For example, an ultrasound of your heart, called an echocardiogram, will be done once in awhile to give an estimate of how well your heart is pumping blood with each stroke or beat.

Lifestyle Changes

These modifications often improve or control some of the factors contributing to heart failure. For example, people with heart failure will see an improvement if they:

Modify daily activities and get enough rest to avoid stressing the heart

Eat a heart-healthy diet that is low in sodium and fat

Don’t smoke and avoid exposure to second-hand smoke

Angiotensin II (A-II) receptor blockers (ARBs). These drugs, which include losartan (Cozaar) and valsartan (Diovan), have many of the beneficial effects of ACE inhibitors, but they don’t cause a persistent cough. They may be an alternative for people who can’t tolerate ACE inhibitors.

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Whether the challenge is entering the Japanese market for the first time, moving up the all-important ranking there by market share, or negotiating with a local in-licensing partner, this report is designed to help.
- New drug pricing and price revision processes explained
- Written by an acknowledged expert on the Japanese market with 20 years’ experience
- Fully researched through field interviews conducted in Tokyo and Osaka with industry leaders, government officials and others during March 2008
- Incorporates all pricing rule changes that came into effect from April 2008
- Pro-generic measures critically appraised
- Key role of wholesalers and how they are paid clarified
- Prospects for future reform to the P&R processes discussed
Key Topics Covered:
1. Organisation & Funding of Healthcare System
2. Regulatory Environment
3. Pharmaceutical Business Environment
4. Launch Price Setting
5. Price Revision Process
6. Other Cost Containment Methods
7. Other Market Segments
8. Distribution
9. Future Prospects
List of tables
List of figures
Companies Mentioned:
Astellas
AstraZeneca
Banyu
Bayer-Schering
Boehringer Ingelheim
BMS
Chugai
Daiichi-Sankyo
Dainippon Sumitomo
Eisai
GSK
Hisamitsu
Hospira
Janssen
Kyowa
Hakko Kirin
Meiji Seika
Mitsubishi-Tanabe
Mylan
Nichi-Iko
Novartis
Ono
Otsuka
Pfizer
Roche
Sanofi-Aventis
Sandoz
Sato
Sawai
Servier
Shionogi
SolvaySuntory
SSP
Taiho
Taisho
Taiyo Yakuhin
Takeda
Teva
Towa
Yakult Honsha
Yoshitomi
Zeria
Products covered
Abilify
Aldurazyme
Amlodin
Aricept
Avastin
Blopress
Campto
Clarith
Claritin
Coversyl
Crestor
Depromel
Diovan
Doral
Enbrel
Epogin
Evista
Exjade
Fabrazyme
Farom
Funguard
Gaster
Glivec
Harnal
Iressa
J-Zoloft
Lantus
Leuplin
Lipitor
Luvox
Maxalt
Mevalotin
Micardis
Mohrus Tape
Myozyme
Naglazyme
Nexavar
Nicotinell TTS
Norvasc
Nu-Lotan
Olmetec
Omepral
Pariet
Paxil
Pegasys
Preminent
Prograf
Radicut
Relenza
Remicade
Renivace
Revatio
Risperdal
Somavert
Sutent
Takepron
Taxol
Topotecin
Tracleer
Valtrex
Vesicare
Viagra
Zetia
Zoloft
Zovirax.
For more information visit http://www.researchandmarkets.com/research/b2dd9e/pharmaceutical_pri
COPYRIGHT 2008 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

WITH RECORD NUMBER OF UNINSURED,
AMERICANS TURN TO FOREIGN PHARMACIES FOR
LOWEST-PRICE PRESCRIPTION DRUGS

Consumers Find Indian Pharmacies A Cheaper Resource Than
Canadian Pharmacies, and
Discount-Priced Generic Medications Are Available

TAMPA, Florida With the number of uninsured Americans at a record 47 million, the highest number in more than 20 years*, a growing number of U.S. consumers are buying their prescription drugs from foreign pharmacies, some as far as 8,000 miles away in India. (* Source: US Census, Figure 6, page 27 of 78, http://www.census.gov/prod/2007pubs/p60-233.pdf ) There, they can access the highest quality brand-name and generic drugs at up to 90 percent savings off U.S. prices.
While a few years ago, many American consumers shopped at Canadian online pharmacies to find cheap drug prices, an increasing number of seniors especially have discovered India as a discount paradise for even lower-cost medications, taken by millions of consumers worldwide.
Cecilia, an uninsured senior in the Tampa, Florida suburb of Oldsmar, cant afford to buy her high blood pressure and arthritis drugs from her local pharmacy. The same with Rex, a 72-year-old uninsured Houston veteran, who takes several medications to treat emphysema and COPD. They both are buying their drugs from a licensed pharmacy in India.
American consumers are smart and know an amazing deal when they find it, said Pradeep Dadha, who runs InternationalDrugMart.com, a licensed pharmacy in Chennai, Indias fourth largest city and a major business center. This year our U.S. sales have climbed 25 percent over last year. Every day, we fill and mail about 250 orders to our uninsured American patients, Dadha said. Our U.S. customers are mainly 50 to 64-year olds that dont yet have Medicare coverage, and other uninsured people of all ages. Most of our new business comes from word-of-mouth from our customers that recognize that they cannot find a better buy anywhere else, and they tell their friends and neighbors.
Their customers are pleased with the money-saving pharmacy.
International Drug Mart has been a godsend because we (seniors) cant afford U.S. drug companies high costs, said Rex.

50 to 90 Percent Price Differences
Many medications in India cost 50 to 90 percent less than U.S. retail prices because the Indian government, like that of most countries worldwide, controls drug pricing. Also, Indian pharmacies can sell cheaper, generic versions of Lipitor, Diovan and other expensive brand-name drugs for which generic medications are typically unavailable at U.S. and Canadian pharmacies. While generics can go to market quickly in India, the United States has strict U.S. drug patent protections that often prevent generics from coming to market for years. This gives Indian pharmacies a distinct price advantage.
For example, the cholesterol lowering drug Lipitor (40mg/90tablets) costs $361.99 at CVS.com, a U.S. online pharmacy. In comparison, InternationalDrugMart.com sells a generic version of the identical drug for $127.31, a 65 percent savings. And, the high blood pressure medication Diovan (160mg/90tabs) costs $224.68 at Walmart.com, a U.S. discount pharmacy. At InternationalDrugMart.com, Generic Diovan is $88.07, a 61 percent savings. (All prices in US$ as of 6 June 2008 and subject to change) Neither U.S. pharmacy sells generic versions of either drug.
Visitors to the Indian pharmacys website can obtain drug prices in less than 30 seconds time, and all prices are marked in U.S. dollars.
Dadhas staff of 10 people, includes two licensed pharmacists that manage orders for U.S. and other international customers and operates 24 hours a day, 7 days a week. When a U.S. order arrives, his team follows a careful and stringent four-step safety process to complete it. Finished orders are typically sent out one to two business days after receipt. They also serve customers in other countries including the UK, France, Switzerland, Japan and Canada.
Our U.S. customers urgently need their discount-priced medications so we work very fast, said Dadha, who like many of his U.S. counterparts, counts on his Blackberry phone to sends quick text messages to business associates and suppliers during his 15-hour work days.
Dadha never would have dreamed that he would one day serve U.S. customers.
I couldnt imagine that there were customers that because of financial constraints would be on the brink of deciding whether they could afford their medications or their food, but not both — especially in the U.S. It gives me considerable satisfaction to know that we can help American customers, and that they dont need to sacrifice one for the other, Dadha added.
As a testament to Indias low drug prices, Dadha says several Indian pharmacies fill orders for Canadian mail order pharmacies serving American customers.
Customers Protect Their Health
Indian drugs are usually made there by world-class drug companies recognized for high quality including Wyeth, Pfizer, GlaxoSmithKline and Novartis. And, leading Indian generic drug companies produce generic versions of many medications that they distribute for sale in India and worldwide. These companies include Ranbaxy, CIPLA, Torrent Pharmaceuticals and Sun Pharma.
While the U.S. government says that it is usually illegal for Americans to buy drugs overseas that isnt preventing cost-conscious seniors from protecting their good health. The U.S. Food and Drug Administration has been focused on finding rogue pharmacies, not on tracking down a fixed-income grandma who is buying cheaper drugs overseas for her personal use.
Ironically, many prescription drugs bought at U.S. pharmacies are made overseas. According to the Newark Star-Ledger (May 2, 2008), An estimated four out of 10 prescription drugs sold in the United States are manufactured abroad, and about 80 percent of the active pharmaceutical ingredients used by U.S. manufacturers to make prescription drugs are imported.
The U.S. has the highest drug prices in the world and is one of few countries that does not control prices that drugmakers charge. This puts the uninsured, or 15.8 percent of the population, (Source: US Census, same as graph #3), and many that cannot afford the steep costs, at greatest risk.
To reach InternationalDrugMart.com, visit its website at www.internationaldrugmart.com or call toll-free, 1-866-419-7475. Pharmacy phone hours are 9:00 am to 8:00 pm Eastern time (6:00 am to 5:00 pm Pacific). A prescription is required for prescription medications, and patients can order up to a three-month supply of drugs at one time. Regular air mail delivery costs US$6.99 for any size order and takes about two to three weeks to arrive. The pharmacy is approved by PharmacyChecker.com, a leading independent pharmacy verification program. # # #

CONSUMER CONTACT: 1-866-419-7475

MEDIA CONTACT:
To develop a story and interview Pradeep Dadha, Managing Director of InternationalDrugMart.com, or a local customer of the pharmacy, email Michael Pirages of Pirages Communications (Chicago) at mpirages@piragescom.com or call
773-769-1616. Michael also can provide color jpg photos of the InternationalDrugMart.com pharmacy.

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Postmarketing clinical research has also become a key feature of product lifecycle management. Phase IIIb/IV trials are increasingly being used in company specific initiatives to provide strategic guidance in areas such as payor approval and reimbursement, indication expansion, franchise development and marketing. ‘Emerging Role of Postmarketing Clinical Research’ is a new report published by Business Insights that uses detailed case studies and market scenarios to examine the latest issues surrounding phase IV trial applications. The potential to leverage competitive advantage with postmarketing research is assessed by measuring the implications for formulary access, product marketing, indication expansion and reimbursement coverage.
This report also explores the regulatory issues and requirements affecting mandatory postmarketing trial conduct and identifies the key components of effective phase IV trial design and completion. Identify the latest regulatory developments affecting postmarketing clinical research, use case studies to evaluate recent phase IV trial implementations and understand the competitive potential of successful trial designs.
* Assess the industry impact of recent regulatory developments in postmarketing commitment trials and surveillance studies
* Use detailed case studies to understand the influence of phase IV trials upon lifecycle management, indication expansion and reimbursement
* Identify how postmarketing strategies can enhance product differentiation, market development and formulary coverage
* Evaluate the operational objectives and trial management/outsourcing trends for phase IV trials across key industry sectors
* US Government initiatives have almost doubled the number of post-approval commitments since 2003-2004, following growing numbers of black box warnings and late-stage drug withdrawals.
* The EMEA and FDA will continue to harmonize regulatory approaches for phase IV monitoring and study commitments in areas of common interest, including pandemic vaccines, medicines for children, rare diseases and cancer medicines.
* Big Pharma companies conducted 145 (75%) of the 243 industry trials publicly registered with the FDA between 1998-2007. Of these trials, 109 were independently undertaken by big pharma as strategic initiatives. Average Big Pharma patient numbers (1743) far exceeded those of mid-tier biopharma companies (952).
* The implementation of a networked model of stakeholder involvement has become crucial to the success of drug developers by enabling access to new development platforms and facilitating effective trial management/sponsorship
* Active controls featured in 71 industry-sponsored trials, the majority of which were conducted under randomized, open label, parallel assignments. Of the 14 registered trials for medical devices, seven were undertaken with active control comparators in an interventional setting.
Key questions answered
* Revised R&D resource allocation. As regulators and companies increasingly apply postmarketing surveillance to justify product positioning and long term safety/efficacy profiles, financial investment in phase IIIb/IV trials will grow at a relatively higher rate than other stages of clinical development.
* New regulatory policies. The FDA will soon require mandatory submission of phase IV surveillance data over a large patient population. In addition, products approved on the grounds of accelerated procedures, or those which incorporated surrogate endpoints/biostatistical modelling techniques in early phase data, will require further commitment studies after conditional approval.
* Impact on lifecycle management. Marketing and product labelling companies are under pressure to justify claims through postmarketing study data submission, whilst indication expansion development strategies require postmarketing product data submission to support applications for extended approval.
* Importance of trial design/management. With multiple applications for trial data, trial design and management is crucial in identifying potential issues or adjustments as early as possible. Proactive adaptive designs and electronic data capture techniques are necessary for the ongoing analysis of collated datasets.

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Daniel Vasella, 54, president and CEO of Novartis, the $37 billion Basel, Switzerland-based maker of patented and generic pharmaceuticals, vaccines and over-the-counter products, does not appear troubled by this. In true Swiss fashion, he tries not to gloat about his company’s pipelines (138 projects in development), which are considered by analysts to be among the strongest in the industry. Wall Street sees its key growth drivers (Diovan, Tekturna, Gleevec, Tasigna, Exjade and Aclasta) as the company’s “cliff protection”–when branded drugs go off patent and face competition from generics. By 2012 the top 10 drugs in the world (e.g. Prevacid 2007, Lipitor 2010, Nexium 2011, Plavix 2011) will have gone generic, leaving many large-cap pharma stocks on the wrong side of the cliff. With soon-to-be-genericized products representing 20 percent or more of earnings in some cases, a general industry concern is how Big Pharma can grow. Since it was formed in 1996, as a result of a merger of Sandoz and Ciba-Geigy, Novartis has been more diversified, with only 60 percent of its revenues dependent on patented drugs. Vasella has had to pursue a different course than his competitors.
Earlier this year, the company had its share of woes when the FDA rejected its most important pipeline product (Galvus) and watched rival Merck charge ahead. Last March the FDA asked Novartis to stop selling, at least temporarily, its chronic constipation drug Zelnorm after a combined 29 clinical studies turned up an increased cardiovascular risk. It, too, faces a revenue hole from patent-expiring drugs such as Lamisil and Trileptal but doesn’t have to face a major problem until 2012, when the $4.2 billion Diovan goes off patent. The company is facing problems with patent issues in India and is planning to shift its major R & D center to China. Still, through its Sandoz division, Novartis gained European regulatory approval of its Epo alfa drug, a cut-price “biosimilar” version of Amgen’s Epogen, the drug that made Amgen one of a handful of successful biotech companies. The move is an important step in the fast-growing $55 billion world market for biological medicines.
Having traveled a considerable distance from his clinical practice in Bern, Switzerland, Vasella is an unassuming figure for the CEO of the world’s fourth largest pharma with a market cap of over $125 billion–and it’s not just because he is Swiss. As a student at the University of Fribourg, where his father was a professor, he was something of a wild-eyed Trotskyite. (The highest paid executive in Switzerland says it was the “authoritarianness” of its adherents that ultimately turned him against Marxism.) He says he continues to question authority–even his own judgment–because “one should assume nothing.”
A private but relaxed leader, Vasella likes to ride a Harley-Davidson on weekends and enjoys the solitude of mountain hikes in Austria or family getaways in Tanzania. CE’s J.P. Donlon recently caught up with him in New York.
Given that Big Pharma is investing twice as much in R & D as it did 10 years ago to yield 40 percent of the new drugs it produced then, is it time for the industry to change its development model?
That’s only partly true. Ten years ago, the industry had very high that has been resolved. Over the last 40 years, approval rates have seen highs and lows. Taking this into consideration, the industry’s approvals today are about average. However, we pay much more per compound, which means the dollar amount spent for each approved drug is more expensive by anywhere from 1.2 to 1.5 times what we used to spend. The output hasn’t declined, but the productivity certainly has. And, of course, what is being approved today was discovered 10 to 15 years ago, so you would have to look at the research productivity 10 to 15 years ago.
Today, pipelines are fuller than ever. As a result, we potentially have more approvals coming, particularly in biologics. However, we also see a regulatory authority that has become much more conservative.
Clinical trials are longer. The risks are higher. There are more technologies to finance; the studies are more complex. And they don’t want just one study; they want four. Years ago a study had a few hundred patients. Now, it’s thousands of patients. In one drug study we had 18,000 patients. At such large numbers it’s very expensive.
How do you resolve this problem?
First, we compete in an industry where the hurdles are big for everybody. It makes market entry high. Second, the question is, Are you better than the competition? To do this, one must attract and retain great talent to create an environment in which they have all the technologies available and the freedom to operate. This is especially important in the discovery area. When one reaches the development stage, one must be much more disciplined. Five years ago, we created a new institute in Cambridge, Mass., where we’ve moved our research headquarters from Switzerland to the U.S. We’re now opening a new center in Shanghai.