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	<title>Pharmaceutical News &#187; Canadian Pharmacy</title>
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		<title>The Glorious Story of Online Pharmacies</title>
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		<pubDate>Wed, 15 Mar 2017 16:32:01 +0000</pubDate>
		<dc:creator><![CDATA[Hank]]></dc:creator>
				<category><![CDATA[Pharmacy]]></category>
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		<description><![CDATA[There were times when people could not afford important drugs and struggled to find the best way to heal their wounds. There were times when patients had to break law in order to obtain some drugs. Those were dark times… &#8230; <a href="http://www.pharmaceutical-news.org/the-glorious-story-of-online-pharmacies.html">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
				<content:encoded><![CDATA[<p style="text-align: justify;">There were times when people could not afford important drugs and struggled to find the best way to heal their wounds. There were times when patients had to break law in order to obtain some drugs. Those were dark times… Today, we live in a much better place. The internet made communications, commercializing, and marketing much easier and more accessible to smaller companies. Many independent smaller pharmacies compete in a free market against huge corporations and old established retail networks.</p>
<p style="text-align: justify;"><img class="aligncenter  wp-image-528" src="http://www.pharmaceutical-news.org/wp-content/uploads/2017/03/The-Glorious-Story-of-Online-Pharmacies-1024x682.jpg" alt="The Glorious Story of Online Pharmacies" width="560" height="373" /></p>
<p style="text-align: justify;">The online market is a vast place where thousands of business try to fight for the attention from customers that like when they can purchase drugs for a low price and receive them in a timely manner. However, there are many problems with online pharmacies that we cannot ignore. While the history of pharmaceuticals sold via the internet is a story of a huge success celebrated by both manufacturers and customers, there are issues that we cannot overlook.</p>
<p style="text-align: justify;">Due to the fact that there are simply too many companies and too many online pharmacies, choosing the most reliable company is hard. My Canadian Pharmacy Online <a href="http://www.mycanadianpharmacymall.com" target="_blank">mycanadianpharmacymall.com</a> has a noble purpose. We want to make sure that our visitors have an access to a wide variety of branded and generic drugs and purchase them without bothering with the quality. This is a very important service today. How did we end up with a situation when having a reliable advisor like My Canadian Online Pharmacy is imperative?</p>
<h2 style="text-align: center;">The Beginning</h2>
<p style="text-align: justify;">Just like any other domain, pharmaceutical industry was ruled by several huge corporations that dictated both pricing and distribution methods heavily limiting the access to their products. Due to various corporate policies employed by British Company or Roche, many patients could not receive drugs that they needed. Some could not afford them. Some simple could not purchase them anywhere. The problem with corporations is that they don’t care about people and shrink their ethics to a size of a walnut when it comes to providing something for free or for a lower price when bigger profits can be made.</p>
<p style="text-align: justify;">This led to a very concerning situation specifically in North America. In 1998, Sildenafil AKA Viagra was released in USA after being approved by FDA. This was a drug that changed how men perceived their impotence. Before sildenafil, men believed that impotence is a sentence. However, Viagra changed that and men could use a modern medication to counteract one of the most concerning issues – erectile dysfunction.</p>
<p style="text-align: justify;">One of the problems with the release was the price. The drug was dramatically overpriced and many people simply could not afford to use it. The saving grace was that the drug is a when-needed medication. Some men could purchase several pills and use them across the whole month. Nonetheless, for the vast majority of men this was not even close to an efficient solution.</p>
<h3 style="text-align: center;">The Arrival</h3>
<p style="text-align: justify;">In parallel with British Company, other companies studied sildenafil and tried to create drugs based on the compound. In 1998, FDA approved sildenafil and British Company started distributing it under the brand Viagra. In 2000s, a plethora of new PDE5 inhibitors arrived to the marker. Cialis and Levitra are most notable additions to the market. Three companies took a commanding position in the North American market and controlled the market for over a decade.</p>
<p style="text-align: justify;">Within first 5 years after the sensational release of Viagra in USA, the world became accustomed not only with the term Viagra, but also with a looser term Viagra Professional. We obviously talk about generics of the drug that were developed by Indian and Turkish pharmaceutical companies and sold primarily in SEA region, Africa, and Europe. At that time, generics were less popular and people simple did not know much about them.</p>
<p style="text-align: justify;"><strong>However, the reign of generic drugs was inevitable. There were distinct advantages to generics:</strong></p>
<ul style="text-align: justify;">
<li>Due to lower administrative and operational expenses, manufacturers priced their generics democratically allowing more customers to afford them;</li>
<li>New marketing and distribution channels started to appear namely the internet and selling VIA mail which made shopping simpler;</li>
<li>The variety of dosages was much more versatile, Viagra Professional is available in various dosages including 25mg, 50mg, and even 100mg;</li>
<li>The competition created by generics forced many companies to rethink their pricing patterns and lower their prices.</li>
</ul>
<p style="text-align: justify;">This was the moment for the internet to step up. In 2007, we observed a rapidly growing market where many companies operated without any control and oversight. We decided to create a company that would follow a set of standards and ethics that could be defined as a “reliable and responsible service”. For over 10 years, we have been analyzing the market, searching for the best products, and testing them continuously in order to ensure that our customers enjoy the best service and effective medications.</p>
<h3 style="text-align: center;">The Sea of Information. The Sea of Issues</h3>
<p style="text-align: justify;">Many specialists and industry experts justly pointed out that many companies were highly unreliable and tried to sell expired drugs or fakes. At the same time, some manufacturers are definitely shadier than others. This means that many customers who purchase drugs online end up becoming victims to scams and irresponsible online merchants. This problem is why My Canadian Pharmacy became so popular amongst men all over the world.</p>
<p style="text-align: justify;">Viagra is not a drug that can be substituted with a placebo zero-effect pill. However, some irresponsible sellers believe so and sell fakes to their clients. This makes the whole industry look bad. The issue with scams blossoms on the rich soil of oversaturation of information in the internet. We simply have too much information to handle and too many companies competing for top spots in search results. This means that many trash tier companies manage to break through and compromise the whole market.</p>
<p style="text-align: justify;">My Canadian Pharmacy was created to filter out irresponsible retailers and search for the best products out there. We test all our products, inspect how the delivery works, ensure high quality customer support, and constantly renew our partnerships. Only by constantly processing data and analyzing it, we can stay afloat in the sea of information that is internet today.</p>
<p style="text-align: justify;">Simultaneously, we help thousands of active internet users to filter out bad offers and search for the most profitable and efficient deals without compromising quality. You can pick from a wide assortment of offers and enjoy regular bonuses, seasonal deals, and promotions including free shipments, free consultations, and reliable customer support.</p>
<h3 style="text-align: center;">Online Shopping VS Land Based Pharmacies</h3>
<p style="text-align: justify;">Various studies show that in USA only people save up to 80% by purchasing drugs and their generic versions online. On average, customers save about 65% on each deal. Before the internet, people started using international mail to purchase drugs from Thailand, India, Turkey, and other countries. Many smart people purchased drugs in Mexico for personal usage. Some US citizens purchase drugs in Canada where pharmaceuticals slightly cheaper on average. Canadians often can use online pharmacies freer than Americans.</p>
<p style="text-align: justify;">Shopping online is much easier. If you need Viagra Professional, <a href="http://www.mycanadianpharmacymall.com/viagra-professional" target="_blank">check various options</a> at My Canadian Pharmacy Online and enjoy your right choice!</p>
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		<title>The unparalleled experience of shopping for meds starts here</title>
		<link>http://www.pharmaceutical-news.org/the-unparalleled-experience-of-shopping-for-meds-starts-here.html</link>
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		<pubDate>Tue, 01 Mar 2016 18:17:26 +0000</pubDate>
		<dc:creator><![CDATA[Hank]]></dc:creator>
				<category><![CDATA[Canadian Pharmacies]]></category>
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		<description><![CDATA[My Canadian Pharmacy is created to eliminate the most crucial issues preventing thousands of people from buying meds online and refraining the growth of the industry. With the emergence of the web and its development online shopping is flourishing, although &#8230; <a href="http://www.pharmaceutical-news.org/the-unparalleled-experience-of-shopping-for-meds-starts-here.html">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
				<content:encoded><![CDATA[<p style="text-align: justify;"><strong>My Canadian Pharmacy is created to eliminate the most crucial issues preventing thousands of people from buying meds online and refraining the growth of the industry.</strong> With the emergence of the web and its development online shopping is flourishing, although it poorly applies to online medications sales. So what are the main factors that holding the progress of the niche? The answers lie on the surface: lack of trustworthiness, caused by huge amounts of scam, questionable quality assurance mechanisms, prolonged delivery… and that’s just the top of the list. My Canadian Pharmacy takes advantage of local centralization and eliminates the potentially negative factors preventing people from buying medications and companies from selling products.</p>
<h2 style="text-align: center;">What is Canadian Pharmacy?</h2>
<p><img class="alignright  wp-image-519" src="http://www.pharmaceutical-news.org/wp-content/uploads/2016/03/shopping-for-meds.jpg" alt="shopping for meds " width="314" height="209" /></p>
<p style="text-align: justify;">Canadian Pharmacy (or CP) is a brand-new platform gathering products, services and information under one roof. That’s a one-stop place to get comprehensive information on drugs, buy quality preparations and even get a professional consultation, free of charge. CP goes out on a limb in providing online shopping for drugs: the platform aggregates dozens of Canadian local pharmacies (and even a number of international ones), accumulates piles of useful information on meds (indications for use, pharmacological action, side effects, reviews, etc.) and provides you with an array of services, such as professional consultations. Since its launch just a couple of month ago it has already plugged in 50+ pharmaceutical stores and increased the lineup of medications by 2,440% due to expansion, and these numbers are constantly growing.</p>
<h3 style="text-align: center;">So why should you stop by Canadian Pharmacy www.mycanadianpharmacyrx.com? The platform grants access to hundreds of popular and the most affordable medications</h3>
<p style="text-align: justify;">You can compare the prices effortlessly and make your choice in favour of the best price-value options. The platform features both original, branded drugs by manufacturers approved by FDA as well as offers rare generic modifications &#8211; the totally affordable drugs by companies mostly located in Southeast Asia. Currently, the platform bets on the following drug categories: men’s and women’s health, pain relief, antibiotics, antidepressants, anxiety, blood pressure, skin care, eye care and a bunch of more. The selection is not random: the list includes a multitude of bestselling drugs and focuses on the US Top 500 most demanded preparations.</p>
<h3 style="text-align: center;">Targeting erectile dysfunction issues</h3>
<p style="text-align: justify;"><strong>The release of Viagra in 1998 has revolutionized the treatment of erectile dysfunction and even contributed to reconsideration of disease concept.</strong> After a couple of years since the preparation has landed at pharmacies across the US it became obvious it is doomed to success, as more and more trials reveals the drug has a positive impact on sexual function in 69% &#8211; 84% of clinical trial groups. However, the price remained a huge factor that limited the access to the panacea for millions, and the emergence of generic drugs was inevitable. Unfortunately, the release of generic PDE-5 inhibitors didn’t solve the problem, as with the cheap preparations the amount of counterfeit and poorly effective products has risen to sky-high marks. Buying a decent quality medication on the web has turned into an extremely complicated task, especially when it comes to ED pills (according to MedScape, Viagra and Cialis are 40th and 45th most prescribed medications in the United States as for 2014).</p>
<p style="text-align: justify;"><strong>And this is where My Canadian Pharmacy www.mycanadianpharmacyrx.com comes to the rescue: it gathers proven, diligent drugstores offering finest quality products at reasonable prices.</strong> You can choose from hundreds of meds modification and dosage types: the lineup of ED drugs is created and replenished taking into account a variety of treatment requirements. Thus, 60+ males and those suffering from kidney and/or liver problems can purchase 2.5mg Cialis or 5mg Viagra &#8211; the lowest dosage meds that come as pills already and require no splitting. Selfsame, those having an insufficient effect can make a choice in favour of heavy artillery &#8211; Cialis 40mg or Viagra 100mg that guarantee the most comprehensive effect. Moreover, you can always opt for more rare, yet no less powerful options: the platform carries a good number of products targeting particular ED issues, such as premature ejaculation. Therefore, you can take advantage of double-component series of drugs, comprised with dapoxetine and sildenafil citrate active ingredients (e.g. Viagra Super) that help you deal with the issues effortlessly.</p>
<p style="text-align: center;">Customer service: the advantages you’d be pleased to have</p>
<p style="text-align: justify;">So why have thousands of people started using the platform? The answers are pretty obvious, and perhaps one of the strongest reasons is the risk of buying zero-quality product or become a victim of some scam scheme reduced almost to nothing. Your choice is thoroughly protected with proper selection and monitoring of all the sellers represented at the platform, so if some serious violation is revealed, the company gets excluded from the platform. Another vital factor that makes Canadian Pharmacy stand out from the crowd is a huge array of products and totally transparent payment processes &#8211; the common payment methods in conjunction with helpful support guarantee absolutely comfortable shopping experience. Finally, an opportunity to get professional consultation when you need it most is simply priceless, and it costs you nothing!</p>
<p style="text-align: justify;">Just like in an average drugstore neither you need a prescription nor providing sensitive personal info is required (insurance no., ID, etc.). All the products are delivered to your door, and the time frame depends on the order size and your location; plus you can choose from various delivery options (depending on the seller), yet on average you can expect having your package delivered in 3 &#8211; 10 days on average.</p>
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		<title>Canadian Pharmacy News: Success rates for experimental drugs falls</title>
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		<pubDate>Thu, 17 Feb 2011 11:52:31 +0000</pubDate>
		<dc:creator><![CDATA[Hank]]></dc:creator>
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		<description><![CDATA[Risks Associated with Veterinary Compounding Pharmacy Choices (AAEP 2010) More than 12,000 compounding pharmacies operate in the United States, and each year compounded product sales reach $300 million&#8211;25% of that is spent in the animal pharmaceutical industry alone. The Food &#8230; <a href="http://www.pharmaceutical-news.org/canadian-pharmacy-news-success-rates-for-experimental-drugs-falls.html">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
				<content:encoded><![CDATA[<h3 style="text-align: justify;">Risks Associated with Veterinary Compounding Pharmacy Choices (AAEP 2010)</h3>
<p style="text-align: justify;">More than 12,000 compounding pharmacies operate in the United States, and each year compounded product sales reach $300 million&#8211;25% of that is spent in the animal pharmaceutical industry alone. The Food &amp; Drug Administration (FDA) has developed regulations to provide assurances for safety and efficacy of drugs and devices, to ensure food supply safety, and to regulate food chain supplies and animal foods; so how do these apply to compounding? At the 2010 American Association of Equine Practitioners (AAEP) Convention, held Dec. 4-8 in Baltimore, Md., Scott Stanley, PhD, professor of Equine Analytical Chemistry at the University of California, Davis, discussed FDA&#8217;s ongoing attempts to ensure safety of drugs produced by compounding pharmacies (that provide individualized medications ordered by prescribers which are unavailable through normal means).</p>
<p style="text-align: justify;">He described a study conducted by the FDA in which scientists analyzed 29 samples from 12 compounders. Stanley noted that 10 of the samples failed to meet the FDA standard for quality testing (which for potency is ±10% of the labeled concentration), yielding a 34% failure rate as compared to the typical 2% failure rate seen among the entire pharmaceutical industry in general. More than half of the failed samples contained less than 70% of the labeled potency.</p>
<p style="text-align: justify;">Equine practitioners must evaluate the integrity of compounding pharmacies as well as the quality and consistency of drugs produced. Stanley remarked than many practitioners express concerns about efficacy of products that different compounding pharmacies compound, noting that just because a pharmacy prepares a product doesn&#8217;t mean that it&#8217;s efficacious&#8211;what an owner might perceive as a legitimate, reliable source of medication might not always be. In addition, veterinarians must consider the quality (potency, purity, and stability) and consistency of drugs as well as their liabilities for using that particular product.</p>
<p style="text-align: justify;">Stanley explained that the FDA does not permit compounding, but rather uses &#8220;enforcement discretion,&#8221; meaning that if a product cannot be obtained to control a life-threatening disease process or to control suffering, then use of a compounded product is permitted.</p>
<p style="text-align: justify;">The Animal Medicinal Drug Use Clarification Act (AMDUCA) allows manufacturing, preparation, propagation, processing, and compounding of drugs as long as a product is not already commercially available. In addition, there must be a valid veterinarian-client-patient relationship to dispense these drugs. Three categories of drugs are available for use:<br />
FDA-approved &#8220;pioneer&#8221; drugs: These are studied through clinical trials that show efficacy, safety, and quality; it often costs $30 million to get a drug through the FDA-approval process;<br />
Generic drugs: These are subjected to an abbreviated process for verifying efficacy&#8211;companies must demonstrate that generics are the biologic and/or chemical equivalent of a drug and must meet label claims for that product; and<br />
Compounded drugs.</p>
<p style="text-align: justify;">Compounding a drug is a form of adulteration, according to Stanley, since it is any manipulation of a drug formulation to produce a dosing form different from label requirements. He said that pharmacies should not provide drugs that are commercially available or those slightly altered by flavoring or by small changes in drug strength.</p>
<p style="text-align: justify;">There is little external oversight; compounding pharmacies are mostly self-regulated. A compounded product cannot be called a generic equivalent and cannot be substituted for an available FDA-approved product. A compounder may reformulate an approved animal or human drug to change its delivery, as for example turning powder into paste, or if a formerly FDA-approved drug is no longer available. In addition, only a 72-hour supply should be kept on-hand at the pharmacy for dispensing. In every compounding case there must be a valid veterinarian-client-patient relationship. Label instructions include specific details on how it is to be used.</p>
<p style="text-align: justify;">Before choosing a compounding pharmacy, Stanley recommends researching information about the pharmacy, asking if it is accredited by the Pharmacy Compounding Accreditation Board (PAB), if the pharmacist has obtained appropriate training, and if the pharmacy has liability insurance. He also recommends finding out if the product you&#8217;re seeking is prepared using pharmaceutical or chemical (bulk) grade materials and where these were obtained.</p>
<p style="text-align: justify;">He noted red flags that are causes for concern, such as an overly long expiration date&#8211;by law the longest expiration date on a compounded product can only be six months. Other red flags include statements of sterility, marketing materials presenting the product as cheaper than an available FDA-approved product, or AVMA or pharmaceutical complaints that have been filed. Clients should be concerned about websites that advertise compounded drugs, particularly when medications are available without necessary prescriptions.</p>
<p style="text-align: justify;">Stanley described omeprazole as an example of compounding issues that arise. Two FDA-approved products (Gastrogard and Ulcergard) with demonstrated efficacy and stability are available. Any compounded formulation with omeprazole is currently considered pirated since Merial still owns the use patent. The pH of omeprazole is very sensitive&#8211;pH less than 7.8 results in rapid deterioration. Compounded pirated omeprazole products showed low pH values as well as dosing inconsistencies&#8211;only one of six products met FDA potency requirements upon arrival at the test lab. Similar findings occurred with non-steroidal anti-inflammatory medications: Levels were only 68% of label-claimed potency in injectable flunixin meglumine (Banamine) and 72% potency in powdered phenylbutazone (Bute).</p>
<p style="text-align: justify;">FDA regulations on medical devices are stringent&#8211;a medical device is defined as an external device that does not result in a chemical reaction within or on the body. There are several products FDA-approved as medical devices but used as drugs for intra-articular therapies; therefore, Stanley remarked that any injectable medical &#8220;device&#8221; is considered a drug. Should a practitioner choose to use a device as a pharmaceutical, he or she should be aware that these products have not been evaluated to determine their suitability for that usage by any regulatory agency.</p>
<p style="text-align: justify;">Stanley also stressed that a client cannot consent to substandard care (per legal standards for medical malpractice). Clients might not understand that just because a product is formulated and prepared for resale doesn&#8217;t mean it is therapeutic to achieve desired results. Stanley also emphasized the importance of client education, including counseling the client regarding potential adverse reactions and possible efficacy failure.</p>
<p style="text-align: justify;">He summed up the possibilities of what can go wrong in compounding:<br />
Inadequate oversight of quality assurance and control, resulting in formulation error or drug used in an improper application;<br />
Inadequate storage&#8211; If the potency is low (deteriorated) then the drug might not work (therapeutic failure). If the drug degrades into a toxic intermediate, the patient can become sick or die from it;<br />
Lack of product testing;<br />
Lack of recall procedures (if a product were to test as unsafe, sufficient structure might not exist to be able to recall the products, as there would be with an FDA-approved product);<br />
Inadequate processing facilities regarding cleanliness (resulting in a potentially contaminated product).Improper operation and maintenance of equipment; and<br />
Oversight by FDA and state pharmacy boards can be difficult/limited due to economic cutbacks.</p>
<p style="text-align: justify;">AAEP has now required PCAB accreditation of compounding pharmacies with exhibits at their annual convention trade show to meet a minimum standard.</p>
<h3 style="text-align: justify;">Bid to end duplicate drug research</h3>
<p style="text-align: justify;">A radical plan to end the &#8220;madness&#8221; of wasteful and pointless research by rival drug companies has been outlined.</p>
<p style="text-align: justify;">The new initiative will promote freer and faster early stage drug development through collaboration rather than competition.</p>
<p style="text-align: justify;">Central to the idea is banishing the secrecy tied to intellectual property that causes the same work to be duplicated even after it has led nowhere.</p>
<p style="text-align: justify;">On Wednesday around 30 academics, research funders and pharmaceutical industry representatives from around the world meet in Toronto, Canada, to hammer out plans for the new model.</p>
<p style="text-align: justify;">The objective is to launch a prototype scheme by the end of the year at an estimated annual cost of around £124 million.</p>
<p style="text-align: justify;">Neuroscientist Dr Chas Bountra, head of the Structural Genomics Consortium at Oxford University, who is organising the conference, believes the pharmaceutical industry is in crisis and branded wasteful research as &#8220;madness&#8221;.</p>
<p style="text-align: justify;">Speaking in London, he pointed out that under the present system different organisations can spend many years and enormous amounts of money chasing the same therapeutic targets.</p>
<p style="text-align: justify;">The work can continue even after results that are never shared show that it is futile and will never provide a useful outcome. More than 90% of the molecules investigated by drug companies fail at the Phase II trial stage, when their effectiveness is tested on patients, said Dr Bountra.</p>
<p style="text-align: justify;">The scheme, currently known as POC (Public/private partnership, Open innovation, Clinical consortium), would ensure that all pre-Phase II research results are publicly accessible.</p>
<p style="text-align: justify;">&#8220;What we will do is publish that data immediately and hopefully we&#8217;ll stop other organisations doing the same and repeating these studies with their own assets,&#8221; said Dr Bountra. &#8220;This will save resources and, importantly, prevent exposing patients to medicines that will fail.&#8221;</p>
<h3 style="text-align: justify;">Success rates for experimental drugs falls: study</h3>
<p style="text-align: justify;">The success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.</p>
<p style="text-align: justify;">And while oncology has been one of the hottest and most active therapeutic areas for drug development, drugmakers may want to take note of a finding that new cancer drugs have proven far more difficult to gain approval than medicines for infectious and autoimmune diseases.</p>
<p style="text-align: justify;">Drugmakers have been complaining about the difficulty of bringing new products to market in a regulatory climate that has become increasingly unpredictable and more likely to err on the side of safety in deciding risk/benefit ratios of experimental medicines.</p>
<p style="text-align: justify;">Data from this new study appears to bear that out.</p>
<p style="text-align: justify;">&#8220;It ain&#8217;t getting any easier to develop new therapies.&#8221; said Alan Eisenberg, head of emerging companies and business development for the biotech trade group Biotechnology Industry Organization (BIO), putting the findings succinctly.</p>
<p style="text-align: justify;">&#8220;Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing,&#8221; he said.</p>
<p style="text-align: justify;">The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.</p>
<p style="text-align: justify;">The study, conducted by BIO and BioMedTracker, which collects data on drugs in development, reviewed more than 4,000 drugs from companies large and small and both publicly traded and private. It was released in conjunction with the annual BioCEO and Investor conference in New York.</p>
<p style="text-align: justify;">Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.</p>
<p style="text-align: justify;">When broken down by therapeutic categories, the highest overall success rate from Phase 1 through likelihood of approval was infectious diseases, such as hepatitis and HIV drugs, at 12 percent, followed by endocrine system drugs, featuring diabetes treatments, at 10.4 percent, and autoimmune diseases, such as rheumatoid arthritis, at 9.4 percent, the study found.</p>
<p style="text-align: justify;">John Craighead, BIO&#8217;s managing director for investor relations, said clinical trial goals and the approval pathways for infectious diseases and diabetes drugs are clear and very well-established.</p>
<p style="text-align: justify;">&#8220;The Phase II results are very predictive of the Phase III outcomes and very predictive of approval,&#8221; he said.</p>
<p style="text-align: justify;">&#8220;The overall success rate in oncology was the lowest of the therapeutic areas that we looked at,&#8221; he said, noting that cancer studies vary dramatically in design and extending survival sets a high bar for approval.</p>
<p style="text-align: justify;">The cancer drug success rate was a mere 4.7 percent, with cardiovascular drugs second-worst at 5.7 percent, as regulators are increasingly demanding proof that heart drugs reduce heart attacks and strokes rather than just lower a risk factor, such as cholesterol levels.</p>
<p style="text-align: justify;">The largest dropout rate along the clinical pathway came in advancing drugs from mid-stage Phase II studies to late-stage Phase III testing.</p>
<p style="text-align: justify;">Some 63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.</p>
<p style="text-align: justify;">Not surprisingly, the numbers increase after that as the drugs had already shown success in the clinic.</p>
<p style="text-align: justify;">Approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval, although only about half were approved on their initial FDA review.</p>
<p style="text-align: justify;">The 80 percent approval rate, while seemingly high, is down from 93 percent seen in studies of earlier years.</p>
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